RecruitingPhase 2

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

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 the safety and effects of CAPOX chemotherapy (capecitabine and oxaliplatin) with cemiplimab, with or without fianlimab or REGN7075, before surgery. It is for adults with rectal cancer that has grown locally but has not spread to distant parts of the body. The cancer must be MSS or pMMR, meaning its system for fixing DNA errors still works.

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).

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

Eligibility

Who can join

  • Be 18 or older and able to do most daily activities with little or no help.
  • Have rectal adenocarcinoma confirmed by a tissue test, with MSS or pMMR test results.
  • Have a tumor in the required part of the rectum, confirmed by a scan or ultrasound.
  • Have stage T2 cancer with nearby lymph node involvement, or stage T3 cancer with or without nearby lymph node involvement. There must be no distant spread, and lymph nodes must meet study rules.
  • Have had no prior cancer treatment that acts throughout the body and no radiation.
  • Be able to have surgery after study treatment that preserves the muscles used to control bowel movements.
  • Have organ and bone marrow test results that meet study rules. A heart scan within 6 months must show a pumping strength of at least 50%.
  • Use acceptable birth control during the study and be able and willing to sign a consent form.

Who can't join

  • Have used an experimental drug or device within 28 days, had surgery other than a minor procedure within 28 days, or expect to need other cancer treatment during the study.
  • Have had certain immune-based cancer drugs before, use ongoing steroids that act throughout the body, or have had a severe allergic reaction to an antibody medicine.
  • Have active autoimmune disease, where the immune system attacks the body; a donated tissue or organ transplant; or certain brain or nerve conditions within the past year.
  • Have uncontrolled HIV, hepatitis B or C, tuberculosis, or another uncontrolled illness. Also excluded are serious heart disease, certain high heart blood-test results, low blood oxygen, or home oxygen use.
  • Be pregnant or breastfeeding, or have health, substance use, or other problems that prevent following study visits and procedures, including difficulty accessing veins.
  • Have had a live vaccine within 30 days before treatment, or COVID-19 vaccination within 1 week before treatment. Planned COVID-19 vaccinations must be finished at least 1 week before treatment.
  • Have T4 cancer or N2 disease, defined here as at least 4 lymph nodes each measuring at least 10 mm.
  • Have a tumor within 3 mm of the tissue layer around the rectum, or an untreated bowel blockage from the cancer that causes symptoms.

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

Official eligibility criteria

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 * M: No evidence of metastasis * cT3 node-negative * T: Tumor has grown through the muscularis propria into the serosa but has not invaded nearby organs * N: No perirectal lymph nodes ≥ 5 mm in size that suggest tumor involvement * M: No evidence of metastasis * cT3 node-positive * T: Tumor has grown through the muscularis propria into the serosa but has not invaded nearby organs * N: At least 1 perirectal lymph node ≥ 5 mm and no more than 4 perirectal lymph nodes \> 10 mm in size in short axis * M: No evidence of metastasis * Absence of distant metastases on CT or MRI imaging * Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures. * LVEF assessment with documented LVEF ≥ 50% 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. 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. * 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. * 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. * Patient is pregnant or breastfeeding. * Unwilling or unable to follow the study schedule for any reason. * Patient received a live vaccine within 30 days of planned start of study medication. * Receipt of COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study medication. * Patients with T4 disease or N2 disease (as defined by \>/= 4 lymph nodes, each greater or equal to 10 mm in short axis). * Evidence that the tumor is adjacent to (defined as within 3 mm of) the mesorectal fascia on pre-operative MRI or endorectal ultrasound or pelvic CT scan. * Patients with symptomatic untreated bowel obstruction due to rectal cancer.

Study sites (1)

MD