New trial for colorectal cancer: could your patient benefit?

some clinical trials colorectal cancer I started recently. Perhaps some of your patients are eligible to participate.

Lynch syndrome At least 6 months have passed since any cancer-directed treatment. Adult patients with this hereditary cancer syndrome will be included in a randomized controlled phase 2b study at the National Cancer Institute. This trial evaluates whether trivalent adenovirus 5 vaccine (TriAd5) and the IL-15 superagonist nogapendequin alfa invaxcept (N803) can prevent the development of colorectal neoplasms. People with Lynch syndrome have a 15% to 80% lifetime risk of colorectal cancer.

In this study, one group of participants will receive subcutaneous injections of the TriAd5-N803 combination at baseline and then at weeks 4, 8, and 52. The other group will receive a placebo injection on the same schedule.Everyone will receive standard treatment colonoscopy Biopsies will be performed at baseline and at 1 and 2 years. Centers in Arizona, Illinois, Kansas, Michigan and Texas began recruiting his 186 participants in May 2023. Facilities in California, Colorado, Massachusetts, Minnesota, Ohio, Utah and Puerto Rico are also planned.adenoma, advanced adenoma, and colon cancer is the primary endpoint. Quality of life (QoL) was a secondary outcome measure. Overall survival is not measured. For more information, visit clinicaltrials.gov.

Richard Goldberg, M.D., professor emeritus at the university, said, “Interventions to reduce the risk of cancer in people with Lynch syndrome are often targeted at patients with the syndrome who have lost an immediate family member to cancer, as well as healthcare professionals and Urgently needed by family caregivers.” West Virginia University Cancer Institute.

Stage IIB-III colon cancer with BRAF mutations. Adults with this cancer who received standard surgery and chemotherapy underwent a randomized, open-label, phase 2/3 trial. encorafenib plus cetuximab It can delay or prevent the recurrence of the disease. This combination is currently indicated for the treatment of adults with metastatic colorectal cancer who carry the BRAF V600E mutation.

In this trial, one group of participants will receive usual care (observation) after surgery and chemotherapy. The second group will take encorafenib capsules daily and receive weekly intravenous (IV) infusions of cetuximab.

Primary endpoints in the phase 2 portion of the study include circulating tumor DNA (ctDNA) clearance in patients with detectable ctDNA status at the time of randomization or ctDNA recurrence-free survival 6 months after randomization . Disease-free survival, assessed up to 6 years after randomization, is the primary outcome of Phase 3. Overall survival is a secondary outcome. Her QoL measures other than fatigue are not tracked. The trial will begin enrollment in nine states in May 2023 and is recruiting 394 participants. For more information, visit clinicaltrials.gov.

“In a study of advanced colorectal cancer patients with BRAF mutations, [this] The high recurrence rates associated with BRAF mutations make this an “important area of ​​investigation,” Goldberg added.

Colorectal cancer with at least one measurable tumor. Adults with this diagnosis can participate in open-label phase 2 trials evaluating new diagnostic imaging agents. ⁸⁹Zr-gilentuximab. This radiolabeled monoclonal antibody from Telix Pharmaceuticals targets carbonic anhydrase IX (CAIX), an enzyme that controls cell proliferation and is highly expressed in many tumor types.

Participants will receive an IV ⁸⁹Zr-gilentuximab followed by PET or CT scan approximately 5 days later. ⁸⁹Uptake of Zr-gilentuximab by tumors is the main outcome. Safety measures are a secondary outcome. Overall survival and QoL are not tracked. The Virginia and Washington sites opened in June 2023 and sought 100 participants with various types of solid tumors. For more information, visit clinicaltrials.gov.

“Because this study is evaluating a new diagnosis, not a treatment strategy, enrollment in this trial will not directly benefit study subjects,” Goldberg said.

Familial adenomatous polyposis With duodenal or residual colon/rectum/pouch involvement. People with this rare disease who have undergone colectomy or subtotal colectomy can enroll in an open-label Phase 2 trial to see if REC-4881 shrinks remaining polyps. Familial adenomatous polyposis predisposes to the development of gastrointestinal polyps and frequently transforms into gastrointestinal cancer. There are currently no drugs approved for such patients.

REC-4881, developed by Recursion, inhibits the MEK pathway, a powerhouse of cancer cell biology. All participants will take a capsule of REC-4881 daily, and researchers will assess adverse events over a period of up to 30 weeks. Centers in Arizona, California, Florida, Louisiana, Pennsylvania, and Utah began recruiting 37 participants for the trial in July 2023. The main outcomes are safety and polyp burden. Overall survival and QoL are not tracked. For more information, visit clinicaltrials.gov.

“While there may be some benefit for individual patients, the main focus of this study is safety and drug resistance,” Goldberg said.

Untreated T4N0 or stage III mismatch repair-deficient/high microsatellite instability (dMMR/MSI-H) colon cancer. Adults facing this clinical scenario and who are candidates for surgery can participate in an open-label, randomized, phase 3 trial investigating the efficacy of the PD-1 inhibitor dostarlimab in the adjuvant setting. Dostarlimab is currently indicated for the treatment of dMMR recurrent or advanced endometrial cancer and other solid tumors.

In this study, one group of individuals will receive IV infusions of dostarlimab before and after surgery, every 3 weeks for the first 4 weeks, and every 6 weeks thereafter. The second group will receive standard treatment, either observation or FOLFOX/CAPEOX. The Canadian center has begun accepting 711 trial participants scheduled for August 2023. Trial sites in her 14 U.S. states, the District of Columbia, and 21 other countries are preparing. The primary outcome was event-free survival. Overall survival over 5 years was a secondary outcome. QoL is not measured. For more information, visit clinicaltrials.gov.

“Dostarlimab showed significant activity in a small study of rectal cancer patients with mismatch repair failure,” Goldberg said. “We expect to see similar findings in subjects randomly assigned to the dostarlimab arm of this trial.”

Diagnosed with stage I-III colorectal cancer within the past 12 months. Adults with this type of cancer who have completed standard treatment are eligible for a randomized controlled phase 2 trial evaluating a new personalized self-management training program called RISE (Reinvent, Integrate, Strengthen, and Expand). There is a possibility that Cancer centers typically provide standardized self-management training after treatment. However, the approaches being tested here are individualized and include motivational interviewing, cognitive behavioral therapy, collaborative problem solving, and accountability.

Over a six-week period, one group of participants will participate in RISE and the other group will participate in a standardized program. Cedars-Sinai Medical Center in Los Angeles began recruiting his 120 participants in October 2023. The primary outcome is adherence to the program, determined based on measurements such as body composition and physical activity. QoL is a secondary outcome and overall survival is not measured. For more information, visit clinicaltrials.gov.

“There is evidence that lifestyle modifications in this setting may reduce the risk of recurrence and second cancers,” Goldberg said.

All trial information was obtained from the National Institutes of Health’s U.S. National Library of Medicine (online, clinicaltrials.gov).

Mr. Goldberg was not involved in the case featured here.

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