Melanoma
Conditions
Brief summary
The purpose of this study is to determine the effects of combination treatment of Nivolumab with Ipilimumab followed by Nivolumab monotherapy in patients with previously untreated advanced Melanoma.
Interventions
DRUGNivolumab
DRUGIpilimumab
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Potential subjects must have advanced Melanoma (stage III or IV as confirmed by biopsy) with spread to other sites in the body and unable to be removed by surgery. * Potential subjects must be newly diagnosed with advanced melanoma and received no treatment for the advanced disease. NOTE: Prior adjuvant or neoadjuvant melanoma therapy (including anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways, such as anti-CD-137) is permitted if the therapy was used in the adjuvant or neoadjuvant setting but not in the metastatic setting. These drugs must be discontinued 6 months prior to study entry and the side effects related to the prior therapy resolved. * Potential subjects (with disease spread to brain) who previously received primary treatment are permitted if there was no evidence of disease as confirmed by the MRI (at least 2 weeks after the primary treatment is complete and with in 6 weeks of the first dose of the study drug). Potential subjects must not have received intravenous steroid treatment (\>10 mg/day) intravenously for at least 2 weeks prior to study drug administration.
Exclusion criteria
* Leptomenigeal metastases * Subjects with autoimmune disease. Subjects with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. * All side effects from previous primary treatments other than alopecia, fatigue, or peripheral neuropathy must have resolved to Grade 1 or baseline before administration of study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | From first dose to 30 days after last dose (up to approximately 37 months) | Incidence of participants with high-grade (CTCAE v4.0 grade 3-5) treatment-related, select adverse events of potentially immune-mediated etiology including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Time to Onset (Grades 3-4) of Select Adverse Events | From first dose to 30 days after last dose (up to approximately 37 months) | Median time to onset (grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity |
| Median Time to Resolution (Grades 3-4) of Select Adverse Events | From first dose to 30 days after last dose (up to approximately 37 months) | Median time to resolution (Grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity |
| Time to Resolution of an Adverse Event (AE) | From first dose to 30 days after last dose (up to approximately 37 months) | Resolution of an adverse event (AE) is defined as a participant experiencing complete resolution or improvement to the baseline of any grade AE including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity |
| Overall Survival (OS) | Up to approximately 37 months | Overall survival is defined from the time of first dosing date to the date of death. A participant who has not died will be censored at the last known date alive |
| Incidence of Participants With Adverse Events | From first dose to 30 days after last dose (up to approximately 37 months) | The assessment of safety is measured by the incidence of participants who experienced any grade of adverse events (AEs), treatment-related AEs, serious adverse events (SAEs), and deaths |
| Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | From first dose to 30 days after last dose (up to approximately 37 months) | Incidence of participants with high-grade (grade 3-5) select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, infusion-related, or hypersensitivity |
| Incidence of Participants With Laboratory Abnormalities - Liver | From first dose to 30 days after last dose (up to approximately 37 months) | Safety assessment is measured by the incidence of participants who experienced a liver laboratory abnormality in Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Upper Limit of Normal (ULN) |
| Incidence of Participants With Laboratory Abnormalities - Thyroid | From first dose to 30 days after last dose (up to approximately 37 months) | Safety assessment is measured by the incidence of participants who experienced a thyroid laboratory abnormality in Free T3 (FT3), Free T4 (FT4), Lower Limit of Normal (LLN) |
| Objective Response Rate (ORR) | Up to approximately 37 months | Objective response rate is defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of all treated participants |
| Progression Free Survival (PFS) | Up to approximately 37 months | Progression free survival per investigator assessment is defined as radiological evidence of progression, significant clinical symptomatic progression, or the need to introduce a non-study drug therapy. |
| Incidence of Participants With Select Adverse Events | From first dose to 30 days after last dose (up to approximately 37 months) | The assessment of safety is measured by the incidence of participants who experienced any grade of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity |
Countries
Australia, Austria, Belgium, Finland, France, Germany, Ireland, Italy, Norway, Sweden, Switzerland, United Kingdom
Participant flow
Pre-assignment details
533 participants treated
Participants by arm
| Arm | Count |
|---|---|
| Nivolumab + Ipilimumab Total Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months
Then
Part 2: Nivolumab (3mg/kg or 240 mg) IV Q2W up to 21 months | 533 |
| Total | 533 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event unrelated to study drug | 23 |
| Overall Study | Death | 26 |
| Overall Study | Disease progression | 153 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Maximum Clinical Benefit | 7 |
| Overall Study | Other Reasons | 95 |
| Overall Study | Participant no longer met study criteria | 7 |
| Overall Study | Participant request to discontinue study treatment | 13 |
| Overall Study | Participant withdrew consent | 5 |
| Overall Study | Poor/non-compliance | 1 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Study drug toxicity | 201 |
Baseline characteristics
| Characteristic | Nivolumab + Ipilimumab Total |
|---|---|
| Age, Continuous | 59.0 Years STANDARD_DEVIATION 13.55 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 515 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 10 Participants |
| Race (NIH/OMB) White | 521 Participants |
| Sex: Female, Male Female | 217 Participants |
| Sex: Female, Male Male | 316 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 199 / 533 | 169 / 477 | 29 / 55 | 13 / 42 | 20 / 32 | 41 / 64 | 107 / 365 | 6 / 10 | 25 / 62 |
| other Total, other adverse events | 503 / 533 | 453 / 477 | 49 / 55 | 37 / 42 | 28 / 32 | 61 / 64 | 347 / 365 | 10 / 10 | 57 / 62 |
| serious Total, serious adverse events | 356 / 533 | 324 / 477 | 31 / 55 | 31 / 42 | 26 / 32 | 40 / 64 | 238 / 365 | 9 / 10 | 43 / 62 |
Outcome results
Primary
Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events
Incidence of participants with high-grade (CTCAE v4.0 grade 3-5) treatment-related, select adverse events of potentially immune-mediated etiology including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Population: All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nivolumab + Ipilimumab Total | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Gastrointestinal: Grade 5 | 1 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Renal: Grade 5 | 1 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Endocrine: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hepatic: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Gastrointestinal: Grade 3-4 | 83 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Endocrine: Grade 3-4 | 58 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Skin: Grade 3-4 | 35 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Skin: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Pulmonary: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Renal: Grade 3-4 | 10 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hepatic: Grade 3-4 | 82 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Pulmonary: Grade 3-4 | 7 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 3-4 | 1 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Pulmonary: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Skin: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 3-4 | 1 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Renal: Grade 3-4 | 9 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Endocrine: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Gastrointestinal: Grade 3-4 | 79 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Pulmonary: Grade 3-4 | 7 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Endocrine: Grade 3-4 | 58 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hepatic: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Gastrointestinal: Grade 5 | 1 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hepatic: Grade 3-4 | 75 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Renal: Grade 5 | 1 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Skin: Grade 3-4 | 31 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Skin: Grade 3-4 | 4 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Gastrointestinal: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Pulmonary: Grade 3-4 | 0 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hepatic: Grade 3-4 | 7 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Pulmonary: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Renal: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Skin: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 3-4 | 0 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Gastrointestinal: Grade 3-4 | 4 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hepatic: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Renal: Grade 3-4 | 1 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Endocrine: Grade 3-4 | 0 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Endocrine: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Gastrointestinal: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Pulmonary: Grade 3-4 | 0 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Pulmonary: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Gastrointestinal: Grade 3-4 | 5 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Skin: Grade 3-4 | 1 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Skin: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Renal: Grade 3-4 | 1 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Renal: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hepatic: Grade 3-4 | 6 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hepatic: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Endocrine: Grade 3-4 | 5 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Endocrine: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 3-4 | 0 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hepatic: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Gastrointestinal: Grade 3-4 | 5 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Skin: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Skin: Grade 3-4 | 3 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 3-4 | 0 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Pulmonary: Grade 3-4 | 0 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Renal: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Renal: Grade 3-4 | 0 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Pulmonary: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Gastrointestinal: Grade 5 | 1 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Endocrine: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hepatic: Grade 3-4 | 2 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Endocrine: Grade 3-4 | 2 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Pulmonary: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Endocrine: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hepatic: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Skin: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Skin: Grade 3-4 | 7 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Gastrointestinal: Grade 3-4 | 9 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Gastrointestinal: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Endocrine: Grade 3-4 | 6 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 3-4 | 0 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Pulmonary: Grade 3-4 | 1 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hepatic: Grade 3-4 | 17 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Renal: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Renal: Grade 3-4 | 1 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Gastrointestinal: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Renal: Grade 3-4 | 8 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Renal: Grade 5 | 1 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hepatic: Grade 3-4 | 56 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Gastrointestinal: Grade 3-4 | 57 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hepatic: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Endocrine: Grade 3-4 | 43 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Pulmonary: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Endocrine: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 3-4 | 1 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Pulmonary: Grade 3-4 | 6 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Skin: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Skin: Grade 3-4 | 20 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Endocrine: Grade 3-4 | 1 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Pulmonary: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hepatic: Grade 3-4 | 1 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Renal: Grade 3-4 | 0 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Skin: Grade 3-4 | 1 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Endocrine: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Renal: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Pulmonary: Grade 3-4 | 0 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Gastrointestinal: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Skin: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 3-4 | 0 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hepatic: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Gastrointestinal: Grade 3-4 | 1 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Endocrine: Grade 3-4 | 6 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Gastrointestinal: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Renal: Grade 3-4 | 1 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Gastrointestinal: Grade 3-4 | 11 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hepatic: Grade 3-4 | 6 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Renal: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 3-4 | 0 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Skin: Grade 3-4 | 4 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Endocrine: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Hepatic: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Pulmonary: Grade 3-4 | 0 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Skin: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events | Pulmonary: Grade 5 | 0 Participants |
Secondary
Incidence of Participants With Adverse Events
The assessment of safety is measured by the incidence of participants who experienced any grade of adverse events (AEs), treatment-related AEs, serious adverse events (SAEs), and deaths
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Population: All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nivolumab + Ipilimumab Total | Incidence of Participants With Adverse Events | Adverse Events (AEs) | 533 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With Adverse Events | Treatment-Related AEs | 484 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With Adverse Events | Serious Adverse Events (SAEs) | 356 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With Adverse Events | Deaths | 199 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Adverse Events | Deaths | 169 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Adverse Events | Adverse Events (AEs) | 477 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Adverse Events | Treatment-Related AEs | 444 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Adverse Events | Serious Adverse Events (SAEs) | 324 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Adverse Events | Treatment-Related AEs | 40 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Adverse Events | Deaths | 29 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Adverse Events | Serious Adverse Events (SAEs) | 31 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Adverse Events | Adverse Events (AEs) | 55 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Adverse Events | Adverse Events (AEs) | 42 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Adverse Events | Treatment-Related AEs | 33 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Adverse Events | Serious Adverse Events (SAEs) | 31 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Adverse Events | Deaths | 13 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Adverse Events | Serious Adverse Events (SAEs) | 26 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Adverse Events | Treatment-Related AEs | 26 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Adverse Events | Adverse Events (AEs) | 32 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Adverse Events | Deaths | 20 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Adverse Events | Deaths | 41 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Adverse Events | Adverse Events (AEs) | 64 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Adverse Events | Serious Adverse Events (SAEs) | 40 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Adverse Events | Treatment-Related AEs | 61 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Adverse Events | Serious Adverse Events (SAEs) | 238 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Adverse Events | Treatment-Related AEs | 332 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Adverse Events | Deaths | 107 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Adverse Events | Adverse Events (AEs) | 365 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Adverse Events | Treatment-Related AEs | 8 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Adverse Events | Deaths | 6 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Adverse Events | Serious Adverse Events (SAEs) | 9 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Adverse Events | Adverse Events (AEs) | 10 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Adverse Events | Adverse Events (AEs) | 62 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Adverse Events | Deaths | 25 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Adverse Events | Serious Adverse Events (SAEs) | 43 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Adverse Events | Treatment-Related AEs | 35 Participants |
Secondary
Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events
Incidence of participants with high-grade (grade 3-5) select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, infusion-related, or hypersensitivity
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Population: All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nivolumab + Ipilimumab Total | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Renal: Grade 5 | 1 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Pulmonary: Grade 3-4 | 8 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 3-4 | 2 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Gastrointestinal: Grade 3-4 | 87 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hepatic: Grade 5 | 1 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Gastrointestinal: Grade 5 | 1 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hepatic: Grade 3-4 | 101 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Skin: Grade 3-4 | 39 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Renal: Grade 3-4 | 13 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Renal: Grade 5 | 1 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Renal: Grade 3-4 | 12 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hepatic: Grade 5 | 1 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Skin: Grade 3-4 | 35 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Pulmonary: Grade 3-4 | 8 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 3-4 | 2 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Gastrointestinal: Grade 3-4 | 83 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Gastrointestinal: Grade 5 | 1 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hepatic: Grade 3-4 | 93 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hepatic: Grade 3-4 | 8 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Renal: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Renal: Grade 3-4 | 1 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Gastrointestinal: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Pulmonary: Grade 3-4 | 0 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Gastrointestinal: Grade 3-4 | 4 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 3-4 | 0 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hepatic: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Skin: Grade 3-4 | 4 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Pulmonary: Grade 3-4 | 0 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Gastrointestinal: Grade 3-4 | 5 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hepatic: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Renal: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Gastrointestinal: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Skin: Grade 3-4 | 1 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hepatic: Grade 3-4 | 11 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Renal: Grade 3-4 | 1 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 3-4 | 0 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Renal: Grade 3-4 | 0 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Pulmonary: Grade 3-4 | 0 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Gastrointestinal: Grade 3-4 | 5 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Gastrointestinal: Grade 5 | 1 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Skin: Grade 3-4 | 3 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Renal: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hepatic: Grade 3-4 | 4 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hepatic: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 3-4 | 0 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Pulmonary: Grade 3-4 | 1 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Skin: Grade 3-4 | 8 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hepatic: Grade 5 | 1 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Gastrointestinal: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Renal: Grade 3-4 | 1 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hepatic: Grade 3-4 | 21 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Renal: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Gastrointestinal: Grade 3-4 | 9 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 3-4 | 0 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 3-4 | 1 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Pulmonary: Grade 3-4 | 7 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Renal: Grade 3-4 | 10 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Skin: Grade 3-4 | 22 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Gastrointestinal: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Renal: Grade 5 | 1 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hepatic: Grade 3-4 | 67 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Gastrointestinal: Grade 3-4 | 61 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hepatic: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Skin: Grade 3-4 | 1 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Gastrointestinal: Grade 3-4 | 1 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hepatic: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Renal: Grade 3-4 | 1 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 3-4 | 0 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Renal: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Pulmonary: Grade 3-4 | 0 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hepatic: Grade 3-4 | 1 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Gastrointestinal: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Renal: Grade 3-4 | 1 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Renal: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Gastrointestinal: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hepatic: Grade 3-4 | 8 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Gastrointestinal: Grade 3-4 | 11 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hepatic: Grade 5 | 0 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Pulmonary: Grade 3-4 | 0 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Hypersensitivity/Infusion Reaction: Grade 3-4 | 1 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events | Skin: Grade 3-4 | 5 Participants |
Secondary
Incidence of Participants With Laboratory Abnormalities - Liver
Safety assessment is measured by the incidence of participants who experienced a liver laboratory abnormality in Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Upper Limit of Normal (ULN)
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Population: All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups with at least one on-treatment measurement of the corresponding laboratory parameter
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nivolumab + Ipilimumab Total | Incidence of Participants With Laboratory Abnormalities - Liver | TOTAL BILIRUBIN > 2XULN | 12 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With Laboratory Abnormalities - Liver | CONCURRENT ALT OR AST ELEVATION > 3XULN; TOTAL BILIRUBIN > 2XULN IN 30 DAYS | 4 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 5XULN | 75 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 3XULN | 113 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 20XULN | 12 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 10XULN | 30 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With Laboratory Abnormalities - Liver | CONCURRENT ALT OR AST ELEVATION > 3XULN; TOTAL BILIRUBIN > 2XULN IN 1 DAY | 1 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 20XULN | 11 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 3XULN | 106 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Laboratory Abnormalities - Liver | CONCURRENT ALT OR AST ELEVATION > 3XULN; TOTAL BILIRUBIN > 2XULN IN 30 DAYS | 4 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 5XULN | 69 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Laboratory Abnormalities - Liver | CONCURRENT ALT OR AST ELEVATION > 3XULN; TOTAL BILIRUBIN > 2XULN IN 1 DAY | 1 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 10XULN | 27 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Laboratory Abnormalities - Liver | TOTAL BILIRUBIN > 2XULN | 12 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Laboratory Abnormalities - Liver | CONCURRENT ALT OR AST ELEVATION > 3XULN; TOTAL BILIRUBIN > 2XULN IN 30 DAYS | 0 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Laboratory Abnormalities - Liver | CONCURRENT ALT OR AST ELEVATION > 3XULN; TOTAL BILIRUBIN > 2XULN IN 1 DAY | 0 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 20XULN | 1 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Laboratory Abnormalities - Liver | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 5XULN | 6 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 10XULN | 3 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 3XULN | 7 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 10XULN | 0 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Laboratory Abnormalities - Liver | CONCURRENT ALT OR AST ELEVATION > 3XULN; TOTAL BILIRUBIN > 2XULN IN 30 DAYS | 0 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 20XULN | 0 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Laboratory Abnormalities - Liver | CONCURRENT ALT OR AST ELEVATION > 3XULN; TOTAL BILIRUBIN > 2XULN IN 1 DAY | 0 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 3XULN | 11 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Laboratory Abnormalities - Liver | TOTAL BILIRUBIN > 2XULN | 1 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 5XULN | 4 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 20XULN | 1 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 3XULN | 7 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 5XULN | 5 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 10XULN | 2 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Laboratory Abnormalities - Liver | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Laboratory Abnormalities - Liver | CONCURRENT ALT OR AST ELEVATION > 3XULN; TOTAL BILIRUBIN > 2XULN IN 1 DAY | 0 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Laboratory Abnormalities - Liver | CONCURRENT ALT OR AST ELEVATION > 3XULN; TOTAL BILIRUBIN > 2XULN IN 30 DAYS | 0 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 10XULN | 4 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Laboratory Abnormalities - Liver | CONCURRENT ALT OR AST ELEVATION > 3XULN; TOTAL BILIRUBIN > 2XULN IN 1 DAY | 0 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 3XULN | 21 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Laboratory Abnormalities - Liver | TOTAL BILIRUBIN > 2XULN | 3 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 20XULN | 2 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Laboratory Abnormalities - Liver | CONCURRENT ALT OR AST ELEVATION > 3XULN; TOTAL BILIRUBIN > 2XULN IN 30 DAYS | 0 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 5XULN | 13 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Laboratory Abnormalities - Liver | TOTAL BILIRUBIN > 2XULN | 8 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 20XULN | 7 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Laboratory Abnormalities - Liver | CONCURRENT ALT OR AST ELEVATION > 3XULN; TOTAL BILIRUBIN > 2XULN IN 1 DAY | 1 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Laboratory Abnormalities - Liver | CONCURRENT ALT OR AST ELEVATION > 3XULN; TOTAL BILIRUBIN > 2XULN IN 30 DAYS | 4 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 10XULN | 22 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 3XULN | 72 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 5XULN | 48 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 20XULN | 0 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 10XULN | 0 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Laboratory Abnormalities - Liver | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 5XULN | 1 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Laboratory Abnormalities - Liver | CONCURRENT ALT OR AST ELEVATION > 3XULN; TOTAL BILIRUBIN > 2XULN IN 30 DAYS | 0 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Laboratory Abnormalities - Liver | CONCURRENT ALT OR AST ELEVATION > 3XULN; TOTAL BILIRUBIN > 2XULN IN 1 DAY | 0 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 3XULN | 2 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 3XULN | 11 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Laboratory Abnormalities - Liver | CONCURRENT ALT OR AST ELEVATION > 3XULN; TOTAL BILIRUBIN > 2XULN IN 1 DAY | 0 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Laboratory Abnormalities - Liver | CONCURRENT ALT OR AST ELEVATION > 3XULN; TOTAL BILIRUBIN > 2XULN IN 30 DAYS | 0 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 5XULN | 8 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Laboratory Abnormalities - Liver | TOTAL BILIRUBIN > 2XULN | 1 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 10XULN | 2 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Laboratory Abnormalities - Liver | ALT OR AST > 20XULN | 2 Participants |
Secondary
Incidence of Participants With Laboratory Abnormalities - Thyroid
Safety assessment is measured by the incidence of participants who experienced a thyroid laboratory abnormality in Free T3 (FT3), Free T4 (FT4), Lower Limit of Normal (LLN)
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Population: All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups with at least one on-treatment TSH measurement
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nivolumab + Ipilimumab Total | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 37 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN | 130 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 59 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH TSH >= LLN AT BASELINE | 168 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH < LLN WITH FT3/FT4 TEST MISSING | 26 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH < LLN | 178 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 101 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN WITH FT3/FT4 TEST MISSING | 26 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 80 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN WITH TSH <= ULN AT BASELINE | 113 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 76 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 35 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH < LLN WITH FT3/FT4 TEST MISSING | 25 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 53 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 98 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN WITH TSH <= ULN AT BASELINE | 108 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH TSH >= LLN AT BASELINE | 159 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH < LLN | 169 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN WITH FT3/FT4 TEST MISSING | 25 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN | 123 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN WITH TSH <= ULN AT BASELINE | 5 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN | 7 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 4 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 2 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN WITH FT3/FT4 TEST MISSING | 1 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH < LLN | 9 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH TSH >= LLN AT BASELINE | 9 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 3 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 6 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH < LLN WITH FT3/FT4 TEST MISSING | 1 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH TSH >= LLN AT BASELINE | 14 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 8 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH < LLN | 14 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 7 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 3 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN WITH TSH <= ULN AT BASELINE | 11 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 5 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN | 12 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH < LLN WITH FT3/FT4 TEST MISSING | 2 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN WITH FT3/FT4 TEST MISSING | 2 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 1 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 8 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 5 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN WITH FT3/FT4 TEST MISSING | 2 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN | 8 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH < LLN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH < LLN | 11 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 3 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN WITH TSH <= ULN AT BASELINE | 6 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH TSH >= LLN AT BASELINE | 11 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH < LLN | 23 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN WITH FT3/FT4 TEST MISSING | 2 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN | 12 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 6 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH TSH >= LLN AT BASELINE | 21 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 8 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN WITH TSH <= ULN AT BASELINE | 10 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 12 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 4 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH < LLN WITH FT3/FT4 TEST MISSING | 4 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH TSH >= LLN AT BASELINE | 116 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 27 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN WITH FT3/FT4 TEST MISSING | 21 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN WITH TSH <= ULN AT BASELINE | 79 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH < LLN | 124 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH < LLN WITH FT3/FT4 TEST MISSING | 19 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 72 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN | 91 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 40 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 55 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH TSH >= LLN AT BASELINE | 4 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN WITH TSH <= ULN AT BASELINE | 3 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH < LLN | 4 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH < LLN WITH FT3/FT4 TEST MISSING | 1 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 2 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN | 4 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 2 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 1 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 2 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 12 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 7 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 3 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH < LLN | 16 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN WITH FT3/FT4 TEST MISSING | 1 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 7 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN WITH TSH <= ULN AT BASELINE | 15 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH < LLN WITH FT3/FT4 TEST MISSING | 2 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH > ULN | 15 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Laboratory Abnormalities - Thyroid | TSH <LLN WITH TSH >= LLN AT BASELINE | 16 Participants |
Secondary
Incidence of Participants With Select Adverse Events
The assessment of safety is measured by the incidence of participants who experienced any grade of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Population: All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nivolumab + Ipilimumab Total | Incidence of Participants With Select Adverse Events | Hepatic | 185 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With Select Adverse Events | Hypersensitivity/Infusion Reaction | 8 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With Select Adverse Events | Gastrointestinal | 252 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With Select Adverse Events | Pulmonary | 28 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With Select Adverse Events | Renal | 43 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With Select Adverse Events | Skin | 319 Participants |
| Nivolumab + Ipilimumab Total | Incidence of Participants With Select Adverse Events | Endocrine | 242 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Select Adverse Events | Renal | 42 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Select Adverse Events | Pulmonary | 26 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Select Adverse Events | Hypersensitivity/Infusion Reaction | 7 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Select Adverse Events | Gastrointestinal | 236 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Select Adverse Events | Endocrine | 231 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Select Adverse Events | Skin | 296 Participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Incidence of Participants With Select Adverse Events | Hepatic | 173 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Select Adverse Events | Hypersensitivity/Infusion Reaction | 1 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Select Adverse Events | Endocrine | 11 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Select Adverse Events | Renal | 1 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Select Adverse Events | Hepatic | 12 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Select Adverse Events | Gastrointestinal | 16 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Select Adverse Events | Skin | 23 Participants |
| Nivolumab + Ipilimumab ECOG PS2 | Incidence of Participants With Select Adverse Events | Pulmonary | 2 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Select Adverse Events | Skin | 23 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Select Adverse Events | Hypersensitivity/Infusion Reaction | 0 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Select Adverse Events | Renal | 4 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Select Adverse Events | Endocrine | 20 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Select Adverse Events | Pulmonary | 2 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Select Adverse Events | Hepatic | 16 Participants |
| Nivolumab + Ipilimumab Brain Metastasis | Incidence of Participants With Select Adverse Events | Gastrointestinal | 14 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Select Adverse Events | Renal | 2 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Select Adverse Events | Pulmonary | 2 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Select Adverse Events | Gastrointestinal | 13 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Select Adverse Events | Skin | 17 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Select Adverse Events | Hepatic | 7 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Select Adverse Events | Endocrine | 15 Participants |
| Nivolumab + Ipilimumab Mucosal | Incidence of Participants With Select Adverse Events | Hypersensitivity/Infusion Reaction | 0 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Select Adverse Events | Skin | 34 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Select Adverse Events | Endocrine | 29 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Select Adverse Events | Pulmonary | 3 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Select Adverse Events | Hepatic | 35 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Select Adverse Events | Renal | 2 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Select Adverse Events | Hypersensitivity/Infusion Reaction | 0 Participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Incidence of Participants With Select Adverse Events | Gastrointestinal | 31 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Select Adverse Events | Hepatic | 128 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Select Adverse Events | Renal | 34 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Select Adverse Events | Endocrine | 166 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Select Adverse Events | Hypersensitivity/Infusion Reaction | 5 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Select Adverse Events | Skin | 228 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Select Adverse Events | Pulmonary | 21 Participants |
| Nivolumab + Ipilimumab Cutaneous | Incidence of Participants With Select Adverse Events | Gastrointestinal | 175 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Select Adverse Events | Renal | 1 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Select Adverse Events | Skin | 8 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Select Adverse Events | Hepatic | 2 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Select Adverse Events | Gastrointestinal | 6 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Select Adverse Events | Hypersensitivity/Infusion Reaction | 0 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Select Adverse Events | Endocrine | 5 Participants |
| Nivolumab + Ipilimumab Acral | Incidence of Participants With Select Adverse Events | Pulmonary | 0 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Select Adverse Events | Pulmonary | 2 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Select Adverse Events | Endocrine | 27 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Select Adverse Events | Hypersensitivity/Infusion Reaction | 3 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Select Adverse Events | Gastrointestinal | 27 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Select Adverse Events | Hepatic | 13 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Select Adverse Events | Skin | 32 Participants |
| Nivolumab + Ipilimumab Other | Incidence of Participants With Select Adverse Events | Renal | 4 Participants |
Secondary
Median Time to Onset (Grades 3-4) of Select Adverse Events
Median time to onset (grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Population: All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups with at least one select adverse event from the category
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Nivolumab + Ipilimumab Total | Median Time to Onset (Grades 3-4) of Select Adverse Events | Hypersensitivity/Infusion Reaction | 291.5 Days |
| Nivolumab + Ipilimumab Total | Median Time to Onset (Grades 3-4) of Select Adverse Events | Skin | 32.0 Days |
| Nivolumab + Ipilimumab Total | Median Time to Onset (Grades 3-4) of Select Adverse Events | Hepatic | 63.0 Days |
| Nivolumab + Ipilimumab Total | Median Time to Onset (Grades 3-4) of Select Adverse Events | Endocrine | 75.0 Days |
| Nivolumab + Ipilimumab Total | Median Time to Onset (Grades 3-4) of Select Adverse Events | Gastrointestinal | 49.0 Days |
| Nivolumab + Ipilimumab Total | Median Time to Onset (Grades 3-4) of Select Adverse Events | Renal | 52.5 Days |
| Nivolumab + Ipilimumab Total | Median Time to Onset (Grades 3-4) of Select Adverse Events | Pulmonary | 51.5 Days |
| Nivolumab + Ipilimumab ECOG PS0-1 | Median Time to Onset (Grades 3-4) of Select Adverse Events | Skin | 35.0 Days |
| Nivolumab + Ipilimumab ECOG PS0-1 | Median Time to Onset (Grades 3-4) of Select Adverse Events | Gastrointestinal | 49.0 Days |
| Nivolumab + Ipilimumab ECOG PS0-1 | Median Time to Onset (Grades 3-4) of Select Adverse Events | Hepatic | 63.0 Days |
| Nivolumab + Ipilimumab ECOG PS0-1 | Median Time to Onset (Grades 3-4) of Select Adverse Events | Pulmonary | 51.5 Days |
| Nivolumab + Ipilimumab ECOG PS0-1 | Median Time to Onset (Grades 3-4) of Select Adverse Events | Renal | 43.0 Days |
| Nivolumab + Ipilimumab ECOG PS0-1 | Median Time to Onset (Grades 3-4) of Select Adverse Events | Endocrine | 75.0 Days |
| Nivolumab + Ipilimumab ECOG PS0-1 | Median Time to Onset (Grades 3-4) of Select Adverse Events | Hypersensitivity/Infusion Reaction | 291.5 Days |
| Nivolumab + Ipilimumab ECOG PS2 | Median Time to Onset (Grades 3-4) of Select Adverse Events | Hepatic | 63.0 Days |
| Nivolumab + Ipilimumab ECOG PS2 | Median Time to Onset (Grades 3-4) of Select Adverse Events | Gastrointestinal | 61.0 Days |
| Nivolumab + Ipilimumab ECOG PS2 | Median Time to Onset (Grades 3-4) of Select Adverse Events | Skin | 17.5 Days |
| Nivolumab + Ipilimumab ECOG PS2 | Median Time to Onset (Grades 3-4) of Select Adverse Events | Renal | 540.0 Days |
| Nivolumab + Ipilimumab Brain Metastasis | Median Time to Onset (Grades 3-4) of Select Adverse Events | Renal | 106.0 Days |
| Nivolumab + Ipilimumab Brain Metastasis | Median Time to Onset (Grades 3-4) of Select Adverse Events | Skin | 14.0 Days |
| Nivolumab + Ipilimumab Brain Metastasis | Median Time to Onset (Grades 3-4) of Select Adverse Events | Endocrine | 67.0 Days |
| Nivolumab + Ipilimumab Brain Metastasis | Median Time to Onset (Grades 3-4) of Select Adverse Events | Gastrointestinal | 83.0 Days |
| Nivolumab + Ipilimumab Brain Metastasis | Median Time to Onset (Grades 3-4) of Select Adverse Events | Hepatic | 64.0 Days |
| Nivolumab + Ipilimumab Mucosal | Median Time to Onset (Grades 3-4) of Select Adverse Events | Hepatic | 139.0 Days |
| Nivolumab + Ipilimumab Mucosal | Median Time to Onset (Grades 3-4) of Select Adverse Events | Endocrine | 153.0 Days |
| Nivolumab + Ipilimumab Mucosal | Median Time to Onset (Grades 3-4) of Select Adverse Events | Skin | 48.0 Days |
| Nivolumab + Ipilimumab Mucosal | Median Time to Onset (Grades 3-4) of Select Adverse Events | Gastrointestinal | 42.5 Days |
| Nivolumab + Ipilimumab Ocular/Uveal | Median Time to Onset (Grades 3-4) of Select Adverse Events | Pulmonary | 51.0 Days |
| Nivolumab + Ipilimumab Ocular/Uveal | Median Time to Onset (Grades 3-4) of Select Adverse Events | Gastrointestinal | 39.0 Days |
| Nivolumab + Ipilimumab Ocular/Uveal | Median Time to Onset (Grades 3-4) of Select Adverse Events | Skin | 36.5 Days |
| Nivolumab + Ipilimumab Ocular/Uveal | Median Time to Onset (Grades 3-4) of Select Adverse Events | Hepatic | 64.0 Days |
| Nivolumab + Ipilimumab Ocular/Uveal | Median Time to Onset (Grades 3-4) of Select Adverse Events | Endocrine | 70.0 Days |
| Nivolumab + Ipilimumab Ocular/Uveal | Median Time to Onset (Grades 3-4) of Select Adverse Events | Renal | 23.0 Days |
| Nivolumab + Ipilimumab Cutaneous | Median Time to Onset (Grades 3-4) of Select Adverse Events | Pulmonary | 52.0 Days |
| Nivolumab + Ipilimumab Cutaneous | Median Time to Onset (Grades 3-4) of Select Adverse Events | Gastrointestinal | 49.0 Days |
| Nivolumab + Ipilimumab Cutaneous | Median Time to Onset (Grades 3-4) of Select Adverse Events | Renal | 106.0 Days |
| Nivolumab + Ipilimumab Cutaneous | Median Time to Onset (Grades 3-4) of Select Adverse Events | Skin | 17.5 Days |
| Nivolumab + Ipilimumab Cutaneous | Median Time to Onset (Grades 3-4) of Select Adverse Events | Hepatic | 62.0 Days |
| Nivolumab + Ipilimumab Cutaneous | Median Time to Onset (Grades 3-4) of Select Adverse Events | Endocrine | 71.5 Days |
| Nivolumab + Ipilimumab Cutaneous | Median Time to Onset (Grades 3-4) of Select Adverse Events | Hypersensitivity/Infusion Reaction | 22.0 Days |
| Nivolumab + Ipilimumab Acral | Median Time to Onset (Grades 3-4) of Select Adverse Events | Hepatic | 101.0 Days |
| Nivolumab + Ipilimumab Acral | Median Time to Onset (Grades 3-4) of Select Adverse Events | Skin | 89.0 Days |
| Nivolumab + Ipilimumab Acral | Median Time to Onset (Grades 3-4) of Select Adverse Events | Endocrine | 114.0 Days |
| Nivolumab + Ipilimumab Acral | Median Time to Onset (Grades 3-4) of Select Adverse Events | Gastrointestinal | 7.0 Days |
| Nivolumab + Ipilimumab Acral | Median Time to Onset (Grades 3-4) of Select Adverse Events | Renal | 16.0 Days |
| Nivolumab + Ipilimumab Other | Median Time to Onset (Grades 3-4) of Select Adverse Events | Renal | 6.0 Days |
| Nivolumab + Ipilimumab Other | Median Time to Onset (Grades 3-4) of Select Adverse Events | Endocrine | 39.5 Days |
| Nivolumab + Ipilimumab Other | Median Time to Onset (Grades 3-4) of Select Adverse Events | Skin | 100.0 Days |
| Nivolumab + Ipilimumab Other | Median Time to Onset (Grades 3-4) of Select Adverse Events | Hepatic | 80.0 Days |
| Nivolumab + Ipilimumab Other | Median Time to Onset (Grades 3-4) of Select Adverse Events | Gastrointestinal | 79.0 Days |
| Nivolumab + Ipilimumab Other | Median Time to Onset (Grades 3-4) of Select Adverse Events | Hypersensitivity/Infusion Reaction | 561.0 Days |
Secondary
Median Time to Resolution (Grades 3-4) of Select Adverse Events
Median time to resolution (Grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Population: All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups with at least one select adverse event from the category
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Nivolumab + Ipilimumab Total | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Pulmonary | 19.0 Days |
| Nivolumab + Ipilimumab Total | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Renal | 19.0 Days |
| Nivolumab + Ipilimumab Total | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Hypersensitivity/Infusion Reaction | 4.5 Days |
| Nivolumab + Ipilimumab Total | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Gastrointestinal | 22.0 Days |
| Nivolumab + Ipilimumab Total | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Endocrine | NA Days |
| Nivolumab + Ipilimumab Total | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Hepatic | 42.0 Days |
| Nivolumab + Ipilimumab Total | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Skin | 24.0 Days |
| Nivolumab + Ipilimumab ECOG PS0-1 | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Pulmonary | 19.0 Days |
| Nivolumab + Ipilimumab ECOG PS0-1 | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Endocrine | NA Days |
| Nivolumab + Ipilimumab ECOG PS0-1 | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Renal | 23.0 Days |
| Nivolumab + Ipilimumab ECOG PS0-1 | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Hypersensitivity/Infusion Reaction | 4.5 Days |
| Nivolumab + Ipilimumab ECOG PS0-1 | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Skin | 24.0 Days |
| Nivolumab + Ipilimumab ECOG PS0-1 | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Gastrointestinal | 22.0 Days |
| Nivolumab + Ipilimumab ECOG PS0-1 | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Hepatic | 38.0 Days |
| Nivolumab + Ipilimumab ECOG PS2 | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Skin | 20.0 Days |
| Nivolumab + Ipilimumab ECOG PS2 | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Hepatic | 67.0 Days |
| Nivolumab + Ipilimumab ECOG PS2 | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Gastrointestinal | NA Days |
| Nivolumab + Ipilimumab ECOG PS2 | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Renal | 11.0 Days |
| Nivolumab + Ipilimumab Brain Metastasis | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Renal | 7.0 Days |
| Nivolumab + Ipilimumab Brain Metastasis | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Gastrointestinal | 107.5 Days |
| Nivolumab + Ipilimumab Brain Metastasis | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Skin | 67.0 Days |
| Nivolumab + Ipilimumab Brain Metastasis | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Hepatic | 17.5 Days |
| Nivolumab + Ipilimumab Brain Metastasis | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Endocrine | NA Days |
| Nivolumab + Ipilimumab Mucosal | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Gastrointestinal | 25.0 Days |
| Nivolumab + Ipilimumab Mucosal | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Endocrine | NA Days |
| Nivolumab + Ipilimumab Mucosal | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Skin | 8.0 Days |
| Nivolumab + Ipilimumab Mucosal | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Hepatic | 126.0 Days |
| Nivolumab + Ipilimumab Ocular/Uveal | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Gastrointestinal | 14.0 Days |
| Nivolumab + Ipilimumab Ocular/Uveal | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Hepatic | 55.0 Days |
| Nivolumab + Ipilimumab Ocular/Uveal | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Pulmonary | 6.0 Days |
| Nivolumab + Ipilimumab Ocular/Uveal | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Skin | 17.5 Days |
| Nivolumab + Ipilimumab Ocular/Uveal | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Renal | 23.0 Days |
| Nivolumab + Ipilimumab Ocular/Uveal | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Endocrine | NA Days |
| Nivolumab + Ipilimumab Cutaneous | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Endocrine | NA Days |
| Nivolumab + Ipilimumab Cutaneous | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Hypersensitivity/Infusion Reaction | 2.0 Days |
| Nivolumab + Ipilimumab Cutaneous | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Skin | 24.0 Days |
| Nivolumab + Ipilimumab Cutaneous | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Pulmonary | 30.0 Days |
| Nivolumab + Ipilimumab Cutaneous | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Gastrointestinal | 23.0 Days |
| Nivolumab + Ipilimumab Cutaneous | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Renal | 11.0 Days |
| Nivolumab + Ipilimumab Cutaneous | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Hepatic | 30.0 Days |
| Nivolumab + Ipilimumab Acral | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Skin | 15.0 Days |
| Nivolumab + Ipilimumab Acral | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Renal | NA Days |
| Nivolumab + Ipilimumab Acral | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Gastrointestinal | 5.0 Days |
| Nivolumab + Ipilimumab Acral | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Hepatic | 29.0 Days |
| Nivolumab + Ipilimumab Acral | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Endocrine | NA Days |
| Nivolumab + Ipilimumab Other | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Renal | 66.0 Days |
| Nivolumab + Ipilimumab Other | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Endocrine | NA Days |
| Nivolumab + Ipilimumab Other | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Hepatic | 117.0 Days |
| Nivolumab + Ipilimumab Other | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Gastrointestinal | 12.0 Days |
| Nivolumab + Ipilimumab Other | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Skin | 28.0 Days |
| Nivolumab + Ipilimumab Other | Median Time to Resolution (Grades 3-4) of Select Adverse Events | Hypersensitivity/Infusion Reaction | 7.0 Days |
Secondary
Objective Response Rate (ORR)
Objective response rate is defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of all treated participants
Time frame: Up to approximately 37 months
Population: All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab + Ipilimumab Total | Objective Response Rate (ORR) | 44.5 Percentage of participants |
| Nivolumab + Ipilimumab ECOG PS0-1 | Objective Response Rate (ORR) | 46.1 Percentage of participants |
| Nivolumab + Ipilimumab ECOG PS2 | Objective Response Rate (ORR) | 30.9 Percentage of participants |
| Nivolumab + Ipilimumab Brain Metastasis | Objective Response Rate (ORR) | 52.4 Percentage of participants |
| Nivolumab + Ipilimumab Mucosal | Objective Response Rate (ORR) | 43.8 Percentage of participants |
| Nivolumab + Ipilimumab Ocular/Uveal | Objective Response Rate (ORR) | 9.4 Percentage of participants |
| Nivolumab + Ipilimumab Cutaneous | Objective Response Rate (ORR) | 51.2 Percentage of participants |
| Nivolumab + Ipilimumab Acral | Objective Response Rate (ORR) | 30.0 Percentage of participants |
| Nivolumab + Ipilimumab Other | Objective Response Rate (ORR) | 43.5 Percentage of participants |
Secondary
Overall Survival (OS)
Overall survival is defined from the time of first dosing date to the date of death. A participant who has not died will be censored at the last known date alive
Time frame: Up to approximately 37 months
Population: All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab + Ipilimumab Total | Overall Survival (OS) | NA Months |
| Nivolumab + Ipilimumab ECOG PS0-1 | Overall Survival (OS) | NA Months |
| Nivolumab + Ipilimumab ECOG PS2 | Overall Survival (OS) | 11.01 Months |
| Nivolumab + Ipilimumab Brain Metastasis | Overall Survival (OS) | NA Months |
| Nivolumab + Ipilimumab Mucosal | Overall Survival (OS) | 12.55 Months |
| Nivolumab + Ipilimumab Ocular/Uveal | Overall Survival (OS) | 15.21 Months |
| Nivolumab + Ipilimumab Cutaneous | Overall Survival (OS) | NA Months |
| Nivolumab + Ipilimumab Acral | Overall Survival (OS) | 20.83 Months |
| Nivolumab + Ipilimumab Other | Overall Survival (OS) | 34.76 Months |
Secondary
Progression Free Survival (PFS)
Progression free survival per investigator assessment is defined as radiological evidence of progression, significant clinical symptomatic progression, or the need to introduce a non-study drug therapy.
Time frame: Up to approximately 37 months
Population: All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab + Ipilimumab Total | Progression Free Survival (PFS) | 4.96 Months |
| Nivolumab + Ipilimumab ECOG PS0-1 | Progression Free Survival (PFS) | 5.45 Months |
| Nivolumab + Ipilimumab ECOG PS2 | Progression Free Survival (PFS) | 2.46 Months |
| Nivolumab + Ipilimumab Brain Metastasis | Progression Free Survival (PFS) | 3.35 Months |
| Nivolumab + Ipilimumab Mucosal | Progression Free Survival (PFS) | 2.94 Months |
| Nivolumab + Ipilimumab Ocular/Uveal | Progression Free Survival (PFS) | 2.83 Months |
| Nivolumab + Ipilimumab Cutaneous | Progression Free Survival (PFS) | 6.77 Months |
| Nivolumab + Ipilimumab Acral | Progression Free Survival (PFS) | 2.56 Months |
| Nivolumab + Ipilimumab Other | Progression Free Survival (PFS) | 5.22 Months |
Secondary
Time to Resolution of an Adverse Event (AE)
Resolution of an adverse event (AE) is defined as a participant experiencing complete resolution or improvement to the baseline of any grade AE including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity
Time frame: From first dose to 30 days after last dose (up to approximately 37 months)
Population: All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups with at least one select adverse event from the category
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Nivolumab + Ipilimumab Total | Time to Resolution of an Adverse Event (AE) | Hypersensitivity/Infusion Reaction | 1.0 Days |
| Nivolumab + Ipilimumab Total | Time to Resolution of an Adverse Event (AE) | Gastrointestinal | 18.0 Days |
| Nivolumab + Ipilimumab Total | Time to Resolution of an Adverse Event (AE) | Renal | 56.0 Days |
| Nivolumab + Ipilimumab Total | Time to Resolution of an Adverse Event (AE) | Pulmonary | 35.0 Days |
| Nivolumab + Ipilimumab Total | Time to Resolution of an Adverse Event (AE) | Endocrine | NA Days |
| Nivolumab + Ipilimumab Total | Time to Resolution of an Adverse Event (AE) | Hepatic | 44.0 Days |
| Nivolumab + Ipilimumab Total | Time to Resolution of an Adverse Event (AE) | Skin | 89.0 Days |
| Nivolumab + Ipilimumab ECOG PS0-1 | Time to Resolution of an Adverse Event (AE) | Renal | 56.0 Days |
| Nivolumab + Ipilimumab ECOG PS0-1 | Time to Resolution of an Adverse Event (AE) | Endocrine | NA Days |
| Nivolumab + Ipilimumab ECOG PS0-1 | Time to Resolution of an Adverse Event (AE) | Pulmonary | 43.0 Days |
| Nivolumab + Ipilimumab ECOG PS0-1 | Time to Resolution of an Adverse Event (AE) | Gastrointestinal | 18.0 Days |
| Nivolumab + Ipilimumab ECOG PS0-1 | Time to Resolution of an Adverse Event (AE) | Hypersensitivity/Infusion Reaction | 1.0 Days |
| Nivolumab + Ipilimumab ECOG PS0-1 | Time to Resolution of an Adverse Event (AE) | Skin | 88.0 Days |
| Nivolumab + Ipilimumab ECOG PS0-1 | Time to Resolution of an Adverse Event (AE) | Hepatic | 43.0 Days |
| Nivolumab + Ipilimumab ECOG PS2 | Time to Resolution of an Adverse Event (AE) | Gastrointestinal | 12.0 Days |
| Nivolumab + Ipilimumab ECOG PS2 | Time to Resolution of an Adverse Event (AE) | Skin | NA Days |
| Nivolumab + Ipilimumab ECOG PS2 | Time to Resolution of an Adverse Event (AE) | Hypersensitivity/Infusion Reaction | 1.0 Days |
| Nivolumab + Ipilimumab ECOG PS2 | Time to Resolution of an Adverse Event (AE) | Pulmonary | 7.5 Days |
| Nivolumab + Ipilimumab ECOG PS2 | Time to Resolution of an Adverse Event (AE) | Hepatic | 80.5 Days |
| Nivolumab + Ipilimumab ECOG PS2 | Time to Resolution of an Adverse Event (AE) | Endocrine | NA Days |
| Nivolumab + Ipilimumab ECOG PS2 | Time to Resolution of an Adverse Event (AE) | Renal | 11.0 Days |
| Nivolumab + Ipilimumab Brain Metastasis | Time to Resolution of an Adverse Event (AE) | Hepatic | 20.5 Days |
| Nivolumab + Ipilimumab Brain Metastasis | Time to Resolution of an Adverse Event (AE) | Gastrointestinal | 36.0 Days |
| Nivolumab + Ipilimumab Brain Metastasis | Time to Resolution of an Adverse Event (AE) | Skin | 257.0 Days |
| Nivolumab + Ipilimumab Brain Metastasis | Time to Resolution of an Adverse Event (AE) | Renal | 5.5 Days |
| Nivolumab + Ipilimumab Brain Metastasis | Time to Resolution of an Adverse Event (AE) | Pulmonary | NA Days |
| Nivolumab + Ipilimumab Brain Metastasis | Time to Resolution of an Adverse Event (AE) | Endocrine | NA Days |
| Nivolumab + Ipilimumab Mucosal | Time to Resolution of an Adverse Event (AE) | Skin | 84.0 Days |
| Nivolumab + Ipilimumab Mucosal | Time to Resolution of an Adverse Event (AE) | Pulmonary | NA Days |
| Nivolumab + Ipilimumab Mucosal | Time to Resolution of an Adverse Event (AE) | Renal | 9.5 Days |
| Nivolumab + Ipilimumab Mucosal | Time to Resolution of an Adverse Event (AE) | Hepatic | 97.0 Days |
| Nivolumab + Ipilimumab Mucosal | Time to Resolution of an Adverse Event (AE) | Gastrointestinal | 14.0 Days |
| Nivolumab + Ipilimumab Mucosal | Time to Resolution of an Adverse Event (AE) | Endocrine | NA Days |
| Nivolumab + Ipilimumab Ocular/Uveal | Time to Resolution of an Adverse Event (AE) | Endocrine | NA Days |
| Nivolumab + Ipilimumab Ocular/Uveal | Time to Resolution of an Adverse Event (AE) | Gastrointestinal | 14.0 Days |
| Nivolumab + Ipilimumab Ocular/Uveal | Time to Resolution of an Adverse Event (AE) | Skin | 33.5 Days |
| Nivolumab + Ipilimumab Ocular/Uveal | Time to Resolution of an Adverse Event (AE) | Pulmonary | 19.0 Days |
| Nivolumab + Ipilimumab Ocular/Uveal | Time to Resolution of an Adverse Event (AE) | Renal | 27.5 Days |
| Nivolumab + Ipilimumab Ocular/Uveal | Time to Resolution of an Adverse Event (AE) | Hepatic | 34.0 Days |
| Nivolumab + Ipilimumab Cutaneous | Time to Resolution of an Adverse Event (AE) | Gastrointestinal | 19.0 Days |
| Nivolumab + Ipilimumab Cutaneous | Time to Resolution of an Adverse Event (AE) | Pulmonary | 43.0 Days |
| Nivolumab + Ipilimumab Cutaneous | Time to Resolution of an Adverse Event (AE) | Skin | 102.0 Days |
| Nivolumab + Ipilimumab Cutaneous | Time to Resolution of an Adverse Event (AE) | Renal | 56.0 Days |
| Nivolumab + Ipilimumab Cutaneous | Time to Resolution of an Adverse Event (AE) | Hepatic | 37.0 Days |
| Nivolumab + Ipilimumab Cutaneous | Time to Resolution of an Adverse Event (AE) | Endocrine | NA Days |
| Nivolumab + Ipilimumab Cutaneous | Time to Resolution of an Adverse Event (AE) | Hypersensitivity/Infusion Reaction | 1.0 Days |
| Nivolumab + Ipilimumab Acral | Time to Resolution of an Adverse Event (AE) | Renal | NA Days |
| Nivolumab + Ipilimumab Acral | Time to Resolution of an Adverse Event (AE) | Gastrointestinal | 5.0 Days |
| Nivolumab + Ipilimumab Acral | Time to Resolution of an Adverse Event (AE) | Endocrine | NA Days |
| Nivolumab + Ipilimumab Acral | Time to Resolution of an Adverse Event (AE) | Skin | 46.0 Days |
| Nivolumab + Ipilimumab Acral | Time to Resolution of an Adverse Event (AE) | Hepatic | 129.0 Days |
| Nivolumab + Ipilimumab Other | Time to Resolution of an Adverse Event (AE) | Pulmonary | NA Days |
| Nivolumab + Ipilimumab Other | Time to Resolution of an Adverse Event (AE) | Hepatic | 29.0 Days |
| Nivolumab + Ipilimumab Other | Time to Resolution of an Adverse Event (AE) | Endocrine | NA Days |
| Nivolumab + Ipilimumab Other | Time to Resolution of an Adverse Event (AE) | Skin | 59.5 Days |
| Nivolumab + Ipilimumab Other | Time to Resolution of an Adverse Event (AE) | Hypersensitivity/Infusion Reaction | 1.0 Days |
| Nivolumab + Ipilimumab Other | Time to Resolution of an Adverse Event (AE) | Renal | NA Days |
| Nivolumab + Ipilimumab Other | Time to Resolution of an Adverse Event (AE) | Gastrointestinal | 36.0 Days |