Study on Nivolumab and Low Dose Ipilimumab for Stage III and Resected Stage IV Melanoma

Sponsor: Brown University

Sponsor score: 0

ClinicalTrials ID:NCT02656706

Provider View

This clinical trial is testing a combination of two immunotherapy drugs, nivolumab and ipilimumab, to see if they can help prevent the return of melanoma after surgery in patients with high-risk stage III or resected stage IV melanoma.

Patient Parameters

Program Overview

The study aims to find out if using nivolumab and a low dose of ipilimumab can effectively prevent melanoma from coming back in patients who have had surgery to remove the cancer. This treatment is being tested because the current standard treatment, high dose interferon, can be very toxic and is not very effective. The trial will last for six months, with patients receiving nivolumab every two weeks and ipilimumab every six weeks.

Description

This study is exploring a new treatment approach for patients with high-risk melanoma that has been surgically removed. The treatment involves two immunotherapy drugs, nivolumab and ipilimumab, which are given to help the immune system fight off any remaining cancer cells and prevent the cancer from returning. The study will last for six months, with patients receiving regular doses of these medications. Researchers hope this combination will be more effective and less toxic than the current standard treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with melanoma, which may be located on the skin or other areas like the eyes or rectum.
  • Cancer must be completely removed by surgery, either stage III with lymph node involvement or resected stage IV. Patients with stage T4BN0 are also eligible.
  • No previous treatment for melanoma other than surgery or radiation, with at least 4 weeks since surgery and 3 weeks since radiation.
  • Aged 18 years or older.
  • In good overall health, with a performance status score of 0 or 1.
  • Adequate organ and bone marrow function, as shown by specific blood test results.
  • Not pregnant or nursing, with women of childbearing potential having a negative pregnancy test before starting treatment.
  • Willing to use effective birth control during the study and for two months after treatment.
  • Able to provide informed consent to participate in the study.

Exclusion Criteria

  • Currently receiving any cancer treatment or investigational drugs.
  • Have brain metastases or cancer spread to the brain or bones.
  • Pregnant or breastfeeding.
  • Unable or unwilling to follow study procedures.
  • Have serious or uncontrolled medical conditions that could increase risks or interfere with the study.
  • Have had another active cancer within the past two years, except for certain skin or localized cancers that have been treated and cured.
  • Have an active autoimmune disease, except for certain controlled conditions.
  • Require systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of starting the study.
  • Have previously received anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.
  • Test positive for hepatitis B or C, or have a history of HIV/AIDS.
  • Have had severe allergic reactions to monoclonal antibodies.
  • Have unstable or new-onset angina or recent heart attack.
  • Have had an organ transplant or autologous transplant.

Locations

FACILITYZIPCITYSTATE
Rhode Island Hospital and The Miriam Hospital02903/02906ProvidenceRhode Island

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.