NCT07750158 · Exelixis
Zanzalintinib Alone or in Combination With Pembrolizumab and Berahyaluronidase Alfa in Participants With Colorectal Cancer With Molecular Residual Disease
(STELLAR-316)
What this study is about
The primary objective of this study is to evaluate the effectiveness of zanzalintinib + Pembrolizumab (+) berahyaluronidase alfa and zanzalintinib alone compared with placebo.
View original scientific description
The primary objective of this study is to evaluate the effectiveness of zanzalintinib + Pembrolizumab (+) berahyaluronidase alfa and zanzalintinib alone compared with placebo.
Interventions
DRUG
Zanzalintinib
Oral tablets administered once daily.
BIOLOGICAL
Pembrolizumab (+) Berahyaluronidase alfa
Pembrolizumab + berahyaluronidase alfa fixed-dose combination administered via subcutaneous (SC) injection once every 3 weeks (Q3W).
DRUG
Placebo
Placebo to match zanzalintinib oral tablets administered once daily.
Primary outcome measures
Disease-Free Survival (DFS) in Zanzalintinib + MK-3475A Versus Placebo as Assessed by the Investigator
Time frame: Up to 24 months
DFS in Zanzalintinib Monotherapy Versus Placebo as Assessed by the Investigator
Time frame: Up to 24 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Council Bluffs, Iowa
- Grand Island, Nebraska
- Omaha, Nebraska
- Papillion, Nebraska
- Bridgewater, New Jersey
- East Brunswick, New Jersey
- Edison, New Jersey
- Monroe, New Jersey
- Somerset, New Jersey
- Toms River, New Jersey
Collaborators
Merck Sharp & Dohme LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 21, 2026 · Source of record for eligibility and locations