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New treatment option for Colorectal Cancer
Official title Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer
ClinicalTrials.gov ID: NCT06205836
What this study is testing
What is Cemiplimab?
Cemiplimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal cancer.
Also referred to as REGN2810, LIBTAYO.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- for Cohorts A and B:
- 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...
- Currently using any chronic systemic steroids.
See the full eligibility 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. 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 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.
- for Cohorts A and B:
- 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.
- Patient has received a live vaccine within 30 days of the first dose of study drug.
- 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...
- Active autoimmune disease.
- Any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft.
- Patient has a pulse oximetry of \<92% on room air.
- Patient is on supplemental home oxygen.
- Has clinically significant heart disease.
- Cohort B Only: Troponin T (TnT) or troponin I (TnI) \> 2x institutional ULN at baseline.
- 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 Exclusion for Cohort C and D:
- 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.
- Currently using any chronic systemic steroids.
- Patient has received a live vaccine within 30 days of the first dose of study drug.
- History of severe hypersensitivity reaction to any monoclonal antibody.
- Any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft.
- Patient is pregnant or breastfeeding.
- Cohort D Only: Troponin T (TnT) or troponin I (TnI) \> 2x institutional ULN at baseline.
- 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.
- Participation deemed not in the best interest of the patient.
- Unwilling or unable to follow the study schedule for any reason.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.