High Dose IL-2 and Anti-PD-1 Therapy for Overcoming Resistance in Advanced Melanoma and Kidney Cancer

Sponsor: Gregory Daniels

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03991130

Provider View

This study is testing a combination of high dose IL-2 and nivolumab to see if it can help patients with advanced melanoma and kidney cancer who have not responded to previous anti-PD-1 treatments. The trial will measure how well the treatment works and its safety.

Patient Parameters

Program Overview

The main goal of this study is to see if combining high dose IL-2 with nivolumab can help shrink tumors in patients with advanced melanoma and kidney cancer who have not responded to previous anti-PD-1 treatments. The study will also look at the safety and side effects of this treatment combination. Patients will be evaluated after each treatment cycle to see how their cancer responds.

Description

This clinical trial is exploring a new treatment approach for patients with advanced melanoma or kidney cancer who have not responded to previous anti-PD-1 therapy. The treatment combines high dose IL-2 with nivolumab, an anti-PD-1 drug, to see if it can help shrink tumors. The study will measure the overall response rate, which includes complete and partial responses, using specific guidelines.

The trial will also assess the safety and side effects of the treatment, as well as how long patients remain free from cancer progression after receiving at least one course of therapy. Researchers will collect data on certain markers in the blood and tumor tissue to see if they correlate with the treatment's effectiveness.

The study will last up to 48 months and include up to 25 participants. Patients will be treated for one course beyond their best response, with a maximum of three courses.

Eligibility Criteria

Inclusion Criteria

  • Must be able to understand and sign a consent form.
  • Age 18 or older.
  • Previously received at least 6 weeks of anti-PD-1 therapy and experienced cancer progression.
  • Diagnosed with advanced melanoma or kidney cancer that cannot be surgically removed.
  • Have at least one measurable tumor based on scans.
  • Good overall health with a performance status of 0 or 1.
  • Adequate liver, kidney, and blood function based on specific tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use two forms of birth control.
  • Men must agree to use contraception if not surgically sterile.
  • Previous treatment side effects must have improved to a mild level.

Exclusion Criteria

  • Active infection requiring treatment.
  • Pregnant or breastfeeding women.
  • Another active cancer within the past 5 years, except for certain skin, cervical, or prostate cancers.
  • Active brain metastases causing symptoms.
  • Recent major surgery.
  • Uncontrolled high blood pressure.
  • Serious wounds or fractures.
  • Recent heart attack or stroke.
  • Conditions that could affect safety or compliance.
  • Mental or medical conditions preventing informed consent.
  • Allergies to study drugs.
  • History of active tuberculosis.
  • High-dose steroid therapy.
  • Active autoimmune diseases requiring treatment.
  • Recent treatment with investigational drugs.

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