Advanced Renal Cell Carcinoma
Conditions
Keywords
Nivolumab, Ipilimumab, OPDIVO, IgG1 kappa immunoglobulin
Brief summary
Phase II trial of nivolumab in 120 treatment naïve patients with ccRCC.
Detailed description
Eligible patients with biopsiable (biopsied) disease will receive nivolumab 240 mg IV every 2 weeks x 6 doses then 360 mg every 3 weeks for up to 84 weeks. Tumor response will be assessed at weeks 12, 18 and 24 and then every 12 weeks. For patients who experience RECIST 1.1 defined PD, but remain clinically stable (and asymptomatic), a confirmatory scan after 6 weeks (± 1 week) of additional therapy is suggested. Patients with persistent PD at confirmatory scan will be evaluated for enrollment on Part B of this study. Symptomatic patients may be evaluated for Part B immediately. Patients without confirmed PD can continue on nivolumab therapy. Patients who experience symptomatic or confirmed PD (or have best response of SD at 12 months) on nivolumab monotherapy will be eligible for consideration for Part B. Part B involves the addition of ipilimumab for up to 4 doses while maintaining nivolumab therapy. Dose of ipilimumab will be 1 mg/kg every 3 weeks together with nivolumab changed to 3 mg/kg every 3 weeks for up to 4 doses. Nivolumab will revert to 360 mg every 3 weeks after the completion of treatment with ipilimumab (beginning week 13-19 of Part B) for up to 48 weeks. Patients will be followed with serial imaging assessments weeks 12, 18 and 24 and then every 12 weeks after the initiation of ipilimumab. The tumor measurements at the time of ipilimumab institution will be the new baseline. If unequivocal symptomatic or confirmed new PD (as defined above) develops, treatment will be discontinued. Patients for Part B must still meet the eligibility criteria for initial study enrollment. Patients with Grade 3 toxicity on nivolumab monotherapy, serious symptomatic disease that in the opinion of the site investigator requires immediate use of an alternative treatment approach or continued PR/CR will be excluded from enrolling in Part B. It is estimated that roughly half of the patients accrued to the first-line treatment will go on to enroll in Part B. An additional biopsy will be performed of a metastatic lesion at time of confirmed PD in all patients enrolling in Part B. Confirmation of tumor in the biopsy specimen must occur prior to initiation of treatment on Part B. FFPE and frozen tissue will be stored from this sample and used for correlative studies described below. An additional cohort of 40 non-ccRCC patients will be enrolled and analyzed separately for evidence of anti-tumor activity (CR, PR and SD and PFS at 1 year of nivolumab). These patients will also be eligible for participation in Part B. We anticipate that the accrual of these 40 patients will be able to be completed within the 1.5 years needed for accrual of the ccRCC patients. Part A: Nivolumab Administration. Nivolumab will be given every 2 weeks x 6 at a dose of 240 mg Intravenously (IV) and then every 3 weeks at a dose of 360 mg IV until toxicity, complete response, disease progression, SD at 12 months or a maximum of 96 total weeks (12 weeks induction, 84 weeks maintenance) Patients with disease progression (at any time) or SD at 12 months will be eligible to be considered for participation in Part B of the study. Part B: Nivolumab + Ipilimumab. Patients with Grade 3 toxicity on nivolumab monotherapy, (excluding endocrine toxicity), serious symptomatic disease that in the opinion of the site investigator requires immediate use of an alternative treatment approach or continued PR/CR will be excluded from enrolling in Part B. It is estimated that roughly half of the patients accrued to the first line treatment will go on to enroll in Part B. Ipilimumab will be given 1 mg/kg every 3 weeks together with nivolumab 240 mg every 3 weeks for up to 4 doses. Nivolumab will revert to 3 mg/kg every 3 weeks after the completion of combination treatment with ipilimumab . Following the first 4 doses of the combination of nivolumab and ipilimumab, nivolumab monotherapy will again be given every 3 weeks at a dose of 360 mg for a maximum of 48 weeks. Patients may be dosed no less than 18 days from the previous dose of drug; and dosed up to 3 days after the scheduled date, if necessary.
Interventions
DRUGNivolumab 240 mg
PART A Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment
Ipilimumab 1 mg/kg every 3 weeks x 4
DRUGNivolumab 3mg/kg
In combination with Ipilimumab
DRUGNivolumab 360mg
Continue Nivolumab 360 mg IV every 3 weeks
Sponsors
Bristol-Myers Squibb
Hoosier Cancer Research Network
Michael B. Atkins, MD
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Part A: Subject must meet all of the following applicable inclusion criteria to participate in this study: * Patients must have histologically confirmed advanced RCC (any histology). Collecting duct tumors and tumors originating from the renal pelvis or upper urinary tract are considered of urothelial origin and are excluded from this protocol. * Patients must have at least one measurable site of disease, per RECIST 1.1, that has not been previously irradiated. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation. * Archival tissue of a metastatic lesion obtained within 1 year prior to study registration (within 4 weeks preferred) and tumor tissue from nephrectomy is required if available. In addition to archival tissue of a metastatic lesion and nephrectomy, patients must have at least one site of disease (not including bone metastases) accessible for biopsy. If biopsy/resection of a new lesion or primary tumor and slow freezing of fresh tissue for single cell RNAseq study (as specified in the CLM) is not feasible, the subject is not eligible for the study. All biopsies must be core needle or excisional. Fine needle aspirate is not acceptable. NOTE: The tissue collected from a surgical resection or multiple core biopsies of either a metastatic lesion or primary tumor for the slow freezing of fresh tissue after the patient has signed consent for the study could also be used for collecting the FFPE specimens. * ECOG performance status 0-2. * Age ≥ 18 years. * Have signed the current approved informed consent form. * Patients must have adequate organ function within 14 days prior to study entry as evidenced by screening laboratory values that must meet the following criteria: * Hematological: * White blood cell (WBC) ≥ 2000/µL * Absolute Neutrophil Count (ANC) ≥ 1500/μL * Platelets (Plt) ≥ 100 x103/μL * Hemoglobin (Hgb) \> 9.0 g/dL (with or without transfusion) * Renal: * Serum Creatinine ≤ 1.5 x ULN; if creatinine \> 1.5, subject must demonstrate CrCl as outlined below. * Calculated creatinine clearance ≥ 40 mL/min using Cockcroft-Gault formula * Hepatic: * Bilirubin ≤ 1.5× upper limit of normal (ULN); Except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL * Aspartate aminotransferase (AST) ≤ 3 × ULN * Alanine aminotransferase (ALT) ≤ 3 × ULN * Patients should not have received prior systemic therapy for metastatic RCC. Prior radiotherapy must have been completed at least 2 weeks prior to the administration of study drug. Patients must be 2 weeks from prior major surgery and 1 week from pre-treatment biopsy. Prior systemic adjuvant therapy (excluding with PD1 or CTLA4 pathway blockers) is allowed if treatment completed \> 12 months previously. * Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 5 months after the last dose of study drug. NOTE: Contraception is not required for male participants. * Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) during screening for registration purposes. This pregnancy test should be repeated within 24 hours prior to the start of nivolumab. NOTE: Women of childbearing potential is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/ml. * Women must not be breastfeeding. * Be willing and able to comply with this protocol.
Exclusion criteria
* Patients are excluded if they have active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for 2 weeks of more after treatment is complete and within 28 days prior to the first dose of nivolumab administration. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (\> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration. * Patients with controlled brain metastases are allowed on protocol if they had solitary brain metastases that was surgically resected without recurrence or treated with SRS without progression x 4 weeks. * Patients should be excluded if they have an active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger. * Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. * As there is potential for hepatic toxicity with nivolumab or nivolumab/ipilimumab combinations, drugs with a predisposition to hepatoxicity should be used with caution in patients treated with nivolumab-containing regimen * Active infection requiring systemic therapy * Has any other medical or personal condition that, in the opinion of the site investigator, may potentially compromise the safety or compliance of the patient, or may preclude the patient's successful completion of the clinical trial * Patients should be excluded if they are positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection * Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) * Allergies and Adverse Drug Reaction * History of allergy to study drug components * History of severe hypersensitivity reaction to any monoclonal antibody * Known additional malignancies within the past 3 years (excluding basal of squamous cell skin cancers, CIS or localized prostate cancer that has been treated or is being observed) Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-year Progression Free Survival (PFS) Rate for ccRCC Patients | 1 year | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. 1-year Progression-Free Survival (PFS) Rate refers to the percentage of patients who have not experienced disease progression or death from any cause within one year of starting treatment. The 1-year PFS rate of nivolumab in treatment-naïve patients with clear cell renal cell carcinoma (ccRCC) was assessed according to tumor PD-L1 expression levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate for ccRCC Patients Treated With Nivolumab Monotherapy | Up to 39 Months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. ORR = CR +PR Evaluate ORR for nivolumab in patients with treatment naïve clear cell renal cell carcinoma (ccRCC) based on PD-L1 expression. |
| Objective Response Rate (ORR) for ccRCC Patients Treated With Nivolumab and Ipilimumab | Up to 39 Months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. ORR = CR +PR. Evaluate ORR in combined nivolumab and ipilimumab therapy at the time of nivolumab failure for ccRCC patients based on PD-L1 expression. |
| Clinical Activity for nccRCC Patients | Up to 39 Months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Clinical Activity = CR +PR+SD. Evaluate the clinical activity of nivolumab in patients with treatment naive nccRCC. |
| 1-year Progression Free Survival (PFS) Rate for nccRCC Patients | 1 year | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. 1-year Progression-Free Survival (PFS) Rate refers to the percentage of patients who have not experienced disease progression or death from any cause within one year of starting treatment. |
| Number of Participants With Adverse Events | Up to 28 months | Adverse events will be assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort A: Nivolumab and Salvage Nivolumab/Ipilimumab in Clear Cell RCC All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B).
PART A: Nivolumab
Nivolumab 240 mg: Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment.
Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks
PART B: Nivolumab + Ipilimumab
Ipilimumab 1mg/kg: Ipilimumab 1 mg/kg every 3 weeks x 4.
Nivolumab 3mg/kg: In combination with Ipilimumab
Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks | 128 |
| Cohort B: Nivolumab and Salvage Nivolumab/Ipilimumab in Non-clear Cell RCC All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B).
PART A: Nivolumab
Nivolumab 240 mg: PART A Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment
Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks
PART B: Nivolumab + Ipilimumab
Ipilimumab 1mg/kg: Ipilimumab 1 mg/kg every 3 weeks x 4
Nivolumab 3mg/kg: In combination with Ipilimumab
Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks | 35 |
| Total | 163 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Not meeting inclusion criteria | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Cohort B: Nivolumab and Salvage Nivolumab/Ipilimumab in Non-clear Cell RCC | Cohort A: Nivolumab and Salvage Nivolumab/Ipilimumab in Clear Cell RCC |
|---|---|---|---|
| Age, Continuous | 64 years | 63 years | 65 years |
| ECOG Performance Status ECOG = 0 | 97 participants | 16 participants | 81 participants |
| ECOG Performance Status ECOG = 1 | 63 participants | 17 participants | 46 participants |
| ECOG Performance Status ECOG = 2 | 3 participants | 2 participants | 1 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 0 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 154 Participants | 34 Participants | 120 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 8 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 132 Participants | 25 Participants | 107 Participants |
| Region of Enrollment United States | 163 participants | 35 participants | 128 participants |
| Sex: Female, Male Female | 40 Participants | 4 Participants | 36 Participants |
| Sex: Female, Male Male | 123 Participants | 31 Participants | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 38 / 128 | 28 / 40 | 11 / 35 | 15 / 17 |
| other Total, other adverse events | 127 / 128 | 38 / 40 | 34 / 35 | 17 / 17 |
| serious Total, serious adverse events | 41 / 128 | 19 / 40 | 8 / 35 | 5 / 17 |
Outcome results
Primary
1-year Progression Free Survival (PFS) Rate for ccRCC Patients
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. 1-year Progression-Free Survival (PFS) Rate refers to the percentage of patients who have not experienced disease progression or death from any cause within one year of starting treatment. The 1-year PFS rate of nivolumab in treatment-naïve patients with clear cell renal cell carcinoma (ccRCC) was assessed according to tumor PD-L1 expression levels.
Time frame: 1 year
Population: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint progression-free survival for ccRCC patients was defined as all patients treated with nivolumab and has PD-L1 expression.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | 1-year Progression Free Survival (PFS) Rate for ccRCC Patients | PD-L1 0% | 34.6 Percentage of participants |
| Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | 1-year Progression Free Survival (PFS) Rate for ccRCC Patients | PD-L1 1-5% | 53.8 Percentage of participants |
| Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | 1-year Progression Free Survival (PFS) Rate for ccRCC Patients | PD-L1 5-20% | 33.3 Percentage of participants |
| Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | 1-year Progression Free Survival (PFS) Rate for ccRCC Patients | PD-L1 > 20% | 75 Percentage of participants |
Secondary
1-year Progression Free Survival (PFS) Rate for nccRCC Patients
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. 1-year Progression-Free Survival (PFS) Rate refers to the percentage of patients who have not experienced disease progression or death from any cause within one year of starting treatment.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | 1-year Progression Free Survival (PFS) Rate for nccRCC Patients | 25.4 Percentage of participants |
Secondary
Clinical Activity for nccRCC Patients
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Clinical Activity = CR +PR+SD. Evaluate the clinical activity of nivolumab in patients with treatment naive nccRCC.
Time frame: Up to 39 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | Clinical Activity for nccRCC Patients | 60 Percentage of participants |
Secondary
Number of Participants With Adverse Events
Adverse events will be assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Time frame: Up to 28 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | Number of Participants With Adverse Events | 128 Participants |
| Cohort B: Nivolumab and Salvage Nivolumab/Ipilimumab in Non-clear Cell RCC | Number of Participants With Adverse Events | 35 Participants |
Secondary
Objective Response Rate for ccRCC Patients Treated With Nivolumab Monotherapy
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. ORR = CR +PR Evaluate ORR for nivolumab in patients with treatment naïve clear cell renal cell carcinoma (ccRCC) based on PD-L1 expression.
Time frame: Up to 39 Months
Population: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint progression-free survival for ccRCC patients was defined as all patients treated with nivolumab and has PD-L1 expression.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | Objective Response Rate for ccRCC Patients Treated With Nivolumab Monotherapy | PD-L1 0% | 26.9 Percentage of participants |
| Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | Objective Response Rate for ccRCC Patients Treated With Nivolumab Monotherapy | PD-L1 1-5% | 53.8 Percentage of participants |
| Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | Objective Response Rate for ccRCC Patients Treated With Nivolumab Monotherapy | PD-L1 5-20% | 33.3 Percentage of participants |
| Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | Objective Response Rate for ccRCC Patients Treated With Nivolumab Monotherapy | PD-L1 > 20% | 75 Percentage of participants |
Secondary
Objective Response Rate (ORR) for ccRCC Patients Treated With Nivolumab and Ipilimumab
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. ORR = CR +PR. Evaluate ORR in combined nivolumab and ipilimumab therapy at the time of nivolumab failure for ccRCC patients based on PD-L1 expression.
Time frame: Up to 39 Months
Population: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint progression-free survival for Part B (treated with Nivolumab and Ipilimumab) ccRCC patients was defined as all patients who entered Part B and had PD-L1 expression.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | Objective Response Rate (ORR) for ccRCC Patients Treated With Nivolumab and Ipilimumab | PD-L1 0% | 7.7 Percentage of participants |
| Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | Objective Response Rate (ORR) for ccRCC Patients Treated With Nivolumab and Ipilimumab | PD-L1 1-5% | 66.7 Percentage of participants |
| Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | Objective Response Rate (ORR) for ccRCC Patients Treated With Nivolumab and Ipilimumab | PD-L1 5-20% | 0 Percentage of participants |