Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could one drug replace the standard triple therapy for rectal cancer?

NCT ID NCT05723562

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a single immunotherapy drug, dostarlimab, can effectively treat people with a specific type of advanced rectal cancer (dMMR/MSI-H) that has not been treated before. About 154 participants will receive the drug and, if their cancer completely disappears, they will be closely monitored instead of receiving the usual treatments of chemotherapy, radiation, and surgery. The goal is to see if this approach can lead to long-term remission without the need for harsh treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

154 people

The number who actually took part.

Started

Apr 2023

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Locally advanced rectal cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neoplasms, rectal

Contacts and locations

Locations

  • GSK Investigational Site

    Los Angeles, California, 90027, United States

  • GSK Investigational Site

    Albuquerque, New Mexico, 87131, United States

  • GSK Investigational Site

    New York, New York, 10022, United States

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15232, United States

  • GSK Investigational Site

    Nashville, Tennessee, 37203, United States

  • GSK Investigational Site

    Dallas, Texas, 75390, United States

  • GSK Investigational Site

    Richmond, Virginia, 23298, United States

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6, Canada

  • GSK Investigational Site

    Toronto, Ontario, M5G 2M9, Canada

  • GSK Investigational Site

    Montreal, Quebec, H2X 0C1, Canada

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 5N4, Canada

  • GSK Investigational Site

    Besançon, 25030, France

  • GSK Investigational Site

    Marseille, 13273, France

  • GSK Investigational Site

    Paris, 75012, France

  • GSK Investigational Site

    Pessac, 33604, France

  • GSK Investigational Site

    Rennes, 35000, France

  • GSK Investigational Site

    Berlin, 13353, Germany

  • GSK Investigational Site

    Dresden, 01307, Germany

  • GSK Investigational Site

    Düsseldorf, 40225, Germany

  • GSK Investigational Site

    Frankfurt, 60488, Germany

  • GSK Investigational Site

    München, 81377, Germany

  • GSK Investigational Site

    Milan, 20133, Italy

  • GSK Investigational Site

    Padova, 35128, Italy

  • GSK Investigational Site

    Roma, 00168, Italy

  • GSK Investigational Site

    Chiba, 277-8577, Japan

  • GSK Investigational Site

    Kanagawa, 232-0024, Japan

  • GSK Investigational Site

    Osaka, 540-0006, Japan

  • GSK Investigational Site

    Osaka, 565-0871, Japan

  • GSK Investigational Site

    Utrecht, 3584 CX, Netherlands

  • GSK Investigational Site

    Seoul, 05505, South Korea

  • GSK Investigational Site

    Seoul, 06591, South Korea

  • GSK Investigational Site

    Seoul, 120-752, South Korea

  • GSK Investigational Site

    Seoul, 135-710, South Korea

  • GSK Investigational Site

    Barcelona, 08035, Spain

  • GSK Investigational Site

    Granada, 18014, Spain

  • GSK Investigational Site

    Madrid, 28007, Spain

  • GSK Investigational Site

    Madrid, 28041, Spain

  • GSK Investigational Site

    Santander, 39008, Spain

  • GSK Investigational Site

    Valencia, 46010, Spain

  • GSK Investigational Site

    Leeds West Yorkshire, LS9 7TF, United Kingdom

  • GSK Investigational Site

    London, EC1A 7BE, United Kingdom

  • GSK Investigational Site

    Sutton, SM2 5PT, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.