RecruitingPhase 2NCT04114136

Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies

A Phase II Clinical Trial of Anti-PD-1 mAb Therapy Alone or With Metabolic Modulators to Reverse Tumor Hypoxia and Immune Dysfunction in Solid Tumor Malignancies

Sponsor

Dan Zandberg

Enrollment

72 participants

Start Date

Sep 14, 2020

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma Melanoma Esophageal Adenocarcinoma NSCLC HNSCC Urothelial Cancer Gastric Adenocarcinoma Microsatellite Instability-High Solid Malignant Tumor

Summary

Patients with histologically or cytologically confirmed advanced melanoma, renal cell carcinoma, NSCLC, HCC (Child Pugh Class A only), MSI-High solid tumors, Urothelial Cancer, GE junction/Gastric Adenocarcinoma, or HNSCC for which current standard of care treatment for their stage of disease would be with Pembrolizumab or Nivolumab monotherapy, who meet eligibility criteria will undergo a biopsy (core or excisional/incisional; FNA not adequate) for baseline tissue. Patients will then be randomized to one of 3 arms: Anti-PD-1 mAb plus Metformin 500mg po BID, Anti-PD-1 mAb alone, Anti-PD-1 mAb plus Rosiglitazone 4mg po qdaily. Five weeks (+/- 7 days) after initiation of therapy a patient will undergo a repeat biopsy (core or excisional/incisional; FNA not adequate) for correlative analysis. The patient will then continue on study therapy for up to 2 years, or until progression of disease or unacceptable toxicity, whichever occurs first. RECIST 1.1 with modifications, to allow for continued therapy until progressive disease is confirmed if the patient is clinically stable, will be used in the trial.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a metabolic drug (one that changes how cancer cells use energy) to a standard immunotherapy drug (pembrolizumab or nivolumab) can improve outcomes in people with advanced cancers such as melanoma, kidney cancer, lung cancer, liver cancer, bladder cancer, stomach cancer, or head and neck cancer. **You may be eligible if...** - You are 18 years old or older - You have one of these advanced cancers: melanoma, renal cell carcinoma, non-small cell lung cancer, liver cancer (Child Pugh A), MSI-High solid tumours, urothelial cancer, gastric/GE junction adenocarcinoma, or head and neck squamous cell carcinoma - Standard treatment for your cancer type would normally be pembrolizumab or nivolumab alone - You have a tumour that can be safely biopsied - Your blood counts and organ function are within normal limits **You may NOT be eligible if...** - You have already received immunotherapy - You do not have a tumour accessible for biopsy - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNivolumab or Pembrolizumab (dependent upon approved indication)

Anti-PD-1 mAb (monoclonal antibody)

DRUGMetformin

Acts directly or indirectly on the liver to lower glucose production, and acts on the gut to increase glucose utilisation, increase GLP-1 and alter the microbiome.

DRUGRosiglitazone

A member of the thiazolidinedione class of antidiabetic agents, improves glycemic control by improving insulin sensitivity. Rosiglitazone is a highly selective and potent agonist for the peroxisome proliferator-activated receptor-gamma (PPARγ).