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Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced Melanoma

NCT04091750 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-03-03

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • MedStar Franklin Square Medical Center

    collaborator OTHER

  • Hackensack Meridian Health

    collaborator OTHER

  • Exelixis

    collaborator INDUSTRY

  • Georgetown University

    lead OTHER

Principal Investigators

  • Geoffrey T Gibney, MD · MedStar Georgetown University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-02
Primary Completion
2023-08-08
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04091750 on ClinicalTrials.gov