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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best overall response
Secondary outcome measures
Number of Participants Experiencing Adverse Events Attributed to Treatment
Overall Survival (OS)
Progression-free survival (PFS)
Other outcome measures
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
216 Total Patients Enrolled
Dan P ZandbergPrincipal InvestigatorUPMC Hillman Cancer Center
1 Previous Clinical Trials
188 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not allergic to metformin, rosiglitazone, pembrolizumab, or nivolumab.I am currently taking Rifampin or Gemfibrozil for another health condition.I have severe heart failure symptoms.My kidneys are functioning well enough for treatment.I haven't had cancer in the past 2 years, except for certain skin, cervical, or prostate cancers.I haven't needed strong medication for an autoimmune disease in the last 3 months.I haven't taken any experimental drugs in the last 14 days.I have had lung inflammation treated with steroids, or I currently have it.I have been treated with anti-PD-1 or anti-PD-L1 therapy before.My organ and bone marrow functions are normal.My brain scans show no active cancer growth if I've had brain metastases.I cannot take pills by mouth or through a feeding tube.You have mental health problems or other issues in your personal life that may make it difficult for you to follow the study instructions and requirements.You have a history of acidosis (a condition where your body has too much acid) or you regularly drink five or more alcoholic beverages every day.My tumor can be biopsied before and after treatment.My cancer type is recommended to be treated with Pembrolizumab or Nivolumab.I agree to use birth control during and for 4 months after the study.I have type 1 diabetes or have taken diabetes medications in the last 60 days.I have type 2 diabetes but haven't taken diabetes medication in the last 60 days.I am willing to use birth control or abstain from sex during and for 120 days after the study.I can take care of myself and am up and about more than half of my waking hours.I am 18 years old or older.I do not have any uncontrolled heart conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Anti-PD-1 mAb (nivolumab or pembrozilumab) plus Rosiglitazone
- Group 2: Anti-PD-1 mAb (nivolumab or pembrozilumab) plus Metformin
- Group 3: Anti-PD-1 mAb (nivolumab or pembrozilumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the typical applications of Nivolumab or Pembrolizumab (depending on approved indication)?
"Nivolumab and Pembrolizumab (based on the allowed indication) are frequently used to treat inoperable melanoma. Additionally, it can be applied for patients with high risk of recurrence microsatellite instability-high or squamous cell carcinoma."
Answered by AI
Are there currently any openings for participants in this research endeavor?
"As per the clinicaltrials.gov listing, this trial is still open to participants; it was initiated on August 18th 2020 and had its most recent changes posted on February 10th 2022."
Answered by AI
How many volunteers have been accepted into the experiment?
"Affirmative. Evidence hosted on clinicaltrials.gov indicates that the trial, which was initially posted on August 18th 2020 is actively seeking patient enrollment. A total of 108 individuals need to be recruited at a single site."
Answered by AI
What safety risks, if any, do Nivolumab or Pembrolizumab pose for patients according to their approved indications?
"A score of 2 has been assigned to Nivolumab and Pembrolizumab due to the lack of efficacy-related data, despite having some safety data from Phase 2 trials."
Answered by AI
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