Clinical trial · Interventional
A Study of the Duration of Dostarlimab in Untreated Mismatch Repair Deficient (dMMR)/ Microsatellite Instability-high (MSI-H) Locally Advanced Rectal Cancer
A Phase 3b, Open-label Study Investigating the Duration of Neoadjuvant Dostarlimab Monotherapy in Participants With Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is conducted in adults with rectal cancer that has a certain genetic type. The main goal is to find out whether a longer treatment period with dostarlimab can help more participants have a complete response to treatment and avoid standard treatments like chemotherapy, radiation treatment, or surgery. Scans and endoscopy tests will be conducted to see if the tumor disappears and how long the cancer stays under control. The study will also collect information on side effects and health outcomes after dostarlimab.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms, Rectal | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dostarlimab | Biological | Dostarlimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dostarlimab
- interventionNames
- Biological: Dostarlimab
Primary outcomes (1)
- measure
- Percentage of participants who achieve clinical complete response (cCR) amongst participants who receive > 9 cycles (> 6 months) of dostarlimab monotherapy by investigator assessment
- timeFrame
- Up to 168 weeks
Secondary outcomes (6)
- measure
- Overall cCR rate by investigator assessment
- timeFrame
- Up to 171 weeks
- description
- Overall cCR rate is defined as the percentage of participants achieving cCR by investigator assessment at any disease assessment, regardless of duration of dostarlimab therapy among all enrolled participants.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 a tumor demonstrating the presence of either: 1. dMMR status; MMR status must be assessed by immunohistochemistry for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of 1 or more proteins indicates dMMR; MMR status will be determined locally; or 2. MSI-H phenotype as determined by polymerase chain reaction or by tissue next generation sequencing; MSI-H will be determined locally. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Has adequate organ function. Exclusion Criteria: * 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. Participants with a history of bowel obstruction are eligible after obstruction is relieved by a diverting stoma (defunctioning colostomy). Patients with a history of bowel obstruction in the context of current rectal cancer diagnosis and treated with stenting are not eligible. * Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. * Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to enrollment. * Is receiving any other anticancer or experimental therapy.
References
Publications (0)
Data not yet available