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RecruitingPhase 2

Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer

Evaluating a Surgical-Sparing Approach Using Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe cemiplimab is and how well it works, alone or with fianlimab, for colon or rectal cancer that has not spread to distant body parts. The cancer must have certain changes called dMMR or MSI-H, which affect how cells repair DNA. The study is for people age 70 or older, or adults age 18 or older who cannot safely have surgery or do not want surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Groups A and B: Be age 70 or older. Groups C and D: Be age 18 or older and have a surgeon decide surgery is not a good option, or choose not to have surgery.
  • Have colon or rectal cancer confirmed by a tissue test, with dMMR or MSI-H changes. The cancer must be limited to its starting area or nearby areas.
  • Meet the study’s rating for daily activity: ECOG 0–2 for groups A and B, or 0–3 for groups C and D.
  • Have had no prior cancer treatment that travels through the body and no radiation treatment.
  • Agree to a tumor biopsy, which removes a small tissue sample, and 24 months of CT scans and checks with a thin viewing tube.
  • Have blood tests showing that organs and bone marrow work well enough.
  • Groups A and B: Have a heart test within 6 months before treatment showing that the heart pumps out at least 45% of the blood in its main pumping chamber.
  • Use an accepted form of birth control during the study, and be able and willing to sign the study consent form.

Who can't join

  • All groups: Used an experimental drug or device within 28 days before the first dose, or expect to need other cancer treatment during the study.
  • All groups: Take ongoing steroids that act throughout the body, received a live vaccine within 30 days before the first dose, or had a severe allergic reaction to a monoclonal antibody drug.
  • All groups: Have received donor tissue or an organ transplant, including a cornea transplant in the eye.
  • All groups: Cannot or will not follow study visits and procedures. This may include health problems, alcohol or drug dependence, or veins that are too hard to access.
  • Groups A and B: Had surgery other than a minor procedure within 28 days before treatment, or received certain immune-based drugs in the 5 years before the cancer diagnosis.
  • Groups A and B: Have an active disease where the immune system attacks the body, an uncontrolled illness, cancer that has spread to distant sites, or serious heart disease. Also excluded: blood oxygen below 92% without added oxygen, or use of oxygen at home.
  • Groups B and D only: Have a starting troponin blood test, a marker of heart injury, more than twice the lab’s upper normal limit.
  • Groups C and D: Are pregnant or breastfeeding, or study staff decide joining is not in your best interest.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 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 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 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 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.

Study sites (1)

MD