Adding immunotherapy to chemotherapy for advanced rectal cancer

Plain-English translation of NCT06940388 on ClinicalTrials.gov ↗ · Source last updated July 2025 · Translation generated July 2026 · How we translate trials

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 study is testing whether adding a new immunotherapy drug called to standard chemotherapy and radiation treatment can help more people with advanced rectal cancer avoid surgery or need surgery less often. You would receive either standard treatment alone or standard treatment combined with the medication. The goal is to see if this medication improves how well the treatment works.

Currently, about half of patients with advanced rectal cancer still need surgery even after chemotherapy and radiation. Researchers hope that adding this medication to the standard treatment might help more people have a complete response to therapy, potentially avoiding or delaying surgery.

Do you qualify?

You likely qualify if…

you have been diagnosed with locally advanced rectal cancer that has not been treated before
your cancer is located 12 centimeters or less from your anal opening
you are at least 18 years old and in reasonably good overall health
you have normal kidney, liver, and blood cell counts based on recent lab work
you are able to swallow tablets and willing to attend regular treatment visits and monitoring appointments
if you are a woman of childbearing age, you have a negative pregnancy test and can use reliable birth control during and after treatment

You likely don't qualify if…

you have an autoimmune disease (like rheumatoid arthritis or lupus) or history of vasculitis
you have had any prior chemotherapy, immunotherapy, or radiation therapy for rectal cancer
you have had prior treatment with other checkpoint inhibitor immunotherapy drugs
you have had an organ transplant or bone marrow transplant
you have another active cancer diagnosis within the past 2 years

What participation looks like

You will first receive 6 weeks of chemotherapy combined with radiation therapy. Then, after a 4-week break, you'll receive 16 weeks of additional chemotherapy given every 2 weeks — either alone (standard group) or combined with the new immunotherapy medication (experimental group). Eight weeks after finishing treatment, you'll have scans to check how well the treatment worked. Depending on the results, you may have surgery or be closely monitored for any signs of cancer return. You'll continue follow-up visits according to standard cancer care guidelines.

AI-generated summary from trial data · Jul 3, 2026 · Not medical advice

Adding immunotherapy to chemotherapy for advanced rectal cancer

What is this trial?

Do you qualify?

What participation looks like

Trial locations