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PD-1 Inhibitor

PD-1 Inhibitor + Diabetes Drugs for Solid Malignant Tumors

Phase 2

Recruiting

Led By Dan P Zandberg

Research Sponsored by Dan Zandberg

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Creatinine clearance ≥40 mL/min/1.73 m2

If known to have prior brain metastases, must not have evidence of active (enlarging and/or symptomatic lesions) brain disease on MRI/CT evaluation.

Must not have

Hypersensitivity to metformin, rosiglitazone, pembrolizumab or nivolumab

Patients that require active treatment with Rifampin or Gemfibrozil for other medical conditions.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding the diabetes drugs metformin or rosiglitazone to the cancer drug pembrolizumab or nivolumab can help to treat advanced melanoma, renal cell carcinoma, NSCLC, HCC, MSI-High solid tumors, Urothelial Cancer, GE junction/Gastric Adenocarcinoma, or HNSCC.

Who is the study for?

Adults with certain advanced cancers (like melanoma, lung, liver, stomach cancer) who can take pills and have a tumor that can be biopsied. They should not have had recent treatment with similar drugs or have serious health issues like uncontrolled heart disease or active autoimmune diseases. Women of childbearing age must test negative for pregnancy and agree to use birth control.

What is being tested?

The trial tests Anti-PD-1 antibodies (Nivolumab or Pembrolizumab) alone or combined with Metformin or Rosiglitazone in patients with specific solid tumors. Participants will be randomly assigned to one of three groups and treated for up to two years unless they experience unacceptable side effects.

What are the potential side effects?

Possible side effects include immune system reactions affecting organs, infusion-related reactions, fatigue, digestive problems like nausea and diarrhea, blood sugar changes due to diabetes medications involved in the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidneys are functioning well enough for treatment.

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My brain scans show no active cancer growth if I've had brain metastases.

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My tumor can be biopsied before and after treatment.

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My cancer type is recommended to be treated with Pembrolizumab or Nivolumab.

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I can take care of myself and am up and about more than half of my waking hours.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not allergic to metformin, rosiglitazone, pembrolizumab, or nivolumab.

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I am currently taking Rifampin or Gemfibrozil for another health condition.

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I have severe heart failure symptoms.

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I have had lung inflammation treated with steroids, or I currently have it.

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I have been treated with anti-PD-1 or anti-PD-L1 therapy before.

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I cannot take pills by mouth or through a feeding tube.

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I do not have any uncontrolled heart conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Best overall response

Secondary study objectives

Number of Participants Experiencing Adverse Events Attributed to Treatment

Overall Survival (OS)

Progression-free survival (PFS)

Other study objectives

Change in Lymphocyte Cell Status

Restoration (change) of Mitochondrial Function in Nodal Infiltrating Lymphocytes

Restoration (change) of Mitochondrial Function in Peripheral Blood Lymphocytes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Anti-PD-1 mAb (nivolumab or pembrozilumab) plus RosiglitazoneExperimental Treatment2 Interventions

nivolumab (480mg IV q 4 weeks) or pembrozilumab (200mg IV q 3 weeks) - dependent upon approved indication. (If both agents are approved for the disease indication, selection is at the discretion of the investigator) Rosiglitazone - 4 mg by mouth once daily

Group II: Anti-PD-1 mAb (nivolumab or pembrozilumab) plus MetforminExperimental Treatment2 Interventions

Group III: Anti-PD-1 mAb (nivolumab or pembrozilumab)Active Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metformin

2006

Completed Phase 4

~2430

Rosiglitazone

2008