Pembrolizumab and Ipilimumab After Prior Immunotherapy for Melanoma

Part of paid clinical trials in Mobile, Alabama.

Sponsor
University of Chicago
Study ID
NCT02743819
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab given every 3 weeks (200 mg) by IV infusion.
  • Ipilimumab — DRUG
    Ipilimumab given every 3 weeks (200 mg) by IV infusion for total of 4 doses.

Study Details

Phase II study evaluating the benefit of the combination of anti-PD1 (pembrolizumab) and anti-CTLA4 (ipilimumab) antibodies in advanced melanoma. The study will determine the response rate of the combination and evaluate other clinical parameters such as progression-free survival and safety of the combination following anti-PD1/L1 antibody. The study will also provide the opportunity to investigate blood or tumor based factors that may predict response to anti-PD1 antibody in combination with anti-CTLA4.

Key Dates

Start date
Jun 28, 2016
Status verified
Jun 2025
Primary completion
Jun 1, 2022
Completion
Jun 30, 2026

Study Design

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

Arms

  • Experimental: Treatment
    Treatment with the combination of pembrolizumab and ipilimumab.

Primary Outcome Measure

Overall Response Rate (OR) Per irRECIST [ Time Frame: 16 weeks ]

Locations (10)

FacilityCityStateZIPSite coordinators
University of South AlabamaMobileAlabama36604-
Mount Sinai Medical Center of FloridaMiami BeachFlorida33140-
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
University of ChicagoChicagoIllinois60637-
Decatur Memorial HospitalDecaturIllinois62526-
NorthShore University HealthSystemEvanstonIllinois60201-
Oncology Specialists S.C.Park RidgeIllinois60068-
Illinois Cancer CarePeoriaIllinois61615-
Fort Wayne Medical Oncology and Hematology, Inc.Fort WayneIndiana46804-
Virginia Commonwealth University/ Massey Cancer CenterRichmondVirginia23298-

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