Botensilimab and Balstilimab for Colorectal Cancer After Surgery and Chemotherapy
This study is looking at whether a combination of two drugs, botensilimab and balstilimab, followed by balstilimab alone, can help people with colorectal cancer. You might be able to join if you have colorectal cancer that has spread to the liver (colorectal liver metastases) or is stage III, and you still have signs of cancer (measurable residual disease, or MRD) after surgery and chemotherapy. The researchers want to see if these drugs can clear up the remaining cancer cells (ctDNA clearance) or prevent the cancer from coming back (recurrence-free survival). The study is currently unclear on its recruitment status.
- Study design
- This study has two parts. Part 1 is a non-randomized study with 54 participants, and Part 2 is a randomized, placebo-controlled, double-blind study with 230 participants.
- What's involved
- All participants will receive botensilimab intravenously (IV) on day 1 of a 42-day cycle for 4 doses. All participants will also receive balstilimab IV on days 1, 15, and 29 of the 42-day cycle, and then continue balstilimab alone for two more cycles.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure ctDNA clearance at 6 months and recurrence-free survival at 1 year.
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NCT07227636
A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy
Recruiting
PHASE2Ages 18+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~284 participants
Updated 2026-02-06 on ClinicalTrials.gov
What's tested:BotensilimabBalstilimabPlacebo
At a glance
Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of ctDNA clearance (Cohort 1a)
Measured over 6 months
+3 more outcomes measured
Conditions
Where it's being run
7 sites across 2 statesNew York4
New Jersey3
Study leadership
- Neil Segal, MD, PhD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Subject or legally authorized representative, is willing and able to provide written informed consent.
Histologically- or cytologically- confirmed colorectal cancer.
≥ 18 years of age on day of signing informed consent.
Consent for use of archival tissue and blood draws for research purposes.
Performance status of ECOG 0 or 1.
Known non-MSI-H/pMMR by IHC, PCR or NGS testing. MSKCC confirmation of non-MSI-H/pMMR status is not mandatory prior to enrollment and treatment on the study. For patients with outside testing, if sufficient tissue is available testing may be repeated at MSKCC and will not impact initial eligibility.
Consent to undergo MSK IMPACT or NGS, if not previously done
Disease specific criteria:
Positive ctDNA following completion of appropriate standard of care therapy.
Patients must sign informed consent within 6 weeks of positive ctDNA result. The 6 weeks is considered from the date that the ctDNA is resulted, and not the date it is drawn.
Subjects of childbearing potential (or with partners of childbearing potential) must use effective contraception for the course of the study starting with the screening visit through at least 5 months after the last dose of study treatment. Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom).
Exclusion
Presence of metastatic or recurrent disease.
Known DNA polymerase epsilon (POLE) or DNA polymerase delta (POLD) activating mutation.
R1 (microscopic residual tumor) or R2 resection (macroscopic residual tumor at resection margin).
Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
Hypersensitivity to botensilimab or balstilimab or any of its excipients.
Chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent
History of, or any evidence of active, non-infectious pneumonitis.
Active infection requiring systemic therapy.
Current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 90 days after the last dose of trial treatment.
Prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 agent.
Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years of the start of study treatment (i.e., with use of disease-modifying agents or immunosuppressive drugs). The following are exceptions:
Known active TB (Bacillus tuberculosis).
Uncontrolled infection with human immunodeficiency virus (HIV). Patients on stable highly active antiretroviral therapy with undetectable viral load and normal CD4 counts for at least 6 months prior to study entry are eligible. Serological testing for HIV at screening is not required
Known to be positive for hepatitis B virus (HBV) surface antigen, or any other positive test for HBV indicating acute or chronic infection. Patients who are receiving or who have received anti-HBV therapy and have undetectable HBV DNA prior to study entry are eligible. Serological testing for HBV at screening is not required.
Known active hepatitis C virus (HCV) as determined by positive serology and confirmed by polymerase chain reaction (PCR). Patients on or who have received antiretroviral therapy are eligible provided they are virus-free by PCR for at least 6 months prior to study entry. Serological testing for HCV at screening is not required.
Received a live vaccine within 30 days of planned start of study therapy
What this trial measures
- Rate of ctDNA clearance (Cohort 1a)6 months
The 6 months ctDNA clearance will be estimated using the binomial distribution along with exact 95% confidence intervals separately in each cohort.
- Rate of ctDNA clearance (Cohort 1b)6 months
The 6 months ctDNA clearance will be estimated using the binomial distribution along with exact 95% confidence intervals separately in each cohort.
- Recurrence-free survival (RFS) (Cohort 2a)1 year
- Recurrence-free survival (RFS) (Cohort 2b)1 year