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

ConditionsColorectal CancerRectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    Placebo

Treatment groups

284 Participants
are divided into 4 treatment groups
Group A: Cohort 1a: Stage III MSS Colorectal Cancer (Botensilimab and Balstilimab)Experimental treatment 2 interventions
Group B: Cohort 1b: MSS CRLM (Botensilimab and Balstilimab)Experimental treatment 2 interventions
Group C: Cohort 2a: Stage 3 MSS Colorectal Cancer (Botensilimab and Balstilimab vs. Placebo) RandomizedExperimental treatment 3 interventions
Group D: Cohort 2b: MSS CRLM (Botensilimab and Balstilimab vs. Placebo) RandomizedExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Rate of ctDNA clearance (Cohort 1a)

The 6 months ctDNA clearance will be estimated using the binomial distribution along with exact 95% confidence intervals separately in each cohort.

Time frame
6 months
2

Rate of ctDNA clearance (Cohort 1b)

The 6 months ctDNA clearance will be estimated using the binomial distribution along with exact 95% confidence intervals separately in each cohort.

Time frame
6 months
3

Recurrence-free survival (RFS) (Cohort 2a)

Time frame
1 year
4

Recurrence-free survival (RFS) (Cohort 2b)

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Agenus Inc.

Collaborator

Source ClinicalTrials.gov
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