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

Sponsor
Canadian Cancer Trials Group
Study ID
NCT07152821
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Best Supportive Care — OTHER
    Measures designed to provide palliation of symptoms and improve quality of life as much as possible
  • Balstilimab — DRUG
    450mg IV every 3 weeks
  • Botensilimab — DRUG
    75mg IV every 6 weeks x 4 doses

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
834 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Best Supportive Care
  • Experimental: Botensilimab + Balstilimab and Best Supportive Care

Primary Outcome Measure

Overall Survival [ Time Frame: 34 months ]

Central Contacts

Related Studies