Zanzalintinib Alone or in Combination With Pembrolizumab and Berahyaluronidase Alfa in Participants With Colorectal Cancer With Molecular Residual Disease

Sponsor
Exelixis
Study ID
NCT07750158
Phase
PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

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

Interventions

  • Zanzalintinib — DRUG
    Oral tablets administered once daily.
  • Pembrolizumab (+) Berahyaluronidase alfa — BIOLOGICAL
    Pembrolizumab + berahyaluronidase alfa fixed-dose combination administered via subcutaneous (SC) injection once every 3 weeks (Q3W).
  • Placebo — DRUG
    Placebo to match zanzalintinib oral tablets administered once daily.

Study Details

The primary objective of this study is to evaluate the effectiveness of zanzalintinib + Pembrolizumab (+) berahyaluronidase alfa and zanzalintinib alone compared with placebo.

Key Dates

First listed
Aug 6, 2026
Start date
Aug 6, 2026
Status verified
Aug 2026
Primary completion
Apr 5, 2030
Completion
Apr 5, 2030

Study Design

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

Arms

  • Experimental: Zanzalintinib + Pembrolizumab (+) Berahyaluronidase alfa
    Participants will receive zanzalintinib in combination with pembrolizumab (+) berahyaluronidase alfa for up to 2 years.
  • Experimental: Zanzalintinib Monotherapy
    Participants will receive zanzalintinib for up to 2 years.
  • Experimental: Placebo
    Participants will receive placebo to match zanzalintinib for up to 2 years.

Primary Outcome Measure

Disease-Free Survival (DFS) in Zanzalintinib + MK-3475A Versus Placebo as Assessed by the Investigator [ Time Frame: Up to 24 months ]

Central Contacts

Find similar trials

Nationwide
Colorectal cancer trialsOncology trialsGI oncology trials

Related Studies