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

ConditionColorectal Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorExelixis

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Zanzalintinib

    Drug

    Oral tablets administered once daily.

  • Pembrolizumab (+) Berahyaluronidase alfa

    Biological/Vaccine

    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.

Treatment groups

600 Participants
are divided into 3 treatment groups
Group A: Zanzalintinib + Pembrolizumab (+) Berahyaluronidase alfaExperimental treatment 2 interventions
Group B: Zanzalintinib MonotherapyExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Disease-Free Survival (DFS) in Zanzalintinib + MK-3475A Versus Placebo as Assessed by the Investigator

Time frame
Up to 24 months
2

DFS in Zanzalintinib Monotherapy Versus Placebo as Assessed by the Investigator

Time frame
Up to 24 months

Secondary outcomes

1

Proportion of Participants with ctDNA Clearance in Zanzalintinib + MK-3475A Versus Placebo

Time frame
Up to 24 months
2

Proportion of Participants with ctDNA Clearance in Zanzalintinib Monotherapy Versus Placebo

Time frame
Up to 24 months
3

Overall Survival (OS) in Zanzalintinib + MK-3475A Versus Placebo

Time frame
Up to 24 months
4

OS in Zanzalintinib Monotherapy Versus Placebo

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

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

Exelixis

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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