Advanced Melanoma, Unresectable Melanoma
Conditions
Brief summary
This is Phase II trial of nivolumab plus axitinib for patients with unresectable stage III or IV melanoma who have progressed on prior anti-PD1 therapy with or without concomitant anti-CTLA4 therapy. Patients will receive treatment with nivolumab 480 mg intravenously every 4 weeks and axitinib 5 mg twice daily by mouth. Patients may continue both agents for up to two years if they do not experience disease progression or dose-limiting toxicities.
Detailed description
This trial hypothesizes that decreasing hypoxia in the TME will re-sensitize melanoma tumors to anti-PD1 therapy. Axitinib has already been safely combined with anti-PD1 therapy and was overall well-tolerated. With nivolumab plus axitinib taken together, based on previously published work and data from our laboratories, it is hypothesized that axitinib can metabolically remodel the TME to render it more sensitive to ICB, specifically by reducing intra-tumoral hypoxia, increasing T cell infiltration, and increasing polyfunctional T cells. It will determined if treatment with nivolumab plus axitinib will prolong both progression-free and overall survival.
Interventions
DRUGNivolumab
Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of Immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer.
DRUGAxitinib
Axitinib (AG013736; trade name Inlyta) is a small molecule tyrosine kinase inhibitor.Its primary mechanism of action is thought to be vascular endothelial growth factor receptor 1-3, c-KIT and PDGFR inhibition, this, in turn, enables it to inhibit angiogenesis (the formation of new blood vessels by tumours)
Sponsors
Pfizer
Bristol-Myers Squibb
Yana Najjar
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have unresectable (stage III) or advanced (stage IV) cutaneous or mucosal melanoma. Patients with uveal melanoma are not eligible. * Progressed on prior anti-PD1 therapy with or without anti-CTLA4 therapy. Patients may have progressed in the adjuvant setting if treated within the last 6 months. Prior treatment with BRAF/MEK inhibitors permitted, however, not required. Progression must be radiographic, and progression of disease will be confirmed by a radiologist. Patients must have progressed during anti-PD-1 therapy, defined as unequivocal progression on or within 3 months of the last dose of anti-PD-1 therapy if treated in the metastatic setting, or within 6 months if treated in the adjuvant setting. * Have measurable disease based on RECIST 1.1. * Patients do not have to have biopsiable disease to be eligible. However, patients with biopsiable disease must undergo biopsy at study entry and at week 12. * Have a performance status of 0 or 1 on the ECOG Performance Scale. * Demonstrate adequate organ function, per protocol * Patients with brain metastases are permitted if they are asymptomatic or previously treated with CNS directed therapy with stable CNS disease for at least 2 weeks. Stable is defined as asymptomatic or not progressing on imaging. * Female patients of childbearing potential - negative pregnancy testing; use of birth control, surgically sterile or abstain from heterosexual activity during study and for 5 months after the last dose of study medication. * Male subjects - agree to use an adequate contraception starting with the first dose of study therapy through 7 months after the last dose of study therapy; abstinence acceptable
Exclusion criteria
* Prior history of Grade 3 or 4 immune-related adverse events or immune-related adverse events requiring discontinuation of prior therapies. * History of hypertensive crisis or hypertensive encephalopathy. * Significant thrombotic (e.g. deep vein thrombosis or pulmonary embolism) or hemorrhagic event within 6 months prior to enrollment. * History of prior immune-related adverse event due to an anti-PD1 or anti-CTLA4 that has not resolved to grade 1 on a steroid dose of prednisone 10 mg or less at the time of study entry (excluding vitiligo and endocrine toxicity). * Patients with prior myocarditis or other immune-mediated cardiac adverse events, prior Guillain-Barre syndrome, encephalitis, meningitis, or transverse myelitis, prior Stevens-Johnson syndrome or toxic epidermal necrolysis are excluded regardless of grade. * Poorly controlled hypertension defined as systolic blood pressure (SBP) \> 160 and/or diastolic blood pressure (DBP) \> 100 despite antihypertensives. If subject is above this goal, treatment with anti-hypertensives to achieve better blood pressure control is permitted. Ambulatory blood pressure assessment is permitted if there is concern for discrepant blood pressure readings while patients are in clinic. * Has Class III or IV heart failure based on the New York Heart Association. * Has had major surgery within 4 weeks of randomization. This does not include outpatient surgeries that do not require post-operative admission. * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (greater than the equivalent of prednisone 10 mg daily, unless for prior endocrine toxicity) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment (premedication with steroids for contrast imaging studies is permitted). * Has a known history of active TB (Bacillus Tuberculosis). * Hypersensitivity to nivolumab or axitinib, or any of their excipients. * Has had prior chemotherapy or targeted small molecule therapy within 1 week prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. * Has had radiation within 2 weeks of randomization. * Has current use or anticipated need for treatment with drugs or foods that are known strong cytochrome P450 (CYP34A4/5) inhibitors including but not limited to atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, and grapefruit or grapefruit juice. NOTE: The topical use of these medications, such as 2% ketoconazole cream is allowed. * Has current use or anticipated need for treatment with drugs known to be strong CYP3A4/5 inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St. John's wort. * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, in situ cervical cancer, in situ colon cancer, or nonmetastatic prostate cancer not on systemic therapy. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 2 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability. * Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. * Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis. * Has an active infection requiring systemic IV antibiotic therapy. * Has had any of the following within the past 6 months * Myocardial infarction or unstable angina * Ventricular arrythmia * Acute decompensated heart failure * Cerebrovascular accident * Hypertensive emergency requiring ICU admission * Presence of a disorder that may impact absorption of axitinib, such as inability to take oral medication, requirement for IV alimentation, prior gastric resection, treatment for active peptic ulcer confirmed by endoscopy within the past 3 months, active GI bleed, malabsorption syndrome. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 5 months after the last dose of trial treatment for females and 7 months after the last dose of trial treatment for males. * Has a known history of HIV (HIV 1/2 antibodies) if the CD4 count is less than 350 mm3 or serum HIV viral load is \< 25,000 IU/mL. * Has a known history of or is positive for hepatitis B (hepatitis B surface antigen \[HBsAg\] reactive) or hepatitis C (hepatitis C virus \[HCV\] RNA \[qualitative\] is detected). Note: Without known history, testing only needs to be performed if there is clinical suspicion for Hepatitis B or C. * Is currently incarcerated or otherwise detained. * Has received a live vaccine within 30 days of planned start of study therapy. (intranasal iNinfluenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed) Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | Up to 12 weeks from baseline (after treatment) | Percentage of patients who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| Overall Response Rate (ORR) - Prior Ipilimumab / Nivolumab Treatment | Up to 12 weeks from baseline (after treatment) | Percentage of patients (prior Ipilimumab/Nivolumab treatment) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| Overall Response Rate (ORR) - no Prior Ipilimumab / Nivolumab | Up to 12 weeks from baseline (after treatment) | Percentage of patients (no prior Ipilimumab/Nivolumab treatment) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| Overall Response Rate (ORR) - Prior Lines of Therapy <=3 | Up to 12 weeks from baseline (after treatment) | Percentage of patients (\<=3 prior lines of therapy) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| Overall Response Rate (ORR) - Prior Lines of Therapy >3 | Up to 12 weeks from baseline (after treatment) | Percentage of patients (\>3 prior lines of therapy) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| Overall Response Rate (ORR) by iRECIST | Up to 12 weeks from baseline (after treatment) | Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per iRECIST. (CR): disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 mm. (PR): at least 30% decrease in sum of diameters of target lesions, with reference the baseline sum diameters. Can have had iUPD (one or more instances), but not iCPD, before iCR, iPR, or iSD |
| Overall Response Rate (ORR) - Primary IO Resistance | Up to 12 weeks from baseline (after treatment) | Percentage of patients (with primary IO resistance) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| Overall Response Rate (ORR) - Secondary IO Resistance | Up to 12 weeks from baseline (after treatment) | Percentage of patients (with secondary IO resistance) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| Overall Response Rate (ORR) - Acral Histology | Up to 12 weeks from baseline (after treatment) | Percentage of patients (acral histology) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| Overall Response Rate (ORR) - Cutaneous Histology | Up to 12 weeks from baseline (after treatment) | Percentage of patients (with cutaneous histology) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| Overall Response Rate (ORR) - Mucosal Histology | Up to 12 weeks from baseline (after treatment) | Percentage of patients (with mucosal histology) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| Disease Control Rate (DCR) | Up to 12 weeks from baseline (after treatment) | Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. |
| Disease Control Rate (DCR) - no Prior Ipilimumab / Nivolumab Treatment | Up to 12 weeks from baseline (after treatment) | Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. |
| Disease Control Rate (DCR) - Prior Ipilimumab / Nivolumab Treatment | Up to 12 weeks from baseline (after treatment) | Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. |
| Disease Control Rate (DCR) - Prior Lines of Therapy <=3 | Up to 12 weeks from baseline (after treatment) | Percentage of patients (\<=3 prior lines of therapy) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. |
| Disease Control Rate (DCR) - Prior Lines of Therapy >3 | Up to 12 weeks from baseline (after treatment) | Percentage of patients (\>3 prior lines of therapy) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. |
| Disease Control Rate (DCR) by iRECIST | Up to 12 weeks from baseline (after treatment) | Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per iRECIST. (CR): disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 mm. (PR): at least 30% decrease in sum of diameters of target lesions, with reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference the smallest sum diameters while on study. Can have had iUPD (one or more instances), but not iCPD, before iCR, iPR, or iSD |
| Disease Control Rate (DCR) - Secondary IO Resistance | Up to 12 weeks from baseline (after treatment) | Percentage of patients (with secondary IO resistance) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. |
| Disease Control Rate (DCR) - Primary IO Resistance | Up to 12 weeks from baseline (after treatment) | Percentage of patients (with primary IO resistance) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. |
| Disease Control Rate (DCR) - Acral Histology | Up to 12 weeks from baseline (after treatment) | Percentage of patients (with acral histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. |
| Disease Control Rate (DCR) - Cutaneous Histology | Up to 12 weeks from baseline (after treatment) | Percentage of patients (with cutaneous histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. |
| Disease Control Rate (DCR) - Mucosal Histology | Up to 12 weeks from baseline (after treatment) | Percentage of patients (with mucosal histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. |
| Best Response | Up to 12 weeks from baseline (after treatment) | Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression). |
| Best Response - no Prior Ipilimumab / Nivolumab | Up to 12 weeks from baseline (after treatment) | Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression). |
| Best Response - Prior Ipilimumab / Nivolumab Treatment | Up to 12 weeks from baseline (after treatment) | Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression). |
| Best Response - Acral Histology | Up to 12 weeks from baseline (after treatment) | Percentage of patients (with acral histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression). |
| Best Response - Cutaneous Histology | Up to 12 weeks from baseline (after treatment) | Percentage of patients (with cutaneous histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression |
| Best Response - Mucosal Histology | Up to 12 weeks from baseline (after treatment) | Percentage of patients (with mucosal histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression |
| Best Response - Prior Lines of Therapy <=3 | Up to 12 weeks from baseline (after treatment) | Percentage of patients (\<=3 prior lines of therapy) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression). |
| Best Response - Prior Lines of Therapy >3 | Up to 12 weeks from baseline (after treatment) | Percentage of patients (\>3 prior lines of therapy) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression). |
| Best Response by iRECIST | Up to 12 weeks from baseline (after treatment) | Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per iRECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Can have had iUPD (one or more instances), but not iCPD, before iCR, iPR, or iSD |
| Best Response - Primary IO Resistance | Up to 12 weeks from baseline (after treatment) | Percentage of patients (w/ primary IO resistance) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progres |
| Best Response - Secondary IO Resistance | Up to 12 weeks from baseline (after treatment) | Percentage of patients (w/ secondary IO resistance) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progres |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6-month Overall Survival (OS) - Primary IO Resistance | Up to 6 months | Percentage of patients (Primary IO resistance) alive from the start of treatment that patients remain alive, until death from any cause up to 6 months. |
| 12-month Overall Survival (OS) - Primary IO Resistance | Up to 12 months | Percentage of patients (Primary IO resistance) alive from the start of treatment that patients remain alive, until death from any cause up to 12 months. |
| 24-month Overall Survival (OS) - Primary IO Resistance | Up to 24 months | Percentage of patients (Primary IO resistance) alive from the start of treatment that patients remain alive, until death from any cause up to 24 months. |
| Overall Survival (OS) - Overall Cohort - Secondary IO Resistance | Up to 45 months | The median number of months from the start of treatment that patients with Secondary IO resistance remain alive, until death from any cause. |
| 6-month Overall Survival (OS) - Secondary IO Resistance | Up to 6 months | Percentage of patients with Secondary IO resistance alive from the start of treatment that patients remain alive, until death from any cause up to 6 months. |
| 12-month Overall Survival (OS) - Secondary IO Resistance | Up to 12 months | Percentage of patients with Secondary IO resistance alive from the start of treatment that patients remain alive, until death from any cause up to 12 months. |
| 24-month Overall Survival (OS) - Secondary IO Resistance | Up to 24 months | Percentage of patients with Secondary IO resistance alive from the start of treatment that patients remain alive, until death from any cause up to 24 months. |
| Progression-free Survival (PFS) - Overall Cohort | Up to 4 years and 3 months | The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 6-month Progression-free Survival (PFS) | Up to 6 months | The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 12-month Progression-free Survival (PFS) | Up to 12 months | The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 24-month Progression-free Survival (PFS) | Up to 24 months | The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| Progression-free Survival (PFS) - Prior Ipilimumab / Nivolumab Treatment | Up to 4 years and 3 months | The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 6-month Progression-free Survival (PFS) - Prior Ipilimumab / Nivolumab Treatment | Up to 6 months | The percentage of patients (previously treated with Ipilimumab/Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 12-month Progression-free Survival (PFS) - Prior Ipilimumab / Nivolumab Treatment | Up to 12 months | The percentage of patients (previously treated with Ipilimumab / Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 24-month Progression-free Survival (PFS) - Prior Ipilimumab / Nivolumab Treatment | Up to 24 months | The percentage of patients (previously treated with Ipilimumab/Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| Progression-free Survival (PFS) - no Prior Ipilimumab /Nivolumab Treatment | Up to 4 years and 3 months | The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 6-month Progression-free Survival (PFS) - no Prior Ipilimumab/Nivolumab Treatment | Up to 6 months | The percentage of patients (not previously treated with Ipilimumab /Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 12-month Progression-free Survival (PFS) - no Prior Ipilimumab / Nivolumab Treatment | Up to 12 months | The percentage of patients (not previously treated with Ipilimumab /Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 24-month Progression-free Survival (PFS) - no Prior Ipilimumab /Nivolumab Treatment | Up to 24 months | The percentage of patients (not previously treated with Ipilimumab /Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| Progression-free Survival (PFS) - Overall Cohort - Mucosal Histology | Up to 4 years and 3 months | The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. in patients with mucosal histology. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 6-month Progression-free Survival (PFS) - Mucosal Histology | Up to 6 months | The percentage of patients (with mucosal histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 12-month Progression-free Survival (PFS) - Mucosal Histology | Up to 12 months | The percentage of patients (with mucosal histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 24-month Progression-free Survival (PFS) - Mucosal Histology | Up to 24 months | The percentage of patients (with mucosal histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| Progression-free Survival (PFS) - Overall Cohort - Cutaneous Histology | Up to 4 years and 3 months | The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. in patients with mucosal histology. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 6-month Progression-free Survival (PFS) - Cutaneous Histology | Up to 6 months | The percentage of patients (with cutaneous histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 12-month Progression-free Survival (PFS) - Cutaneous Histology | Up to 12 months | The percentage of patients (with cutaneous histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 24-month Progression-free Survival (PFS) - Cutaneous Histology | Up to 24 months | The percentage of patients (with cutaneous histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| Progression-free Survival (PFS) - Overall Cohort - Acral Histology | Up to 4 years and 3 months | The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. in patients with mucosal histology. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 6-month Progression-free Survival (PFS) - Acral Histology | Up to 6 months | The percentage of patients (with acral histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 12-month Progression-free Survival (PFS) - Acral Histology | Up to 12 months | The percentage of patients (with acral histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 24-month Progression-free Survival (PFS) - Acral Histology | Up to 24 months | The percentage of patients (with acral histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| Progression-free Survival (PFS) - Overall Cohort - Prior Lines <= 3 | Up to 4 years and 3 months | The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. in patients with mucosal histology. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 6-month Progression-free Survival (PFS) - Prior Lines <= 3 | Up to 6 months | The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 12-month Progression-free Survival (PFS) - Prior Lines <= 3 | Up to 12 months | The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 24-month Progression-free Survival (PFS) - Prior Lines <= 3 | Up to 24 months | The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| Progression-free Survival (PFS) - Overall Cohort - Prior Lines >3 | Up to 4 years and 3 months | The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. in patients with mucosal histology. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 6-month Progression-free Survival (PFS) - Prior Lines > 3 | Up to 6 months | The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 12-month Progression-free Survival (PFS) - Prior Lines > 3 | Up to 12 months | The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 24-month Progression-free Survival (PFS) - Prior Lines > 3 | Up to 24 months | The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| Duration of Response (DoR) - Overall Cohort | Up to 4 years and 3 months | Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| 6-month Duration of Response (DoR) - Overall Cohort | Up to 6 months | Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| 12-month Duration of Response (DoR) - Overall Cohort | Up to 12 months | Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| 24-month Duration of Response (DoR) - Overall Cohort | Up to 24 months | Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| Duration of Response (DoR) - Prior Ipilimumab / Nivolumab Treatment | Up to 4 years and 3 months | Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| 6-month Duration of Response (DoR) - Prior Ipilimumab / Nivolumab Treatment | Up to 6 months | Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| 12-month Duration of Response (DoR) - Prior Ipilimumab / Nivolumab Treatment | Up to 12 months | Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| 24-month Duration of Response (DoR) - Prior Ipilimumab / Nivolumab Treatment | Up to 24 months | Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| Duration of Response (DoR) - no Prior Ipilimumab / Nivolumab Treatment | Up to 4 years and 3 months | Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| 6-month Duration of Response (DoR) - no Prior Ipilimumab / Nivolumab Treatment | Up to 6 months | Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| 12-month Duration of Response (DoR) - no Prior Ipilimumab / Nivolumab Treatment | Up to 12 months | Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| 24-month Duration of Response (DoR) - no Prior Ipilimumab / Nivolumab Treatment | Up to 24 months | Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| Duration of Response (DoR) - Acral Histology | Up to 4 years and 3 months | Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| 6-month Duration of Response (DoR) - Acral Histology | Up to 6 months | Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| 12-month Duration of Response (DoR) - Acral Histology | Up to 12 months | Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| 24-month Duration of Response (DoR) - Acral Histology | Up to 24 months | Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| Duration of Response (DoR) - Mucosal Histology | Up to 4 years and 3 months | Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| 6-month Duration of Response (DoR) - Mucosal Histology | Up to 6 months | Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| 12-month Duration of Response (DoR) - Mucosal Histology | Up to 12 months | Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| 24-month Duration of Response (DoR) - Mucosal Histology | Up to 24 months | Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| Duration of Response (DoR) - Cutaneous Histology | Up to 4 years and 3 months | Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| 6-month Duration of Response (DoR) - Cutaneous Histology | Up to 6 months | Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| 12-month Duration of Response (DoR) - Cutaneous Histology | Up to 12 months | Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| 24-month Duration of Response (DoR) - Cutaneous Histology | Up to 24 months | Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| Duration of Disease Control (DoDC) - Overall Cohort | Up to 4 years and 3 months | Median number of months from the date of first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 6-month Duration of Disease Control (DoDC) - Overall Cohort | Up to 6 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 12-month Duration of Disease Control (DoDC) - Overall Cohort | Up to 12 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 24-month Duration of Disease Control (DoDC) - Overall Cohort | Up to 24 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| Duration of Disease Control (DoDC) - Prior Ipilimumab / Nivolumab Treatment | Up to 4 years and 3 months | Median number of months from the date of first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 6-month Duration of Disease Control (DoDC) - Prior Ipilimumab / Nivolumab Treatment | Up to 6 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 12-month Duration of Disease Control (DoDC) - Prior Ipilimumab / Nivolumab Treatment | Up to 12 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 24-month Duration of Disease Control (DoDC) - Prior Ipilimumab / Nivolumab Treatment | Up to 24 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| Duration of Disease Control (DoDC) - no Prior Ipilimumab / Nivolumab Treatment | Up to 4 years and 3 months | Median number of months from the date of first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 6-month Duration of Disease Control (DoDC) - no Prior Ipilimumab / Nivolumab Treatment | Up to 6 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| Overall Survival (OS) - Overall Cohort | Up to 45 months | The median number of months from the start of treatment that patients remain alive, until death from any cause. |
| 24-month Duration of Disease Control (DoDC) - no Prior Ipilimumab / Nivolumab Treatment | Up to 24 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| Duration of Disease Control (DoDC) - Acral Histology | Up to 4 years and 3 months | Median number of months from the date of first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 6-month Duration of Disease Control (DoDC) - Acral Histology | Up to 6 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 12-month Duration of Disease Control (DoDC) - Acral Histology | Up to 12 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 24-month Duration of Disease Control (DoDC) - Acral Histology | Up to 24 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| Duration of Disease Control (DoDC) - Mucosal Histology | Up to 4 years and 3 months | Median number of months from the date of first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 6-month Duration of Disease Control (DoDC) - Mucosal Histology | Up to 6 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 12-month Duration of Disease Control (DoDC) - Mucosal Histology | Up to 12 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 24-month Duration of Disease Control (DoDC) - Mucosal Histology | Up to 24 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| Duration of Disease Control (DoDC) - Cutaneous Histology | Up to 4 years and 3 months | Median number of months from the date of first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 6-month Duration of Disease Control (DoDC) - Cutaneous Histology | Up to 6 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 12-month Duration of Disease Control (DoDC) - Cutaneous Histology | Up to 12 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 24-month Duration of Disease Control (DoDC) - Cutaneous Histology | Up to 24 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| Duration of Disease Control (DoDC) - Prior Lines > 3 | Up to 4 years and 3 months | Median number of months from the date of first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 6-month Duration of Disease Control (DoDC) - Prior Lines > 3 | Up to 6 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 12-month Duration of Disease Control (DoDC) - Prior Lines > 3 | Up to 12 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 24-month Duration of Disease Control (DoDC) - Prior Lines > 3 | Up to 24 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| Duration of Disease Control (DoDC) - Prior Lines <= 3 | Up to 4 years and 3 months | Median number of months from the date of first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 6-month Duration of Disease Control (DoDC) - Prior Lines <= 3 | Up to 6 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 12-month Duration of Disease Control (DoDC) - Prior Lines <= 3 | Up to 12 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 24-month Duration of Disease Control (DoDC) - Prior Lines <= 3 | Up to 24 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| Duration of Disease Control (DoDC) - Overall Cohort - Primary IO Resistance | Up to 4 years and 3 months | Median number of months from the date of first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 6-month Duration of Disease Control (DoDC) - Primary IO Resistance | Up to 6 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 12-month Duration of Disease Control (DoDC) - Primary IO Resistance | Up to 12 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 24-month Duration of Disease Control (DoDC) - Primary IO Resistance | Up to 24 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| Duration of Disease Control (DoDC) - Overall Cohort - Secondary IO Resistance | Up to 4 years and 3 months | Median number of months from the date of first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 6-month Duration of Disease Control (DoDC) - Secondary IO Resistance | Up to 6 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 12-month Duration of Disease Control (DoDC) - Secondary IO Resistance | Up to 12 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 24-month Duration of Disease Control (DoDC) - Secondary IO Resistance | Up to 24 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| Grade 3 or Greater Adverse Events Possibly, Probably or Definitely Related to Study Treatment | Up to 28 days after discontinuation of study treatment (up to 24 months) | Adverse Events determined to be possibly, probably or definitely related to study treatment SAEs are defined as grade 3 and higher toxicity events that are attributable to the study combination therapy. Evaluated by NCI Common Terminology for Adverse Events (CTCAE v5.0). |
| 12-month Duration of Disease Control (DoDC) - no Prior Ipilimumab / Nivolumab Treatment | Up to 12 months | Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions |
| 6-month Overall Survival (OS) | Up to12 months | Percentage of patients alive from the start of treatment that patients remain alive, until death from any cause up to 6 months. |
| 12-month Overall Survival (OS) | Up to 12 months | Percentage of patients alive from the start of treatment that patients remain alive, until death from any cause up to 12 months. |
| 24-month Overall Survival (OS) | Up to 24 months | Percentage of patients alive from the start of treatment that patients remain alive, until death from any cause up to 24 months. |
| Overall Survival (OS) - Prior Ipilimumab/Nivolumab Treatment | Up to 45 months | The median number of months from the start of treatment that patients (who received prior Ipilimumab/Nivolumab treatment) remained alive, until death from any cause. |
| 6-month Overall Survival (OS) - Prior Ipilimumab /Nivolumab Treatment | Up to 6 months | Percentage of patients (previously treated with Ipilimumab/Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 6 months. |
| 12-month Overall Survival (OS) - Prior Ipilimumab / Nivolumab Treatment | Up to 12 months | Percentage of patients (previously treated with Ipilimumab/Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 12 months. |
| 24-month Overall Survival (OS) - Prior Ipilimumab / Nivolumab Treatment | Up to 24 months | Percentage of patients (previously treated with Ipilimumab/Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 24 months. |
| Overall Survival (OS) - no Prior Ipilimumab / Nivolumab Treatment | Up to 45 months | The median number of months from the start of treatment that patients (who did not receive prior Ipilimumab /Nivolumab treatment) remained alive, until death from any cause. |
| 6-month Overall Survival (OS) - no Prior Ipilimumab /Nivolumab Treatment | Up to 6 months | Percentage of patients (not previously treated with Ipilimumab /Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 6 months. |
| 12-month Overall Survival (OS) - no Prior Ipilimumab /Nivolumab Treatment | Up to 12 months | Percentage of patients (not previously treated with Ipilimumab /Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 12 months. |
| 24-month Overall Survival (OS) - no Prior Ipilimumab /Nivolumab Treatment | Up to 24 months | Percentage of patients (not previously treated with Ipilimumab/Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 24 months. |
| Overall Survival (OS) - Acral Histology | Up to 45 months | The median number of months from the start of treatment that patients (with acral histology) remain alive, until death from any cause in patients with acral melanoma histology. |
| 6-month Overall Survival (OS) - Acral Histology | Up to 6 months | Percentage of patients with acral melanoma histology that remain alive up to 6 months from start of treatment until death from any cause. |
| 12-month Overall Survival (OS) - Acral Histology | Up to 12 months | Percentage of patients with acral melanoma histology that remain alive up to 12 months from start of treatment until death from any cause. |
| 24-month Overall Survival (OS) - Acral Histology | Up to 24 months | Percentage of patients with acral melanoma histology that remain alive up to 24 months from start of treatment until death from any cause. |
| Overall Survival (OS) - Mucosal Histology | Up to 45 months | The median number of months from the start of treatment that patients remain alive, until death from any cause in patients with mucosal histology. |
| 6-month Overall Survival (OS) - Mucosal Histology | Up to 6 months | Percentage of patients with mucosal melanoma histology that remain alive up to 6 months from start of treatment until death from any cause. |
| 12-month Overall Survival (OS) - Mucosal Histology | Up to 12 months | Percentage of patients with mucosal melanoma histology that remain alive up to 12 months from start of treatment until death from any cause. |
| 24-month Overall Survival (OS) - Mucosal Histology | Up to 24 months | Percentage of patients with mucosal melanoma histology that remain alive up to 24 months from start of treatment until death from any cause. |
| Overall Survival (OS) - Cutaneous Histology | Up to 45 months | The median number of months from the start of treatment that patients remain alive, until death from any cause in patients with cutaneous melanoma histology. |
| 6-month Overall Survival (OS) - Cutaneous Histology | Up to 6 months | Percentage of patients with cutaneous melanoma histology that remain alive up to 6 months from start of treatment until death from any cause. |
| 12-month Overall Survival (OS) - Cutaneous Histology | Up to 12 months | Percentage of patients with cutaneous melanoma histology that remain alive up to 12 months from start of treatment until death from any cause. |
| 24-month Overall Survival (OS) - Cutaneous Histology | Up to 24 months | Percentage of patients with cutaneous melanoma histology that remain alive up to 24 months from start of treatment until death from any cause. |
| Overall Survival (OS) - Prior Lines of Therapy >3 | Up to 45 months | The median number of months from the start of treatment that patients with greater than 3 prior lines of treatment remain alive, until death from any cause. |
| 6-month Overall Survival (OS) - Prior Lines of Therapy >3 | Up to 6 months | Percentage of patients (who received \> 3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 6 months. |
| 12-month Overall Survival (OS) - Prior Lines of Therapy >3 | Up to 12 months | Percentage of patients (who received \> 3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 12 months. |
| 24-month Overall Survival (OS) - Prior Lines of Therapy >3 | Up to 24 months | Percentage of patients (who received \> 3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 24 months. |
| Overall Survival (OS) - Prior Lines of Therapy <=3 | Up to 45 months | The median number of months from the start of treatment that patients who received 3 or less prior lines of treatment remain alive, until death from any cause. |
| 6-month Overall Survival (OS) - Prior Lines of Therapy <=3 | Up to 6 months | Percentage of patients (who received \<=3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 6 months. |
| 12-month Overall Survival (OS) - Prior Lines of Therapy <=3 | Up to 12 months | Percentage of patients (who received \<=3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 12 months. |
| 24-month Overall Survival (OS) - Prior Lines of Therapy <=3 | Up to 24 months | Percentage of patients (who received \<=3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 24 months. |
| Overall Survival (OS) - Overall Cohort - Primary IO Resistance | Up to 45 months | The median number of months from the start of treatment that patients with Primary IO resistance remain alive, until death from any cause. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nivolumab Plus Axitinib Nivolumab 480mg, IV, every 4 weeks, for up to two years.
Axitinib 5mg, PO, BID, for up to two years. | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | Nivolumab Plus Axitinib |
|---|---|
| Age, Continuous | 67.2903 years STANDARD_DEVIATION 12.8924 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 29 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 26 / 31 |
| other Total, other adverse events | 31 / 31 |
| serious Total, serious adverse events | 15 / 31 |
Outcome results
Primary
Best Response
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients who were evaluable for radiologic response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab Plus Axitinib | Best Response | Partial Response | 10 percentage of patients |
| Nivolumab Plus Axitinib | Best Response | Stable Disease | 35 percentage of patients |
| Nivolumab Plus Axitinib | Best Response | Progressive Disease | 55 percentage of patients |
Primary
Best Response - Acral Histology
Percentage of patients (with acral histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients with acral histology who were evaluable for radiologic response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab Plus Axitinib | Best Response - Acral Histology | Partial Response | 14.3 percentage of patients |
| Nivolumab Plus Axitinib | Best Response - Acral Histology | Stable Disease | 57.1 percentage of patients |
| Nivolumab Plus Axitinib | Best Response - Acral Histology | Progressive Disease | 28.6 percentage of patients |
Primary
Best Response by iRECIST
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per iRECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Can have had iUPD (one or more instances), but not iCPD, before iCR, iPR, or iSD
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients who were evaluable for radiologic response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab Plus Axitinib | Best Response by iRECIST | iCPD/iUPD | 60 percentage of patients |
| Nivolumab Plus Axitinib | Best Response by iRECIST | iSD | 40 percentage of patients |
Primary
Best Response - Cutaneous Histology
Percentage of patients (with cutaneous histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients with cutaneous histology who were evaluable for radiologic response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab Plus Axitinib | Best Response - Cutaneous Histology | Partial Response | 5.9 percentage of patients |
| Nivolumab Plus Axitinib | Best Response - Cutaneous Histology | Stable Disease | 29.4 percentage of patients |
| Nivolumab Plus Axitinib | Best Response - Cutaneous Histology | Progressive Disease | 64.7 percentage of patients |
Primary
Best Response - Mucosal Histology
Percentage of patients (with mucosal histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients with mucosal histology who were evaluable for radiologic response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab Plus Axitinib | Best Response - Mucosal Histology | Partial Response | 14.3 percentage of patients |
| Nivolumab Plus Axitinib | Best Response - Mucosal Histology | Stable Disease | 28.6 percentage of patients |
| Nivolumab Plus Axitinib | Best Response - Mucosal Histology | Progressive Disease | 57.1 percentage of patients |
Primary
Best Response - no Prior Ipilimumab / Nivolumab
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients who were not previously treated with Ipilimumab /Nivolumab and were evaluable for radiologic response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab Plus Axitinib | Best Response - no Prior Ipilimumab / Nivolumab | Partial Response | 13.3 percentage of patients |
| Nivolumab Plus Axitinib | Best Response - no Prior Ipilimumab / Nivolumab | Stable Disease | 20.0 percentage of patients |
| Nivolumab Plus Axitinib | Best Response - no Prior Ipilimumab / Nivolumab | Progressive Disease | 66.7 percentage of patients |
Primary
Best Response - Primary IO Resistance
Percentage of patients (w/ primary IO resistance) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progres
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients with primary IO resistance who were evaluable for radiologic response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab Plus Axitinib | Best Response - Primary IO Resistance | Partial Response | 0.0 percentage of patients |
| Nivolumab Plus Axitinib | Best Response - Primary IO Resistance | Stable Disease | 53.3 percentage of patients |
| Nivolumab Plus Axitinib | Best Response - Primary IO Resistance | Progressive Disease | 46.7 percentage of patients |
Primary
Best Response - Prior Ipilimumab / Nivolumab Treatment
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients who were previously treated with Ipilimumab/Nivolumab and were evaluable for radiologic response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab Plus Axitinib | Best Response - Prior Ipilimumab / Nivolumab Treatment | Partial Response | 6.3 percentage of patients |
| Nivolumab Plus Axitinib | Best Response - Prior Ipilimumab / Nivolumab Treatment | Stable Disease | 50.0 percentage of patients |
| Nivolumab Plus Axitinib | Best Response - Prior Ipilimumab / Nivolumab Treatment | Progressive Disease | 43.8 percentage of patients |
Primary
Best Response - Prior Lines of Therapy <=3
Percentage of patients (\<=3 prior lines of therapy) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients who received \<=3 prior lines of therapy and were evaluable for radiologic response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab Plus Axitinib | Best Response - Prior Lines of Therapy <=3 | Partial Response | 15.0 percentage of patients |
| Nivolumab Plus Axitinib | Best Response - Prior Lines of Therapy <=3 | Stable Disease | 35.0 percentage of patients |
| Nivolumab Plus Axitinib | Best Response - Prior Lines of Therapy <=3 | Progressive Disease | 50.0 percentage of patients |
Primary
Best Response - Prior Lines of Therapy >3
Percentage of patients (\>3 prior lines of therapy) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients who received \<=3 prior lines of therapy and were evaluable for radiologic response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab Plus Axitinib | Best Response - Prior Lines of Therapy >3 | Partial Response | 0 percentage of patients |
| Nivolumab Plus Axitinib | Best Response - Prior Lines of Therapy >3 | Stable Disease | 36.4 percentage of patients |
| Nivolumab Plus Axitinib | Best Response - Prior Lines of Therapy >3 | Progressive Disease | 63.6 percentage of patients |
Primary
Best Response - Secondary IO Resistance
Percentage of patients (w/ secondary IO resistance) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progres
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients with secondary IO resistance who were evaluable for radiologic response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab Plus Axitinib | Best Response - Secondary IO Resistance | Partial Response | 18.8 percentage of patients |
| Nivolumab Plus Axitinib | Best Response - Secondary IO Resistance | Stable Disease | 18.8 percentage of patients |
| Nivolumab Plus Axitinib | Best Response - Secondary IO Resistance | Progressive Disease | 62.5 percentage of patients |
Primary
Disease Control Rate (DCR)
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | Disease Control Rate (DCR) | 45.2 percentage of patients |
Primary
Disease Control Rate (DCR) - Acral Histology
Percentage of patients (with acral histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients with acral histology who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | Disease Control Rate (DCR) - Acral Histology | 71.4 percentage of patients |
Primary
Disease Control Rate (DCR) by iRECIST
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per iRECIST. (CR): disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 mm. (PR): at least 30% decrease in sum of diameters of target lesions, with reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference the smallest sum diameters while on study. Can have had iUPD (one or more instances), but not iCPD, before iCR, iPR, or iSD
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | Disease Control Rate (DCR) by iRECIST | 40.0 percentage of patients |
Primary
Disease Control Rate (DCR) - Cutaneous Histology
Percentage of patients (with cutaneous histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients with cutaneous histology who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | Disease Control Rate (DCR) - Cutaneous Histology | 35.3 percentage of patients |
Primary
Disease Control Rate (DCR) - Mucosal Histology
Percentage of patients (with mucosal histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients with mucosal histology who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | Disease Control Rate (DCR) - Mucosal Histology | 42.9 percentage of patients |
Primary
Disease Control Rate (DCR) - no Prior Ipilimumab / Nivolumab Treatment
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients who were not previously treated with Ipilimumab /Nivolumab and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | Disease Control Rate (DCR) - no Prior Ipilimumab / Nivolumab Treatment | 33.3 percentage of patients |
Primary
Disease Control Rate (DCR) - Primary IO Resistance
Percentage of patients (with primary IO resistance) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients with primary IO resistance who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | Disease Control Rate (DCR) - Primary IO Resistance | 53.3 percentage of patients |
Primary
Disease Control Rate (DCR) - Prior Ipilimumab / Nivolumab Treatment
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients who were previously treated with Ipilimumab /Nivolumab and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | Disease Control Rate (DCR) - Prior Ipilimumab / Nivolumab Treatment | 56.3 percentage of patients |
Primary
Disease Control Rate (DCR) - Prior Lines of Therapy <=3
Percentage of patients (\<=3 prior lines of therapy) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients who received\<=3 prior lines of therapy and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | Disease Control Rate (DCR) - Prior Lines of Therapy <=3 | 50 percentage of patients |
Primary
Disease Control Rate (DCR) - Prior Lines of Therapy >3
Percentage of patients (\>3 prior lines of therapy) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients who received \>3 prior lines of therapy and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | Disease Control Rate (DCR) - Prior Lines of Therapy >3 | 36.4 percentage of patients |
Primary
Disease Control Rate (DCR) - Secondary IO Resistance
Percentage of patients (with secondary IO resistance) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients with secondary IO resistance who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | Disease Control Rate (DCR) - Secondary IO Resistance | 37.5 percentage of patients |
Primary
Overall Response Rate (ORR)
Percentage of patients who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | Overall Response Rate (ORR) | 10 percentage of patients |
Primary
Overall Response Rate (ORR) - Acral Histology
Percentage of patients (acral histology) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients with acral histology who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | Overall Response Rate (ORR) - Acral Histology | 14.3 percentage of patients |
Primary
Overall Response Rate (ORR) by iRECIST
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per iRECIST. (CR): disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 mm. (PR): at least 30% decrease in sum of diameters of target lesions, with reference the baseline sum diameters. Can have had iUPD (one or more instances), but not iCPD, before iCR, iPR, or iSD
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | Overall Response Rate (ORR) by iRECIST | 0 percentage of patients |
Primary
Overall Response Rate (ORR) - Cutaneous Histology
Percentage of patients (with cutaneous histology) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients with cutaneous histology who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | Overall Response Rate (ORR) - Cutaneous Histology | 5.9 percentage of patients |
Primary
Overall Response Rate (ORR) - Mucosal Histology
Percentage of patients (with mucosal histology) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients with mucosal histology who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | Overall Response Rate (ORR) - Mucosal Histology | 14.3 percentage of patients |
Primary
Overall Response Rate (ORR) - no Prior Ipilimumab / Nivolumab
Percentage of patients (no prior Ipilimumab/Nivolumab treatment) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients who were not previously treated with Ipilimumab/Nivolumab and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | Overall Response Rate (ORR) - no Prior Ipilimumab / Nivolumab | 13.3 percentage of patients |
Primary
Overall Response Rate (ORR) - Primary IO Resistance
Percentage of patients (with primary IO resistance) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | Overall Response Rate (ORR) - Primary IO Resistance | 0 percentage of patients |
Primary
Overall Response Rate (ORR) - Prior Ipilimumab / Nivolumab Treatment
Percentage of patients (prior Ipilimumab/Nivolumab treatment) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients who were previously treated with Ipilimumab/Nivolumab and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | Overall Response Rate (ORR) - Prior Ipilimumab / Nivolumab Treatment | 6.3 percentage of patients |
Primary
Overall Response Rate (ORR) - Prior Lines of Therapy <=3
Percentage of patients (\<=3 prior lines of therapy) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients who received \<=3 prior lines of therapy and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | Overall Response Rate (ORR) - Prior Lines of Therapy <=3 | 15 percentage of patients |
Primary
Overall Response Rate (ORR) - Prior Lines of Therapy >3
Percentage of patients (\>3 prior lines of therapy) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients who received \>3 prior lines of therapy were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | Overall Response Rate (ORR) - Prior Lines of Therapy >3 | 0 percentage of patients |
Primary
Overall Response Rate (ORR) - Secondary IO Resistance
Percentage of patients (with secondary IO resistance) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 12 weeks from baseline (after treatment)
Population: Treated patients who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | Overall Response Rate (ORR) - Secondary IO Resistance | 18.8 percentage of patients |
Secondary
12-month Duration of Disease Control (DoDC) - Acral Histology
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 12 months
Population: Treated patients with acral histology who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Duration of Disease Control (DoDC) - Acral Histology | 0 percentage of patients |
Secondary
12-month Duration of Disease Control (DoDC) - Cutaneous Histology
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 12 months
Population: Treated patients with cutaneous histology who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Duration of Disease Control (DoDC) - Cutaneous Histology | 33 percentage of patients |
Secondary
12-month Duration of Disease Control (DoDC) - Mucosal Histology
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 12 months
Population: Treated patients with mucosal histology who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Duration of Disease Control (DoDC) - Mucosal Histology | 0 percentage of patients |
Secondary
12-month Duration of Disease Control (DoDC) - no Prior Ipilimumab / Nivolumab Treatment
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 12 months
Population: Treated patients who did not received Prior Ipilimumab / Nivolumab Treatment and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Duration of Disease Control (DoDC) - no Prior Ipilimumab / Nivolumab Treatment | 0 percentage of patients |
Secondary
12-month Duration of Disease Control (DoDC) - Overall Cohort
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 12 months
Population: Treated patients who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Duration of Disease Control (DoDC) - Overall Cohort | 15 percentage of patients |
Secondary
12-month Duration of Disease Control (DoDC) - Primary IO Resistance
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 12 months
Population: Treated patients with primary IO resistance who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Duration of Disease Control (DoDC) - Primary IO Resistance | 14 percentage of patients |
Secondary
12-month Duration of Disease Control (DoDC) - Prior Ipilimumab / Nivolumab Treatment
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 12 months
Population: Treated patients who received Prior Ipilimumab / Nivolumab Treatment and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Duration of Disease Control (DoDC) - Prior Ipilimumab / Nivolumab Treatment | 22 percentage of patients |
Secondary
12-month Duration of Disease Control (DoDC) - Prior Lines <= 3
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 12 months
Population: Treated patients who received \<= 3 prior lines of therapy and who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Duration of Disease Control (DoDC) - Prior Lines <= 3 | 11 percentage of patients |
Secondary
12-month Duration of Disease Control (DoDC) - Prior Lines > 3
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 12 months
Population: Treated patients who received \> 3 prior lines of therapy and who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Duration of Disease Control (DoDC) - Prior Lines > 3 | 25 percentage of patients |
Secondary
12-month Duration of Disease Control (DoDC) - Secondary IO Resistance
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 12 months
Population: Treated patients with Secondary IO resistance who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Duration of Disease Control (DoDC) - Secondary IO Resistance | 17 percentage of patients |
Secondary
12-month Duration of Response (DoR) - Acral Histology
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 12 months
Population: Treated patients with acral histology who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Duration of Response (DoR) - Acral Histology | 0 percentage of patients |
Secondary
12-month Duration of Response (DoR) - Cutaneous Histology
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 12 months
Population: Treated patients with cutaneous histology who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Duration of Response (DoR) - Cutaneous Histology | 0 percentage of patients |
Secondary
12-month Duration of Response (DoR) - Mucosal Histology
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 12 months
Population: Treated patients with mucosal histology who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Duration of Response (DoR) - Mucosal Histology | 0 percentage of patients |
Secondary
12-month Duration of Response (DoR) - no Prior Ipilimumab / Nivolumab Treatment
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 12 months
Population: Treated patients who did not received prior Ipilimumab/Nivolumab treatment were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Duration of Response (DoR) - no Prior Ipilimumab / Nivolumab Treatment | 0 percentage of patients |
Secondary
12-month Duration of Response (DoR) - Overall Cohort
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 12 months
Population: Treated patients who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Duration of Response (DoR) - Overall Cohort | 0 percentage of patients |
Secondary
12-month Duration of Response (DoR) - Prior Ipilimumab / Nivolumab Treatment
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 12 months
Population: Treated patients who received prior Ipilimumab/Nivolumab treatment were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Duration of Response (DoR) - Prior Ipilimumab / Nivolumab Treatment | 0 percentage of patients |
Secondary
12-month Overall Survival (OS)
Percentage of patients alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.
Time frame: Up to 12 months
Population: All enrolled patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Overall Survival (OS) | 35 percentage of patients |
Secondary
12-month Overall Survival (OS) - Acral Histology
Percentage of patients with acral melanoma histology that remain alive up to 12 months from start of treatment until death from any cause.
Time frame: Up to 12 months
Population: Treated patients with acral melanoma histology.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Overall Survival (OS) - Acral Histology | 14 percentage of patients |
Secondary
12-month Overall Survival (OS) - Cutaneous Histology
Percentage of patients with cutaneous melanoma histology that remain alive up to 12 months from start of treatment until death from any cause.
Time frame: Up to 12 months
Population: Treated patients with cutaneous melanoma histology.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Overall Survival (OS) - Cutaneous Histology | 41 percentage of patients |
Secondary
12-month Overall Survival (OS) - Mucosal Histology
Percentage of patients with mucosal melanoma histology that remain alive up to 12 months from start of treatment until death from any cause.
Time frame: Up to 12 months
Population: Treated patients with mucosal melanoma histology.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Overall Survival (OS) - Mucosal Histology | 43 percentage of patients |
Secondary
12-month Overall Survival (OS) - no Prior Ipilimumab /Nivolumab Treatment
Percentage of patients (not previously treated with Ipilimumab /Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.
Time frame: Up to 12 months
Population: Treated patients who were not previously treated with Ipilimumab/Nivolumab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Overall Survival (OS) - no Prior Ipilimumab /Nivolumab Treatment | 40 percentage of patients |
Secondary
12-month Overall Survival (OS) - Primary IO Resistance
Percentage of patients (Primary IO resistance) alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.
Time frame: Up to 12 months
Population: Treated patients with Primary IO resistance.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Overall Survival (OS) - Primary IO Resistance | 40 percentage of patients |
Secondary
12-month Overall Survival (OS) - Prior Ipilimumab / Nivolumab Treatment
Percentage of patients (previously treated with Ipilimumab/Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.
Time frame: Up to 12 months
Population: Treated patients who were previously treated with Ipilimumab/Nivolumab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Overall Survival (OS) - Prior Ipilimumab / Nivolumab Treatment | 31 percentage of patients |
Secondary
12-month Overall Survival (OS) - Prior Lines of Therapy <=3
Percentage of patients (who received \<=3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.
Time frame: Up to 12 months
Population: Treated patients who received \<=3 prior lines of therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Overall Survival (OS) - Prior Lines of Therapy <=3 | 40 percentage of patients |
Secondary
12-month Overall Survival (OS) - Prior Lines of Therapy >3
Percentage of patients (who received \> 3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.
Time frame: Up to 12 months
Population: Treated patients who received \>3 prior lines of therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Overall Survival (OS) - Prior Lines of Therapy >3 | 27 percentage of patients |
Secondary
12-month Overall Survival (OS) - Secondary IO Resistance
Percentage of patients with Secondary IO resistance alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.
Time frame: Up to 12 months
Population: Treated patients with Secondary IO resistance.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Overall Survival (OS) - Secondary IO Resistance | 31 percentage of patients |
Secondary
12-month Progression-free Survival (PFS)
The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 12 months
Population: Treated patients who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Progression-free Survival (PFS) | 11 percentage of patients |
Secondary
12-month Progression-free Survival (PFS) - Acral Histology
The percentage of patients (with acral histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 12 months
Population: Treated patients with acral histology and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Progression-free Survival (PFS) - Acral Histology | 0 percentage of patients |
Secondary
12-month Progression-free Survival (PFS) - Cutaneous Histology
The percentage of patients (with cutaneous histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 12 months
Population: Treated patients with cutaneous histology and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Progression-free Survival (PFS) - Cutaneous Histology | 18 percentage of patients |
Secondary
12-month Progression-free Survival (PFS) - Mucosal Histology
The percentage of patients (with mucosal histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 12 months
Population: Treated patients with mucosal histology and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Progression-free Survival (PFS) - Mucosal Histology | 0 percentage of patients |
Secondary
12-month Progression-free Survival (PFS) - no Prior Ipilimumab / Nivolumab Treatment
The percentage of patients (not previously treated with Ipilimumab /Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 12 months
Population: Treated patients who were not previously treated with Ipilimumab /Nivolumab and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Progression-free Survival (PFS) - no Prior Ipilimumab / Nivolumab Treatment | 9 percentage of patients |
Secondary
12-month Progression-free Survival (PFS) - Prior Ipilimumab / Nivolumab Treatment
The percentage of patients (previously treated with Ipilimumab / Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 12 months
Population: Treated patients who were previously treated with Ipilimumab /Nivolumab and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Progression-free Survival (PFS) - Prior Ipilimumab / Nivolumab Treatment | 13 percentage of patients |
Secondary
12-month Progression-free Survival (PFS) - Prior Lines <= 3
The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 12 months
Population: Treated patients who received \<=3 prior lines of therapy and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Progression-free Survival (PFS) - Prior Lines <= 3 | 11 percentage of patients |
Secondary
12-month Progression-free Survival (PFS) - Prior Lines > 3
The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 12 months
Population: Treated patients who received \>3 prior lines of therapy and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 12-month Progression-free Survival (PFS) - Prior Lines > 3 | 9 percentage of patients |
Secondary
24-month Duration of Disease Control (DoDC) - Acral Histology
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 24 months
Population: Treated patients with acral histology who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Duration of Disease Control (DoDC) - Acral Histology | 0 percentage of patients |
Secondary
24-month Duration of Disease Control (DoDC) - Cutaneous Histology
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 24 months
Population: Treated patients with cutaneous histology who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Duration of Disease Control (DoDC) - Cutaneous Histology | 0 percentage of patients |
Secondary
24-month Duration of Disease Control (DoDC) - Mucosal Histology
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 24 months
Population: Treated patients with mucosal histology who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Duration of Disease Control (DoDC) - Mucosal Histology | 0 percentage of patients |
Secondary
24-month Duration of Disease Control (DoDC) - no Prior Ipilimumab / Nivolumab Treatment
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 24 months
Population: Treated patients who did not received Prior Ipilimumab / Nivolumab Treatment and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Duration of Disease Control (DoDC) - no Prior Ipilimumab / Nivolumab Treatment | 0 percentage of patients |
Secondary
24-month Duration of Disease Control (DoDC) - Overall Cohort
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 24 months
Population: Treated patients who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Duration of Disease Control (DoDC) - Overall Cohort | 0 percentage of patients |
Secondary
24-month Duration of Disease Control (DoDC) - Primary IO Resistance
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 24 months
Population: Treated patients with primary IO resistance who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Duration of Disease Control (DoDC) - Primary IO Resistance | 0 percentage of patients |
Secondary
24-month Duration of Disease Control (DoDC) - Prior Ipilimumab / Nivolumab Treatment
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 24 months
Population: Treated patients who received Prior Ipilimumab / Nivolumab Treatment and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Duration of Disease Control (DoDC) - Prior Ipilimumab / Nivolumab Treatment | 0 percentage of patients |
Secondary
24-month Duration of Disease Control (DoDC) - Prior Lines <= 3
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 24 months
Population: Treated patients who received \<= 3 prior lines of therapy and who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Duration of Disease Control (DoDC) - Prior Lines <= 3 | 0 percentage of patients |
Secondary
24-month Duration of Disease Control (DoDC) - Prior Lines > 3
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 24 months
Population: Treated patients who received \> 3 prior lines of therapy and who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Duration of Disease Control (DoDC) - Prior Lines > 3 | 0 percentage of patients |
Secondary
24-month Duration of Disease Control (DoDC) - Secondary IO Resistance
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 24 months
Population: Treated patients with Secondary IO resistance who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Duration of Disease Control (DoDC) - Secondary IO Resistance | 0 percentage of patients |
Secondary
24-month Duration of Response (DoR) - Acral Histology
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 24 months
Population: Treated patients with acral histology who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Duration of Response (DoR) - Acral Histology | 0 percentage of patients |
Secondary
24-month Duration of Response (DoR) - Cutaneous Histology
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 24 months
Population: Treated patients with cutaneous histology who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Duration of Response (DoR) - Cutaneous Histology | 0 percentage of patients |
Secondary
24-month Duration of Response (DoR) - Mucosal Histology
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 24 months
Population: Treated patients with mucosal histology who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Duration of Response (DoR) - Mucosal Histology | 0 percentage of patients |
Secondary
24-month Duration of Response (DoR) - no Prior Ipilimumab / Nivolumab Treatment
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 24 months
Population: Treated patients who did not received prior Ipilimumab/Nivolumab treatment were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Duration of Response (DoR) - no Prior Ipilimumab / Nivolumab Treatment | 0 percentage of patients |
Secondary
24-month Duration of Response (DoR) - Overall Cohort
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 24 months
Population: Treated patients who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Duration of Response (DoR) - Overall Cohort | 0 percentage of patients |
Secondary
24-month Duration of Response (DoR) - Prior Ipilimumab / Nivolumab Treatment
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 24 months
Population: Treated patients who received prior Ipilimumab/Nivolumab treatment were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Duration of Response (DoR) - Prior Ipilimumab / Nivolumab Treatment | 0 percentage of patients |
Secondary
24-month Overall Survival (OS)
Percentage of patients alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.
Time frame: Up to 24 months
Population: All enrolled patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Overall Survival (OS) | 21 percentage of patients |
Secondary
24-month Overall Survival (OS) - Acral Histology
Percentage of patients with acral melanoma histology that remain alive up to 24 months from start of treatment until death from any cause.
Time frame: Up to 24 months
Population: Treated patients with acral melanoma histology.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Overall Survival (OS) - Acral Histology | 14 percentage of patients |
Secondary
24-month Overall Survival (OS) - Cutaneous Histology
Percentage of patients with cutaneous melanoma histology that remain alive up to 24 months from start of treatment until death from any cause.
Time frame: Up to 24 months
Population: Treated patients with cutaneous melanoma histology.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Overall Survival (OS) - Cutaneous Histology | 24 percentage of patients |
Secondary
24-month Overall Survival (OS) - Mucosal Histology
Percentage of patients with mucosal melanoma histology that remain alive up to 24 months from start of treatment until death from any cause.
Time frame: Up to 24 months
Population: Treated patients with mucosal melanoma histology.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Overall Survival (OS) - Mucosal Histology | 21 percentage of patients |
Secondary
24-month Overall Survival (OS) - no Prior Ipilimumab /Nivolumab Treatment
Percentage of patients (not previously treated with Ipilimumab/Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.
Time frame: Up to 24 months
Population: Treated patients who were not previously treated with Ipilimumab/Nivolumab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Overall Survival (OS) - no Prior Ipilimumab /Nivolumab Treatment | 24 percentage of patients |
Secondary
24-month Overall Survival (OS) - Primary IO Resistance
Percentage of patients (Primary IO resistance) alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.
Time frame: Up to 24 months
Population: Treated patients with Primary IO resistance.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Overall Survival (OS) - Primary IO Resistance | 24 percentage of patients |
Secondary
24-month Overall Survival (OS) - Prior Ipilimumab / Nivolumab Treatment
Percentage of patients (previously treated with Ipilimumab/Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.
Time frame: Up to 24 months
Population: Treated patients who were previously treated with Ipilimumab /Nivolumab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Overall Survival (OS) - Prior Ipilimumab / Nivolumab Treatment | 19 percentage of patients |
Secondary
24-month Overall Survival (OS) - Prior Lines of Therapy <=3
Percentage of patients (who received \<=3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.
Time frame: Up to 24 months
Population: Treated patients who received \<=3 prior lines of therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Overall Survival (OS) - Prior Lines of Therapy <=3 | 23 percentage of patients |
Secondary
24-month Overall Survival (OS) - Prior Lines of Therapy >3
Percentage of patients (who received \> 3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.
Time frame: Up to 24 months
Population: Treated patients who received \>3 prior lines of therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Overall Survival (OS) - Prior Lines of Therapy >3 | 18 percentage of patients |
Secondary
24-month Overall Survival (OS) - Secondary IO Resistance
Percentage of patients with Secondary IO resistance alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.
Time frame: Up to 24 months
Population: Treated patients with Secondary IO resistance.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Overall Survival (OS) - Secondary IO Resistance | 19 percentage of patients |
Secondary
24-month Progression-free Survival (PFS)
The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 24 months
Population: Treated patients who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Progression-free Survival (PFS) | 0 percentage of patients |
Secondary
24-month Progression-free Survival (PFS) - Acral Histology
The percentage of patients (with acral histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 24 months
Population: Treated patients with acral histology and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Progression-free Survival (PFS) - Acral Histology | 0 percentage of patients |
Secondary
24-month Progression-free Survival (PFS) - Cutaneous Histology
The percentage of patients (with cutaneous histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 24 months
Population: Treated patients with cutaneous histology and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Progression-free Survival (PFS) - Cutaneous Histology | 0 percentage of patients |
Secondary
24-month Progression-free Survival (PFS) - Mucosal Histology
The percentage of patients (with mucosal histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 24 months
Population: Treated patients with mucosal histology and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Progression-free Survival (PFS) - Mucosal Histology | 0 percentage of patients |
Secondary
24-month Progression-free Survival (PFS) - no Prior Ipilimumab /Nivolumab Treatment
The percentage of patients (not previously treated with Ipilimumab /Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 24 months
Population: Treated patients who were not previously treated with Ipilimumab /Nivolumab and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Progression-free Survival (PFS) - no Prior Ipilimumab /Nivolumab Treatment | 0 percentage of patients |
Secondary
24-month Progression-free Survival (PFS) - Prior Ipilimumab / Nivolumab Treatment
The percentage of patients (previously treated with Ipilimumab/Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 24 months
Population: Treated patients who were previously treated with Ipilimumab /Nivolumab and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Progression-free Survival (PFS) - Prior Ipilimumab / Nivolumab Treatment | 0 percentage of patients |
Secondary
24-month Progression-free Survival (PFS) - Prior Lines <= 3
The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 24 months
Population: Treated patients who received \<=3 prior lines of therapy and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Progression-free Survival (PFS) - Prior Lines <= 3 | 0 percentage of patients |
Secondary
24-month Progression-free Survival (PFS) - Prior Lines > 3
The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 24 months
Population: Treated patients who received \>3 prior lines of therapy and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 24-month Progression-free Survival (PFS) - Prior Lines > 3 | 0 percentage of patients |
Secondary
6-month Duration of Disease Control (DoDC) - Acral Histology
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 6 months
Population: Treated patients with acral histology who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Duration of Disease Control (DoDC) - Acral Histology | 20 percentage of patients |
Secondary
6-month Duration of Disease Control (DoDC) - Cutaneous Histology
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 6 months
Population: Treated patients with cutaneous histology who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Duration of Disease Control (DoDC) - Cutaneous Histology | 50 percentage of patients |
Secondary
6-month Duration of Disease Control (DoDC) - Mucosal Histology
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 6 months
Population: Treated patients with mucosal histology who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Duration of Disease Control (DoDC) - Mucosal Histology | 67 percentage of patients |
Secondary
6-month Duration of Disease Control (DoDC) - no Prior Ipilimumab / Nivolumab Treatment
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 6 months
Population: Treated patients who did not received Prior Ipilimumab / Nivolumab Treatment and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Duration of Disease Control (DoDC) - no Prior Ipilimumab / Nivolumab Treatment | 80 percentage of patients |
Secondary
6-month Duration of Disease Control (DoDC) - Overall Cohort
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 6 months
Population: Treated patients who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Duration of Disease Control (DoDC) - Overall Cohort | 39 percentage of patients |
Secondary
6-month Duration of Disease Control (DoDC) - Primary IO Resistance
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 6 months
Population: Treated patients with primary IO resistance who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Duration of Disease Control (DoDC) - Primary IO Resistance | 29 percentage of patients |
Secondary
6-month Duration of Disease Control (DoDC) - Prior Ipilimumab / Nivolumab Treatment
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 6 months
Population: Treated patients who received Prior Ipilimumab / Nivolumab Treatment and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Duration of Disease Control (DoDC) - Prior Ipilimumab / Nivolumab Treatment | 22 percentage of patients |
Secondary
6-month Duration of Disease Control (DoDC) - Prior Lines <= 3
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 6 months
Population: Treated patients who received \<= 3 prior lines of therapy and who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Duration of Disease Control (DoDC) - Prior Lines <= 3 | 45 percentage of patients |
Secondary
6-month Duration of Disease Control (DoDC) - Prior Lines > 3
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 6 months
Population: Treated patients who received \> 3 prior lines of therapy and who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Duration of Disease Control (DoDC) - Prior Lines > 3 | 25 percentage of patients |
Secondary
6-month Duration of Disease Control (DoDC) - Secondary IO Resistance
Percentage of patients with first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 6 months
Population: Treated patients with Secondary IO resistance who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Duration of Disease Control (DoDC) - Secondary IO Resistance | 50 percentage of patients |
Secondary
6-month Duration of Response (DoR) - Acral Histology
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 6 months
Population: Treated patients with acral histology who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Duration of Response (DoR) - Acral Histology | 100 percentage of patients |
Secondary
6-month Duration of Response (DoR) - Cutaneous Histology
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 6 months
Population: Treated patients with cutaneous histology who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Duration of Response (DoR) - Cutaneous Histology | 0 percentage of patients |
Secondary
6-month Duration of Response (DoR) - Mucosal Histology
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 6 months
Population: Treated patients with mucosal histology who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Duration of Response (DoR) - Mucosal Histology | 100 percentage of patients |
Secondary
6-month Duration of Response (DoR) - no Prior Ipilimumab / Nivolumab Treatment
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 6 months
Population: Treated patients who did not received prior Ipilimumab/Nivolumab treatment were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Duration of Response (DoR) - no Prior Ipilimumab / Nivolumab Treatment | 100.00 percentage of patients |
Secondary
6-month Duration of Response (DoR) - Overall Cohort
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 6 months
Population: Treated patients who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Duration of Response (DoR) - Overall Cohort | 67 percentage of patients |
Secondary
6-month Duration of Response (DoR) - Prior Ipilimumab / Nivolumab Treatment
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 6 months
Population: Treated patients who received prior Ipilimumab/Nivolumab treatment were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Duration of Response (DoR) - Prior Ipilimumab / Nivolumab Treatment | 0 percentage of patients |
Secondary
6-month Overall Survival (OS)
Percentage of patients alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.
Time frame: Up to12 months
Population: All enrolled patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Overall Survival (OS) | 71 percentage of patients |
Secondary
6-month Overall Survival (OS) - Acral Histology
Percentage of patients with acral melanoma histology that remain alive up to 6 months from start of treatment until death from any cause.
Time frame: Up to 6 months
Population: Treated patients with acral melanoma histology.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Overall Survival (OS) - Acral Histology | 57 percentage of patients |
Secondary
6-month Overall Survival (OS) - Cutaneous Histology
Percentage of patients with cutaneous melanoma histology that remain alive up to 6 months from start of treatment until death from any cause.
Time frame: Up to 6 months
Population: Treated patients with cutaneous melanoma histology.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Overall Survival (OS) - Cutaneous Histology | 76 percentage of patients |
Secondary
6-month Overall Survival (OS) - Mucosal Histology
Percentage of patients with mucosal melanoma histology that remain alive up to 6 months from start of treatment until death from any cause.
Time frame: Up to 6 months
Population: Treated patients with mucosal melanoma histology.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Overall Survival (OS) - Mucosal Histology | 71 percentage of patients |
Secondary
6-month Overall Survival (OS) - no Prior Ipilimumab /Nivolumab Treatment
Percentage of patients (not previously treated with Ipilimumab /Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.
Time frame: Up to 6 months
Population: Treated patients who were not previously treated with Ipilimumab/Nivolumab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Overall Survival (OS) - no Prior Ipilimumab /Nivolumab Treatment | 93 percentage of patients |
Secondary
6-month Overall Survival (OS) - Primary IO Resistance
Percentage of patients (Primary IO resistance) alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.
Time frame: Up to 6 months
Population: Treated patients with Primary IO resistance.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Overall Survival (OS) - Primary IO Resistance | 53 percentage of patients |
Secondary
6-month Overall Survival (OS) - Prior Ipilimumab /Nivolumab Treatment
Percentage of patients (previously treated with Ipilimumab/Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.
Time frame: Up to 6 months
Population: Treated patients who were previously treated with Ipilimumab/Nivolumab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Overall Survival (OS) - Prior Ipilimumab /Nivolumab Treatment | 50 percentage of patients |
Secondary
6-month Overall Survival (OS) - Prior Lines of Therapy <=3
Percentage of patients (who received \<=3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.
Time frame: Up to 6 months
Population: Treated patients who received \<=3 prior lines of therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Overall Survival (OS) - Prior Lines of Therapy <=3 | 70 percentage of patients |
Secondary
6-month Overall Survival (OS) - Prior Lines of Therapy >3
Percentage of patients (who received \> 3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.
Time frame: Up to 6 months
Population: Treated patients who received \>3 prior lines of therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Overall Survival (OS) - Prior Lines of Therapy >3 | 73 percentage of patients |
Secondary
6-month Overall Survival (OS) - Secondary IO Resistance
Percentage of patients with Secondary IO resistance alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.
Time frame: Up to 6 months
Population: Treated patients with Secondary IO resistance.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Overall Survival (OS) - Secondary IO Resistance | 88 percentage of patients |
Secondary
6-month Progression-free Survival (PFS)
The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 6 months
Population: Treated patients who were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Progression-free Survival (PFS) | 21 percentage of patients |
Secondary
6-month Progression-free Survival (PFS) - Acral Histology
The percentage of patients (with acral histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 6 months
Population: Treated patients with acral histology and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Progression-free Survival (PFS) - Acral Histology | 29 percentage of patients |
Secondary
6-month Progression-free Survival (PFS) - Cutaneous Histology
The percentage of patients (with cutaneous histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 6 months
Population: Treated patients with cutaneous histology and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Progression-free Survival (PFS) - Cutaneous Histology | 18 percentage of patients |
Secondary
6-month Progression-free Survival (PFS) - Mucosal Histology
The percentage of patients (with mucosal histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 6 months
Population: Treated patients with mucosal histology and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Progression-free Survival (PFS) - Mucosal Histology | 29 percentage of patients |
Secondary
6-month Progression-free Survival (PFS) - no Prior Ipilimumab/Nivolumab Treatment
The percentage of patients (not previously treated with Ipilimumab /Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 6 months
Population: Treated patients who were not previously treated with Ipilimumab /Nivolumab and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Progression-free Survival (PFS) - no Prior Ipilimumab/Nivolumab Treatment | 27 percentage of patients |
Secondary
6-month Progression-free Survival (PFS) - Prior Ipilimumab / Nivolumab Treatment
The percentage of patients (previously treated with Ipilimumab/Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 6 months
Population: Treated patients who were previously treated with Ipilimumab /Nivolumab and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Progression-free Survival (PFS) - Prior Ipilimumab / Nivolumab Treatment | 19 percentage of patients |
Secondary
6-month Progression-free Survival (PFS) - Prior Lines <= 3
The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 6 months
Population: Treated patients who received \<=3 prior lines of therapy and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Progression-free Survival (PFS) - Prior Lines <= 3 | 28 percentage of patients |
Secondary
6-month Progression-free Survival (PFS) - Prior Lines > 3
The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 6 months
Population: Treated patients who received \>3 prior lines of therapy and were evaluable for radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Plus Axitinib | 6-month Progression-free Survival (PFS) - Prior Lines > 3 | 9 percentage of patients |
Secondary
Duration of Disease Control (DoDC) - Acral Histology
Median number of months from the date of first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 4 years and 3 months
Population: Treated patients with acral histology who were evaluable for radiologic response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Duration of Disease Control (DoDC) - Acral Histology | 3.00 months |
Secondary
Duration of Disease Control (DoDC) - Cutaneous Histology
Median number of months from the date of first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 4 years and 3 months
Population: Treated patients with cutaneous histology who were evaluable for radiologic response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Duration of Disease Control (DoDC) - Cutaneous Histology | 6.00 months |
Secondary
Duration of Disease Control (DoDC) - Mucosal Histology
Median number of months from the date of first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 4 years and 3 months
Population: Treated patients with mucosal histology who were evaluable for radiologic response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Duration of Disease Control (DoDC) - Mucosal Histology | 8.00 months |
Secondary
Duration of Disease Control (DoDC) - no Prior Ipilimumab / Nivolumab Treatment
Median number of months from the date of first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 4 years and 3 months
Population: Treated patients who did not received prior Ipilimumab / Nivolumab treatment and were evaluable for radiologic response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Duration of Disease Control (DoDC) - no Prior Ipilimumab / Nivolumab Treatment | 8.00 months |
Secondary
Duration of Disease Control (DoDC) - Overall Cohort
Median number of months from the date of first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 4 years and 3 months
Population: Treated patients who were evaluable for radiologic response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Duration of Disease Control (DoDC) - Overall Cohort | 4.00 months |
Secondary
Duration of Disease Control (DoDC) - Overall Cohort - Primary IO Resistance
Median number of months from the date of first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 4 years and 3 months
Population: Treated patients with primary IO resistance who were evaluable for radiologic response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Duration of Disease Control (DoDC) - Overall Cohort - Primary IO Resistance | 3.00 months |
Secondary
Duration of Disease Control (DoDC) - Overall Cohort - Secondary IO Resistance
Median number of months from the date of first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 4 years and 3 months
Population: Treated patients with Secondary IO resistance who were evaluable for radiologic response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Duration of Disease Control (DoDC) - Overall Cohort - Secondary IO Resistance | 6.00 months |
Secondary
Duration of Disease Control (DoDC) - Prior Ipilimumab / Nivolumab Treatment
Median number of months from the date of first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 4 years and 3 months
Population: Treated patients who received prior Ipilimumab / Nivolumab treatment and were evaluable for radiologic response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Duration of Disease Control (DoDC) - Prior Ipilimumab / Nivolumab Treatment | 3.00 months |
Secondary
Duration of Disease Control (DoDC) - Prior Lines <= 3
Median number of months from the date of first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 4 years and 3 months
Population: Treated patients who received \<= 3 prior lines of therapy and were evaluable for radiologic response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Duration of Disease Control (DoDC) - Prior Lines <= 3 | 5.00 months |
Secondary
Duration of Disease Control (DoDC) - Prior Lines > 3
Median number of months from the date of first disease control (i.e. complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) to progression \[PD\]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 4 years and 3 months
Population: Treated patients who received \>3 prior lines of therapy and were evaluable for radiologic response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Duration of Disease Control (DoDC) - Prior Lines > 3 | 2.00 months |
Secondary
Duration of Response (DoR) - Acral Histology
Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 4 years and 3 months
Population: Treated patients with acral histology who were evaluable for radiologic response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Duration of Response (DoR) - Acral Histology | 9.0 months |
Secondary
Duration of Response (DoR) - Cutaneous Histology
Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 4 years and 3 months
Population: Treated patients with cutaneous histology who were evaluable for radiologic response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Duration of Response (DoR) - Cutaneous Histology | 4.00 months |
Secondary
Duration of Response (DoR) - Mucosal Histology
Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 4 years and 3 months
Population: Treated patients with mucosal histology who were evaluable for radiologic response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Duration of Response (DoR) - Mucosal Histology | 8.00 months |
Secondary
Duration of Response (DoR) - no Prior Ipilimumab / Nivolumab Treatment
Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 4 years and 3 months
Population: Treated patients who did not receive prior Ipilimumab / Nivolumab treatment and were evaluable for radiologic response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Duration of Response (DoR) - no Prior Ipilimumab / Nivolumab Treatment | 8.50 months |
Secondary
Duration of Response (DoR) - Overall Cohort
Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 4 years and 3 months
Population: Treated patients who were evaluable for radiologic response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Duration of Response (DoR) - Overall Cohort | 8.00 months |
Secondary
Duration of Response (DoR) - Prior Ipilimumab / Nivolumab Treatment
Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 4 years and 3 months
Population: Treated patients who received prior Ipilimumab/Nivolumab treatment were evaluable for radiologic response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Duration of Response (DoR) - Prior Ipilimumab / Nivolumab Treatment | 0 months |
Secondary
Grade 3 or Greater Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Adverse Events determined to be possibly, probably or definitely related to study treatment SAEs are defined as grade 3 and higher toxicity events that are attributable to the study combination therapy. Evaluated by NCI Common Terminology for Adverse Events (CTCAE v5.0).
Time frame: Up to 28 days after discontinuation of study treatment (up to 24 months)
Population: Treated patients who experienced an SAE \>= grade 3
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab Plus Axitinib | Grade 3 or Greater Adverse Events Possibly, Probably or Definitely Related to Study Treatment | Diarrhea | 1 participants |
| Nivolumab Plus Axitinib | Grade 3 or Greater Adverse Events Possibly, Probably or Definitely Related to Study Treatment | Lower gastrointestinal hemorrhage | 1 participants |
| Nivolumab Plus Axitinib | Grade 3 or Greater Adverse Events Possibly, Probably or Definitely Related to Study Treatment | Chills | 1 participants |
| Nivolumab Plus Axitinib | Grade 3 or Greater Adverse Events Possibly, Probably or Definitely Related to Study Treatment | Fatigue | 1 participants |
| Nivolumab Plus Axitinib | Grade 3 or Greater Adverse Events Possibly, Probably or Definitely Related to Study Treatment | dacryocystitis | 1 participants |
| Nivolumab Plus Axitinib | Grade 3 or Greater Adverse Events Possibly, Probably or Definitely Related to Study Treatment | Wound complication | 1 participants |
| Nivolumab Plus Axitinib | Grade 3 or Greater Adverse Events Possibly, Probably or Definitely Related to Study Treatment | Alkaline phosphatase increased | 1 participants |
| Nivolumab Plus Axitinib | Grade 3 or Greater Adverse Events Possibly, Probably or Definitely Related to Study Treatment | Hematuria | 1 participants |
| Nivolumab Plus Axitinib | Grade 3 or Greater Adverse Events Possibly, Probably or Definitely Related to Study Treatment | Pneumonitis | 1 participants |
| Nivolumab Plus Axitinib | Grade 3 or Greater Adverse Events Possibly, Probably or Definitely Related to Study Treatment | Rash maculo-papular | 1 participants |
Secondary
Overall Survival (OS) - Acral Histology
The median number of months from the start of treatment that patients (with acral histology) remain alive, until death from any cause in patients with acral melanoma histology.
Time frame: Up to 45 months
Population: Treated patients with acral melanoma histology.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Overall Survival (OS) - Acral Histology | 8.00 months |
Secondary
Overall Survival (OS) - Cutaneous Histology
The median number of months from the start of treatment that patients remain alive, until death from any cause in patients with cutaneous melanoma histology.
Time frame: Up to 45 months
Population: Treated patients with cutaneous melanoma histology
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Overall Survival (OS) - Cutaneous Histology | 11.00 months |
Secondary
Overall Survival (OS) - Mucosal Histology
The median number of months from the start of treatment that patients remain alive, until death from any cause in patients with mucosal histology.
Time frame: Up to 45 months
Population: Treated patients with mucosal melanoma histology.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Overall Survival (OS) - Mucosal Histology | 11.00 months |
Secondary
Overall Survival (OS) - no Prior Ipilimumab / Nivolumab Treatment
The median number of months from the start of treatment that patients (who did not receive prior Ipilimumab /Nivolumab treatment) remained alive, until death from any cause.
Time frame: Up to 45 months
Population: Treated patients who do not receive prior Ipilimumab /Nivolumab treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Overall Survival (OS) - no Prior Ipilimumab / Nivolumab Treatment | 11.0 months |
Secondary
Overall Survival (OS) - Overall Cohort
The median number of months from the start of treatment that patients remain alive, until death from any cause.
Time frame: Up to 45 months
Population: All enrolled patients.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Overall Survival (OS) - Overall Cohort | 10.0 months |
Secondary
Overall Survival (OS) - Overall Cohort - Primary IO Resistance
The median number of months from the start of treatment that patients with Primary IO resistance remain alive, until death from any cause.
Time frame: Up to 45 months
Population: Treated patients with Primary IO resistance.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Overall Survival (OS) - Overall Cohort - Primary IO Resistance | 7.00 months |
Secondary
Overall Survival (OS) - Overall Cohort - Secondary IO Resistance
The median number of months from the start of treatment that patients with Secondary IO resistance remain alive, until death from any cause.
Time frame: Up to 45 months
Population: Treated patients with Primary IO resistance.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Overall Survival (OS) - Overall Cohort - Secondary IO Resistance | 11.00 months |
Secondary
Overall Survival (OS) - Prior Ipilimumab/Nivolumab Treatment
The median number of months from the start of treatment that patients (who received prior Ipilimumab/Nivolumab treatment) remained alive, until death from any cause.
Time frame: Up to 45 months
Population: Treated patients who received prior Ipilimumab/Nivolumab treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Overall Survival (OS) - Prior Ipilimumab/Nivolumab Treatment | 7.0 months |
Secondary
Overall Survival (OS) - Prior Lines of Therapy <=3
The median number of months from the start of treatment that patients who received 3 or less prior lines of treatment remain alive, until death from any cause.
Time frame: Up to 45 months
Population: Treated patients who received greater than 3 prior lines of treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Overall Survival (OS) - Prior Lines of Therapy <=3 | 11.00 months |
Secondary
Overall Survival (OS) - Prior Lines of Therapy >3
The median number of months from the start of treatment that patients with greater than 3 prior lines of treatment remain alive, until death from any cause.
Time frame: Up to 45 months
Population: Treated patients who received greater than 3 prior lines of treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Overall Survival (OS) - Prior Lines of Therapy >3 | 8.00 months |
Secondary
Progression-free Survival (PFS) - no Prior Ipilimumab /Nivolumab Treatment
The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 4 years and 3 months
Population: Treated patients who were not previously treated with Ipilimumab /Nivolumab and were evaluable for radiologic response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Progression-free Survival (PFS) - no Prior Ipilimumab /Nivolumab Treatment | 3.00 months |
Secondary
Progression-free Survival (PFS) - Overall Cohort
The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 4 years and 3 months
Population: Treated patients who were evaluable for radiologic response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Progression-free Survival (PFS) - Overall Cohort | 3.00 months |
Secondary
Progression-free Survival (PFS) - Overall Cohort - Acral Histology
The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. in patients with mucosal histology. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 4 years and 3 months
Population: Treated patients with acral histology who were evaluable for radiologic response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Progression-free Survival (PFS) - Overall Cohort - Acral Histology | 4.00 months |
Secondary
Progression-free Survival (PFS) - Overall Cohort - Cutaneous Histology
The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. in patients with mucosal histology. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 4 years and 3 months
Population: Treated patients with cutaneous histology who were evaluable for radiologic response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Progression-free Survival (PFS) - Overall Cohort - Cutaneous Histology | 3.00 months |
Secondary
Progression-free Survival (PFS) - Overall Cohort - Mucosal Histology
The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. in patients with mucosal histology. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 4 years and 3 months
Population: Treated patients with mucosal histology who were evaluable for radiologic response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Progression-free Survival (PFS) - Overall Cohort - Mucosal Histology | 3.00 months |
Secondary
Progression-free Survival (PFS) - Overall Cohort - Prior Lines <= 3
The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. in patients with mucosal histology. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 4 years and 3 months
Population: Treated patients who received prior lines \<= 3 and who were evaluable for radiologic response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Progression-free Survival (PFS) - Overall Cohort - Prior Lines <= 3 | 3.50 months |
Secondary
Progression-free Survival (PFS) - Overall Cohort - Prior Lines >3
The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. in patients with mucosal histology. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 4 years and 3 months
Population: Treated patients who received \>3 prior lines and who were evaluable for radiologic response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Progression-free Survival (PFS) - Overall Cohort - Prior Lines >3 | 3.00 months |
Secondary
Progression-free Survival (PFS) - Prior Ipilimumab / Nivolumab Treatment
The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: Up to 4 years and 3 months
Population: Treated patients who were previously treated with Ipilimumab/Nivolumab and were evaluable for radiologic response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Plus Axitinib | Progression-free Survival (PFS) - Prior Ipilimumab / Nivolumab Treatment | 4.00 months |