NCT07750158RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
The primary objective of this study is to evaluate the effectiveness of zanzalintinib + Pembrolizumab (+) berahyaluronidase alfa and zanzalintinib alone compared with placebo.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 3 Aug 2026
- Start date
- 25 Aug 2026
- Primary completion date
- 5 Apr 2030
- Lead sponsor
- Exelixis
- Diseases
- Colorectal cancer
- NCT number
- NCT07750158
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 600
- From 25 Aug 2026 to the primary completion date, 5 Apr 2030
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Astera Cancer Care Coordinator of this site? Confirm its status | Bridgewater | United States | Recruiting |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists - Council Bluffs Coordinator of this site? Confirm its status | Council Bluffs | United States | Recruiting |
| Astera Cancer Care Coordinator of this site? Confirm its status | East Brunswick | United States | Recruiting |
| Astera Cancer Care Coordinator of this site? Confirm its status | Edison | United States | Recruiting |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists - Regional Coordinator of this site? Confirm its status | Grand Island | United States | Recruiting |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island Coordinator of this site? Confirm its status | Grand Island | United States | Recruiting |
| Astera Cancer Care Coordinator of this site? Confirm its status | Monroe | United States | Recruiting |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists - Methodist Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists - Bergan Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists - Papillion Coordinator of this site? Confirm its status | Papillion | United States | Recruiting |
| Astera Cancer Care Coordinator of this site? Confirm its status | Somerset | United States | Recruiting |
| Astera Cancer Care Coordinator of this site? Confirm its status | Toms River | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.