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Pembrolizumab + Metformin for Head and Neck Cancer
Phase 2
Waitlist Available
Led By Trisha Wise-Draper, MD, PhD
Research Sponsored by Trisha Wise-Draper
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status ≤2
Histologically or cytologically confirmed recurrent or metastatic non-cutaneous HNSCC for which there are no surgical or radiation curative options
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will test whether combining metformin with pembrolizumab can help treat recurrent or metastatic head and neck squamous cell cancer.
Who is the study for?
This trial is for adults with recurrent or metastatic non-cutaneous head and neck cancers (HNSCC) who have tried up to three treatments without a cure. They should be fairly active and able to care for themselves (ECOG ≤2). People can't join if they've had certain cancer drugs recently, are already on metformin, or have nasopharyngeal HNSCC.Check my eligibility
What is being tested?
The study tests combining Pembrolizumab, an immune therapy drug, with Metformin Extended Release tablets in patients with advanced head and neck cancer. The goal is to see how well tumors respond to this combination treatment.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects like inflammation in organs, skin reactions, fatigue, and flu-like symptoms. Metformin can lead to digestive issues such as stomach pain and diarrhea but is generally well-tolerated.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
Select...
My head or neck cancer has returned or spread, and surgery or radiation can't cure it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response by RECIST 1.1 and iRECIST
Secondary outcome measures
Number of patients with adverse events measured by CTCAE v5.0
Overall Survival (OS)
Progression Free Survival (PFS)
Other outcome measures
Cytokine levels including IL-2, IL-4, IL-6, IL-8, IL-10, INFgamma, TNFalpha in Plasma via ELISA based technology.
Percent secretion of NKG2D soluble ligands via ELISA.
Percent tumor infiltrating NK cells determined by immunofluorescence
+3 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2: Metformin after PembrolizumabExperimental Treatment2 Interventions
D-21 Begin Pembrolizumab 200mg. D-7 begin Metformin ER 1000mg daily. D1 begin Metformin ER 2000mg daily. Continue Pembrolizumab 200mg every 3 weeks.
Group II: Arm 1: Metformin before PembrolizumabExperimental Treatment2 Interventions
Metformin ER 1000mg daily D-14 to D-7. Metformin ER 2000mg daily D-7 to D1. D1 Begin Pembrolizumab 200mg every 3 weeks, while continuing Metformin ER 2000mg daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Metformin
FDA approved
Find a Location
Who is running the clinical trial?
American Cancer Society, Inc.OTHER
224 Previous Clinical Trials
110,435 Total Patients Enrolled
Trisha Wise-DraperLead Sponsor
5 Previous Clinical Trials
212 Total Patients Enrolled
Trisha Wise-Draper, MD, PhD3.02 ReviewsPrincipal Investigator - University of Cincinnati
University of Cincinnati
4 Previous Clinical Trials
176 Total Patients Enrolled
1Patient Review
I would not recommend this doctor to anyone. She was cold and had a nasty attitude. I don't think she knows what she's doing.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have cancer in the upper part of my throat behind the nose.I can take care of myself but might not be able to do heavy physical work.My head or neck cancer has returned or spread, and surgery or radiation can't cure it.I haven't had chemotherapy or radiotherapy in the last 2 weeks.I still have side effects from previous cancer treatments.I have had up to 3 treatments for my cancer since it spread or came back.I am currently taking metformin or have taken it in the last 6 months.I have been treated with PD-1 or PD-L1 inhibitors for my cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: Metformin before Pembrolizumab
- Group 2: Arm 2: Metformin after Pembrolizumab
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
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 popular applications for Pembrolizumab?
"Pembrolizumab is the standard treatment for unresectable melanoma. Other conditions that respond well to this medication include microsatellite instability high, high risk of recurrence, and disease."
Answered by AI
How many people have been recruited to participate in this research project?
"The clinicaltrials.gov website has the most recent information on this trial, which is actively recruiting patients. The 20 participants will be recruited from a single location, and the trial was originally posted on 8/31/2020 with the last update taking place on 10/3/2022."
Answered by AI
Can people with the required qualifications participate in this trial right now?
"The answer is affirmative, the medical study detailed on clinicaltrials.gov has an open call for patients. This experiment was originally advertised on 8/31/2020 and updated as recently as 10/3/2022. They are looking for a total of 20 individuals across 1 centre(s)."
Answered by AI
What other cancer research studies has Pembrolizumab been a part of?
"Pembrolizumab is being researched in 1175 clinical trials, 167 of which are currently active. The many studies for Pembrolizumab originate from Houston, Texas, but the treatment is being tested at 37942 locations globally."
Answered by AI
Has Pembrolizumab been authorized by the FDA?
"Pembrolizumab's score of 2 on our Power team's safety scale indicates that while there is some data affirming its safety, there is currently no evidence to support its efficacy."
Answered by AI
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