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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
Histologically and/or cytologically confirmed pleural or peritoneal malignant mesothelioma
Disease not amenable to curative surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years.
Awards & highlights

Tremelimumab Trial 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.Check my eligibility
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.See study design
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.

Tremelimumab Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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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My condition cannot be cured with surgery.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My advanced disease worsened after 1-2 treatments including a pemetrexed-platinum combo.
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I have recovered from previous cancer treatment side effects, except for minor ones.
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My blood, liver, and kidney tests are all within normal ranges.
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I am using effective birth control and will continue for 6 months after my last treatment dose.
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I am a man who can father children and will use effective birth control during and 90 days after treatment.

Tremelimumab Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Disease Control Rate by Treatment Arm
Upper arm
Upper arm
+6 more

Side effects data

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

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
~3380

Find a Location

Who is running the clinical trial?

MedImmune LLCLead Sponsor
347 Previous Clinical Trials
793,333 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age limit for this research extend beyond 65 years old?

"The specific age range for this clinical trial is much larger than average, as it encompasses patients from 18 to 99 years old. There are 49 other trials underway for people who are under 18 and 1742 different ones for patients over 65."

Answered by AI

Are there any positions available for participants in this research?

"Currently, this study is not looking for new patients according to the clinicaltrials.gov website. The trial was first posted on May 17th, 2013 and last edited on August 30th, 2022. Even though this specific study isn't taking candidates, there are 1,749 other trials that are actively recruiting right now."

Answered by AI

Is Tremelimumab a new or experimental medication?

"Tremelimumab was first investigated in 2007 at Research Site. Since then, there have been 18353 completed studies on the medication. As of now, 94 clinical trials are ongoing; a majority of these are located in Sainte Foy, Quebec."

Answered by AI

Is this a ground-breaking clinical trial?

"Tremelimumab has been under medical research scrutiny since 2007. A trial was completed in that year, with AstraZeneca footing the bill. 37 people were involved in the first study. After Phase 2 drug approval, 94 active studies involving 263 cities and 48 countries began to use Tremelimumab."

Answered by AI

In how many different medical clinics is this clinical study being conducted today?

"Currently, this clinical trial is enrolling patients at 22 sites which are situated in cities including Sainte Foy, Philadelphia and La Jolla. If you choose to enroll in the trial, it may be advantageous to select a location nearest to you so as to reduce travel time commitment."

Answered by AI

What is the limit to how many patients can join this experiment?

"Unfortunately, this study is no longer admitting patients. The listing was created on May 17th, 2013 and last updated on August 20th, 2022. For those still seeking studies, there are 1655 active clinical trials for lung cancer and 94 actively enrolling Tremelimumab candidates."

Answered by AI

What have been the most common side effects that patients experience with Tremelimumab?

"Tremelimumab's safety is rated as a 2 by our team at Power. While there isn't data attesting to its efficacy, tremelimumab has undergone some clinical trials that support its safety."

Answered by AI

How can I get involved with this clinical trial?

"The ideal candidate for this particular clinical trial would be between the ages of 18 and 99, has a diagnosis of lung cancer, and there are 571 total patients being sought."

Answered by AI
Recent research and studies
~49 spots leftby Feb 2025