Neoadjuvant and Adjuvant Checkpoint Blockade

Part of paid clinical trials in New York, New York.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02519322
Phase
PHASE2
Status
Completed

Conditions

  • Cutaneous Melanoma
  • Mucosal Melanoma
  • Ocular Melanoma
  • Stage III Acral Lentiginous Melanoma AJCC v7
  • Stage IIIB Cutaneous Melanoma AJCC v7
  • Stage IIIB Uveal Melanoma AJCC v7
  • Stage IIIC Cutaneous Melanoma AJCC v7
  • Stage IIIC Uveal Melanoma AJCC v7
  • Stage IV Acral Lentiginous Melanoma AJCC v6 and v7
  • Stage IV Cutaneous Melanoma AJCC v6 and v7
  • Stage IV Uveal Melanoma AJCC v7

Eligibility Criteria

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

Interventions

  • Ipilimumab — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Nivolumab — BIOLOGICAL
    Given IV
  • Relatlimab — BIOLOGICAL
    Given IV
  • Therapeutic Conventional Surgery — PROCEDURE
    Undergo surgery

Study Details

This randomized phase II trial studies how well nivolumab with or without ipilimumab or relatlimab before surgery works in treating patients with stage IIIB-IV melanoma that can be removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, and relatlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab alone or in combination with ipilimumab or relatlimab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Key Dates

Start date
Feb 2, 2016
Status verified
Apr 2024
Primary completion
Jan 26, 2023
Completion
Jan 26, 2023

Study Design

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

Arms

  • Experimental: Arm A (nivolumab, surgery)
    Patients receive nivolumab IV over 30 minutes on days 1, 15, 29, and 43. Patients then undergo surgery on day 57. After surgery, patients receive nivolumab IV over 30 minutes every 2 weeks for 13 doses in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm B (nivolumab, ipilimumab, surgery)
    Patients receive nivolumab IV over 1 hour and ipilimumab IV over 90 minutes on days 1, 22, and 43. Patients then undergo surgery on day 57. After surgery, patients receive nivolumab IV over 30 minutes every 2 weeks for 13 doses in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm C (nivolumab, relatlimab, surgery)
    Patients receive nivolumab IV over 1 hour and relatlimab IV over 1 hour on days 1 and 29. Patients then undergo surgery on day 57. After surgery, patients receive nivolumab IV over 1 hour and relatlimab IV over 1 hour every 4 weeks for 10 doses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Arm C: Number of Participants With the Pathologic Response Rate [ Time Frame: up to 2 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in New York, NY

By research site
Memorial Sloan Kettering Cancer Center· New York, NYM D Anderson Cancer Center· Houston, TX

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