NCT04091750

Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced Melanoma

Phase II Study of Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced Melanoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this phase II advanced melanoma study, all patients will receive treatment with nivolumab/ipilimumab plus cabozantinib for a 12 week induction period followed by nivolumab plus cabozantinib maintanence to complete up to 2 years of therapy unless disease progression, dose limiting toxicity, provider/patient decision or patient withdrawal of consent occurs. The primary endpoint is the one year PFS rate. Patients will have staging scans at baseline and every 12 weeks during the first 2 years on study. Safety evaluations including labs, EKG and history and physical will occur at each visit. Baseline tumor sample is required and on treatment biopsy will be optional of superficial tumor in the skin, subcutaneous tissue or lymph node that is palpable.

Detailed description

Subjects will receive nivolumab, ipilimumab and cabozantinib until either disease progression, the occurrence of unacceptable drug-related toxicity or for other reason(s) for subject withdrawal. Treatment will continue for up to 2 years unless there is disease progression, drug intolerance or other reason for discontinuation discussed with the principal investigator (PI). Patients with ongoing complete or partial response may discontinue therapy after 1 year on treatment at the discretion of the treating investigator.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Nivolumab	Induction: 3mg/kg IV every 3 weeks x 4 cycles Maintenance: 480mg IV every 4 weeks for up to 92 weeks
DRUG	Ipilimumab	Induction: 1mg/kg IV every 3 weeks x 4 cycles
DRUG	Cabozantinib	Induction and Maintenance: 40mg PO daily

Timeline

• Start date: 2020-03-02
• Primary completion: 2023-08-08
• Completion: 2026-12-01
• First posted: 2019-09-17
• Last updated: 2026-03-03
• Results posted: 2024-11-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study