A Biomarker Study in Advanced Mucosal or Acral Lentiginous Melanoma Receiving Nivolumab in Combination With Ipilimumab

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

Sponsor
Georgetown University
Study ID
NCT02978443
Phase
PHASE2
Status
Terminated

Conditions

  • Acral Lentiginous Melanoma
  • Mucosal Melanoma

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    nivolumab administered IV over 60 minutes at 1 mg/kg every 3 weeks for 4 treatment cycles (Induction) then continue with nivolumab administered IV over 60 minutes at 3 mg/kg every 2 weeks
  • Ipilimumab — DRUG
    ipilimumab administered IV over 90 minutes at 3 mg/kg every 3 weeks for 4 treatment cycles (Induction)

Study Details

Participants with advanced or metastatic mucosal melanoma (cohort A) and acral lentiginous melanoma (cohort B) eligible for treatment with nivolumab in combination with ipilimumab followed by nivolumab therapy will submit tissue blocks from tumors of malignant melanoma for histopathology review and immunohistochemistry analysis at Georgetown University-Lombardi Comprehensive Cancer Center. Pretreatment blood will be drawn and stored in the Melanoma Research Foundation Breakthrough Consortium Virtual Repository at each participating institution. At the end of participation, samples will be sent to Georgetown University-Lombardi Comprehensive Cancer Center for processing and storage. An optional pretreatment biopsy of an accessible tumor lesion will be performed in a subset of enrolled patients. Patients will receive nivolumab in combination with ipilimumab according to the standard FDA approved treatment regimen.

Key Dates

Start date
Jul 26, 2017
Status verified
Mar 2024
Primary completion
Jul 28, 2020
Completion
Aug 2, 2022

Study Design

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

Arms

  • Experimental: Nivolumab-Ipilimumab Combination Therapy
    All patients will receive nivolumab administered IV over 60 minutes at 1 mg/kg combined with ipilimumab administered IV over 90 minutes at 3 mg/kg every 3 weeks for 4 treatment cycles (Induction) then continue with nivolumab administered IV over 60 minutes at 3 mg/kg every 2 weeks until progression, intolerable toxicity, or a maximum of 48 weeks, whichever comes first (Maintenance). Patients exhibiting complete response (CR) should continue nivolumab monotherapy at least 12 weeks beyond documentation of CR, if possible.

Primary Outcome Measure

Objective Response Rate (ORR) With Mucosal Melanoma (MCM) [ Time Frame: 24 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20007-
Washington Cancer Institute at MedStar Washington Hospital CenterWashington D.C.District of Columbia20010-
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
John Theurer Cacner Center at Hackensack University Medical CenterHackensackNew Jersey07601-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in Washington D.C., DC

By research site
Lombardi Comprehensive Cancer Center· Washington D.C., DCWashington Cancer Institute at MedStar Washington Hospital Center· Washington D.C., DCH. Lee Moffitt Cancer Center and Research Institute· Tampa, FLJohn Theurer Cacner Center at Hackensack University Medical Center· Hackensack, NJMemorial Sloan Kettering Cancer Center· New York, NY

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