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

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

Trial Details

NCT ID
NCT04114136
Phase
PHASE2
Sponsor
Dan Zandberg
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Nivolumab or Pembrolizumab (dependent upon approved indication)
  • Metformin
  • Rosiglitazone
Locations (sample)
  • Pittsburgh, Pennsylvania, United States|40.44062,-79.99589

Key Eligibility Criteria

  • Histologically or cytologically confirmed advanced melanoma, renal cell carcinoma, NSCLC, HCC (Child Pugh Class A only), MSI-High solid tumors, Uro…
  • Accessible tumor for pretreatment (baseline) and post treatment biopsy. Tumor must be accessible for core or surgical biopsy (excisional/incisional…
  • Age ≥ 18 years
  • Have at least one measurable area of disease (Target Lesion) based on RECIST 1.1.

For full eligibility, visit ClinicalTrials.gov.

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