A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy

Conditions

• Colorectal Cancer
• Rectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Botensilimab — DRUG
  All patients will receive botensilimab IV on day 1 of the 42 day cycle for 4 doses
• Balstilimab — DRUG
  All patients will receive balstilimab IV on days 1, 15, and 29 of the 42 day cyclePatient then continues balstilimab alone for an additional two cycles IV on days 1, 15, and 29 of the 42 day cycle.
• Placebo — OTHER
  Placebo

Study Details

The researchers are doing this study to find out whether the combination of botensilimab and balstilimab (BOT/BAL), followed by balstilimab alone, is an effective treatment for people with microsatellite stable (MSS) colorectal cancer or colorectal liver metastases (CRLM) who have measurable residual disease (MRD) after standard treatment with surgery and chemotherapy or total neoadjuvant therapy (TNT).

Key Dates

Start date

Nov 7, 2025

Status verified

Feb 2026

Primary completion

Nov 30, 2030

Completion

Nov 30, 2030

Study Design

Enrollment

284 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1a: Stage III MSS Colorectal Cancer (Botensilimab and Balstilimab)
  All patients will receive botensilimab IV on day 1 of the 42 day cycle for 4 doses, balstilimab IV on days 1, 15, and 29 of the 42 day cycle. Patient then continues balstilimab alone for an additional two cycles IV on days 1, 15, and 29 of the 42 day cycle.
• Experimental: Cohort 1b: MSS CRLM (Botensilimab and Balstilimab)
  All patients will receive botensilimab IV on day 1 of the 42 day cycle for 4 doses, balstilimab IV on days 1, 15, and 29 of the 42 day cycle. Patient then continues balstilimab alone for an additional two cycles IV on days 1, 15, and 29 of the 42 day cycle.
• Experimental: Cohort 2a: Stage 3 MSS Colorectal Cancer (Botensilimab and Balstilimab vs. Placebo) Randomized
  All patients will receive botensilimab IV on day 1 of the 42 day cycle for 4 doses, balstilimab IV on days 1, 15, and 29 of the 42 day cycle. Patient then continues balstilimab alone for an additional two cycles IV on days 1, 15, and 29 of the 42 day cycle OR Placebo
• Experimental: Cohort 2b: MSS CRLM (Botensilimab and Balstilimab vs. Placebo) Randomized
  All patients will receive botensilimab IV on day 1 of the 42 day cycle for 4 doses, balstilimab IV on days 1, 15, and 29 of the 42 day cycle. Patient then continues balstilimab alone for an additional two cycles IV on days 1, 15, and 29 of the 42 day cycle OR Placebo

Primary Outcome Measure

Rate of ctDNA clearance (Cohort 1a) [ Time Frame: 6 months ]

Central Contacts

• Neil Segal, MD, PhD
  646-888-4187
  [email protected]
• Luis Diaz, MD
  646-888-4641

Locations (7)

Find similar trials in Basking Ridge, NJ

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