RecruitingColorectal Cancer
Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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).
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
You may qualify if…
- ✓ 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:
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.
- ✕ 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.
Where it's recruiting
Maryland
Baltimore
Source: ClinicalTrials.gov · NCT07281768 · last updated 2026-07-21