Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced M… (NCT06205836) | Clinical Trial Compass
RecruitingPhase 2
Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer
United States44 participantsStarted 2024-06-13
Plain-language summary
The purpose of this study is to evaluate the safety and clinical activity of cemiplimab and the combination of cemiplimab/fianlimab in microsatellite unstable localized or locally advanced colorectal cancer diagnosed in patients age 70 or greater or in patients age 18 or greater considered poor candidates for surgery or unwilling to undergo surgery.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for Cohort A and B:
* Age ≥70 years.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
* Have histologically proven localized or locally advanced mismatch repair deficient (dMMR) or microsatellite unstable (MSI-H) colorectal cancer.
* Must not have received any prior systemic treatment or radiation.
* Must be agreeable to endoscopic, and CT surveillance for a total of 24 months.
* Patient's acceptance to have a tumor biopsy.
* Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.
* LVEF assessment with documented LVEF ≥ 45% by either TTE or MUGA (TTE preferred) within 6 months from first study drug administration.
* For both Women and Men, must use acceptable form of birth control while on study.
* Ability to understand and willingness to sign a written informed consent document.
Inclusion Criteria for Cohort C and D:
* Age ≥18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 -3.
* Have histologically proven localized or locally advanced mismatch repair deficient (dMMR) or microsatellite unstable (MSI-H) colorectal cancer.
* Patient deemed a poor surgical candidate after evaluation by a surgeon or unwilling to undergo surgery.
* Must not have received any prior systemic treatment or radiation.
* Must be agreeable to endoscopic, and CT surveillance for a total of 24 months.
* Patient's acceptance to have a tumor biopsy.
* Patients must have adequate organ …
What they're measuring
1
Complete Response Rate
Timeframe: 6 Months
Trial details
NCT IDNCT06205836
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins