Trial Outcomes & Findings for Nivolumab Plus Axitinib in Patients With Anti-PD1 Refractory Advanced Melanoma (NCT NCT04493203)

NCT ID: NCT04493203

Last Updated: 2025-07-15

Results Overview

Percentage of patients who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 31 participants
• Primary outcome timeframe: Up to 12 weeks from baseline (after treatment)
• Results posted on: 2025-07-15

Participant Flow

Participant milestones

Measure	Nivolumab Plus Axitinib Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Overall Study STARTED	31
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nivolumab Plus Axitinib in Patients With Anti-PD1 Refractory Advanced Melanoma

Baseline characteristics by cohort

Measure	Nivolumab Plus Axitinib n=31 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Age, Continuous	67.2903 years STANDARD_DEVIATION 12.8924 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients who were evaluable for radiologic response.

Percentage of patients who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=31 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Overall Response Rate (ORR)	10 percentage of patients Interval 2.0 to 25.8

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients who were previously treated with Ipilimumab/Nivolumab and were evaluable for radiologic response.

Percentage of patients (prior Ipilimumab/Nivolumab treatment) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=16 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Overall Response Rate (ORR) - Prior Ipilimumab / Nivolumab Treatment	6.3 percentage of patients Interval 0.2 to 30.2

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients who were not previously treated with Ipilimumab/Nivolumab and were evaluable for radiologic response.

Percentage of patients (no prior Ipilimumab/Nivolumab treatment) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=15 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Overall Response Rate (ORR) - no Prior Ipilimumab / Nivolumab	13.3 percentage of patients Interval 1.7 to 40.5

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients who received \<=3 prior lines of therapy and were evaluable for radiologic response.

Percentage of patients (<=3 prior lines of therapy) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=20 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Overall Response Rate (ORR) - Prior Lines of Therapy <=3	15 percentage of patients Interval 3.2 to 37.9

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients who received \>3 prior lines of therapy were evaluable for radiologic response.

Percentage of patients (>3 prior lines of therapy) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=11 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Overall Response Rate (ORR) - Prior Lines of Therapy >3	0 percentage of patients Interval 0.0 to 28.5

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients who were evaluable for radiologic response.

Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per iRECIST. (CR): disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. (PR): at least 30% decrease in sum of diameters of target lesions, with reference the baseline sum diameters. Can have had iUPD (one or more instances), but not iCPD, before iCR, iPR, or iSD

Outcome measures

Measure	Nivolumab Plus Axitinib n=15 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Overall Response Rate (ORR) by iRECIST	0 percentage of patients Interval 0.0 to 21.8

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients who were evaluable for radiologic response.

Percentage of patients (with primary IO resistance) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=15 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Overall Response Rate (ORR) - Primary IO Resistance	0 percentage of patients Interval 0.0 to 21.8

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients who were evaluable for radiologic response.

Percentage of patients (with secondary IO resistance) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=16 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Overall Response Rate (ORR) - Secondary IO Resistance	18.8 percentage of patients Interval 4.0 to 45.6

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients with acral histology who were evaluable for radiologic response.

Percentage of patients (acral histology) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=7 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Overall Response Rate (ORR) - Acral Histology	14.3 percentage of patients Interval 0.4 to 57.9

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients with cutaneous histology who were evaluable for radiologic response.

Percentage of patients (with cutaneous histology) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=17 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Overall Response Rate (ORR) - Cutaneous Histology	5.9 percentage of patients Interval 0.1 to 28.7

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients with mucosal histology who were evaluable for radiologic response.

Percentage of patients (with mucosal histology) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=7 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Overall Response Rate (ORR) - Mucosal Histology	14.3 percentage of patients Interval 0.4 to 57.9

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients who were evaluable for radiologic response.

Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

Outcome measures

Measure	Nivolumab Plus Axitinib n=31 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Disease Control Rate (DCR)	45.2 percentage of patients Interval 27.3 to 64.0

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients who were not previously treated with Ipilimumab /Nivolumab and were evaluable for radiologic response.

Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

Outcome measures

Measure	Nivolumab Plus Axitinib n=15 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Disease Control Rate (DCR) - no Prior Ipilimumab / Nivolumab Treatment	33.3 percentage of patients Interval 11.8 to 61.6

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients who were previously treated with Ipilimumab /Nivolumab and were evaluable for radiologic response.

Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

Outcome measures

Measure	Nivolumab Plus Axitinib n=16 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Disease Control Rate (DCR) - Prior Ipilimumab / Nivolumab Treatment	56.3 percentage of patients Interval 29.9 to 80.2

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients who received\<=3 prior lines of therapy and were evaluable for radiologic response.

Percentage of patients (<=3 prior lines of therapy) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

Outcome measures

Measure	Nivolumab Plus Axitinib n=20 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Disease Control Rate (DCR) - Prior Lines of Therapy <=3	50 percentage of patients Interval 27.2 to 72.8

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients who received \>3 prior lines of therapy and were evaluable for radiologic response.

Percentage of patients (>3 prior lines of therapy) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

Outcome measures

Measure	Nivolumab Plus Axitinib n=11 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Disease Control Rate (DCR) - Prior Lines of Therapy >3	36.4 percentage of patients Interval 10.9 to 69.2

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients who were evaluable for radiologic response.

Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per iRECIST. (CR): disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. (PR): at least 30% decrease in sum of diameters of target lesions, with reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference the smallest sum diameters while on study. Can have had iUPD (one or more instances), but not iCPD, before iCR, iPR, or iSD

Outcome measures

Measure	Nivolumab Plus Axitinib n=15 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Disease Control Rate (DCR) by iRECIST	40.0 percentage of patients Interval 16.3 to 67.7

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients with secondary IO resistance who were evaluable for radiologic response.

Percentage of patients (with secondary IO resistance) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

Outcome measures

Measure	Nivolumab Plus Axitinib n=16 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Disease Control Rate (DCR) - Secondary IO Resistance	37.5 percentage of patients Interval 15.2 to 64.6

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients with primary IO resistance who were evaluable for radiologic response.

Percentage of patients (with primary IO resistance) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

Outcome measures

Measure	Nivolumab Plus Axitinib n=15 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Disease Control Rate (DCR) - Primary IO Resistance	53.3 percentage of patients Interval 26.6 to 78.7

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients with acral histology who were evaluable for radiologic response.

Percentage of patients (with acral histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

Outcome measures

Measure	Nivolumab Plus Axitinib n=7 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Disease Control Rate (DCR) - Acral Histology	71.4 percentage of patients Interval 29.0 to 96.3

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients with cutaneous histology who were evaluable for radiologic response.

Percentage of patients (with cutaneous histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

Outcome measures

Measure	Nivolumab Plus Axitinib n=17 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Disease Control Rate (DCR) - Cutaneous Histology	35.3 percentage of patients Interval 14.2 to 61.7

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients with mucosal histology who were evaluable for radiologic response.

Percentage of patients (with mucosal histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

Outcome measures

Measure	Nivolumab Plus Axitinib n=7 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Disease Control Rate (DCR) - Mucosal Histology	42.9 percentage of patients Interval 9.9 to 81.6

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients who were evaluable for radiologic response.

Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).

Outcome measures

Measure	Nivolumab Plus Axitinib n=31 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Best Response Partial Response	10 percentage of patients
Best Response Stable Disease	35 percentage of patients
Best Response Progressive Disease	55 percentage of patients

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients who were not previously treated with Ipilimumab /Nivolumab and were evaluable for radiologic response.

Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).

Outcome measures

Measure	Nivolumab Plus Axitinib n=15 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Best Response - no Prior Ipilimumab / Nivolumab Partial Response	13.3 percentage of patients
Best Response - no Prior Ipilimumab / Nivolumab Stable Disease	20.0 percentage of patients
Best Response - no Prior Ipilimumab / Nivolumab Progressive Disease	66.7 percentage of patients

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients who were previously treated with Ipilimumab/Nivolumab and were evaluable for radiologic response.

Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).

Outcome measures

Measure	Nivolumab Plus Axitinib n=16 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Best Response - Prior Ipilimumab / Nivolumab Treatment Partial Response	6.3 percentage of patients
Best Response - Prior Ipilimumab / Nivolumab Treatment Stable Disease	50.0 percentage of patients
Best Response - Prior Ipilimumab / Nivolumab Treatment Progressive Disease	43.8 percentage of patients

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients with acral histology who were evaluable for radiologic response.

Percentage of patients (with acral histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).

Outcome measures

Measure	Nivolumab Plus Axitinib n=7 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Best Response - Acral Histology Partial Response	14.3 percentage of patients
Best Response - Acral Histology Stable Disease	57.1 percentage of patients
Best Response - Acral Histology Progressive Disease	28.6 percentage of patients

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients with cutaneous histology who were evaluable for radiologic response.

Percentage of patients (with cutaneous histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression

Outcome measures

Measure	Nivolumab Plus Axitinib n=17 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Best Response - Cutaneous Histology Partial Response	5.9 percentage of patients
Best Response - Cutaneous Histology Stable Disease	29.4 percentage of patients
Best Response - Cutaneous Histology Progressive Disease	64.7 percentage of patients

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients with mucosal histology who were evaluable for radiologic response.

Percentage of patients (with mucosal histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression

Outcome measures

Measure	Nivolumab Plus Axitinib n=7 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Best Response - Mucosal Histology Partial Response	14.3 percentage of patients
Best Response - Mucosal Histology Stable Disease	28.6 percentage of patients
Best Response - Mucosal Histology Progressive Disease	57.1 percentage of patients

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients who received \<=3 prior lines of therapy and were evaluable for radiologic response.

Percentage of patients (<=3 prior lines of therapy) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).

Outcome measures

Measure	Nivolumab Plus Axitinib n=20 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Best Response - Prior Lines of Therapy <=3 Partial Response	15.0 percentage of patients
Best Response - Prior Lines of Therapy <=3 Stable Disease	35.0 percentage of patients
Best Response - Prior Lines of Therapy <=3 Progressive Disease	50.0 percentage of patients

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients who received \<=3 prior lines of therapy and were evaluable for radiologic response.

Percentage of patients (>3 prior lines of therapy) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).

Outcome measures

Measure	Nivolumab Plus Axitinib n=11 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Best Response - Prior Lines of Therapy >3 Partial Response	0 percentage of patients
Best Response - Prior Lines of Therapy >3 Stable Disease	36.4 percentage of patients
Best Response - Prior Lines of Therapy >3 Progressive Disease	63.6 percentage of patients

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients who were evaluable for radiologic response.

Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per iRECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Can have had iUPD (one or more instances), but not iCPD, before iCR, iPR, or iSD

Outcome measures

Measure	Nivolumab Plus Axitinib n=15 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Best Response by iRECIST iCPD/iUPD	60 percentage of patients
Best Response by iRECIST iSD	40 percentage of patients

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients with primary IO resistance who were evaluable for radiologic response.

Percentage of patients (w/ primary IO resistance) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progres

Outcome measures

Measure	Nivolumab Plus Axitinib n=15 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Best Response - Primary IO Resistance Partial Response	0.0 percentage of patients
Best Response - Primary IO Resistance Stable Disease	53.3 percentage of patients
Best Response - Primary IO Resistance Progressive Disease	46.7 percentage of patients

PRIMARY outcome

Timeframe: Up to 12 weeks from baseline (after treatment)

Population: Treated patients with secondary IO resistance who were evaluable for radiologic response.

Percentage of patients (w/ secondary IO resistance) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progres

Outcome measures

Measure	Nivolumab Plus Axitinib n=16 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Best Response - Secondary IO Resistance Partial Response	18.8 percentage of patients
Best Response - Secondary IO Resistance Stable Disease	18.8 percentage of patients
Best Response - Secondary IO Resistance Progressive Disease	62.5 percentage of patients

SECONDARY outcome

Timeframe: Up to 45 months

Population: All enrolled patients.

The median number of months from the start of treatment that patients remain alive, until death from any cause.

Outcome measures

Measure	Nivolumab Plus Axitinib n=31 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Overall Survival (OS) - Overall Cohort	10.0 months Interval 7.0 to 16.0

SECONDARY outcome

Timeframe: Up to12 months

Population: All enrolled patients.

Percentage of patients alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.

Outcome measures

Measure	Nivolumab Plus Axitinib n=31 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Overall Survival (OS)	71 percentage of patients Interval 52.0 to 84.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: All enrolled patients.

Percentage of patients alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.

Outcome measures

Measure	Nivolumab Plus Axitinib n=31 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Overall Survival (OS)	35 percentage of patients Interval 19.0 to 52.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: All enrolled patients.

Percentage of patients alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.

Outcome measures

Measure	Nivolumab Plus Axitinib n=30 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Overall Survival (OS)	21 percentage of patients Interval 9.0 to 37.0

SECONDARY outcome

Timeframe: Up to 45 months

Population: Treated patients who received prior Ipilimumab/Nivolumab treatment.

The median number of months from the start of treatment that patients (who received prior Ipilimumab/Nivolumab treatment) remained alive, until death from any cause.

Outcome measures

Measure	Nivolumab Plus Axitinib n=16 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Overall Survival (OS) - Prior Ipilimumab/Nivolumab Treatment	7.0 months Interval 5.0 to 16.0

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients who were previously treated with Ipilimumab/Nivolumab.

Percentage of patients (previously treated with Ipilimumab/Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.

Outcome measures

Measure	Nivolumab Plus Axitinib n=16 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Overall Survival (OS) - Prior Ipilimumab /Nivolumab Treatment	50 percentage of patients Interval 25.0 to 71.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients who were previously treated with Ipilimumab/Nivolumab.

Percentage of patients (previously treated with Ipilimumab/Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.

Outcome measures

Measure	Nivolumab Plus Axitinib n=16 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Overall Survival (OS) - Prior Ipilimumab / Nivolumab Treatment	31 percentage of patients Interval 11.0 to 54.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients who were previously treated with Ipilimumab /Nivolumab.

Percentage of patients (previously treated with Ipilimumab/Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.

Outcome measures

Measure	Nivolumab Plus Axitinib n=16 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Overall Survival (OS) - Prior Ipilimumab / Nivolumab Treatment	19 percentage of patients Interval 5.0 to 40.0

SECONDARY outcome

Timeframe: Up to 45 months

Population: Treated patients who do not receive prior Ipilimumab /Nivolumab treatment.

The median number of months from the start of treatment that patients (who did not receive prior Ipilimumab /Nivolumab treatment) remained alive, until death from any cause.

Outcome measures

Measure	Nivolumab Plus Axitinib n=15 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Overall Survival (OS) - no Prior Ipilimumab / Nivolumab Treatment	11.0 months Interval 7.0 to 23.0

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients who were not previously treated with Ipilimumab/Nivolumab.

Percentage of patients (not previously treated with Ipilimumab /Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.

Outcome measures

Measure	Nivolumab Plus Axitinib n=15 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Overall Survival (OS) - no Prior Ipilimumab /Nivolumab Treatment	93 percentage of patients Interval 61.0 to 99.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients who were not previously treated with Ipilimumab/Nivolumab.

Percentage of patients (not previously treated with Ipilimumab /Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.

Outcome measures

Measure	Nivolumab Plus Axitinib n=15 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Overall Survival (OS) - no Prior Ipilimumab /Nivolumab Treatment	40 percentage of patients Interval 16.0 to 63.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients who were not previously treated with Ipilimumab/Nivolumab.

Percentage of patients (not previously treated with Ipilimumab/Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.

Outcome measures

Measure	Nivolumab Plus Axitinib n=15 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Overall Survival (OS) - no Prior Ipilimumab /Nivolumab Treatment	24 percentage of patients Interval 6.0 to 48.0

SECONDARY outcome

Timeframe: Up to 45 months

Population: Treated patients with acral melanoma histology.

The median number of months from the start of treatment that patients (with acral histology) remain alive, until death from any cause in patients with acral melanoma histology.

Outcome measures

Measure	Nivolumab Plus Axitinib n=7 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Overall Survival (OS) - Acral Histology	8.00 months Interval 2.0 to 11.0

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients with acral melanoma histology.

Percentage of patients with acral melanoma histology that remain alive up to 6 months from start of treatment until death from any cause.

Outcome measures

Measure	Nivolumab Plus Axitinib n=7 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Overall Survival (OS) - Acral Histology	57 percentage of patients Interval 17.0 to 84.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients with acral melanoma histology.

Percentage of patients with acral melanoma histology that remain alive up to 12 months from start of treatment until death from any cause.

Outcome measures

Measure	Nivolumab Plus Axitinib n=7 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Overall Survival (OS) - Acral Histology	14 percentage of patients Interval 1.0 to 46.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients with acral melanoma histology.

Percentage of patients with acral melanoma histology that remain alive up to 24 months from start of treatment until death from any cause.

Outcome measures

Measure	Nivolumab Plus Axitinib n=7 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Overall Survival (OS) - Acral Histology	14 percentage of patients Interval 1.0 to 46.0

SECONDARY outcome

Timeframe: Up to 45 months

Population: Treated patients with mucosal melanoma histology.

The median number of months from the start of treatment that patients remain alive, until death from any cause in patients with mucosal histology.

Outcome measures

Measure	Nivolumab Plus Axitinib n=7 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Overall Survival (OS) - Mucosal Histology	11.00 months Interval 2.0 to Upper bound of 95% CI not reached

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients with mucosal melanoma histology.

Percentage of patients with mucosal melanoma histology that remain alive up to 6 months from start of treatment until death from any cause.

Outcome measures

Measure	Nivolumab Plus Axitinib n=7 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Overall Survival (OS) - Mucosal Histology	71 percentage of patients Interval 26.0 to 92.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients with mucosal melanoma histology.

Percentage of patients with mucosal melanoma histology that remain alive up to 12 months from start of treatment until death from any cause.

Outcome measures

Measure	Nivolumab Plus Axitinib n=7 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Overall Survival (OS) - Mucosal Histology	43 percentage of patients Interval 10.0 to 73.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients with mucosal melanoma histology.

Percentage of patients with mucosal melanoma histology that remain alive up to 24 months from start of treatment until death from any cause.

Outcome measures

Measure	Nivolumab Plus Axitinib n=7 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Overall Survival (OS) - Mucosal Histology	21 percentage of patients Interval 1.0 to 59.0

SECONDARY outcome

Timeframe: Up to 45 months

Population: Treated patients with cutaneous melanoma histology

The median number of months from the start of treatment that patients remain alive, until death from any cause in patients with cutaneous melanoma histology.

Outcome measures

Measure	Nivolumab Plus Axitinib n=17 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Overall Survival (OS) - Cutaneous Histology	11.00 months Interval 6.0 to 23.0

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients with cutaneous melanoma histology.

Percentage of patients with cutaneous melanoma histology that remain alive up to 6 months from start of treatment until death from any cause.

Outcome measures

Measure	Nivolumab Plus Axitinib n=17 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Overall Survival (OS) - Cutaneous Histology	76 percentage of patients Interval 49.0 to 90.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients with cutaneous melanoma histology.

Percentage of patients with cutaneous melanoma histology that remain alive up to 12 months from start of treatment until death from any cause.

Outcome measures

Measure	Nivolumab Plus Axitinib n=17 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Overall Survival (OS) - Cutaneous Histology	41 percentage of patients Interval 19.0 to 63.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients with cutaneous melanoma histology.

Percentage of patients with cutaneous melanoma histology that remain alive up to 24 months from start of treatment until death from any cause.

Outcome measures

Measure	Nivolumab Plus Axitinib n=17 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Overall Survival (OS) - Cutaneous Histology	24 percentage of patients Interval 7.0 to 45.0

SECONDARY outcome

Timeframe: Up to 45 months

Population: Treated patients who received greater than 3 prior lines of treatment.

The median number of months from the start of treatment that patients with greater than 3 prior lines of treatment remain alive, until death from any cause.

Outcome measures

Measure	Nivolumab Plus Axitinib n=11 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Overall Survival (OS) - Prior Lines of Therapy >3	8.00 months Interval 5.0 to 16.0

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients who received \>3 prior lines of therapy.

Percentage of patients (who received > 3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.

Outcome measures

Measure	Nivolumab Plus Axitinib n=11 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Overall Survival (OS) - Prior Lines of Therapy >3	73 percentage of patients Interval 37.0 to 90.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients who received \>3 prior lines of therapy.

Percentage of patients (who received > 3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.

Outcome measures

Measure	Nivolumab Plus Axitinib n=11 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Overall Survival (OS) - Prior Lines of Therapy >3	27 percentage of patients Interval 7.0 to 54.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients who received \>3 prior lines of therapy.

Percentage of patients (who received > 3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.

Outcome measures

Measure	Nivolumab Plus Axitinib n=11 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Overall Survival (OS) - Prior Lines of Therapy >3	18 percentage of patients Interval 3.0 to 44.0

SECONDARY outcome

Timeframe: Up to 45 months

Population: Treated patients who received greater than 3 prior lines of treatment.

The median number of months from the start of treatment that patients who received 3 or less prior lines of treatment remain alive, until death from any cause.

Outcome measures

Measure	Nivolumab Plus Axitinib n=20 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Overall Survival (OS) - Prior Lines of Therapy <=3	11.00 months Interval 5.0 to 18.0

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients who received \<=3 prior lines of therapy.

Percentage of patients (who received <=3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.

Outcome measures

Measure	Nivolumab Plus Axitinib n=20 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Overall Survival (OS) - Prior Lines of Therapy <=3	70 percentage of patients Interval 45.0 to 85.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients who received \<=3 prior lines of therapy.

Percentage of patients (who received <=3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.

Outcome measures

Measure	Nivolumab Plus Axitinib n=20 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Overall Survival (OS) - Prior Lines of Therapy <=3	40 percentage of patients Interval 19.0 to 60.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients who received \<=3 prior lines of therapy.

Percentage of patients (who received <=3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.

Outcome measures

Measure	Nivolumab Plus Axitinib n=20 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Overall Survival (OS) - Prior Lines of Therapy <=3	23 percentage of patients Interval 7.0 to 43.0

SECONDARY outcome

Timeframe: Up to 45 months

Population: Treated patients with Primary IO resistance.

The median number of months from the start of treatment that patients with Primary IO resistance remain alive, until death from any cause.

Outcome measures

Measure	Nivolumab Plus Axitinib n=15 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Overall Survival (OS) - Overall Cohort - Primary IO Resistance	7.00 months Interval 3.0 to 16.0

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients with Primary IO resistance.

Percentage of patients (Primary IO resistance) alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.

Outcome measures

Measure	Nivolumab Plus Axitinib n=15 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Overall Survival (OS) - Primary IO Resistance	53 percentage of patients Interval 26.0 to 74.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients with Primary IO resistance.

Percentage of patients (Primary IO resistance) alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.

Outcome measures

Measure	Nivolumab Plus Axitinib n=15 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Overall Survival (OS) - Primary IO Resistance	40 percentage of patients Interval 16.0 to 63.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients with Primary IO resistance.

Percentage of patients (Primary IO resistance) alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.

Outcome measures

Measure	Nivolumab Plus Axitinib n=14 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Overall Survival (OS) - Primary IO Resistance	24 percentage of patients Interval 6.0 to 48.0

SECONDARY outcome

Timeframe: Up to 45 months

Population: Treated patients with Primary IO resistance.

The median number of months from the start of treatment that patients with Secondary IO resistance remain alive, until death from any cause.

Outcome measures

Measure	Nivolumab Plus Axitinib n=16 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Overall Survival (OS) - Overall Cohort - Secondary IO Resistance	11.00 months Interval 8.0 to 18.0

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients with Secondary IO resistance.

Percentage of patients with Secondary IO resistance alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.

Outcome measures

Measure	Nivolumab Plus Axitinib n=16 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Overall Survival (OS) - Secondary IO Resistance	88 percentage of patients Interval 59.0 to 97.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients with Secondary IO resistance.

Percentage of patients with Secondary IO resistance alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.

Outcome measures

Measure	Nivolumab Plus Axitinib n=16 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Overall Survival (OS) - Secondary IO Resistance	31 percentage of patients Interval 11.0 to 54.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients with Secondary IO resistance.

Percentage of patients with Secondary IO resistance alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.

Outcome measures

Measure	Nivolumab Plus Axitinib n=16 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Overall Survival (OS) - Secondary IO Resistance	19 percentage of patients Interval 5.0 to 40.0

SECONDARY outcome

Timeframe: Up to 4 years and 3 months

Population: Treated patients who were evaluable for radiologic response.

The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=30 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Progression-free Survival (PFS) - Overall Cohort	3.00 months Interval 3.0 to 5.0

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients who were evaluable for radiologic response.

The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=30 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Progression-free Survival (PFS)	21 percentage of patients Interval 9.0 to 37.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients who were evaluable for radiologic response.

The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=30 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Progression-free Survival (PFS)	11 percentage of patients Interval 3.0 to 25.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients who were evaluable for radiologic response.

The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=29 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Progression-free Survival (PFS)	0 percentage of patients Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Up to 4 years and 3 months

Population: Treated patients who were previously treated with Ipilimumab/Nivolumab and were evaluable for radiologic response.

The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=16 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Progression-free Survival (PFS) - Prior Ipilimumab / Nivolumab Treatment	4.00 months Interval 3.0 to 6.0

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients who were previously treated with Ipilimumab /Nivolumab and were evaluable for radiologic response.

The percentage of patients (previously treated with Ipilimumab/Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=16 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Progression-free Survival (PFS) - Prior Ipilimumab / Nivolumab Treatment	19 percentage of patients Interval 5.0 to 40.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients who were previously treated with Ipilimumab /Nivolumab and were evaluable for radiologic response.

The percentage of patients (previously treated with Ipilimumab / Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=16 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Progression-free Survival (PFS) - Prior Ipilimumab / Nivolumab Treatment	13 percentage of patients Interval 2.0 to 33.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients who were previously treated with Ipilimumab /Nivolumab and were evaluable for radiologic response.

The percentage of patients (previously treated with Ipilimumab/Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=15 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Progression-free Survival (PFS) - Prior Ipilimumab / Nivolumab Treatment	0 percentage of patients

SECONDARY outcome

Timeframe: Up to 4 years and 3 months

Population: Treated patients who were not previously treated with Ipilimumab /Nivolumab and were evaluable for radiologic response.

The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=14 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Progression-free Survival (PFS) - no Prior Ipilimumab /Nivolumab Treatment	3.00 months Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients who were not previously treated with Ipilimumab /Nivolumab and were evaluable for radiologic response.

The percentage of patients (not previously treated with Ipilimumab /Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=14 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Progression-free Survival (PFS) - no Prior Ipilimumab/Nivolumab Treatment	27 percentage of patients Interval 8.0 to 50.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients who were not previously treated with Ipilimumab /Nivolumab and were evaluable for radiologic response.

The percentage of patients (not previously treated with Ipilimumab /Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=14 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Progression-free Survival (PFS) - no Prior Ipilimumab / Nivolumab Treatment	9 percentage of patients Interval 1.0 to 32.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients who were not previously treated with Ipilimumab /Nivolumab and were evaluable for radiologic response.

The percentage of patients (not previously treated with Ipilimumab /Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=14 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Progression-free Survival (PFS) - no Prior Ipilimumab /Nivolumab Treatment	0 percentage of patients

SECONDARY outcome

Timeframe: Up to 4 years and 3 months

Population: Treated patients with mucosal histology who were evaluable for radiologic response.

The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. in patients with mucosal histology. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=6 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Progression-free Survival (PFS) - Overall Cohort - Mucosal Histology	3.00 months Interval 1.0 to Upper bound of 95% CI not reached

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients with mucosal histology and were evaluable for radiologic response.

The percentage of patients (with mucosal histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=6 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Progression-free Survival (PFS) - Mucosal Histology	29 percentage of patients Interval 4.0 to 61.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients with mucosal histology and were evaluable for radiologic response.

The percentage of patients (with mucosal histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=6 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Progression-free Survival (PFS) - Mucosal Histology	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients with mucosal histology and were evaluable for radiologic response.

The percentage of patients (with mucosal histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=6 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Progression-free Survival (PFS) - Mucosal Histology	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 4 years and 3 months

Population: Treated patients with cutaneous histology who were evaluable for radiologic response.

The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. in patients with mucosal histology. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=17 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Progression-free Survival (PFS) - Overall Cohort - Cutaneous Histology	3.00 months Interval 2.0 to 6.0

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients with cutaneous histology and were evaluable for radiologic response.

The percentage of patients (with cutaneous histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=17 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Progression-free Survival (PFS) - Cutaneous Histology	18 percentage of patients Interval 4.0 to 38.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients with cutaneous histology and were evaluable for radiologic response.

The percentage of patients (with cutaneous histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=17 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Progression-free Survival (PFS) - Cutaneous Histology	18 percentage of patients Interval 4.0 to 38.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients with cutaneous histology and were evaluable for radiologic response.

The percentage of patients (with cutaneous histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=16 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Progression-free Survival (PFS) - Cutaneous Histology	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 4 years and 3 months

Population: Treated patients with acral histology who were evaluable for radiologic response.

The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. in patients with mucosal histology. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=7 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Progression-free Survival (PFS) - Overall Cohort - Acral Histology	4.00 months Interval 0.0 to 8.0

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients with acral histology and were evaluable for radiologic response.

The percentage of patients (with acral histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=7 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Progression-free Survival (PFS) - Acral Histology	29 percentage of patients Interval 4.0 to 61.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients with acral histology and were evaluable for radiologic response.

The percentage of patients (with acral histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=7 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Progression-free Survival (PFS) - Acral Histology	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients with acral histology and were evaluable for radiologic response.

The percentage of patients (with acral histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=7 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Progression-free Survival (PFS) - Acral Histology	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 4 years and 3 months

Population: Treated patients who received prior lines \<= 3 and who were evaluable for radiologic response.

The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. in patients with mucosal histology. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=19 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Progression-free Survival (PFS) - Overall Cohort - Prior Lines <= 3	3.50 months Interval 2.0 to 6.0

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients who received \<=3 prior lines of therapy and were evaluable for radiologic response.

The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=19 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Progression-free Survival (PFS) - Prior Lines <= 3	28 percentage of patients Interval 11.0 to 49.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients who received \<=3 prior lines of therapy and were evaluable for radiologic response.

The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=19 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Progression-free Survival (PFS) - Prior Lines <= 3	11 percentage of patients Interval 2.0 to 30.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients who received \<=3 prior lines of therapy and were evaluable for radiologic response.

The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=19 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Progression-free Survival (PFS) - Prior Lines <= 3	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 4 years and 3 months

Population: Treated patients who received \>3 prior lines and who were evaluable for radiologic response.

The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. in patients with mucosal histology. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=11 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Progression-free Survival (PFS) - Overall Cohort - Prior Lines >3	3.00 months Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients who received \>3 prior lines of therapy and were evaluable for radiologic response.

The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=11 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Progression-free Survival (PFS) - Prior Lines > 3	9 percentage of patients Interval 1.0 to 33.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients who received \>3 prior lines of therapy and were evaluable for radiologic response.

The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=11 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Progression-free Survival (PFS) - Prior Lines > 3	9 percentage of patients Interval 1.0 to 33.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients who received \>3 prior lines of therapy and were evaluable for radiologic response.

The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=11 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Progression-free Survival (PFS) - Prior Lines > 3	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 4 years and 3 months

Population: Treated patients who were evaluable for radiologic response.

Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=31 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Duration of Response (DoR) - Overall Cohort	8.00 months Interval 4.0 to Upper bound of 95% CI not reached

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients who were evaluable for radiologic response.

Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=3 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Duration of Response (DoR) - Overall Cohort	67 percentage of patients Interval 5.0 to 95.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients who were evaluable for radiologic response.

Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=3 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Duration of Response (DoR) - Overall Cohort	0 percentage of patients

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients who were evaluable for radiologic response.

Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=3 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Duration of Response (DoR) - Overall Cohort	0 percentage of patients

SECONDARY outcome

Timeframe: Up to 4 years and 3 months

Population: Treated patients who received prior Ipilimumab/Nivolumab treatment were evaluable for radiologic response.

Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=1 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Duration of Response (DoR) - Prior Ipilimumab / Nivolumab Treatment	0 months 95% CI not reached

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients who received prior Ipilimumab/Nivolumab treatment were evaluable for radiologic response.

Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=1 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Duration of Response (DoR) - Prior Ipilimumab / Nivolumab Treatment	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients who received prior Ipilimumab/Nivolumab treatment were evaluable for radiologic response.

Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=1 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Duration of Response (DoR) - Prior Ipilimumab / Nivolumab Treatment	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients who received prior Ipilimumab/Nivolumab treatment were evaluable for radiologic response.

Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=1 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Duration of Response (DoR) - Prior Ipilimumab / Nivolumab Treatment	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 4 years and 3 months

Population: Treated patients who did not receive prior Ipilimumab / Nivolumab treatment and were evaluable for radiologic response.

Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=2 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Duration of Response (DoR) - no Prior Ipilimumab / Nivolumab Treatment	8.50 months Interval 8.0 to Upper bound of 95% CI not reached

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients who did not received prior Ipilimumab/Nivolumab treatment were evaluable for radiologic response.

Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=2 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Duration of Response (DoR) - no Prior Ipilimumab / Nivolumab Treatment	100.00 percentage of patients Interval 100.0 to 100.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients who did not received prior Ipilimumab/Nivolumab treatment were evaluable for radiologic response.

Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=2 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Duration of Response (DoR) - no Prior Ipilimumab / Nivolumab Treatment	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients who did not received prior Ipilimumab/Nivolumab treatment were evaluable for radiologic response.

Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=2 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Duration of Response (DoR) - no Prior Ipilimumab / Nivolumab Treatment	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 4 years and 3 months

Population: Treated patients with acral histology who were evaluable for radiologic response.

Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=1 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Duration of Response (DoR) - Acral Histology	9.0 months 95% CI not reached

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients with acral histology who were evaluable for radiologic response.

Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=1 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Duration of Response (DoR) - Acral Histology	100 percentage of patients 95% CI Not Available

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients with acral histology who were evaluable for radiologic response.

Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=1 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Duration of Response (DoR) - Acral Histology	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients with acral histology who were evaluable for radiologic response.

Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=1 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Duration of Response (DoR) - Acral Histology	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 4 years and 3 months

Population: Treated patients with mucosal histology who were evaluable for radiologic response.

Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=1 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Duration of Response (DoR) - Mucosal Histology	8.00 months 95% CI not reached

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients with mucosal histology who were evaluable for radiologic response.

Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=1 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Duration of Response (DoR) - Mucosal Histology	100 percentage of patients 95% CI Not Available

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients with mucosal histology who were evaluable for radiologic response.

Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=1 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Duration of Response (DoR) - Mucosal Histology	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients with mucosal histology who were evaluable for radiologic response.

Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=1 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Duration of Response (DoR) - Mucosal Histology	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 4 years and 3 months

Population: Treated patients with cutaneous histology who were evaluable for radiologic response.

Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=1 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Duration of Response (DoR) - Cutaneous Histology	4.00 months 95% CI not reached

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients with cutaneous histology who were evaluable for radiologic response.

Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=1 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Duration of Response (DoR) - Cutaneous Histology	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients with cutaneous histology who were evaluable for radiologic response.

Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=1 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Duration of Response (DoR) - Cutaneous Histology	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients with cutaneous histology who were evaluable for radiologic response.

Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Measure	Nivolumab Plus Axitinib n=1 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Duration of Response (DoR) - Cutaneous Histology	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 4 years and 3 months

Population: Treated patients who were evaluable for radiologic response.

Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=13 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Duration of Disease Control (DoDC) - Overall Cohort	4.00 months Interval 2.0 to 8.0

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients who were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=13 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Duration of Disease Control (DoDC) - Overall Cohort	39 percentage of patients Interval 14.0 to 63.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients who were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=13 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Duration of Disease Control (DoDC) - Overall Cohort	15 percentage of patients Interval 2.0 to 39.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients who were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=12 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Duration of Disease Control (DoDC) - Overall Cohort	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 4 years and 3 months

Population: Treated patients who received prior Ipilimumab / Nivolumab treatment and were evaluable for radiologic response.

Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=9 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Duration of Disease Control (DoDC) - Prior Ipilimumab / Nivolumab Treatment	3.00 months Interval 2.0 to 15.0

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients who received Prior Ipilimumab / Nivolumab Treatment and were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=9 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Duration of Disease Control (DoDC) - Prior Ipilimumab / Nivolumab Treatment	22 percentage of patients Interval 3.0 to 51.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients who received Prior Ipilimumab / Nivolumab Treatment and were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=9 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Duration of Disease Control (DoDC) - Prior Ipilimumab / Nivolumab Treatment	22 percentage of patients Interval 3.0 to 51.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients who received Prior Ipilimumab / Nivolumab Treatment and were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=9 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Duration of Disease Control (DoDC) - Prior Ipilimumab / Nivolumab Treatment	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 4 years and 3 months

Population: Treated patients who did not received prior Ipilimumab / Nivolumab treatment and were evaluable for radiologic response.

Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=4 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Duration of Disease Control (DoDC) - no Prior Ipilimumab / Nivolumab Treatment	8.00 months Interval 1.0 to Upper bound of 95% CI not reached

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients who did not received Prior Ipilimumab / Nivolumab Treatment and were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=4 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Duration of Disease Control (DoDC) - no Prior Ipilimumab / Nivolumab Treatment	80 percentage of patients Interval 20.0 to 97.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients who did not received Prior Ipilimumab / Nivolumab Treatment and were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=4 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Duration of Disease Control (DoDC) - no Prior Ipilimumab / Nivolumab Treatment	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients who did not received Prior Ipilimumab / Nivolumab Treatment and were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=4 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Duration of Disease Control (DoDC) - no Prior Ipilimumab / Nivolumab Treatment	0 percentage of patients Upper bound of 95% CI not reached

SECONDARY outcome

Timeframe: Up to 4 years and 3 months

Population: Treated patients with acral histology who were evaluable for radiologic response.

Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=5 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Duration of Disease Control (DoDC) - Acral Histology	3.00 months Interval 2.0 to Upper bound of 95% CI not reached

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients with acral histology who were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=5 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Duration of Disease Control (DoDC) - Acral Histology	20 percentage of patients Interval 1.0 to 58.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients with acral histology who were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=5 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Duration of Disease Control (DoDC) - Acral Histology	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients with acral histology who were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=5 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Duration of Disease Control (DoDC) - Acral Histology	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 4 years and 3 months

Population: Treated patients with mucosal histology who were evaluable for radiologic response.

Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=2 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Duration of Disease Control (DoDC) - Mucosal Histology	8.00 months Interval 1.0 to Upper bound of 95% CI not reached

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients with mucosal histology who were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=2 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Duration of Disease Control (DoDC) - Mucosal Histology	67 percentage of patients Interval 5.0 to 95.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients with mucosal histology who were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=2 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Duration of Disease Control (DoDC) - Mucosal Histology	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients with mucosal histology who were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=2 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Duration of Disease Control (DoDC) - Mucosal Histology	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 4 years and 3 months

Population: Treated patients with cutaneous histology who were evaluable for radiologic response.

Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=6 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Duration of Disease Control (DoDC) - Cutaneous Histology	6.00 months Interval 2.0 to Upper bound of 95% CI nor reached

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients with cutaneous histology who were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=6 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Duration of Disease Control (DoDC) - Cutaneous Histology	50 percentage of patients Interval 11.0 to 80.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients with cutaneous histology who were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=6 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Duration of Disease Control (DoDC) - Cutaneous Histology	33 percentage of patients Interval 5.0 to 68.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients with cutaneous histology who were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=5 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Duration of Disease Control (DoDC) - Cutaneous Histology	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 4 years and 3 months

Population: Treated patients who received \>3 prior lines of therapy and were evaluable for radiologic response.

Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=4 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Duration of Disease Control (DoDC) - Prior Lines > 3	2.00 months Interval 2.0 to Upper bound of 95% CI not reached

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients who received \> 3 prior lines of therapy and who were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=4 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Duration of Disease Control (DoDC) - Prior Lines > 3	25 percentage of patients Interval 1.0 to 67.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients who received \> 3 prior lines of therapy and who were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=4 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Duration of Disease Control (DoDC) - Prior Lines > 3	25 percentage of patients Interval 1.0 to 67.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients who received \> 3 prior lines of therapy and who were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=3 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Duration of Disease Control (DoDC) - Prior Lines > 3	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 4 years and 3 months

Population: Treated patients who received \<= 3 prior lines of therapy and were evaluable for radiologic response.

Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=9 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Duration of Disease Control (DoDC) - Prior Lines <= 3	5.00 months Interval 1.0 to 9.0

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients who received \<= 3 prior lines of therapy and who were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=9 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Duration of Disease Control (DoDC) - Prior Lines <= 3	45 percentage of patients Interval 14.0 to 72.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients who received \<= 3 prior lines of therapy and who were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=9 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Duration of Disease Control (DoDC) - Prior Lines <= 3	11 percentage of patients Interval 1.0 to 39.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients who received \<= 3 prior lines of therapy and who were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=9 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Duration of Disease Control (DoDC) - Prior Lines <= 3	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 4 years and 3 months

Population: Treated patients with primary IO resistance who were evaluable for radiologic response.

Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=7 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Duration of Disease Control (DoDC) - Overall Cohort - Primary IO Resistance	3.00 months Interval 2.0 to 8.0

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients with primary IO resistance who were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=7 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Duration of Disease Control (DoDC) - Primary IO Resistance	29 percentage of patients Interval 4.0 to 61.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients with primary IO resistance who were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=7 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Duration of Disease Control (DoDC) - Primary IO Resistance	14 percentage of patients Interval 1.0 to 46.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients with primary IO resistance who were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=6 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Duration of Disease Control (DoDC) - Primary IO Resistance	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 4 years and 3 months

Population: Treated patients with Secondary IO resistance who were evaluable for radiologic response.

Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=6 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Duration of Disease Control (DoDC) - Overall Cohort - Secondary IO Resistance	6.00 months Interval 1.0 to Upper bound of 95% CI not reached

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients with Secondary IO resistance who were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=6 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
6-month Duration of Disease Control (DoDC) - Secondary IO Resistance	50 percentage of patients Interval 11.0 to 80.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients with Secondary IO resistance who were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=6 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
12-month Duration of Disease Control (DoDC) - Secondary IO Resistance	17 percentage of patients Interval 1.0 to 52.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients with Secondary IO resistance who were evaluable for radiologic response.

Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Nivolumab Plus Axitinib n=6 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
24-month Duration of Disease Control (DoDC) - Secondary IO Resistance	0 percentage of patients 95% CI not reached

SECONDARY outcome

Timeframe: Up to 28 days after discontinuation of study treatment (up to 24 months)

Population: Treated patients who experienced an SAE \>= grade 3

Adverse Events determined to be possibly, probably or definitely related to study treatment SAEs are defined as grade 3 and higher toxicity events that are attributable to the study combination therapy. Evaluated by NCI Common Terminology for Adverse Events (CTCAE v5.0).

Outcome measures

Measure	Nivolumab Plus Axitinib n=10 Participants Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Grade 3 or Greater Adverse Events Possibly, Probably or Definitely Related to Study Treatment dacryocystitis	1 participants
Grade 3 or Greater Adverse Events Possibly, Probably or Definitely Related to Study Treatment Wound complication	1 participants
Grade 3 or Greater Adverse Events Possibly, Probably or Definitely Related to Study Treatment Diarrhea	1 participants
Grade 3 or Greater Adverse Events Possibly, Probably or Definitely Related to Study Treatment Lower gastrointestinal hemorrhage	1 participants
Grade 3 or Greater Adverse Events Possibly, Probably or Definitely Related to Study Treatment Chills	1 participants
Grade 3 or Greater Adverse Events Possibly, Probably or Definitely Related to Study Treatment Fatigue	1 participants
Grade 3 or Greater Adverse Events Possibly, Probably or Definitely Related to Study Treatment Alkaline phosphatase increased	1 participants
Grade 3 or Greater Adverse Events Possibly, Probably or Definitely Related to Study Treatment Hematuria	1 participants
Grade 3 or Greater Adverse Events Possibly, Probably or Definitely Related to Study Treatment Pneumonitis	1 participants
Grade 3 or Greater Adverse Events Possibly, Probably or Definitely Related to Study Treatment Rash maculo-papular	1 participants

Adverse Events

Nivolumab Plus Axitinib

Serious events: 15 serious events

Other events: 31 other events

Deaths: 26 deaths

Serious adverse events

Measure	Nivolumab Plus Axitinib n=31 participants at risk Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Cardiac disorders Heart failure	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Abdominal distension	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Abdominal pain	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Diarrhea	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Lower gastrointestinal hemorrhage	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Stomach pain	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Vomiting	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
General disorders Chills	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
General disorders Edema limbs	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
General disorders Fatigue	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
General disorders Flu like symptoms	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Infections and infestations Infections and infestations - Other, specify: dacryocystitis	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Infections and infestations Urinary tract infection	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Injury, poisoning and procedural complications Fall	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Injury, poisoning and procedural complications Wound complication	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Alanine aminotransferase increased	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Alkaline phosphatase increased	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Metabolism and nutrition disorders Hypercalcemia	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Metabolism and nutrition disorders Hyponatremia	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Musculoskeletal and connective tissue disorders Generalized muscle weakness	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Musculoskeletal and connective tissue disorders Pain in extremity	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify: Melanoma	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor hemorrhage	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Nervous system disorders Paresthesia	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Renal and urinary disorders Acute kidney injury	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Renal and urinary disorders Hematuria	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Skin and subcutaneous tissue disorders Rash maculo-papular	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Surgical and medical procedures left brachial and axillary ulnar and radial thrombectomies	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months

Other adverse events

Measure	Nivolumab Plus Axitinib n=31 participants at risk Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.
Blood and lymphatic system disorders Anemia	51.6% 16/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify: Eosinophilia	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify: eosinophilia	9.7% 3/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify: splenic infarct	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Blood and lymphatic system disorders Leukocytosis	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Cardiac disorders Heart failure	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Cardiac disorders Sinus bradycardia	12.9% 4/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Cardiac disorders Sinus tachycardia	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Ear and labyrinth disorders Middle ear inflammation	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Ear and labyrinth disorders Vertigo	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Endocrine disorders Hypothyroidism	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Eye disorders Blurred vision	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Eye disorders Dry eye	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Eye disorders Eye pain	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Abdominal distension	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Abdominal pain	12.9% 4/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Anal fistula	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Bloating	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Constipation	29.0% 9/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Diarrhea	29.0% 9/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Dry mouth	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Dyspepsia	9.7% 3/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Dysphagia	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Esophagitis	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Gastrointestinal disorders - Other, specify: constipation	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Gastrointestinal disorders - Other, specify: diarrhea	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Gastrointestinal disorders - Other, specify: dry heaving (int)	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Ileus	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Lower gastrointestinal hemorrhage	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Mucositis oral	16.1% 5/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Nausea	25.8% 8/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Oral pain	16.1% 5/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Rectal mucositis	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Rectal pain	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Stomach pain	9.7% 3/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Gastrointestinal disorders Vomiting	9.7% 3/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
General disorders Chills	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
General disorders Edema limbs	9.7% 3/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
General disorders Facial pain	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
General disorders Fatigue	54.8% 17/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
General disorders Fever	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
General disorders Flu like symptoms	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
General disorders Gait disturbance	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
General disorders General disorders and administration site conditions - Other, specify: Edema	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
General disorders General disorders and administration site conditions - Other, specify: Fever	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
General disorders General disorders and administration site conditions - Other, specify: Pain	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
General disorders Infusion related reaction	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
General disorders Injection site reaction	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
General disorders Pain	19.4% 6/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Infections and infestations Infections and infestations - Other, specify: Chest Wall Infection	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Infections and infestations Infections and infestations - Other, specify: Covid-19	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Infections and infestations Infections and infestations - Other, specify: Lyme's disease	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Infections and infestations Infections and infestations - Other, specify: dacryocystitis	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Infections and infestations Infections and infestations - Other, specify: skin infection	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Infections and infestations Lung infection	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Infections and infestations Urinary tract infection	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Injury, poisoning and procedural complications Bruising	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Injury, poisoning and procedural complications Fall	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Injury, poisoning and procedural complications Wound complication	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Activated partial thromboplastin time prolonged	16.1% 5/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Alanine aminotransferase increased	22.6% 7/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Alkaline phosphatase increased	25.8% 8/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Aspartate aminotransferase increased	25.8% 8/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Blood bicarbonate decreased	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Blood bilirubin increased	12.9% 4/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Blood lactate dehydrogenase increased	45.2% 14/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations CPK increased	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Creatinine increased	22.6% 7/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Hemoglobin increased	9.7% 3/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations INR increased	9.7% 3/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Investigations - Other, specify: Blood Urea Nitrogen Increased	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Investigations - Other, specify: Free T4 decreased	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Investigations - Other, specify: Increased CRP	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Investigations - Other, specify: Increased D Dimer	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Investigations - Other, specify: T3 Decreased	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Investigations - Other, specify: TSH increased	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Investigations - Other, specify: blood CO2 increased	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Investigations - Other, specify: increased urine ketones	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Investigations - Other, specify: urine microalbumin increased	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Investigations - Other, specify: urine specific gravity increased	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Lipase increased	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Lymphocyte count decreased	32.3% 10/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Lymphocyte count increased	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Neutrophil count decreased	9.7% 3/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Platelet count decreased	19.4% 6/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Thyroid stimulating hormone increased	35.5% 11/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations Weight loss	19.4% 6/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Investigations White blood cell decreased	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Metabolism and nutrition disorders Anorexia	35.5% 11/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Metabolism and nutrition disorders Dehydration	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Metabolism and nutrition disorders Hypercalcemia	19.4% 6/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Metabolism and nutrition disorders Hyperglycemia	29.0% 9/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Metabolism and nutrition disorders Hyperkalemia	9.7% 3/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Metabolism and nutrition disorders Hypermagnesemia	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Metabolism and nutrition disorders Hypernatremia	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Metabolism and nutrition disorders Hyperphosphatemia	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Metabolism and nutrition disorders Hypertriglyceridemia	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Metabolism and nutrition disorders Hypoalbuminemia	35.5% 11/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Metabolism and nutrition disorders Hypocalcemia	22.6% 7/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Metabolism and nutrition disorders Hypoglycemia	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Metabolism and nutrition disorders Hypokalemia	25.8% 8/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Metabolism and nutrition disorders Hyponatremia	71.0% 22/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Metabolism and nutrition disorders Hypophosphatemia	19.4% 6/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Metabolism and nutrition disorders Obesity	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Musculoskeletal and connective tissue disorders Arthralgia	9.7% 3/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Musculoskeletal and connective tissue disorders Back pain	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Musculoskeletal and connective tissue disorders Flank pain	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Musculoskeletal and connective tissue disorders Generalized muscle weakness	16.1% 5/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Musculoskeletal and connective tissue disorders Muscle cramp	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Musculoskeletal and connective tissue disorders Myalgia	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Musculoskeletal and connective tissue disorders Pain in extremity	9.7% 3/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify: Melanoma	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor hemorrhage	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Nervous system disorders Dizziness	12.9% 4/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Nervous system disorders Dysgeusia	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Nervous system disorders Headache	19.4% 6/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Nervous system disorders Paresthesia	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Nervous system disorders Tremor	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Psychiatric disorders Anxiety	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Psychiatric disorders Confusion	12.9% 4/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Psychiatric disorders Delirium	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Psychiatric disorders Hallucinations	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Psychiatric disorders Insomnia	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Renal and urinary disorders Acute kidney injury	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Renal and urinary disorders Hematuria	19.4% 6/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Renal and urinary disorders Proteinuria	22.6% 7/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Renal and urinary disorders Urinary frequency	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Renal and urinary disorders Urinary incontinence	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Renal and urinary disorders Urinary retention	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Reproductive system and breast disorders Prostatic obstruction	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Respiratory, thoracic and mediastinal disorders Atelectasis	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Respiratory, thoracic and mediastinal disorders Cough	9.7% 3/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Respiratory, thoracic and mediastinal disorders Dyspnea	19.4% 6/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Respiratory, thoracic and mediastinal disorders Epistaxis	9.7% 3/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Respiratory, thoracic and mediastinal disorders Hiccups	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Respiratory, thoracic and mediastinal disorders Hoarseness	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Respiratory, thoracic and mediastinal disorders Postnasal drip	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Respiratory, thoracic and mediastinal disorders Pulmonary edema	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify: Septal Atrophy	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify: perforated septum	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Respiratory, thoracic and mediastinal disorders Sore throat	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Respiratory, thoracic and mediastinal disorders Wheezing	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Skin and subcutaneous tissue disorders Alopecia	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Skin and subcutaneous tissue disorders Dry skin	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Skin and subcutaneous tissue disorders Nail changes	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Skin and subcutaneous tissue disorders Pain of skin	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	16.1% 5/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Skin and subcutaneous tissue disorders Pruritus	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Skin and subcutaneous tissue disorders Rash maculo-papular	6.5% 2/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify: Rash	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify: Scrotum Rash	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify: pressure ulcer	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Skin and subcutaneous tissue disorders Skin hypopigmentation	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Surgical and medical procedures Pheresis	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months
Surgical and medical procedures left brachial and axillary ulnar and radial thrombectomies	3.2% 1/31 • Adverse events data collected for to up to 28 days after discontinuation of study treatment (up to 24 months) for individual patients. All-Cause Mortality data were collected for up to up to 4 years and 3 months

Additional Information

Barbara Stadterman, MPH, MSCCR, CCRP, Clinical Research Manager

UPMC Hillman Cancer Center

Phone: 4126475554

Email: stadtermanbm@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place