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Not yet recruiting NCT07750158

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

Phase III Interventional Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Zanzalintinib, MK-34574, Placebo.
Who it may be relevant to
Registry conditions: Colorectal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Randomized Phase 3 Study of Zanzalintinib ± Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus Placebo in Participants With Colorectal Cancer With Stage II/III Molecular Residual Disease Following Definitive Therapy

Overview

The primary objective of this study is to evaluate the effectiveness of zanzalintinib + MK-3475A and zanzalintinib alone compared with placebo.

Interventions

  • Drug Zanzalintinib
    Oral tablets administered once daily.
  • Biological MK-34574
    Pembrolizumab + berahyaluronidase alfa fixed-dose combination administered via subcutaneous (SC) injection once every 3 weeks (Q3W).
  • Drug Placebo
    Placebo to match zanzalintinib oral tablets administered once daily.

Primary outcome measures

  • Disease-Free Survival (DFS) in Zanzalintinib + MK-3475A Versus Placebo as Assessed by the Investigator [Time frame: Up to 24 months]
  • DFS in Zanzalintinib Monotherapy Versus Placebo as Assessed by the Investigator [Time frame: Up to 24 months]
Secondary outcome measures (6)
  • Proportion of Participants with ctDNA Clearance in Zanzalintinib + MK-3475A Versus Placebo [Time frame: Up to 24 months]
  • Proportion of Participants with ctDNA Clearance in Zanzalintinib Monotherapy Versus Placebo [Time frame: Up to 24 months]
  • Overall Survival (OS) in Zanzalintinib + MK-3475A Versus Placebo [Time frame: Up to 24 months]
  • OS in Zanzalintinib Monotherapy Versus Placebo [Time frame: Up to 24 months]
  • DFS in Zanzalintinib + MK-3475A Versus Zanzalintinib Monotherapy as Assessed by the Investigator [Time frame: Up to 24 months]
  • Proportion of Participants with Treatment Emergent Adverse Events (TEAEs) [Time frame: Up to 24 months]

Eligibility criteria

Inclusion criteria

  • Histologically confirmed diagnosis of Stage II or III adenocarcinoma of colon or rectum.
  • Documented local MSI and/or mismatch repair (MMR) test result demonstrating MSS, MSI-low, or pMMR status.
  • Colon or rectal cancer with completed definitive therapy.
  • ctDNA-positive based on local testing using the Natera Signatera tissue-informed molecular residual disease (MRD) assay.
  • No radiographic evidence of disease, as confirmed by a negative baseline computed tomography (CT) of the chest, abdomen, and pelvis (CAP), or CT of chest and magnetic resonance imaging (MRI) of abdomen/pelvis.

Exclusion criteria

  • History of solid organ or allogeneic stem cell transplant.
  • Known additional malignancy that is progressing or has required active treatment within the past 2 years.
  • Prior treatment with immune checkpoint inhibitors (ICIs) or Vascular endothelial growth factor receptor (VEGFR) inhibitors.
  • History of CRC requiring systemic anticancer therapy prior to the definitive therapy.
  • Use of systemic anticancer therapy (including investigational therapy) or radiation therapy after the completion of definitive therapy.
  • Administration of a live, attenuated vaccine within 30 days of randomization and during treatment.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07750158 · XL092-316 · MK-3475A-G72

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗