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Pembrolizumab for Head and Neck Cancers
Phase 2
Waitlist Available
Led By Tanguy Seiwert, M.D.
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have histologically confirmed head and neck cancer (Squamous cell histology as well as HPV+ and/or EBV+ head and neck tumors), Stages IVA, IVB, and select cases of Stage III.
Completed curative intent therapy, without additional standard of care curative intent therapy feasible within 20 weeks prior to study enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing whether adding the immunotherapy drug pembrolizumab to standard treatment can help people with squamous cell carcinoma of the head and neck who are at high risk for the cancer coming back.
Who is the study for?
Adults with head and neck squamous cell carcinoma who've finished curative treatment within the last 20 weeks, at high risk of cancer coming back. They must have good performance status, agree to use contraception, and not be pregnant or breastfeeding. Excluded are those with active infections like TB or hepatitis, recent other treatments or trials, certain autoimmune diseases, another progressing cancer, CNS metastases, or a history of severe reactions to pembrolizumab.Check my eligibility
What is being tested?
The PATHWay Study is testing if pembrolizumab can prevent cancer from returning in patients with high-risk head and neck cancers after they've completed their main treatment. Participants will either receive pembrolizumab or a placebo for one year in this double-blind study where neither doctors nor patients know who's getting the real drug.See study design
What are the potential side effects?
Pembrolizumab may cause immune system-related side effects such as inflammation in various organs including lungs (pneumonitis), liver problems (hepatitis), skin rash, hormone gland issues (like thyroid dysfunction), infusion reactions during administration of the drug and fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is in the head or neck area, confirmed by tests, and is at a specific advanced stage.
Select...
I finished my cancer treatment aimed at curing it and can't have more of such treatments for the next 20 weeks.
Select...
I am at least 18 years old.
Select...
My throat cancer's HPV status is known before treatment starts.
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
Progression free survival
Secondary outcome measures
Overall survival in the overall patient population, and in gene expression signature (GES) positive or PD-L1 positive (≥10%) patients
Progression free survival in gene expression profile (GEP) positive patients
Progression free survival in gene expression profile in PD-L1 >10% positive patients
Side 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: PlaceboExperimental Treatment1 Intervention
iv, every 3 weeks, x 1 year
Group II: PembrolizumabExperimental Treatment1 Intervention
200mg, every three weeks, iv, x 1 year
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,001 Previous Clinical Trials
817,630 Total Patients Enrolled
Tanguy Seiwert, M.D.Principal InvestigatorUniversity of Chicago
5 Previous Clinical Trials
143 Total Patients Enrolled
Alexander Pearson, M.D.Principal InvestigatorUniversity of Chicago
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can provide at least 10 slides of my tumor for testing.I have cancer that has spread to my brain or spinal cord.I have a history of HIV or active Hepatitis B/C.I agree to use birth control during and for 4 months after the study.I haven't taken steroids or immunosuppressants in the last 7 days.I have another cancer that is growing or needs treatment.I have an active tuberculosis infection.I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks.I haven't had cancer treatment or recovered from its side effects in the last 2 weeks.I finished my cancer treatment aimed at curing it and can't have more of such treatments for the next 20 weeks.I am at least 18 years old.I was mostly active before my treatment and am recovering from a treatment aimed at curing me.My organ functions are within normal ranges as per recent tests.I have been treated for an autoimmune disease in the last 2 years.I have or had lung inflammation not caused by an infection.I don't have any health issues that could affect the trial's results or my participation.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I have not received a live vaccine in the last 30 days.My cancer is in the head or neck area, confirmed by tests, and is at a specific advanced stage.I am using two birth control methods or am not having sex to avoid pregnancy during and up to 120 days after the study.My throat cancer's HPV status is known before treatment starts.I have taken a pregnancy test within the last 3 days and it was negative.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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 medical conditions are typically targeted with Pembrolizumab?
"Pembrolizumab is primarily used to treat malignant neoplasms. It can also offer respite for those with unresectable melanoma, microsatellite instability, or who have witnessed disease progression after chemotherapy."
Answered by AI
Is there still capacity for new participants in this clinical experiment?
"According to the information provided on clinicaltrials.gov, this specific study is not currently recruiting patients; it was first posted on 10th May 2017 and last updated 13th April 2022. Nevertheless, there are 2791 other trials actively searching for participants at present."
Answered by AI
What have been the observed risks associated with Pembrolizumab?
"Pembrolizumab's safety score is a 2, as this drug has gone through Phase 2 clinical trials which have provided some evidence of its security but none for its efficacy."
Answered by AI
How many participants is the research team recruiting for this experiment?
"Currently, this trial is not taking in new participants. It was initially posted on May 10th 2017 and last updated April 13th 2022. If you are seeking out other research studies, there are 1,830 active clinical trials for head neoplasms and 961 recruiting patients to test Pembrolizumab's efficacy."
Answered by AI
Are there any other documented attempts to assess the effectiveness of Pembrolizumab?
"At this very moment, the active clinical trials for Pembrolizumabcomprise 961 studies in total. Notably, 122 of those are currently in Phase 3 and 35731 locations across the world offer testing opportunities with pembrozulimab. Houston, Texas is one such location that has multiple projects running on this medication."
Answered by AI
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