Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
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.