A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
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 groupSponsors and collaborators
Memorial Sloan Kettering Cancer Center
Lead sponsor
Agenus Inc.
Collaborator
Source ClinicalTrials.gov