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Tremelimumab for Mesothelioma (Tremelimumab Trial)

Phase 2
Waitlist Available
Research Sponsored by MedImmune LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Progressed after previous receipt of 1-2 prior systemic treatments for advanced disease that included a first-line pemetrexed (or anti-folate)-based regimen in combination with platinum agent
Histologically and/or cytologically confirmed pleural or peritoneal malignant mesothelioma
Must not have
Active or history of diverticulitis
Received any prior mAb against CTLA-4, programmed cell death 1 (PD1) or programmed cell death 1 ligand 1 (PD-L1)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years.

Summary

This trial is testing a new cancer drug for people with mesothelioma who can't have surgery. 564 people will be enrolled and randomly assigned to either receive the drug or a placebo. There will be follow-ups to check safety and long-term effects.

Who is the study for?
This trial is for adults over 18 with confirmed pleural or peritoneal malignant mesothelioma who have progressed after 1-2 systemic treatments including a pemetrexed-based regimen. They must have measurable disease, adequate organ function, no HIV or hepatitis, and not be candidates for curative surgery. Participants should use effective contraception and cannot join if they've had certain autoimmune diseases, other cancers within 3 years (except some exceptions), recent chemotherapy or radiation, severe allergies to similar drugs, active infections, CNS metastasis, are pregnant/breastfeeding or unable to consent.
What is being tested?
The study compares Tremelimumab (a new treatment) with a placebo in patients with unresectable malignant mesothelioma. It's randomized (patients are assigned by chance) and double-blind (neither the researchers nor participants know who gets the real treatment). The ratio of assignment is two patients on Tremelimumab for every one patient on placebo across multiple countries.
What are the potential side effects?
Potential side effects of Tremelimumab may include diarrhea from gastrointestinal conditions; immune-related issues like inflammation of organs; skin reactions; fatigue; liver problems due to hepatic function changes; infusion reactions during drug administration; increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My advanced disease worsened after 1-2 treatments including a pemetrexed-platinum combo.
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My cancer, found in the lining of my chest or abdomen, has been confirmed by lab tests.
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I am 18 years old or older.
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My condition cannot be cured with surgery.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or had diverticulitis.
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I have received treatments targeting immune checkpoints.
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I have had symptoms of an autoimmune disease in the last 3 years.
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I received my last chemotherapy or radiation less than 2 weeks ago.
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I have tried more than 2 treatments for advanced mesothelioma without success.
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I have or had lupus or granulomatosis with polyangiitis.
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I have a history of sarcoidosis.
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I am currently on steroids or other drugs that weaken my immune system.
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I don't have any serious illnesses or infections that would stop me from taking a new treatment.
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I have brain metastases that haven't been treated.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival (OS)
Secondary study objectives
Disease Control Rate by Treatment Arm
Upper arm
Upper arm
+5 more

Side effects data

From 2019 Phase 2 trial • 33 Patients • NCT03007407
38%
Fatigue
21%
Diarrhea
17%
Nausea
17%
Fever
17%
Anorexia
17%
Maculopapular rash
17%
Pruritus
14%
Constipation
14%
Rash maculo-papular
10%
Anemia
10%
Abdominal pain
10%
Itching
7%
Hypothyroidism
7%
Non-cardiac chest pain
7%
Weight loss
7%
Cough
7%
Dry Skin
7%
Dehydration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalumab and Tremelimumab

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TremelimumabExperimental Treatment1 Intervention
Tremelimumab
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tremelimumab
2017
Completed Phase 2
~3070

Find a Location

Who is running the clinical trial?

MedImmune LLCLead Sponsor
347 Previous Clinical Trials
792,909 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT01843374 — Phase 2
Malignant Mesothelioma Research Study Groups: Tremelimumab, Placebo
Malignant Mesothelioma Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT01843374 — Phase 2
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT01843374 — Phase 2
~46 spots leftby Nov 2025
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