Colorectal CancerPhase 3STELLAR-316NCT07750158
Zanzalintinib Alone or in Combination With Pembrolizumab and Berahyaluronidase Alfa in Participants With Colorectal Cancer With Molecular Residual Disease
A Phase 3 study testing Zanzalintinib and Pembrolizumab (+) Berahyaluronidase alfa in people with Colorectal Cancer, run by Exelixis at 13 sites in United States.
Trial summary
The primary objective of this study is to evaluate the effectiveness of zanzalintinib + Pembrolizumab (+) berahyaluronidase alfa and zanzalintinib alone compared with placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Zanzalintinib and Pembrolizumab (+) Berahyaluronidase alfa
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 13 sitesUnited States
- Study dates
- 25 Aug 2026to 5 Apr 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
Astera Cancer Care
Bridgewater, New Jersey, 08807
- Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Council Bluffs
Council Bluffs, Iowa, 51503
- Recruiting
Astera Cancer Care
East Brunswick, New Jersey, 08816
- Recruiting
Astera Cancer Care
Edison, New Jersey, 08820
- Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island
Grand Island, Nebraska, 68803
- Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Regional
Grand Island, Nebraska, 68803
- Recruiting
Astera Cancer Care
Monroe, New Jersey, 08831
- Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Methodist
Omaha, Nebraska, 68114
- Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Bergan
Omaha, Nebraska, 68124
- Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy
Omaha, Nebraska, 68130
- Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Papillion
Papillion, Nebraska, 68046
- Recruiting
Astera Cancer Care
Somerset, New Jersey, 08873
- Recruiting
Astera Cancer Care
Toms River, New Jersey, 08757
About this study
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
The primary objective of this study is to evaluate the effectiveness of zanzalintinib + Pembrolizumab (+) berahyaluronidase alfa and zanzalintinib alone compared with placebo.
- Conditions
- Colorectal Cancer
- Being tested
- Zanzalintinib, Pembrolizumab (+) Berahyaluronidase alfa, Placebo
- Keywords
- Molecular Residual Disease, Stage II, Stage III, Circulating Tumor Deoxyribose Nucleic Acid (ctDNA) Positive, Signatera Test, Recurrence Prevention, Early Stage Resectable Colorectal Cancer (CRC), Curative-Intent Therapy, Microsatellite-Stable (MSS), Microsatellite Instability (MSI) - Low, Mismatch Repair Proficient (pMMR)
- Medical subject headings
- Colorectal Neoplasms, Microsatellite Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanzalintinibDrug
Also called XL092
Oral tablets administered once daily.
Pembrolizumab (+) Berahyaluronidase alfaBiological
Also called KEYTRUDA QLEX™, KEYTRUDA SC, MK-3475A
Pembrolizumab + berahyaluronidase alfa fixed-dose combination administered via subcutaneous (SC) injection once every 3 weeks (Q3W).
PlaceboDrug
Placebo to match zanzalintinib oral tablets administered once daily.
| Study group | Role | What they receive |
|---|---|---|
| Zanzalintinib + Pembrolizumab (+) Berahyaluronidase alfa | Experimental | Participants will receive zanzalintinib in combination with pembrolizumab (+) berahyaluronidase alfa for up to 2 years. Receives: Drug: Zanzalintinib; Biological: Pembrolizumab (+) Berahyaluronidase alfa |
| Zanzalintinib Monotherapy | Experimental | Participants will receive zanzalintinib for up to 2 years. Receives: Drug: Zanzalintinib |
| Placebo | Placebo comparator | Participants will receive placebo to match zanzalintinib for up to 2 years. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival (DFS) in Zanzalintinib + MK-3475A Versus Placebo as Assessed by the Investigator
Measured: Up to 24 months
DFS in Zanzalintinib Monotherapy Versus Placebo as Assessed by the Investigator
Measured: Up to 24 months
Secondary outcomes (6)
Proportion of Participants with ctDNA Clearance in Zanzalintinib + MK-3475A Versus Placebo
Measured: Up to 24 months
Proportion of Participants with ctDNA Clearance in Zanzalintinib Monotherapy Versus Placebo
Measured: Up to 24 months
Overall Survival (OS) in Zanzalintinib + MK-3475A Versus Placebo
Measured: Up to 24 months
OS in Zanzalintinib Monotherapy Versus Placebo
Measured: Up to 24 months
DFS in Zanzalintinib + MK-3475A Versus Zanzalintinib Monotherapy as Assessed by the Investigator
Measured: Up to 24 months
Proportion of Participants with Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start25 Aug 2026 (estimated)
- Primary completion5 Apr 2030 (estimated)
- Study completion5 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by ExelixisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exelixis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Exelixis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750158
- Sponsor's protocol ID
- XL092-316
- Other IDs
- MK-3475A-G72
- Acronym
- STELLAR-316
- Status last verified
- Sep 2026
- First submitted
- 3 Aug 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No