This is Phase II trial of nivolumab plus axitinib for patients with unresectable stage III or IV melanoma who have progressed on prior anti-PD1 therapy with or without concomitant anti-CTLA4 therapy. Patients will receive treatment with nivolumab 480 mg intravenously every 4 weeks and axitinib 5 mg twice daily by mouth. Patients may continue both agents for up to two years if they do not experience disease progression or dose-limiting toxicities.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Overall Response Rate (ORR)
Timeframe: Up to 12 weeks from baseline (after treatment)
Overall Response Rate (ORR) - Prior Ipilimumab / Nivolumab Treatment
Timeframe: Up to 12 weeks from baseline (after treatment)
Overall Response Rate (ORR) - no Prior Ipilimumab / Nivolumab
Timeframe: Up to 12 weeks from baseline (after treatment)
Overall Response Rate (ORR) - Prior Lines of Therapy <=3
Timeframe: Up to 12 weeks from baseline (after treatment)
Overall Response Rate (ORR) - Prior Lines of Therapy >3
Timeframe: Up to 12 weeks from baseline (after treatment)
Overall Response Rate (ORR) by iRECIST
Timeframe: Up to 12 weeks from baseline (after treatment)
Overall Response Rate (ORR) - Primary IO Resistance
Timeframe: Up to 12 weeks from baseline (after treatment)
Overall Response Rate (ORR) - Secondary IO Resistance
Timeframe: Up to 12 weeks from baseline (after treatment)
Overall Response Rate (ORR) - Acral Histology
Timeframe: Up to 12 weeks from baseline (after treatment)
Overall Response Rate (ORR) - Cutaneous Histology
Timeframe: Up to 12 weeks from baseline (after treatment)
Overall Response Rate (ORR) - Mucosal Histology
Timeframe: Up to 12 weeks from baseline (after treatment)
Disease Control Rate (DCR)
Timeframe: Up to 12 weeks from baseline (after treatment)
Disease Control Rate (DCR) - no Prior Ipilimumab / Nivolumab Treatment
Timeframe: Up to 12 weeks from baseline (after treatment)
Disease Control Rate (DCR) - Prior Ipilimumab / Nivolumab Treatment
Timeframe: Up to 12 weeks from baseline (after treatment)
Disease Control Rate (DCR) - Prior Lines of Therapy <=3
Timeframe: Up to 12 weeks from baseline (after treatment)
Disease Control Rate (DCR) - Prior Lines of Therapy >3
Timeframe: Up to 12 weeks from baseline (after treatment)
Disease Control Rate (DCR) by iRECIST
Timeframe: Up to 12 weeks from baseline (after treatment)
Disease Control Rate (DCR) - Secondary IO Resistance
Timeframe: Up to 12 weeks from baseline (after treatment)
Disease Control Rate (DCR) - Primary IO Resistance
Timeframe: Up to 12 weeks from baseline (after treatment)
Disease Control Rate (DCR) - Acral Histology
Timeframe: Up to 12 weeks from baseline (after treatment)
Disease Control Rate (DCR) - Cutaneous Histology
Timeframe: Up to 12 weeks from baseline (after treatment)
Disease Control Rate (DCR) - Mucosal Histology
Timeframe: Up to 12 weeks from baseline (after treatment)
Best Response
Timeframe: Up to 12 weeks from baseline (after treatment)
Best Response - no Prior Ipilimumab / Nivolumab
Timeframe: Up to 12 weeks from baseline (after treatment)
Best Response - Prior Ipilimumab / Nivolumab Treatment
Timeframe: Up to 12 weeks from baseline (after treatment)
Best Response - Acral Histology
Timeframe: Up to 12 weeks from baseline (after treatment)
Best Response - Cutaneous Histology
Timeframe: Up to 12 weeks from baseline (after treatment)
Best Response - Mucosal Histology
Timeframe: Up to 12 weeks from baseline (after treatment)
Best Response - Prior Lines of Therapy <=3
Timeframe: Up to 12 weeks from baseline (after treatment)
Best Response - Prior Lines of Therapy >3
Timeframe: Up to 12 weeks from baseline (after treatment)
Best Response by iRECIST
Timeframe: Up to 12 weeks from baseline (after treatment)
Best Response - Primary IO Resistance
Timeframe: Up to 12 weeks from baseline (after treatment)
Best Response - Secondary IO Resistance
Timeframe: Up to 12 weeks from baseline (after treatment)