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Checkpoint Inhibitor
Pre-Surgery Immunotherapy for Mesothelioma
Phase 2
Recruiting
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years
STEP 2 ELIGIBILITY CRITERIA: Completion of at least 1 cycle of treatment and not have an unresolved adverse event that would preclude surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial tests if immunotherapy given before surgery can help control mesothelioma. It may help the body's immune system attack the cancer.
Who is the study for?
This trial is for adults with stage I-IIIa sarcomatoid mesothelioma who haven't had prior treatments affecting the primary tumor. Candidates must have a stable HIV, no active infections or autoimmune diseases (with some exceptions), and an ECOG performance status of <=2 or Karnofsky >=60%. Pregnant or nursing women are excluded, as well as those with certain heart conditions or other health issues that could interfere with surgery.Check my eligibility
What is being tested?
The trial tests if giving immunotherapy drugs nivolumab and ipilimumab before surgery can better control sarcomatoid mesothelioma compared to immunotherapy alone. These drugs may boost the immune system's ability to fight cancer by targeting specific proteins on tumor cells.See study design
What are the potential side effects?
Potential side effects from nivolumab and ipilimumab include fatigue, diarrhea, skin rash, itching, hormone gland problems (like thyroid dysfunction), liver inflammation, lung issues like pneumonitis, colitis in the digestive tract, and possible infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I've completed at least 1 treatment cycle and am fit for surgery.
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I do not have any active infections needing treatment and I tested negative for hepatitis B and C.
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I don't have conditions that need TNFalpha or immunosuppressant treatments.
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My cancer is mostly sarcomatoid mesothelioma.
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I am mostly self-sufficient and can carry out daily activities.
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I am not pregnant or breastfeeding.
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My cancer is at an early to mid-stage according to UICC standards.
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I can take care of myself but might not be able to do active work.
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My cancer has not progressed to a stage that makes surgery impossible.
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My kidney function, measured by creatinine levels or clearance, is within the normal range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 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 (PFS)
Surgery Rate
Secondary outcome measures
Incidence of adverse events
Major pathologic response
Objective response rate
+1 moreOther outcome measures
Biomarkers
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (nivolumab, ipilimumab, surgery)Experimental Treatment6 Interventions
Patients receive nivolumab IV, ipilimumab IV, and may undergo surgery on study. Patients also undergo CT or MRI and PET throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2008
Completed Phase 2
~2240
Ipilimumab
2014
Completed Phase 3
~2620
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Surgical Procedure
2020
Completed Phase 2
~160
Computed Tomography
2017
Completed Phase 2
~2720
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,612 Total Patients Enrolled
7 Trials studying Mesothelioma
713 Patients Enrolled for Mesothelioma
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,415 Total Patients Enrolled
93 Trials studying Mesothelioma
8,628 Patients Enrolled for Mesothelioma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has not spread to my chest wall, abdomen, opposite lung side, mid-chest organs, spine, or above my collarbone.I am 18 years old or older.I haven't received treatments that would affect the main goal of this study.Your predicted lung function is expected to be more than 35% of normal after surgery.You have a disease that can be measured or a disease that cannot be measured according to specific guidelines.I've completed at least 1 treatment cycle and am fit for surgery.I do not have any active infections needing treatment and I tested negative for hepatitis B and C.I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.I don't have active autoimmune diseases, except for allowed conditions like vitiligo or type I diabetes.I don't have conditions that need TNFalpha or immunosuppressant treatments.I am considered a good candidate for surgery.My cancer is mostly sarcomatoid mesothelioma.I am mostly self-sufficient and can carry out daily activities.I have another cancer type, but it won't affect this trial's treatment.I am not pregnant or breastfeeding.I haven't taken hormones or chemotherapy, except for non-cancer conditions.My cancer is at an early to mid-stage according to UICC standards.I am a woman who can have children and I have a recent negative pregnancy test.I can take care of myself but might not be able to do active work.My cancer has not progressed to a stage that makes surgery impossible.You have enough infection-fighting white blood cells in your body.My kidney function, measured by creatinine levels or clearance, is within the normal range.I finished my initial cancer treatment between 21 and 90 days ago.Your AST and ALT levels in the blood should not be more than 3 times the upper limit of normal.Your bilirubin levels need to be below a certain limit, unless you have Gilbert Syndrome, in which case it can be slightly higher.Your alkaline phosphatase levels are not more than 3 times the upper limit of normal.I have never had symptomatic interstitial lung disease.Your white blood cell count is at least 2000 per cubic millimeter.My heart function is classified as class 2B or better, despite my history of heart issues or treatments.Your blood platelet count is at least 100,000 per cubic millimeter.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (nivolumab, ipilimumab, surgery)
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.
To what extent is this clinical experiment involving human subjects?
"To meet the criteria of this clinical trial, 26 suitable patients must partake in its research. Those interested may do so at PCR Oncology located in Arroyo Grande, California or Beebe South Coastal Health Campus in Frankford, Delaware."
Answered by AI
Are there vacant slots for participants in this exploration?
"Correct. According to clinicaltrials.gov, the trial is currently looking for applicants and was initially published on March 14th 2023 with its last update occurring in July 26th of the same year. They aim to recruit a total of 26 participants from 62 different locations."
Answered by AI
Is the combination of nivolumab, ipilimumab and surgery an effective yet safe approach to treatment?
"The safety of the treatment (nivolumab, ipilimumab, surgery) is judged to be a 2 on our scale due to its Phase 2 trial status. This implies that while there are some studies showing it can be safe, none have demonstrated efficacy yet."
Answered by AI
How many medical facilities are administering this trial presently?
"At present, there are 62 participants of this trial who have been accepted from various locations across the United States. These include PCR Oncology in Arroyo Grande, Beebe South Coastal Health Campus in Frankford and Beebe Medical Centre in Lewes, amongst other sites."
Answered by AI
What are the desired outcomes of this medical research project?
"This trial's primary endpoint is Progression Free Survival (PFS), which will be assessed soon after the completion of neoadjuvant immunotherapy and surgery. Secondary endpoints include Time to Recurrence, Incidence of Adverse Events, and Objective Response Rate."
Answered by AI
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