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Phase 2 Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer
EU CTIS ID: 2023-509583-22-00
What this study is testing
To estimate the efficacy of dostarlimab in participants with Stage II/III (locally advanced) dMMR/MSI-H rectal cancer that has not been previously treated
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Is at least 18 years of age (or the local legal age of consent) at the time of signing the ICF
- Has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+) locally advanced rectal adenocarcinoma
- Has radiologically and endoscopically evaluable disease
- Has an archival FFPE tissue sample that must be available and submitted to the central reference laboratory for testing at Screening
- Has an ECOG performance status of 0 or 1
- Has adequate organ function
You likely can't join if
- Has distant metastatic disease
- Has received prior radiation therapy, systemic therapy, or surgery for management of rectal cancer
- Has a tumor that, in the investigator's judgment, is causing symptomatic bowel obstruction or otherwise requires urgent/emergent local intervention
- Has a known additional malignancy that progressed or required active treatment within the past 2 years (Exceptions include adequately treated superficial skin cancers, superficial bladder cancers, and other in situ cancers)
- Is immunocompromised in the opinion of the investigator
- Has an active autoimmune disease that has required systemic treatment in the past 2 years
See the full eligibility criteria
- Is at least 18 years of age (or the local legal age of consent) at the time of signing the ICF
- Has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+) locally advanced rectal adenocarcinoma
- Has radiologically and endoscopically evaluable disease
- Has an archival FFPE tissue sample that must be available and submitted to the central reference laboratory for testing at Screening
- Has an ECOG performance status of 0 or 1
- Has adequate organ function
- Has a tumor demonstrating the presence of either dMMR status or MSI-H phenotype
- Has distant metastatic disease
- Has received prior radiation therapy, systemic therapy, or surgery for management of rectal cancer
- Has a tumor that, in the investigator's judgment, is causing symptomatic bowel obstruction or otherwise requires urgent/emergent local intervention
- Has a known additional malignancy that progressed or required active treatment within the past 2 years (Exceptions include adequately treated superficial skin cancers, superficial bladder cancers, and other in situ cancers)
- Is immunocompromised in the opinion of the investigator
- Has an active autoimmune disease that has required systemic treatment in the past 2 years
- Is receiving immunosuppressive medication ; Has received systemic corticosteroids
- Has received or plans to receive an organ or stem cell transplant that uses donor stem cells (allogeneic stem cell transplant).
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Canada
- United States
- Korea, Republic of
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Canada; United States; Korea, Republic of; Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.