Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced Melanoma

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT04091750
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 2, 2020
Status verified
Feb 2026
Primary completion
Aug 8, 2023
Completion
Dec 31, 2026

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Nivolumab 3mg/kg IV plus Ipilimumab 1mg/kg IV every 3 weeks x 4 cycles with Cabozantinib 40mg PO daily for 12 weeks (Induction); Followed by Maintenance therapy: Nivolumab 480mg IV every 4 weeks for up to 92 weeks; Cabozantinib 40mg PO daily for up to 92 weeks; Maintenance therapy will continue for up to 92 weeks to complete 2 years total of treatment if tolerating therapy well and disease is controlled.

Primary Outcome Measure

The Progression Free Survival (PFS) for Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced Melanoma. [ Time Frame: 1 year ]

Locations (3)

FacilityCityStateZIPSite coordinators
Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20007-
Medstar Franklin Square Medical Center, Harry and Jeanette Weinberg Cancer InstituteBaltimoreMaryland21237-
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601-

Find similar trials in Washington D.C., DC

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Lombardi Comprehensive Cancer Center· Washington D.C., DCMedstar Franklin Square Medical Center, Harry and Jeanette Weinberg Cancer Institute· Baltimore, MDJohn Theurer Cancer Center at Hackensack University Medical Center· Hackensack, NJ

Related Studies