MedDataX Logo

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

NCT ID: NCT05723562

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-03

Study Completion Date

2029-10-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neoplasms, Rectal

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

JEMPERLI dostarlimab-gxly GSK4057190 Stage II/III rectal cancer Neoadjuvant dMMR MSI-H

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dostarlimab monotherapy

Group Type EXPERIMENTAL

Dostarlimab

Intervention Type BIOLOGICAL

Dostarlimab will be administered.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dostarlimab

Dostarlimab will be administered.

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

JEMPERLI dostarlimab-gxly TSR-042 GSK4057190

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Los Angeles, California, United States

Site Status

GSK Investigational Site

Albuquerque, New Mexico, United States

Site Status

GSK Investigational Site

New York, New York, United States

Site Status

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

GSK Investigational Site

Nashville, Tennessee, United States

Site Status

GSK Investigational Site

Dallas, Texas, United States

Site Status

GSK Investigational Site

Richmond, Virginia, United States

Site Status

GSK Investigational Site

Ottawa, Ontario, Canada

Site Status

GSK Investigational Site

Toronto, Ontario, Canada

Site Status

GSK Investigational Site

Montreal, Quebec, Canada

Site Status

GSK Investigational Site

Sherbrooke, Quebec, Canada

Site Status

GSK Investigational Site

Besançon, , France

Site Status

GSK Investigational Site

Marseille, , France

Site Status

GSK Investigational Site

Paris, , France

Site Status

GSK Investigational Site

Pessac, , France

Site Status

GSK Investigational Site

Rennes, , France

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Dresden, , Germany

Site Status

GSK Investigational Site

Düsseldorf, , Germany

Site Status

GSK Investigational Site

Frankfurt, , Germany

Site Status

GSK Investigational Site

München, , Germany

Site Status

GSK Investigational Site

Milan, , Italy

Site Status

GSK Investigational Site

Padua, , Italy

Site Status

GSK Investigational Site

Roma, , Italy

Site Status

GSK Investigational Site

Chiba, , Japan

Site Status

GSK Investigational Site

Kanagawa, , Japan

Site Status

GSK Investigational Site

Osaka, , Japan

Site Status

GSK Investigational Site

Osaka, , Japan

Site Status

GSK Investigational Site

Utrecht, , Netherlands

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Granada, , Spain

Site Status

GSK Investigational Site

Madrid, , Spain

Site Status

GSK Investigational Site

Madrid, , Spain

Site Status

GSK Investigational Site

Santander, , Spain

Site Status

GSK Investigational Site

Valencia, , Spain

Site Status

GSK Investigational Site

Leeds West Yorkshire, , United Kingdom

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

GSK Investigational Site

Sutton, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada France Germany Italy Japan Netherlands South Korea Spain United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022-003289-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

219369

Identifier Type: -

Identifier Source: org_study_id