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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06205836
• Other study ID #: J23155
• Secondary ID: IRB00415816
• Status: Recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: May 2028

Study information

• Verified date: May 2024
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: Colleen Apostal, RN
• Phone: 410-614-3644
• Email: GIClinicalTrials[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: May 2028
• Est. primary completion date: May 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Cemiplimab
Patients will receive cemiplimab (350 mg administered IV) on Day 1 of each 21 day cycle for a total of 4 cycles of treatment.
• Fianlimab
Patients will receive fianlimab (1600 mg administered IV) on Day 1 of each 21 day cycle for a total of 4 cycles of treatment.

Locations

Country	Name	City	State
United States	Johns Hopkins SKCCC	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants experiencing grade 3 or above drug-related toxicities requiring treatment discontinuation	Defined using NCI CTCAE v5.0	7 Months