600 Participants NeededMy employer runs this trial

Zanzalintinib + Pembrolizumab for Colorectal Cancer

(STELLAR-316 Trial)

Recruiting at 12 trial locations
EC
Overseen ByExelixis Clinical Trials
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Exelixis
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary objective of this study is to evaluate the effectiveness of zanzalintinib + Pembrolizumab (+) berahyaluronidase alfa and zanzalintinib alone compared with placebo.

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Exelixis

Are You a Good Fit for This Trial?

This trial is for people with stage II or III colon or rectal cancer who have finished main treatment, show no signs of cancer on scans, but still have tiny traces of cancer DNA in their blood. Their tumor must meet certain genetic test results.

Inclusion Criteria

This criterion is not specific enough to summarize.
I have finished all main treatments for colon or rectal cancer.
My tumor test shows MSS, MSI-low, or pMMR status.
See 3 more

What Are the Treatments Tested in This Trial?

Interventions

  • Berahyaluronidase alfa
  • Pembrolizumab
  • Zanzalintinib

Trial Overview

The study compares zanzalintinib alone and zanzalintinib combined with pembrolizumab and berahyaluronidase alfa against a placebo to see which works best at preventing colorectal cancer from returning.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Zanzalintinib MonotherapyExperimental Treatment1 Intervention
Group II: Zanzalintinib + Pembrolizumab (+) Berahyaluronidase alfaExperimental Treatment2 Interventions
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Exelixis

Lead Sponsor

Trials
126
Recruited
20,500+
Michael M. Morrissey profile image

Michael M. Morrissey

Exelixis

Chief Executive Officer since 2010

PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin

Vicki L. Goodman profile image

Vicki L. Goodman

Exelixis

Chief Medical Officer since 2022

MD

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University