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.
- Malignant Mesothelioma
1 Primary · 9 Secondary · Reporting Duration: 3 years.
Side Effects for
2 Treatment Groups
1 of 2
1 of 2
571 Total Participants · 2 Treatment Groups
Primary Treatment: Tremelimumab · Has Placebo Group · Phase 2
Who is running the clinical trial?
Age 18 - 99 · All Participants · 11 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- Maio, Michele, Arnaud Scherpereel, Luana Calabrò, Joachim Aerts, Susana Cedres Perez, Alessandra Bearz, Kristiaan Nackaerts, et al.. 2017. “Tremelimumab as Second-line or Third-line Treatment in Relapsed Malignant Mesothelioma (DETERMINE): A Multicentre, International, Randomised, Double-blind, Placebo-controlled Phase 2b Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(17)30446-1.
- Baverel, Paul, Lorin Roskos, Manasa Tatipalli, Nancy Lee, Paul Stockman, Maria Taboada, Paolo Vicini, Kevin Horgan, and Rajesh Narwal. 2019. “Exposure–response Analysis of Overall Survival for Tremelimumab in Unresectable Malignant Mesothelioma: The Confounding Effect of Disease Status”. Clinical and Translational Science. Wiley. doi:10.1111/cts.12633.
- Maio M, Scherpereel A, Calabro L, Aerts J, Perez SC, Bearz A, Nackaerts K, Fennell DA, Kowalski D, Tsao AS, Taylor P, Grosso F, Antonia SJ, Nowak AK, Taboada M, Puglisi M, Stockman PK, Kindler HL. Tremelimumab as second-line or third-line treatment in relapsed malignant mesothelioma (DETERMINE): a multicentre, international, randomised, double-blind, placebo-controlled phase 2b trial. Lancet Oncol. 2017 Sep;18(9):1261-1273. doi: 10.1016/S1470-2045(17)30446-1. Epub 2017 Jul 17.
- 2013. "Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01843374.
Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor