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NCT Number: NCT07750158

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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.

Key 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.

Treatment and study plan

Zanzalintinib

Drug

Oral tablets administered once daily.

Other names: XL092

MK-34574

Biological

Pembrolizumab + berahyaluronidase alfa fixed-dose combination administered via subcutaneous (SC) injection once every 3 weeks (Q3W).

Other names: KEYTRUDA QLEX™, KEYTRUDA SC

Placebo

Drug

Placebo to match zanzalintinib oral tablets administered once daily.

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

  5. DFS in Zanzalintinib + MK-3475A Versus Zanzalintinib Monotherapy as Assessed by the Investigator

    Time frame: Up to 24 months

  6. Proportion of Participants with Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Exelixis Clinical Trials

CONTACT

[email protected]

1-888-393-5494

Sponsors and collaborators

Lead sponsor

Exelixis

Industry

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Acronym: STELLAR-316

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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