CompletedPhase 2

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

United States31 participantsStarted 2020-12-18

Plain-language summary

This is Phase II trial of nivolumab plus axitinib for patients with unresectable stage III or IV melanoma who have progressed on prior anti-PD1 therapy with or without concomitant anti-CTLA4 therapy. Patients will receive treatment with nivolumab 480 mg intravenously every 4 weeks and axitinib 5 mg twice daily by mouth. Patients may continue both agents for up to two years if they do not experience disease progression or dose-limiting toxicities.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Have unresectable (stage III) or advanced (stage IV) cutaneous or mucosal melanoma. Patients with uveal melanoma are not eligible. * Progressed on prior anti-PD1 therapy with or without anti-CTLA4 therapy. Patients may have progressed in the adjuvant setting if treated within the last 6 months. Prior treatment with BRAF/MEK inhibitors permitted, however, not required. Progression must be radiographic, and progression of disease will be confirmed by a radiologist. Patients must have progressed during anti-PD-1 therapy, defined as unequivocal progression on or within 3 months of the last dose of anti-PD-1 therapy if treated in the metastatic setting, or within 6 months if treated in the adjuvant setting. * Have measurable disease based on RECIST 1.1. * Patients do not have to have biopsiable disease to be eligible. However, patients with biopsiable disease must undergo biopsy at study entry and at week 12. * Have a performance status of 0 or 1 on the ECOG Performance Scale. * Demonstrate adequate organ function, per protocol * Patients with brain metastases are permitted if they are asymptomatic or previously treated with CNS directed therapy with stable CNS disease for at least 2 weeks. Stable is defined as asymptomatic or not progressing on imaging. * Female patients of childbearing potential - negative pregnancy testing; use of birth control, surgically sterile or abstain from heterosexual activity during study and for 5 months after the last dose of s…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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)

Trial details

NCT IDNCT04493203

SponsorYana Najjar

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-15

Results submitted2025-04-15

View on ClinicalTrials.gov More Advanced Melanoma trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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)