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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

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 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

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
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) Metformin - 500 mg by mouth twice daily
Group III: Anti-PD-1 mAb (nivolumab or pembrozilumab)Active Control1 Intervention
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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430
Rosiglitazone
2008
Completed Phase 4
~10130

Find a Location

Who is running the clinical trial?

Dan ZandbergLead Sponsor
5 Previous Clinical Trials
184 Total Patients Enrolled
Dan P ZandbergPrincipal InvestigatorUPMC Hillman Cancer Center
1 Previous Clinical Trials
188 Total Patients Enrolled

Media Library

Nivolumab or Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04114136 — Phase 2
Stomach Cancer Research Study Groups: Anti-PD-1 mAb (nivolumab or pembrozilumab) plus Rosiglitazone, Anti-PD-1 mAb (nivolumab or pembrozilumab) plus Metformin, Anti-PD-1 mAb (nivolumab or pembrozilumab)
Stomach Cancer Clinical Trial 2023: Nivolumab or Pembrolizumab Highlights & Side Effects. Trial Name: NCT04114136 — Phase 2
Nivolumab or Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04114136 — Phase 2
~47 spots leftby Apr 2032