RecruitingPhase 2

A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma

United States40 participantsStarted 2025-02-20

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. ≥45 years of age and has not had menses for \>1 year
✓. Patients who have been amenorrhoeic for \<2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation
✓. Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use 2 adequate barrier methods throughout the study.

What they're measuring

Best Overall Response Rate

Timeframe: 1 year

Trial details

NCT IDNCT06843434

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02-20

Contact for this trial

Andrea Cercek, MD

646-888-4189 cerceka@mskcc.org

View on ClinicalTrials.gov More Microsatellite Stable Rectal Carcinoma trials