Enabling Personalized Off-Guideline Treatments for Advanced Cancer Patients at Any U.S. Hospital
PALO ALTO, CA, UNITED STATES, February 18, 2026 /EINPresswire.com/ — Cancer Commons today announced that enrollment is open for its N-of-1 Observational Clinical Study (CCCS001), which is registered on ClinicalTrials.gov (NCT07343024). The study is open to patients with any advanced cancer at any cancer hospital in the United States. Patients participate with their own oncologist, with no travel to a trial site required.
The study uses genomic tests and drug sensitivity tests (DSTs)—which expose a patient’s live cancer cells to hundreds of FDA‑approved drugs—to identify personalized, off-guideline treatments. Of the 300+ FDA‑approved cancer drugs, approximately 90% are not included in the NCCN Guidelines for any given cancer type. This study produces the scientific evidence that enables oncologists to prescribe these off-guideline drugs and insurers to cover them.
Each treatment selection test—genomic mutation matching, genomic pathway matching, or functional drug sensitivity testing—serves as a separate arm of the study. The primary endpoint is the predictive accuracy of each test in identifying effective off-guideline drugs for advanced cancer patients. Patients who undergo more than one test contribute data to multiple arms, accelerating validation across diagnostic methods.
“For patients who have exhausted guideline treatments, the only current path to new options is a clinical trial, which often requires travel, randomization, and may involve experimental compounds,” said Prajit Pillai, PhD, MBA, Director of Clinical Sciences at Cancer Commons and co-Principal Investigator for CCCS001. “This study takes a fundamentally different approach: we use diagnostic tests to identify FDA-approved drugs that are already proven safe but haven’t been tested for a patient’s specific cancer. The study will validate which tests are best at predicting which off-guideline drugs work for a given patient.”
“Over the past 15 years, Cancer Commons has provided personalized guidance to more than 10,000 advanced cancer patients,” said Clifford Reid, PhD, MBA, CEO of Cancer Commons. “This study is the next step: a rigorous, scalable method for unlocking access to the 90% of FDA-approved cancer drugs that sit outside current treatment guidelines. Because the study does not require travel to a trial site, any patient with any cancer, working with any oncologist in the country, can participate.”
For more information, patients and oncologists can call 1-877-971-1200, email studyteam_cccs001@cancercommons.org, or visit www.cancercommons.org/cccs001.
ClinicalTrials.gov listing: https://clinicaltrials.gov/study/NCT07343024.
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About Cancer Commons
Cancer Commons (cancercommons.org) is a patient-centric nonprofit whose compassionate experts build relationships with advanced cancer patients and caregivers to create personalized action plans. Its nurse navigators, PhD scientists, and national experts consult the latest, most promising research to identify, explain, and help patients access their best possible diagnostic and treatment options—so they can be confident they are making the best possible decisions.
Media Contact:
Shan Fowler
Cancer Commons
shan.fowler@cancercommons.org
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