Clinical trial · Interventional
Zanzalintinib Alone or in Combination With Pembrolizumab and Berahyaluronidase Alfa in Participants With Colorectal Cancer With Molecular Residual Disease
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
NCT07750158CI-TRIAL-00123745STELLAR-316recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
The primary objective of this study is to evaluate the effectiveness of zanzalintinib + Pembrolizumab (+) berahyaluronidase alfa and zanzalintinib alone compared with placebo.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pembrolizumab (+) Berahyaluronidase alfa | Biological | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| Zanzalintinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Zanzalintinib + Pembrolizumab (+) Berahyaluronidase alfa
- description
- Participants will receive zanzalintinib in combination with pembrolizumab (+) berahyaluronidase alfa for up to 2 years.
- interventionNames
- Drug: Zanzalintinib
- Biological: Pembrolizumab (+) Berahyaluronidase alfa
- type
- EXPERIMENTAL
- label
- Zanzalintinib Monotherapy
- description
- Participants will receive zanzalintinib for up to 2 years.
- interventionNames
- Drug: Zanzalintinib
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.