Study on Anti-PD-1 Antibody with Metabolic Modulator for Treating Solid Tumors

Sponsor: Dan Zandberg

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04114136

Provider View

This clinical trial is testing a combination of an anti-PD-1 antibody with metabolic modulators like Metformin or Rosiglitazone to see if it can improve treatment outcomes for patients with certain advanced solid tumors.

Patient Parameters

Program Overview

The study aims to find out if adding Metformin or Rosiglitazone to an anti-PD-1 antibody treatment can help the immune system better fight certain advanced cancers, such as melanoma, kidney cancer, and lung cancer. Participants will be randomly assigned to receive either the anti-PD-1 antibody alone or with one of the metabolic modulators. The treatment will last up to two years, or until the cancer progresses or side effects become too severe.

Description

This study is exploring whether combining an anti-PD-1 antibody with Metformin or Rosiglitazone can enhance the immune system's ability to fight cancer. The goal is to see if these combinations can reduce the oxygen consumption of tumors, making them less resistant to immune attacks. Participants will be divided into three groups: one receiving the anti-PD-1 antibody with Metformin, another with Rosiglitazone, and the last group receiving the antibody alone. The study will last up to two years, with regular biopsies to monitor the treatment's effects. Researchers hope to find a more effective way to treat advanced cancers by improving the immune response.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced melanoma, kidney cancer, lung cancer, liver cancer (Child Pugh Class A), MSI-High solid tumors, bladder cancer, gastroesophageal cancer, or head and neck cancer.
  • Tumor must be accessible for a biopsy before and after treatment.
  • Be 18 years or older.
  • Have at least one measurable tumor.
  • Be in good overall health with an ECOG performance status of 0 to 2.
  • Have normal organ and bone marrow function based on specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control during the study and for 120 days after the last dose.
  • Men must agree to use contraception during the study and for 120 days after the last dose.
  • Be able to understand and sign a consent form.
  • If previously had brain metastases, they must be stable and not causing symptoms.
  • If diabetic, must not currently need medication for diabetes and have not used certain diabetes medications recently.

Exclusion Criteria

  • Have previously received anti-PD-1 or anti-PD-L1 therapy.
  • Have type I diabetes or have used certain diabetes medications recently.
  • Be pregnant or breastfeeding.
  • Have an active autoimmune disease requiring treatment in the past 3 months.
  • Have uncontrolled heart disease or recent heart attack.
  • Have severe heart failure.
  • Have psychiatric or social issues that limit compliance.
  • Have a history of lung inflammation requiring steroids.
  • Have used an investigational drug recently.
  • Have had another cancer within the past 2 years, except for certain skin or cervical cancers.
  • Have a condition that might interfere with the study.
  • Have a known history of HIV.
  • Be allergic to Metformin, Rosiglitazone, Pembrolizumab, or Nivolumab.
  • Be unable to take pills.
  • Have a history of acidosis or consume excessive alcohol.
  • Require treatment with Rifampin or Gemfibrozil.

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