Study Comparing Two Treatment Approaches for Stage III Melanoma

Sponsor: The Netherlands Cancer Institute

Sponsor score: 0

ClinicalTrials ID:NCT04949113

This international clinical trial is comparing two treatment strategies for patients with Stage III melanoma. One group will receive a combination of two immunotherapy drugs before surgery, while the other group will receive standard treatment after surgery.

Patient Parameters

Program Overview

This study involves patients with Stage III melanoma, a type of skin cancer. It aims to compare the effectiveness of two treatment approaches. In one approach, patients will receive two cycles of immunotherapy drugs, ipilimumab and nivolumab, before undergoing surgery to remove lymph nodes and any nearby cancerous growths. In the other approach, patients will have surgery first, followed by 12 cycles of the immunotherapy drug nivolumab. The study will monitor patients to see which approach is more effective in controlling the cancer.

Eligibility Criteria

Inclusion Criteria

  • Men and women aged 16 and older.
  • Good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Diagnosed with Stage III melanoma that can be surgically removed, with one or more visible lymph node metastases.
  • No other cancers, unless treated and with a life expectancy of more than 5 years.
  • No previous treatments targeting specific immune checkpoints or genetic mutations.
  • No use of immunosuppressive medications in the past 6 months, except for low-dose steroids.
  • Blood tests showing adequate levels of white blood cells, platelets, hemoglobin, and normal liver and kidney function.
  • Women of childbearing age must use effective birth control during and after treatment.
  • Men must use effective birth control during and after treatment if their partners are of childbearing age.
  • Willingness to follow the study protocol, including attending visits and undergoing tests.
  • Signed informed consent to participate in the study.

Exclusion Criteria

  • Melanoma that has spread to distant parts of the body.
  • Specific types of melanoma, such as those affecting the eyes or mucous membranes.
  • Only having in-transit metastases without lymph node involvement.
  • Active autoimmune diseases or a history of such diseases requiring treatment.
  • Previous radiation therapy.
  • Positive tests for hepatitis B or C, unless treated and clear for at least a year.
  • Positive tests for HIV or AIDS.
  • Allergies to study drugs or severe reactions to similar treatments.
  • Medical conditions or infections that could complicate treatment.
  • Pregnant or breastfeeding women.
  • Need for ongoing immunosuppressive medications.
  • Recent use of other experimental drugs.
  • Conditions that could interfere with following the study protocol.

Locations

FACILITYZIPCITYSTATE
The Angeles Clinic90025Los AngelesCalifornia
MD Anderson Cancer Center77030HoustonTexas

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