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Checkpoint Inhibitor
Pembrolizumab for Oral Cancers
Phase 2
Waitlist Available
Led By Renata Ferrarotto
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Willing to provide tissue from a newly obtained oral biopsy
Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to the development of histologically confirmed oral cancer or death of any cause, whichever occurs first, assessed up to 7 years
Awards & highlights
Study Summary
This trial will study how well pembrolizumab works in treating patients with high risk oral intraepithelial neoplasia.
Who is the study for?
Adults with high-risk oral intraepithelial neoplasia, confirmed by biopsy within the last year. Participants must have certain genetic markers (LOH at specific chromosomal sites), be in good health based on blood counts and liver function tests, and not be pregnant or breastfeeding. They should agree to use contraception during the study period.Check my eligibility
What is being tested?
The trial is testing pembrolizumab, an immunotherapy drug that may help the immune system fight cancer cells in patients with a high risk of developing oral cancer. The study will compare patient outcomes between those receiving pembrolizumab and those under observation.See study design
What are the potential side effects?
Pembrolizumab can cause side effects like fatigue, skin reactions, diarrhea, hormonal gland problems (like thyroid dysfunction), and it might worsen autoimmune diseases or lead to inflammation in organs such as lungs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing to give a tissue sample from a new mouth biopsy.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am 18 years or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization to the development of histologically confirmed oral cancer or death of any cause, whichever occurs first, assessed up to 7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to the development of histologically confirmed oral cancer or death of any cause, whichever occurs first, assessed up to 7 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Oral cancer-free survival
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
Active Control
Group I: Arm B (pembrolizumab)Experimental Treatment2 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (observation)Active Control1 Intervention
Patients undergo observation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,766 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,138 Total Patients Enrolled
Renata FerrarottoPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
154 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I am using two birth control methods or am not having sex to join this study.I have active hepatitis B or C.I have been diagnosed with a precancerous oral condition in the last year.I am willing to give a tissue sample from a new mouth biopsy.I have a history or diagnosis of early-stage oral cancer confirmed by a tissue diagnosis.My oral cancer biopsy shows pre-cancerous changes.My condition is considered high risk.I can take care of myself and am up and about more than half of my waking hours.I agree to use contraception during and for 4 months after the study.I haven't taken steroids or immunosuppressants in the last 7 days.I haven't had cancer antibody treatment in the last 4 weeks or have recovered from its side effects.I do not have any other cancer that is growing or needs treatment, except for certain skin cancers or cervical cancer that hasn't spread.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have been diagnosed with HIV.I am 18 years or older.I haven't had cancer treatment in the last 2 weeks or still have side effects.I am currently on medication for an infection.I have not received a live vaccine in the last 30 days.I have an active tuberculosis infection.I am currently in a cancer treatment study or was in one within the last 4 weeks.I have or had lung inflammation not caused by an infection.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (observation)
- Group 2: Arm B (pembrolizumab)
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.
Could you please tell us about other times that Pembrolizumab has been used in medical research?
"Pembrolizumab is being researched in 122 Phase 3 clinical trials, with a total of 1000 live studies presently. The vast majority of these trials are based in Houston, TX; however, there are 36030 locations running Pembrolizumab clinical trials globally."
Answered by AI
Are we still enrolling patients for this research project?
"At the moment, this particular study is not recruiting patients. The first posting was on June 14th, 2017 and there was a recent update on October 20th, 2022. However, there are 2537 other clinical trials for oral intraepithelial neoplasia and 1000 Pembrolizumab trials that are looking for patients."
Answered by AI
Are there any risks associated with treatment via Pembrolizumab?
"Pembrolizumab falls into the Phase 2 category, which means that while there is data supporting its safety, there is none yet affirming its efficacy. Our team at Power has rated it a 2 on our scale."
Answered by AI
What is the total participants in this research?
"Unfortunately, this study is not currently looking for new participants. Although, it's worth noting that the last update to this clinical trial was on October 20th, 2022. If you're interested in other similar studies, there are 2537 trials for oral intraepithelial neoplasia and 1000 Pembrolizumab trials admitting patients right now."
Answered by AI
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