Health Trials

About this trial

The purpose of this study is to find out whether the combination of botensilimab and balstilimab (BOT/BAL) is a safe and effective treatment that causes few or mild side effects for people with mismatch repair proficient (MMRp)/microsatellite stable (MSS) locally advanced rectal adenocarcinoma. The investigators will also find out whether BOT/BAL is an effective treatment when given in combination with standard chemotherapy.

Eligibility criteria

Qualifiers

Willing and able to provide written informed consent for trial.

Be ≥18 years of age on the date of signing informed consent.

ECOG performance status of 0 or 1.

Histologically confirmed rectal adenocarcinoma.

Disqualifiers

Recurrent rectal cancer.

Prior pelvic radiation therapy, chemotherapy, or surgery for rectal cancer.

Tumor is causing symptomatic bowel obstruction (patients who have a temporary diverting ostomy are eligible).

Other invasive malignancy ≤ 2 years prior to registration. Exceptions are non-melanoma skin cancer that has undergone potentially curative therapy and in situ cervical carcinoma.

Trial design

Treatments tested in this trial

  • Balstilimab
  • Botensilimab

Treatment groups

40 Participants
are divided into 1 treatment group

Locations

7
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)07920, Basking RidgeNew Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)07748, MiddletownNew Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)07645, MontvaleNew Jersey, United States
Memorial Sloan Kettering Cancer Center at Suffolk - Commack (Limited Protocol Activities)11725, CommackNew York, United States

Sponsors and collaborators

Memorial Sloan Kettering Cancer Center

Lead sponsor

Agenus Inc.

Collaborator

Source ClinicalTrials.gov