Anti-PD-1 Therapy with Metabolic Modulators for Advanced Solid Tumors
This study is testing if adding Metformin or Rosiglitazone to standard anti-PD-1 immunotherapy (Nivolumab or Pembrolizumab) can improve treatment for advanced solid tumors like melanoma, lung cancer (NSCLC), and liver cancer (HCC). Researchers believe these metabolic drugs might help the immunotherapy work better by changing the tumor environment. You could be eligible if you have one of these advanced cancers and would normally receive Nivolumab or Pembrolizumab alone. The main goal is to see if combining these drugs leads to a better overall response to treatment. The study plans to enroll 72 participants, but its current status is unclear.
- Study design
- This interventional study plans to enroll 72 participants. You would be randomly assigned to receive anti-PD-1 therapy alone or with Metformin or Rosiglitazone.
- What's involved
- You will undergo a biopsy before treatment and another biopsy about five weeks after starting treatment. The study will track your best overall response from the start of treatment until disease progression or recurrence, up to 48 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your best overall response will be measured from the start of treatment until disease progression or recurrence, up to 48 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Dan P Zandberg · PRINCIPAL_INVESTIGATOR · UPMC Hillman Cancer Center
Who to contact
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What this trial measures
- Best overall responseFrom start of the treatment until disease progression/recurrence up to 48 months
Best overall response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1), by tumor type, recorded from the start of the treatment until disease progression/recurrence. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. Partial Response (PR): ≥ 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Incomplete Response/Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, (reference smallest sum diameters). Progressive Disease (PD): ≥ 20% increase in the sum of diameters of target lesions (reference smallest sum diameters); the sum must also demonstrate an absolute increase of at least 5 mm; (appearance ≥ 1 new lesions is considered progression).