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NCT05723562 · ClinicalTrials.gov registry record · Phase 2
A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer
A Phase 2 study of Neoplasms, Rectal, sponsored by GlaxoSmithKline.
- Active
- Registry status
- Phase 2
- Development phase
- 154
- Enrollment target
- 20
- Study locations
NCT05723562: Active Phase 2 study of Neoplasms, Rectal, sponsored by GlaxoSmithKline.
NCT05723562 is a Phase 2 study of Neoplasms, Rectal that is active but no longer recruiting, run by GlaxoSmithKline. The registered enrollment target is 154 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05723562, a Phase 2 study of Neoplasms, Rectal, is active but no longer recruiting, sponsored by GlaxoSmithKline.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 154 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to investigate dostarlimab monotherapy in participants with locally advanced Mismatch-repair deficient (dMMR)/Microsatellite instability-high (MSI-H) rectal cancer who have received no prior treatment. Participants who achieve complete clinical response (cCR) following dostarlimab treatment will undergo non-operative management (NOM), including close surveillance for recurrent disease. The goal of the study is to determine if Dostarlimab therapy alone is an effective treatment that can allow participants to avoid chemotherapy, radiation, and surgery.
Primary Outcome
cCR12 is achieved when a participant maintains complete clinical response (cCR) as assessed by ICR for 12 months following their post-intervention disease assessment (PIDA)
Conditions Studied
Interventions
- BIOLOGICAL Dostarlimab
Study Locations (20)
Other
- GSK Investigational Site - Besançon
- GSK Investigational Site - Marseille
- GSK Investigational Site - Paris
- GSK Investigational Site - Pessac
- GSK Investigational Site - Rennes
- GSK Investigational Site - Berlin
- GSK Investigational Site - Dresden
- GSK Investigational Site - Düsseldorf
- GSK Investigational Site - Frankfurt
Ontario
- GSK Investigational Site - Ottawa
- GSK Investigational Site - Toronto
Quebec
- GSK Investigational Site - Montreal
- GSK Investigational Site - Sherbrooke
California
- GSK Investigational Site - Los Angeles
New Mexico
- GSK Investigational Site - Albuquerque
New York
- GSK Investigational Site - New York
Pennsylvania
- GSK Investigational Site - Pittsburgh
Tennessee
- GSK Investigational Site - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2023-04-03 |
| Est. Completion | 2029-10-11 |
| Phase | Phase 2 |
What the registry record for NCT05723562 still lists
NCT05723562 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% higher).
The record links to 1 condition, with Neoplasms, Rectal appearing as the primary indexed condition, and to 1 intervention - of which Dostarlimab is the first listed.
NCT05723562 names 20 study sites across 10 states, led by Other, Ontario, Quebec.
Frequently Asked Questions
What is clinical trial NCT05723562 about?
NCT05723562 is a clinical study titled "A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer". The purpose of this study is to investigate dostarlimab monotherapy in participants with locally advanced Mismatch-repair deficient (dMMR)/Microsatellite instability-high (MSI-H) rectal cancer who have received no prior treatment. Participants who achieve complete clinical response (cCR) following d...
What is the current status of trial NCT05723562?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 154 participants. The study started on 2023-04-03. Estimated completion is 2029-10-11.
What conditions does trial NCT05723562 study?
This clinical trial studies the following conditions: Neoplasms, Rectal.
What interventions are being tested in trial NCT05723562?
The interventions under investigation include: Dostarlimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05723562?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05723562 being conducted?
This trial has 20 study locations across California, New Mexico, New York, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05723562's enrollment target sits among peer trials
154 448th of 2000 higher than 1,552 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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