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Chemotherapy
Chemoimmunotherapy for Mesothelioma
Phase 1 & 2
Waitlist Available
Led By Robert Ripley, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female subjects must either be of non-reproductive potential or must have a negative serum pregnancy test upon study entry
Weight >30 Kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up recurrence-free survival of greater than 60% at one year.
Awards & highlights
Study Summary
This trial will test if combination chemoimmunotherapy or dual agent immunotherapy alone improve efficacy for mesothelioma patients. It will assess safety & efficacy and explore biomarkers.
Who is the study for?
This trial is for adults over 18 with mesothelioma that can potentially be removed by surgery. They should have no severe disease outside the chest area, normal organ and bone marrow function, and an ECOG performance status of 0 or 1 (fully active or restricted in physically strenuous activity but ambulatory). Pregnant women and those on immunosuppressants or with certain medical conditions are excluded.Check my eligibility
What is being tested?
The study tests if adding durvalumab/tremelimumab to standard chemotherapy (cisplatin/carboplatin and pemetrexed) improves outcomes for mesothelioma patients who can undergo surgery. It compares this combination against using just durvalumab/tremelimumab without chemo, looking at survival rates without cancer recurrence.See study design
What are the potential side effects?
Durvalumab and tremelimumab may cause immune-related side effects affecting various organs, infusion reactions, fatigue, infections risk increase. Chemotherapy could add nausea, hair loss, blood cell count changes leading to increased infection risk or bleeding problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant or cannot become pregnant.
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I weigh more than 30 kilograms.
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My cancer is in one side of my chest and surgery might be possible.
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I am older than 18 years.
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My mesothelioma is of a specific type (epithelial, mixed, sarcomatoid).
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A specialist has evaluated me for surgery to remove my mesothelioma.
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My cancer has spread to nearby lymph nodes but not beyond.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ recurrence-free survival of greater than 60% at one year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~recurrence-free survival of greater than 60% at one year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recurrence-free survival of greater than 60% at one year.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Platinum cisplatin or carboplatin and pemetrexed chemotherapy plus durvalumab/tremelimumabExperimental Treatment1 Intervention
3 cycles of durvalumab (1500 mg intravenously) + tremelimumab (75 mg intravenously) with cisplatin 75mg/ m2 (or carboplatin AUC 5-6) + pemetrexed 500 mg/m2 (Cohort B).
Group II: Induction dual immunotherapy with durvalumab / tremelimumabExperimental Treatment1 Intervention
3 cycles of durvalumab (1500 mg intravenously) + tremelimumab (75 mg intravenously) starting Cycle1 Day (Cohort A).
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,360 Total Patients Enrolled
3 Trials studying Mesothelioma
43 Patients Enrolled for Mesothelioma
Duke Cancer InstituteOTHER
16 Previous Clinical Trials
2,981 Total Patients Enrolled
Robert Ripley, MDPrincipal InvestigatorBaylor College of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or cannot become pregnant.I have a history of HIV, hepatitis B or C, or another serious infection needing ongoing treatment.I weigh more than 30 kilograms.My cancer is in one side of my chest and surgery might be possible.I have an autoimmune disease but only take a low dose of prednisone or less.My mesothelioma is of a specific type (epithelial, mixed, sarcomatoid).I am older than 18 years.I have had severe side effects from previous immunotherapy.A specialist has evaluated me for surgery to remove my mesothelioma.I have previously been treated with a PD1 or PD-L1 inhibitor.You have received an organ from someone else in the past.My cancer has spread to nearby lymph nodes but not beyond.I am willing and able to follow the study's treatment and visit schedule.I haven't taken immunosuppressive drugs in the last 28 days.I have another type of cancer, but it's stable and doesn't need treatment right now.I am not pregnant, breastfeeding, and I use effective birth control.You have a history of weakened immune system from birth.I have seizures that are not controlled by medication.My organs and bone marrow are functioning well.Your heart's electrical activity takes longer than usual to recharge.I have had cancer spread to the lining of my brain and spinal cord.I received my last cancer treatment less than 28 days ago.I cannot tolerate certain immune therapy drugs.I have no severe side effects from past cancer treatments.I have brain metastases that need treatment.I am fully active or can carry out light work.I am not on antibiotics, antifungals, or antivirals for an infection.I have not received a live vaccine in the last 30 days.The doctor cannot take a tissue sample during the thoracoscopy procedure.I have had lung inflammation caused by an autoimmune disease.
Research Study Groups:
This trial has the following groups:- Group 1: Platinum cisplatin or carboplatin and pemetrexed chemotherapy plus durvalumab/tremelimumab
- Group 2: Induction dual immunotherapy with durvalumab / tremelimumab
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.
Is this research initiative open to new participants?
"The details hosted on clinicaltrials.gov suggest that this study is not presently accepting candidates, although it was initially posted to the site back in September 30th 2023 and last updated June 27th of the same year. However, 138 other trials are actively looking for patients at this moment in time."
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