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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 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. The trial reports 20 study locations across 10 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05723562
The ClinicalTrials.gov registry entry for NCT05723562 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.
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