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Immunotherapy combo shows promise in shrinking colorectal tumors before surgery

NCT ID NCT05571293

Disease control Sponsor: Weill Medical College of Cornell University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 pilot study is testing whether giving two immunotherapy drugs, botensilimab and balstilimab, before surgery can shrink tumors in people with colorectal cancer. The trial includes 26 participants across three groups, with some receiving more doses and one group having a specific genetic marker (dMMR/MSI-High). Researchers are looking at how much the tumor shrinks and whether the treatment causes serious side effects or delays surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
botensilimab and balstilimab (immunotherapy drugs)
What this could lead to
If successful, this could lead to a new treatment option that shrinks colorectal tumors before surgery, potentially improving outcomes and allowing some patients to avoid surgery altogether.
What could go wrong
This is a small, early-phase pilot study with only 26 participants, so results may not apply to everyone. The drugs can cause serious immune-related side effects, and there is a risk of delays in surgery due to adverse events.

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

26 people

The number who actually took part.

Started

Mar 2023

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * 18 years of age or older * Histologically, cytologically, or clinically confirmed adenocarcinoma of the colon or rectal cancer as long as there is no plans for neoadjuvant radiation for the patients with rectal cancer. Note: patients can enroll in cohort B while awaiting mismatch repair testing results. If noted to be dMMR/MSI-High, they would be still considered evaluable and moved to cohort C. * If capable of becoming pregnant, or getting someone else pregnant, must be willing to use highly effective contraception from Screening period through 90 days following the last dose of study drug Exclusion Criteria: * Metastatic cancer (cancer that has spread to other parts of the body) * Previous treatment with immune checkpoint inhibitors targeting CTLA-4, PD-1 or PD-L1 * Currently participating in another study and receiving a study drug * History of severe allergic reactions to immunotherapies * Pregnant or breastfeeding * Active infection requiring treatment * On immunosuppressive medications * Active cardiovascular disease, such as stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure, or serious uncontrolled cardiac arrhythmia requiring medication that may prevent surgery Participants in Cohort C must be dMMR/MSI-High.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm type 1 diabetes mellitus 12

As listed by the trial registrant

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

Colorectal neoplasms

Contacts and locations

Locations

  • Weill Cornell Medicine/New York-Presbyterian Brooklyn Methodist Hospital

    Brooklyn, New York, 11215, United States

  • Weill Cornell Medicine/NewYork Presbyterian - Queens

    Flushing, New York, 11355, United States

  • Weill Cornell Medicine/NewYork-Presbyterian Hospital

    New York, New York, 10021, United States

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