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

NCT06205836 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: J23155IRB00415816
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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 or in patients age 18 or greater considered poor candidates for surgery or unwilling to undergo surgery.

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer; Cemiplimab; Fianlimab; Immunotherapy; Anti-PD-1 therapy; Anti-Lag-3; Adenocarcinoma; Carcinoma

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate

  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.

  6 Months

Secondary Outcomes (1)

• Number of participants experiencing grade 3 or above drug-related toxicities requiring treatment discontinuation

  7 Months

Study Arms (4)

Cohort A - Cemiplimab

EXPERIMENTAL

Drug: Cemiplimab

Cohort B - Cemiplimab with Fianlimab

EXPERIMENTAL

Drug: Cemiplimab; Drug: Fianlimab

Cohort C - Cemiplimab

EXPERIMENTAL

Drug: Cemiplimab

Cohort D - Cemiplimab with Fianlimab

EXPERIMENTAL

Drug: Cemiplimab; Drug: Fianlimab

Interventions

Fianlimab DRUG

Patients will receive fianlimab (1600 mg administered IV) on Day 1 of each 21 day cycle for a total of 4 cycles of treatment.

Also known as: REGN3767

Cohort B - Cemiplimab with Fianlimab; Cohort D - Cemiplimab with Fianlimab

Cemiplimab DRUG

Patients will receive cemiplimab (350 mg administered IV) on Day 1 of each 21 day cycle for a total of 4 cycles of treatment.

Also known as: REGN2810, LIBTAYO

Cohort A - Cemiplimab; Cohort B - Cemiplimab with Fianlimab; Cohort C - Cemiplimab; Cohort D - Cemiplimab with Fianlimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regeneron Pharmaceuticals: collaborator
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Johns Hopkins SKCCC

Baltimore, Maryland, 21231, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Adenocarcinoma; Carcinoma

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Eric Christenson, MD

  Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Medical Institution

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colleen Apostal, RN

CONTACT

410-614-3644; GIClinicalTrials@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: June 13, 2024
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)