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Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer

Combining Capecitabine/Oxaliplatin Chemotherapy With Cemiplimab Alone or in Combination With Fianlimab or REGN7075 for the Neoadjuvant Treatment of Locally Advanced Rectal Cancer

NCT07281768•Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and clinical activity of combining cemiplimab, cemiplimab/fianlimab, or cemiplimab/REGN7075 with capecitabine/oxaliplatin (CAPOX) for the neoadjuvant treatment of patients with microsatellite stable (MSS) locally advanced rectal cancer (T2 node-positive, T3 node-negative, T3 node-positive).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥18 years.
•Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
•Rectal cancer (with tumor tissue present at or below the peritoneal reflection) as determined by MRI pelvis or endoscopic ultrasound.
•Have histologically proven mismatch repair proficient (pMMR) or microsatellite stable (MSS) rectal adenocarcinoma.
•Must not have received any prior systemic treatment or radiation.
•Candidate for sphincter-sparing surgical resection after neoadjuvant therapy according to the primary surgeon.
•Patients have the following clinical staging:
•* cT2 node-positive:
•* T: Tumor is invading the muscularis propria but has not grown through it to the serosa
•* N: At least 1 perirectal lymph node ≥5 mm and no more than 4 perirectal lymph nodes \>10 mm in short axis
+14 more criteria

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.
•Currently using any chronic systemic steroids.
•History of severe hypersensitivity reaction to any monoclonal antibody.
•History of encephalitis, meningitis, dementia, Parkinson's or uncontrolled seizures within 1 year prior to the first dose of study drug.
•Uncontrolled infection of HIV, HBV, HCV, or Tuberculosis.
•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.
+13 more criteria

Locations (1)

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Key Dates

Start Date

April 1, 2026

Primary Completion Date

April 1, 2030

Completion Date

April 1, 2030

Last Updated

March 20, 2026

Enrollment

ESTIMATED participants

Conditions

Colorectal Cancer

Interventions

Oxaliplatin

DRUG

Capecitabine

DRUG

Cemiplimab

DRUG

Fianlimab

DRUG

REGN7075

DRUG

Contacts

Colleen Apostol, RN

CONTACT

410-614-3644 GIClinicalTrials@jhmi.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer

Inclusion Criteria

Exclusion Criteria

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