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New drug could extend life for mesothelioma patients

NCT ID NCT01843374

Disease control Sponsor: MedImmune LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 28, 2026 · Updated 3 times

Summary

This phase 2b trial tests whether the immunotherapy drug tremelimumab can help people with advanced mesothelioma live longer. About 571 patients who have already tried standard chemotherapy will receive either tremelimumab or a placebo. The main goal is to see if the drug improves overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tremelimumab (an immunotherapy drug given by IV)
What this could lead to
If it works, this could offer a new treatment option to extend survival for people with advanced mesothelioma who have run out of standard options.
What could go wrong
This is a mid-stage trial, so results are not yet proven. The drug may not improve survival and could cause immune-related side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

571 people

The number who actually took part.

Started

May 2013

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically and/or cytologically confirmed pleural or peritoneal malignant mesothelioma; 2. Disease not amenable to curative surgery; 3. Age 18 and over at the time of consent; 4. ECOG Performance status 0-1; 5. 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. 6. Recovered from all toxicities associated with prior treatment, to acceptable baseline status, or a NCI CTCAE Grade of 0 or 1, except for toxicities not considered a safety risk, 7. Measurable diseaseby modified RECIST for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma; 8. Adequate bone marrow, hepatic, and renal function determined within 14 days prior to randomization defined as: 9. Negative screening test results for human immunodeficiency virus (HIV), hepatitis A, B and C. 10. Written informed consent and any locally required authorization (eg, HIPAA in the USA, EU Data Privacy Directive authorization in the EU) obtained from the subject/legal representative prior to performing any protocol- related procedures, including screening evaluations; 11. Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of contraception after this point should be discussed with a responsible physician. 12. Nonsterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Days 1 through 90 post last dose. In addition, they must refrain from sperm donation for 90 days after the final dose of investigational product. Exclusion Criteria: 1. Subjects who failed more than 2 prior systemic treatment regimens for advanced malignant mesothelioma; 2. Received any prior mAb against CTLA-4, programmed cell death 1 (PD1) or programmed cell death 1 ligand 1 (PD-L1); 3. History of chronic inflammatory or autoimmune disease with symptomatic disease within the last 3 years prior to randomization. 4. Active, untreated central nervous system (CNS) metastasis 5. Any serious uncontrolled medical disorder or active infection that would impair the subject's ability to receive investigational product; 6. History of other malignancy unless the subject has been disease-free for at least 3 years; 7. Pregnant or breast feeding at time of consent; 8. Any condition that would prohibit the understanding or rendering of information and consent and compliance with the requirements of this protocol; 9. Active or history of diverticulitis; 10. Active or history of inflammatory bowel disease, irritable bowel disease, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea. Active or history of systemic lupus erythematosus or granulomatosis with polyangiitis; 11. History of sarcoidosis syndrome; 12. Currently receiving systemic corticosteroids or other immunosuppressive medications or has a medical condition that requires the chronic use of corticosteroids. 13. Subjects should not be vaccinated with live attenuated vaccines within one month prior to starting tremelimumab treatment; 14. The last dose of prior chemotherapy or radiation therapy was received less than 2 weeks prior to randomization; 15. Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy with the exception of vitiligo and alopecia; 16. 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; 17. Concurrent enrollment in another clinical study or receipt of an investigational product within the last 4 weeks 18. Employees of the study site directly involved with the conduct of the study, or immediate family members of any such individuals; 19. Subjects with a history of hypersensitivity to compounds of similar biologic composition to tremelimumab or any constituent of the product.

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Conditions

The condition(s) this trial relates to.

malignant mesothelioma malignant peritoneal mesothelioma malignant pleural mesothelioma Mesothelioma, Malignant type 1 diabetes mellitus 12

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Unresectable pleural or peritoneal malignant mesothelioma

Contacts and locations

Locations

  • Research Site

    Scottsdale, Arizona, 85259, United States

  • Research Site

    La Jolla, California, 92093, United States

  • Research Site

    Los Angeles, California, 90025, United States

  • Research Site

    San Francisco, California, 94143, United States

  • Research Site

    Santa Monica, California, 90404, United States

  • Research Site

    New Haven, Connecticut, 06511, United States

  • Research Site

    Newark, Delaware, 19718, United States

  • Research Site

    Tampa, Florida, 33612, United States

  • Research Site

    Augusta, Georgia, 30912, United States

  • Research Site

    Chicago, Illinois, 60637, United States

  • Research Site

    Peoria, Illinois, 61615, United States

  • Research Site

    Baltimore, Maryland, 21201, United States

  • Research Site

    Baltimore, Maryland, 21231, United States

  • Research Site

    Minneapolis, Minnesota, 55445, United States

  • Research Site

    New York, New York, 10065, United States

  • Research Site

    Rochester, New York, 14642, United States

  • Research Site

    Durham, North Carolina, 27710, United States

  • Research Site

    Canton, Ohio, 44710, United States

  • Research Site

    Philadelphia, Pennsylvania, 19104, United States

  • Research Site

    Dallas, Texas, 75390, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    Adelaide, 5000, Australia

  • Research Site

    Auchenflower, 4066, Australia

  • Research Site

    Box Hill, 3128, Australia

  • Research Site

    Chermside, 4032, Australia

  • Research Site

    East Bentleigh, 3165, Australia

  • Research Site

    Gosford, 2250, Australia

  • Research Site

    Heidelberg, 3084, Australia

  • Research Site

    Nedlands, 6009, Australia

  • Research Site

    Saint Leonards, 2065, Australia

  • Research Site

    Waratah, 2298, Australia

  • Research Site

    Edegem, 2650, Belgium

  • Research Site

    Ghent, 9000, Belgium

  • Research Site

    Leuven, 3000, Belgium

  • Research Site

    Toronto, Ontario, M5G 2M9, Canada

  • Research Site

    Sainte-Foy, Quebec, G1V 4G5, Canada

  • Research Site

    Copenhagen, 2100, Denmark

  • Research Site

    Caen, 14076, France

  • Research Site

    Le Mans, 72037, France

  • Research Site

    Lille, 59037, France

  • Research Site

    Nice, 06189, France

  • Research Site

    Rennes, 35033, France

  • Research Site

    Toulouse, 31059, France

  • Research Site

    Villejuif, 94805, France

  • Research Site

    Berlin, 13125, Germany

  • Research Site

    Esslingen a.N., 73730, Germany

  • Research Site

    Freiburg im Breisgau, 79106, Germany

  • Research Site

    Gauting, 82131, Germany

  • Research Site

    Großhansdorf, 22927, Germany

  • Research Site

    Hamburg, 21075, Germany

  • Research Site

    Hemer, 58675, Germany

  • Research Site

    Karlsruhe, 76137, Germany

  • Research Site

    Löwenstein, 74245, Germany

  • Research Site

    Lübeck, 23538, Germany

  • Research Site

    Gyöngyös - Mátraháza, 3200, Hungary

  • Research Site

    Törökbálint, 2045, Hungary

  • Research Site

    Beersheba, 84101, Israel

  • Research Site

    Alessandria, 15100, Italy

  • Research Site

    Aviano, 33081, Italy

  • Research Site

    Bergamo, 24125, Italy

  • Research Site

    Bologna, 40138, Italy

  • Research Site

    Candiolo, 10060, Italy

  • Research Site

    Genova, 16132, Italy

  • Research Site

    Meldola, 47014, Italy

  • Research Site

    Milan, 20133, Italy

  • Research Site

    Orbassano, 10043, Italy

  • Research Site

    Padova, 35128, Italy

  • Research Site

    Rozzano, 20089, Italy

  • Research Site

    Siena, 53100, Italy

  • Research Site

    Breda, 4818 CK, Netherlands

  • Research Site

    Eindhoven, 5623EJ, Netherlands

  • Research Site

    Rotterdam, 3015 GD, Netherlands

  • Research Site

    Gdansk, 80-952, Poland

  • Research Site

    Poznan, 60-693, Poland

  • Research Site

    Szczecin, 70-891, Poland

  • Research Site

    Warsaw, 02-781, Poland

  • Research Site

    Craiova, 200385, Romania

  • Research Site

    Moscow, 115478, Russia

  • Research Site

    Nizhny Novgorod, 603006, Russia

  • Research Site

    Saint Petersburg, 197022, Russia

  • Research Site

    Kraaifontein, 7570, South Africa

  • Research Site

    Pretoria, 0081, South Africa

  • Research Site

    Pretoria, 0181, South Africa

  • Research Site

    Jeonnam, 58128, South Korea

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Seoul, 05505, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Barcelona, 08035, Spain

  • Research Site

    Donostia / San Sebastian, 20014, Spain

  • Research Site

    Madrid, 28040, Spain

  • Research Site

    Sabadell (Barcelona), 08208, Spain

  • Research Site

    Seville, 41013, Spain

  • Research Site

    Linköping, 58185, Sweden

  • Research Site

    Lund, 22185, Sweden

  • Research Site

    Umeå, SE90185, Sweden

  • Research Site

    Leeds, LS9 7TF, United Kingdom

  • Research Site

    Leicester, LE1 5WW, United Kingdom

  • Research Site

    London, EC1A 7BE, United Kingdom

  • Research Site

    London, SE1 9RT, United Kingdom

  • Research Site

    Maidstone, ME16 9QQ, United Kingdom

  • Research Site

    Manchester, M23 9LT, United Kingdom

  • Research Site

    Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

  • Research Site

    Plymouth, PL6 8DH, United Kingdom

  • Research Site

    Southampton, SO16 6YD, United Kingdom