Tremelimumab for Mesothelioma

(Tremelimumab Trial)

Not currently recruiting at 123 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: MedImmune LLC

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: Autoimmune disease, CNS metastasis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 14 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called tremelimumab for individuals with mesothelioma that cannot be surgically removed. Researchers aim to determine if tremelimumab can extend patients' lives or improve their condition compared to a placebo, which contains no active ingredients. Participants will be randomly assigned to receive either tremelimumab or a placebo, and researchers will closely monitor their progress. This trial may suit those whose mesothelioma has worsened after previous treatments and cannot be addressed with surgery. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be on systemic corticosteroids or other immunosuppressive medications. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that tremelimumab has been tested in patients with mesothelioma, but it is not yet approved by the FDA for this use. Some studies have found that tremelimumab is generally safe, even when used with other treatments. For instance, when combined with another drug called durvalumab, patients lived longer without major safety issues, suggesting that tremelimumab is well-tolerated.

However, it is important to note that in some studies, tremelimumab did not significantly increase life expectancy compared to a placebo. While it has shown some activity against mesothelioma, its ability to improve survival rates remains under investigation. The FDA has granted tremelimumab "orphan drug" status for mesothelioma, supporting its development due to the rarity of the disease.

Overall, while tremelimumab has been safe in past trials, researchers continue to work on fully understanding its effectiveness in treating mesothelioma. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for mesothelioma?

Tremelimumab is unique because it targets CTLA-4, a protein that helps keep the immune system in check. Unlike traditional chemotherapy for mesothelioma, which attacks cancer cells directly, Tremelimumab ramps up the body's immune response to fight the cancer more effectively. Researchers are excited about this treatment because it offers a new approach by boosting the immune system, potentially leading to more durable and sustained control of the disease.

What evidence suggests that tremelimumab might be an effective treatment for mesothelioma?

In this trial, participants will receive either tremelimumab or a placebo. Research has shown that tremelimumab has produced mixed results in treating mesothelioma, a type of cancer. One study found that tremelimumab did not extend patients' lives compared to a placebo, particularly for those who had already received treatment for mesothelioma. Another study discovered that combining tremelimumab with durvalumab resulted in an average survival of 16.6 months when used as a second treatment option. While tremelimumab appears more promising when combined with other treatments, it has not consistently benefited mesothelioma patients on its own. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Written informed consent and any locally required authorization obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations

My advanced disease worsened after 1-2 treatments including a pemetrexed-platinum combo.

You have a measurable disease in the chest or abdominal lining.

Exclusion Criteria

Pregnant or breast feeding at time of consent

Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results

Any condition that would prohibit the understanding or rendering of information and consent and compliance with the requirements of this protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either tremelimumab or placebo in a randomized, double-blind manner

14 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

Long-term survival follow-up

Participants are monitored for overall survival and disease progression

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Tremelimumab

Trial Overview 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.

How Is the Trial Designed?

Group I: Tremelimumab Experimental Treatment 1 Intervention

Tremelimumab

Group II: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

MedImmune LLC

Lead Sponsor

Trials

348

Recruited

788,000+

Founded

1988

Headquarters

Gaithersburg, USA

Known For

Biologics research

Top Products

Synagis, FluMist

Dr. Reginald Seeto

MedImmune LLC

Chief Medical Officer since 2008

MD from University of Sydney, B.Sc. from University of Sydney

Peter Greenleaf

MedImmune LLC

Chief Executive Officer since 2006

MBA from St. Joseph’s University, B.S. from Western Connecticut State University

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9765708/

Tremelimumab plus durvalumab retreatment and 4-year ... Tremelimumab combined with durvalumab was associated with long-term survival in patients with mesothelioma. Retreatment was safe and resulted in clinically ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28729154/

Tremelimumab as second-line or third-line treatment in ... Tremelimumab did not significantly prolong overall survival compared with placebo in patients with previously treated malignant mesothelioma.

3. astrazeneca.com astrazeneca.com/media-centre/press-releases/2016/astrazeneca-reports-top-line-result-of-tremelimumab-monotherapy-trial-in-mesothelioma-29022016.html

AstraZeneca reports top-line result of tremelimumab ... Trial did not meet primary endpoint of improving overall survival in challenging to treat mesothelioma patients with no currently approved ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2016.34.15_suppl.8502

Tremelimumab as second- or third-line treatment of ... Tremelimumab as second- or third-line treatment of unresectable malignant mesothelioma (MM): Results from the global, double-blind, placebo-controlled ...

5. mesotheliomahope.com mesotheliomahope.com/treatment/immunotherapy/tremelimumab/

Imjudo® (Tremelimumab) for Mesothelioma | What to Expect The NIBIT-MESO-1 trial found that patients had a median overall survival of 16.6 months when tremelimumab and durvalumab were used as a second-line treatment.

6. asbestos.com asbestos.com/treatment/immunotherapy/tremelimumab/

Tremelimumab (Imjudo) for Mesothelioma Imjudo isn't FDA-approved for treating mesothelioma. In 2015, the FDA designated it an orphan drug for this rare, aggressive cancer. This designation encourages ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213260015000922

Articles Efficacy and safety of an intensified schedule of ... CTLA4 blockade by tremelimumab 15 mg/kg every 90 days provided preliminary evidence of activity in patients with pretreated malignant mesothelioma; however, ...