🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT05723562
Active, not recruiting Phase 2

A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer

NCT05723562 · tracked via the Priya Life Science UK tracker
Sponsor
GlaxoSmithKline
Phase
Phase 2
Started
2023-04-03
Last updated
2026-05-26

Condition(s) studied

Neoplasms, Rectal

Investigational drug(s) / intervention(s)

Dostarlimab

Dostarlimab: Dostarlimab will be administered.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Participant has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+), locally advanced rectal cancer * Participant has radiologically and endoscopically evaluable disease. * Participant has a tumor which can be categorized as dMMR or MSI-H by local or central assessment Exclusion Criteria: * Participant has distant metastatic disease. * Participant has received prior radiation therapy, systemic therapy, or surgery for management of rectal cancer. * Participant has any history of interstitial lung disease or pneumonitis * Participant has experienced any of the following with prior immunotherapy: any imAE of Grade ≥3, immune-related severe neurologic events of any grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (Stevens-Johnson Syndrome, toxic epidermal necrolysis, or DRESS syndrome), or myocarditis of any grade. Non clinically significant laboratory abnormalities are not exclusionary. * Participant 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. * Participant 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. * Participant has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or has known allergies to dostarlimab or its excipients. * Has received or plans to receive an organ or stem cell transplant that uses donor stem cells (allogeneic stem cell transplant).

Primary outcome measure(s)

Trial sites (42)

FacilityCityRegionStatus
GSK Investigational Site Los Angeles California
GSK Investigational Site Albuquerque New Mexico
GSK Investigational Site New York New York
GSK Investigational Site Pittsburgh Pennsylvania
GSK Investigational Site Nashville Tennessee
GSK Investigational Site Dallas Texas
GSK Investigational Site Richmond Virginia
GSK Investigational Site Ottawa Ontario
GSK Investigational Site Toronto Ontario
GSK Investigational Site Montreal Quebec
GSK Investigational Site Sherbrooke Quebec
GSK Investigational Site Besançon France
GSK Investigational Site Marseille France
GSK Investigational Site Paris France
GSK Investigational Site Pessac France
GSK Investigational Site Rennes France
GSK Investigational Site Berlin Germany
GSK Investigational Site Dresden Germany
GSK Investigational Site Düsseldorf Germany
GSK Investigational Site Frankfurt Germany
GSK Investigational Site München Germany
GSK Investigational Site Milan Italy
GSK Investigational Site Padova Italy
GSK Investigational Site Roma Italy
GSK Investigational Site Chiba Japan
GSK Investigational Site Kanagawa Japan
GSK Investigational Site Osaka Japan
GSK Investigational Site Osaka Japan
GSK Investigational Site Utrecht Netherlands
GSK Investigational Site Seoul South Korea
GSK Investigational Site Seoul South Korea
GSK Investigational Site Seoul South Korea
GSK Investigational Site Seoul South Korea
GSK Investigational Site Barcelona Spain
GSK Investigational Site Granada Spain
GSK Investigational Site Madrid Spain
GSK Investigational Site Madrid Spain
GSK Investigational Site Santander Spain
GSK Investigational Site Valencia Spain
GSK Investigational Site Leeds West Yorkshire United Kingdom

+ 2 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05723562 on ClinicalTrials.gov ↗ ← All trials in the UK