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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Balstilimab
DrugBalstilimab is a fully human monoclonal IgG4 antibody designed to block PD-1 binding to PD-L1 and PD-L2
Botensilimab
DrugBotensilimab is a novel fully human fragment crystallizable (Fc)-engineered immunoglobulin 1 kappa (IgG1κ) anti-CTLA-4 immunoglobulin G1 (IgG1) antagonist antibody that is designed to optimally promote fragment-crystallizable gamma receptor (FcγR) effector functions that are important for enhancing T cell priming and regulatory T cell (Treg) depletion.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Participants with locally advanced rectal cancerExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Best Overall Response Rate
The primary objective of this study is to determine the best overall response rate (ORR) after initial neoadjuvant combination botensilimab and balstilimab in subjects with MMRp/MSS locally advanced (stage II or III) rectal adenocarcinoma. ORR is defined by rectal MRI and endoscopic exam and graded as progressive disease (PD), stable disease (SD) (sustained for 3 months), partial response (PR), near complete response (nCR) and clinical complete response (cCR). Patients with PR, nCR, or cCR will be considered responders, while the rest will be non-responders.
Time frame
1 yearSponsors and contacts
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Memorial Sloan Kettering Cancer Center
Lead sponsor
Agenus Inc.
Collaborator
Source ClinicalTrials.gov