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DURHAM, N.C. – As colorectal cancer rates rise among young people, most patients with advanced disease still only have one treatment option: chemotherapy. That is rarely a cure, and often life-limiting with very toxic side effects.

New results from a clinical trial at Duke Health are the first to demonstrate the potential of immunotherapy by itself as the initial treatment for patients with the most common type of colorectal cancer. The immunotherapy medications, which use the body’s own immune system to fight the disease, delayed the need for chemotherapy by about 8 months for patients with disease progression and may even replace the need for chemotherapy in some cases. Immunotherapy also tends to have fewer intense side effects than chemotherapy.

Preliminary trial results will be presented on April 21 at the American Association for Cancer Research Annual Meeting in San Diego.

“Delaying or avoiding chemotherapy are very meaningful outcomes, especially for young patients,” said the study’s principal investigator, Nicholas DeVito, M.D., assistant professor in the Department of Medicine at the Duke University School of Medicine.

Therapies that can control cancer, while preserving quality of life, are critical for colorectal cancer patients who are younger. This population of patients faces more aggressive disease, and chemotherapy can be especially disruptive, affecting patients during a time in their life that’s typically focused on building careers, families, and financial stability.

“Chemotherapy is rarely, if ever, curative in the metastatic setting,” DeVito said, “which is why we felt it was crucial to move immunotherapy first rather than testing it later.”

The trial involved patients with stage IV microsatellite stable colorectal cancer that had not spread to the liver, bone, or brain. The patients received a combination of two immunotherapy drugs -- Botensilimab and Balstilimab (BOT/BAL) -- and were monitored with CT scans every six weeks.

In addition to delaying the need for chemo, two patients so far had partial immune responses to BOT/BAL alone, meaning their tumors shrank by at least 30%. DeVito said they may never need chemotherapy, based on how long responses like this to immunotherapy last with a rarer subtype of the disease.

The study was designed as an early phase trial, focused on safety and feasibility of first-line immunotherapy. Researchers at Duke enrolled 15 patients. DeVito said their responses to the treatment, even if limited, are significant in a disease that makes up 85% of colorectal cancer cases and where immunotherapy has historically shown little to no benefit.

The research team hopes to expand and enroll more patients in a phase two trial, with the goal of moving the immunotherapy treatment toward FDA approval.

“We’ve broken a barrier with this trial and demonstrated that immunotherapy can be a first-line therapy for this disease,” said DeVito. “These early results justify us moving forward aggressively to expand this approach, refine biomarkers, and ultimately make this a real option for a more people.”

One of the trial patients who may never need chemo is Spencer Laird, 30. He was first diagnosed with colon cancer at 26-years-old and treated with surgery and chemotherapy. Three years later, he discovered the cancer had spread to his lungs. Scans showed 13 tumors, including several that were golf ball sized or bigger. 

Laird said his doctors in South Carolina told him, even with chemotherapy, he had two to three years to live.

“I was more scared to go on chemo than I was to find out I had cancer again,” said Laird. “The first time I had cancer, I stayed in bed all day. This time, I wasn’t going to lose any more time with my family.”

Urged by his wife, CarleyAnn, to explore alternative treatments, Laird found out about the trial at Duke. Every two weeks since February 2025, the couple travels in an RV four hours one-way from their home in S.C. to the Duke Cancer Center where Spencer receives the dual immunotherapy treatment.

DeVito said Laird’s lung scans show all the tumors are shrinking or have disappeared.

“It's given me the opportunity to go to work and still provide for my family and spend time with my daughter running around the yard, playing, doing all the things that we did before all of this happened,” said Laird. “Without Duke and the opportunity to do this, I just don't believe it would have been the same.”

In addition to DeVito, study authors include Emily Bolch, Aman Opneja, Hope Uronis, Lisa Vlastelica, Gerard C. Blobe, John W. Hickey, Yuexi Kylee Li, Kevin S. Tanager, Cheryl H. Chang, Jingchen Chai, Kara Bonneau, Niharika B. Mettu, Michael A. Morse, Tucker W. Coston, Shiaowen David Hsu, Carol A. Wiggs, Donna Niedzwiecki, Dana A. Warren, and John H. Strickler.

The study was funded by Gateway for Cancer Research.