Ipilimumab vs Ipilimumab Plus Nivolumab in Patients With Stage III-IV Melanoma Who Have Progressed or Relapsed on PD-1 Inhibitor Therapy

Part of paid clinical trials in Los Angeles, California.

Sponsor
Parker Institute for Cancer Immunotherapy
Study ID
NCT02731729
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this research study is to learn whether patients whose disease grows after being treated with nivolumab or pembrolizumab respond to ipilimumab (Yervoy®) alone or in combination with nivolumab (Opdivo®).

Key Dates

Start date
Jun 21, 2016
Status verified
Dec 2022
Primary completion
Aug 27, 2018
Completion
Feb 13, 2019

Study Design

Enrollment
20 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ipilimumab and nivolumab
    For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes.
  • Experimental: ipilimumab
    In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses.

Primary Outcome Measure

Overall Response Rate (ORR) as Defined by RECIST v1.1 at Week 18 [ Time Frame: Week 18 ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095-
University of California, San FranciscoSan FranciscoCalifornia94134-
Memorial Sloan Kettering Basking RidgeBasking RidgeNew Jersey07920-
Memorial Sloan Kettering WestchesterHarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Lehigh Valley Health NetworkAllentownPennsylvania18103-
University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Los Angeles, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
University of California, Los Angeles· Los Angeles, CAUniversity of California, San Francisco· San Francisco, CAMemorial Sloan Kettering Basking Ridge· Basking Ridge, NJMemorial Sloan Kettering Westchester· Harrison, NYMemorial Sloan Kettering Cancer Center· New York, NYLehigh Valley Health Network· Allentown, PA

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