Can two immunotherapy drugs eliminate early rectal cancer without surgery?
NCT ID NCT07735624
First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether a combination of two immunotherapy drugs, botensilimab and balstilimab, can completely eliminate early-stage rectal cancer in people whose tumors are microsatellite stable (MSS). Participants receive one infusion of botensilimab followed by balstilimab every two weeks for up to six months, with the goal of achieving a complete response and avoiding standard treatments like radiation or surgery. The study enrolls 16 adults with T1-T2 N0 rectal cancer who are candidates for surgery but have not yet received standard neoadjuvant therapy.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- a combination of two immunotherapies: botensilimab (given once) and balstilimab (given every two weeks for up to six months)
- What this could lead to
- If successful, this approach could offer a way to cure early rectal cancer without the need for surgery or standard therapies, preserving the rectum and avoiding permanent colostomy.
- What could go wrong
- This is a small, early-phase trial with only 16 participants, so results may not apply to all patients. Immunotherapies can cause serious immune-related side effects, and the combination may not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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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.
Contacts and locations
Locations
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Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, 02215, United States
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Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
More trials for these conditions
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