Recruiting

Testing new immunotherapy drugs instead of surgery for older colorectal cancer patients

Plain-English translation of NCT06205836 on ClinicalTrials.gov ↗ · Source last updated May 2026 · Translation generated July 2026 · How we translate trials

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Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing whether , alone or combined with , can treat a specific type of colorectal cancer without requiring surgery. These are immunotherapy drugs that help your immune system recognize and fight cancer cells. The study is designed for older patients (70 and above) or younger patients who are not good candidates for surgery or prefer to avoid it.

Many older patients and those with serious health conditions face difficult choices when diagnosed with colorectal cancer because surgery carries significant risks for them. This trial exists to see if the new medication can be an effective alternative that shrinks tumors and controls cancer while avoiding the dangers and recovery time of surgery.

Do you qualify?

You likely qualify if…

you are age 70 or older, OR you are 18 or older but considered a poor surgical candidate or unwilling to have surgery
you have been diagnosed with a specific type of colorectal cancer (microsatellite unstable or mismatch repair deficient)
your cancer has not spread widely (it is localized or locally advanced)
you have not received any prior chemotherapy, immunotherapy, or radiation for this cancer
you are willing to have regular surveillance visits including CT scans and endoscopy for 24 months
you have adequate heart, kidney, and liver function as confirmed by blood tests and heart imaging

You likely don't qualify if…

you have received immunotherapy drugs (anti-PD-1, anti-PD-L1, anti-CTLA4, or similar antibodies) within the past 5 years for any reason
you are currently taking chronic systemic steroids or have an active autoimmune disease
you have had major surgery within 28 days of starting the study medication
you have uncontrolled infections, heart failure, unstable heart rhythms, or other serious uncontrolled illnesses
you have received a live vaccine within 30 days of starting the study or have a history of severe allergic reactions to monoclonal antibodies

What participation looks like

You will receive the study medication (either alone or combined with ) as an infusion over several months. Throughout the 24-month study period, you will have regular follow-up visits including CT scans and endoscopic examinations to monitor how well the treatment is working and check for side effects. You will also need to provide a small tumor biopsy sample and have blood tests to monitor your organ function and immune response.

AI-generated summary from trial data · Jul 9, 2026 · Not medical advice

Trial locations(1 site)

United States

Johns Hopkins SKCCC, Baltimore, Maryland