Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer
- Registration Number
- NCT06205836
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
- 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.
- 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.
Exclusion Criteria
- Have received an investigational agent or used an investigational device within 28 days of the first dose of study drug.
- Have expected to require any other form of systemic or localized antineoplastic therapy while on study.
- Have had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.).
- History of prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, or anti-Lag-3 antibodies for any reason in the 5 years proceeding their colorectal cancer diagnosis.
- Currently using any chronic systemic steroids.
- History of severe hypersensitivity reaction to any monoclonal antibody.
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
- Active autoimmune disease.
- Any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft.
- Patient is on supplemental home oxygen.
- Has clinically significant heart disease.
- Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures
- Unwilling or unable to follow the study schedule for any reason
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A - Cemiplimab Cemiplimab - Cohort B - Cemiplimab with Fianlimab Fianlimab - Cohort B - Cemiplimab with Fianlimab Cemiplimab -
- Primary Outcome Measures
Name Time Method Complete Response Rate 6 Months Proportion of subjects with either a pathologic complete response (pCR) at the time of surgery OR a clinical complete response (cCR) at 6 months for those subjects who do not undergo surgery. pCR is defined as subjects with no viable tumor cell noted on pathological evaluation of the resection specimen. cCR is defined as an absence of visible disease on CT imaging by RECIST 1.1 and endoscopic evaluation.
- Secondary Outcome Measures
Name Time Method Number of participants experiencing grade 3 or above drug-related toxicities requiring treatment discontinuation 7 Months Defined using NCI CTCAE v5.0
Trial Locations
- Locations (1)
Johns Hopkins SKCCC
🇺🇸Baltimore, Maryland, United States