MedTrace Logo

Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma

NCT07152821 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 834

Last updated 2026-05-12

No results posted yet for this study

Summary

This study is being done to answer the main question of: Do patients with colorectal cancer that cannot be removed by surgery, that is treated with two new immunotherapy drugs, botensilimab and balstilimab, live longer? Other important questions include: Is their quality of life better? Do their tumours slow in growth or possibly shrink in size? Are there markers in their tumour or blood that can predict whether they achieve any of these benefits? In addition, the study is done to confirm the safety of these immunotherapy drugs and to determine how long it takes for the body to metabolize them.

Conditions

Interventions

OTHER

Best Supportive Care

Measures designed to provide palliation of symptoms and improve quality of life as much as possible

DRUG

Balstilimab

450mg IV every 3 weeks

DRUG

Botensilimab

75mg IV every 6 weeks x 4 doses

Sponsors & Collaborators

  • Agenus Inc.

    collaborator INDUSTRY

  • Australasian Gastro-Intestinal Trials Group

    collaborator NETWORK

  • UNICANCER

    collaborator OTHER

  • Canadian Cancer Trials Group

    lead NETWORK

Principal Investigators

  • Jonathan Loree · BCCA-Vancouver Cancer Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2028-12-31
Completion
2029-06-30
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07152821 on ClinicalTrials.gov