Study Summary
This trial is testing a new drug to see if it, combined with other standard treatments, is effective against a type of solid tumor. The trial will also monitor for side effects.
- Rectal Cancer
- Solid Tumors
- Solid Tumors, Adult
- Stage III Cancer
- Stage II Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: 12 months
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Cohort 1
1 of 1
Experimental Treatment
200 Total Participants · 1 Treatment Group
Primary Treatment: TSR-042 · No Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 12 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Cercek, Andrea, Melissa Lumish, Jenna Sinopoli, Jill Weiss, Jinru Shia, Michelle Lamendola-Essel, Imane H. El Dika, et al.. 2022. “PD-1 Blockade in Mismatch Repair–deficient, Locally Advanced Rectal Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2201445.
- Cercek, Andrea, Melissa Lumish, Jenna Sinopoli, Jill Weiss, Jinru Shia, Michelle Lamendola-Essel, Imane H. El Dika, et al.. 2022. “PD-1 Blockade in Mismatch Repair–deficient, Locally Advanced Rectal Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2201445.
- Costa, Bárbara, and Nuno Vale. 2022. “Dostarlimab: A Review”. Biomolecules. MDPI AG. doi:10.3390/biom12081031.
- Costa B, Vale N. Dostarlimab: A Review. Biomolecules. 2022 Jul 26;12(8):1031. doi: 10.3390/biom12081031.
- 2019. "Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04165772.
Frequently Asked Questions
In how many different places can people participate in this trial?
"There are 11 enrolment sites for this clinical trial, including Lehigh Valley Health Network (Data Collection Only) in Allentown, Pennsylvania, Memorial Sloan Kettering Monmouth - Limited Protocol Activities in Middletown, New Jersey and Memoral Sloan Kettering Westchester - Limited Protocol Activities in Harrison, New York." - Anonymous Online Contributor
Are there any limitations to who can sign up for this particular clinical trial?
"Yes, this research is currently looking for volunteers to participate. The trial was first advertised on December 11th 2019 and has since been updated on October 12th 2020." - Anonymous Online Contributor
What else is known about TSR-042 from past research?
"TSR-042 was first trialled at Withington Hospital in 2005. So far, 555 completed trials have been conducted. Currently, there are 393 ongoing studies recruiting participants, many of which based in Allentown, Pennsylvania." - Anonymous Online Contributor
What are the benefits of TSR-042?
"TSR-042 is an effective medication for patients suffering from metastatic colorectal carcinoma, pancreatic endocrine carcinoma, and refractory ovarian cancer." - Anonymous Online Contributor
Has the FDA cleared TSR-042 for general use?
"Because TSR-042 is only in Phase 2 trials, there is not yet enough data to support its efficacy. However, there is some evidence that suggests it is safe, so it received a score of 2." - Anonymous Online Contributor
How many people are participating in this clinical trial?
"In order to gather the data required, 51 individuals that meet the pre-determined inclusion criteria are needed to participate. These chosen patients can come from different hospitals, such as Lehigh Valley Health Network (Data Collection Only) in Allentown, Pennsylvania and Memorial Sloan Kettering Monmouth - Limited Protocol Activities in Middletown, New Jersey." - Anonymous Online Contributor