Could a single drug replace surgery for rectal cancer?
NCT ID NCT07740720
First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time
Summary
This study tests whether giving the immunotherapy drug dostarlimab for a longer period can completely eliminate tumors in people with a specific genetic type of rectal cancer. Participants have stage II or III rectal cancer that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H). The goal is to see if more people achieve a complete response, avoiding the need for chemotherapy, radiation, or surgery. Doctors will monitor tumor disappearance and how long the cancer stays under control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dostarlimab, an immunotherapy drug
- What this could lead to
- If successful, this could offer a way to cure certain rectal cancers without the need for chemotherapy, radiation, or surgery, preserving quality of life.
- What could go wrong
- The trial is still in phase 3b and results are not guaranteed. Some participants may not respond fully, and immunotherapy can cause side effects. Longer treatment may not improve outcomes for everyone.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+) locally advanced rectal adenocarcinoma. * Has radiologically and endoscopically evaluable disease. * Has a tumor demonstrating the presence of either: 1. dMMR status; MMR status must be assessed by immunohistochemistry for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of 1 or more proteins indicates dMMR; MMR status will be determined locally; or 2. MSI-H phenotype as determined by polymerase chain reaction or by tissue next generation sequencing; MSI-H will be determined locally. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Has adequate organ function. Exclusion Criteria: * Has received prior radiation therapy, systemic therapy, or surgery for management of rectal cancer. * Has a tumor that, in the investigator's judgment, is causing symptomatic bowel obstruction or otherwise requires urgent/emergent local intervention. Participants with a history of bowel obstruction are eligible after obstruction is relieved by a diverting stoma (defunctioning colostomy). Patients with a history of bowel obstruction in the context of current rectal cancer diagnosis and treated with stenting are not eligible. * 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. * Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to enrollment. * Is receiving any other anticancer or experimental therapy.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can two immunotherapy drugs help rectal cancer patients skip pelvic radiation?
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- Could a Tumor's genes reveal who can skip chemo?