Study of Adjuvant Ipilimumab and Nivolumab in Subjects With High-risk Ocular Melanoma

Part of paid clinical trials in San Francisco, California.

Sponsor
Suthee Rapisuwon
Study ID
NCT03528408
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab 240 mg IV over 30 minutes given Day 1, 15 and 29 of each Cycle
  • Ipilimumab — DRUG
    Ipilimumab 1 mg/kg IV over 60 minutes given Day 1 of each Cycle

Study Details

This is an open-label, multi-site, single-arm Phase 2 study of adjuvant nivolumab combined with ipilimumab for the treatment of adult subjects with completely treated high-risk ocular melanoma, as defined in eligibility criteria, without evidence of metastatic disease. All patients enrolled to the study will be treated with nivolumab 240 mg IV every 2 weeks plus ipilimumab 1mg/kg IV every 6 weeks. 1 cycle = 6 weeks. Treatment will continue until disease progression, unacceptable toxicity, patient request to discontinue or completion of treatment. Subjects may receive up to 25 doses of nivolumab and 8 doses of ipilimumab

Key Dates

Start date
Jul 26, 2018
Status verified
Apr 2023
Primary completion
May 31, 2023
Completion
Jun 30, 2023

Study Design

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

Arms

  • Experimental: Nivolumab and Ipilimumab
    All patients enrolled to the study will be treated with nivolumab 240 mg IV every 2 weeks plus ipilimumab 1mg/kg IV every 6 weeks. 1 cycle = 6 weeks.

Primary Outcome Measure

3 year Relapse Free Survival (RFS) [ Time Frame: 36 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94158-
Georgetown UniversityWashington D.C.District of Columbia20057-
Northwestern Univeristy Feinberg School of MedicineChicagoIllinois60611-
Washington University School of MedicineSt LouisMissouri63110-
Columbia UniversityNew YorkNew York10032-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in San Francisco, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
University of California San Francisco· San Francisco, CAGeorgetown University· Washington D.C., DCNorthwestern Univeristy Feinberg School of Medicine· Chicago, ILWashington University School of Medicine· St Louis, MOColumbia University· New York, NYMD Anderson Cancer Center· Houston, TX

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