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PD-1 Inhibitor
Pembrolizumab for Mesothelioma
Phase 2 & 3
Waitlist Available
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have histologically confirmed malignant pleural mesothelioma
ECOG performance status 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 32 months
Awards & highlights
Study Summary
This trial is testing whether pembrolizumab can help people with mesothelioma.
Who is the study for?
This trial is for adults with advanced malignant pleural mesothelioma that can't be removed by surgery. They must be able to receive standard chemo, have a performance status indicating they are relatively active, and not have other serious health issues or recent vaccines. Women and men who can become parents must use effective birth control.Check my eligibility
What is being tested?
The study tests Pembrolizumab, an immunotherapy drug designed to boost the immune system's ability to fight cancer, in combination with standard chemotherapy drugs Cisplatin and Pemetrexed. The goal is to see if this new treatment slows down cancer growth more effectively.See study design
What are the potential side effects?
Pembrolizumab may cause the immune system to attack normal organs/tissues leading to side effects like fatigue, coughing, nausea, itching or skin rash. Chemotherapy drugs like Cisplatin and Pemetrexed can cause side effects such as hair loss, nausea/vomiting, kidney problems and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is confirmed as malignant pleural mesothelioma.
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I am fully active or can carry out light work.
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My cancer cannot be removed by surgery and is not curable with standard treatments.
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I can receive standard chemotherapy with pemetrexed and cisplatin without any health restrictions.
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My treatment will start within 2 days after I am assigned to a treatment group.
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I am 18 years old or older.
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I can provide a sample of my tumor for analysis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 32 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~32 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase II: Progression free survival measured as time from randomization to first observation of objective disease relapse or progression
Phase III: Overall Survival defined as time from randomization to the date of death from any cause
Secondary outcome measures
Number and severity of adverse events
Objective Response rate compared using Fisher's exact test
Overall Survival
+1 moreTrial Design
3Treatment groups
Active Control
Group I: Arm B - Cisplatin/Pemetrexed/PembrolizumabActive Control3 Interventions
Pembrolizumab 200 mg* IV Day 1 over 30 min every 21 days for a total of 2 years Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles
Group II: Arm A - Cisplatin/PemetrexedActive Control2 Interventions
Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles
Group III: Arm C - Pembrolizumab (Phase II only)Active Control1 Intervention
Pembrolizumab 200 mg* IV 30 min Day 1 every 21 days for a total of 2 years
Find a Location
Who is running the clinical trial?
Intergroupe Francophone de Cancerologie ThoraciqueOTHER
57 Previous Clinical Trials
41,780 Total Patients Enrolled
2 Trials studying Mesothelioma
573 Patients Enrolled for Mesothelioma
Merck Sharp & Dohme LLCIndustry Sponsor
3,896 Previous Clinical Trials
5,062,198 Total Patients Enrolled
18 Trials studying Mesothelioma
3,397 Patients Enrolled for Mesothelioma
National Cancer Institute, NaplesOTHER
93 Previous Clinical Trials
51,568 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had major surgery over 28 days ago and my wound has healed.I have an autoimmune disease treated with medication in the last 3 years.I had cancer before but was treated with the intent to cure.My cancer is confirmed as malignant pleural mesothelioma.I have an immune system disorder or I am on long-term steroids.I can attend all treatment, check-up, and follow-up appointments.I have active brain metastases or cancer in the lining of my brain.I can provide a sample of my tumor for analysis.I agree to use two effective birth control methods during and for six months after the study.I have not received a live vaccine in the last 30 days.I am allergic to pembrolizumab or similar medications.I am not currently taking any experimental drugs or cancer treatments.I am fully active or can carry out light work.Your blood test results must show normal levels of white blood cells, platelets, hemoglobin, bilirubin, AST and ALT enzymes, and serum creatinine.My cancer cannot be removed by surgery and is not curable with standard treatments.I can receive standard chemotherapy with pemetrexed and cisplatin without any health restrictions.I have heart problems that are not being treated or controlled.My treatment will start within 2 days after I am assigned to a treatment group.I am 18 years old or older.Your disease can be seen on medical images and measured.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B - Cisplatin/Pemetrexed/Pembrolizumab
- Group 2: Arm A - Cisplatin/Pemetrexed
- Group 3: Arm C - Pembrolizumab (Phase II only)
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.
Does this research project have a significant presence in North America?
"Various hospitals and clinics across Canada are in the process of recruiting patients for this trial, including but not limited to University Health Network in Toronto, The Research Institute of the McGill University in Montreal, and CHUM-Centre Hospitalier de l'Universite de Montreal in Edmonton."
Answered by AI
What cancerous conditions does the Arm A - Cisplatin/Pemetrexed combination therapy commonly target?
"Arm A - Cisplatin/Pemetrexed is commonly used to treat patients with malignant neoplasms. This course of treatment has also been shown to be effective for other conditions, such as unresectable melanoma, microsatellite instability high, and locally advanced nonsquamous non-small cell lung cancer."
Answered by AI
Are there similar ongoing research projects to this one that involve Arm A - Cisplatin/Pemetrexed?
"There are presently 1690 ongoing trials related to Arm A - Cisplatin/Pemetrexed. 385 of these live trials are currently in Phase 3. Most of the clinical trials for Arm A - Cisplatin/Pemetrexed are based in Shanghai, but there are 72459 locations running trials globally."
Answered by AI
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