A Phase 2/3, Randomized, Double-Blind, Controlled Study of Zanzalintinib (XL092) in Combination With Pembrolizumab vs Pembrolizumab in First-Line Treatment of Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
ClinicalTrials.gov processed this data on December 20, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
RECRUITING (See Contacts and Locations)Verified December 2024 by Exelixis, Merck Sharp & Dohme LLC
Sponsor
ExelixisInformation Provided by (Responsible Party)
ExelixisClinicaltrials.gov Identifier
NCT06082167Other Study ID Numbers: XL092-305; KEYNOTE-G06
First Submitted: October 9, 2023
First Posted: October 13, 2023
Last Update Posted: December 27, 2024
Last Verified: December 2024
History of Changes
Disclaimer
Listing a study on this site does not mean it has been evaluated by the U.S. Federal Government. The safety and scientific validity of a study listed on ClinicalTrials.gov is the responsibility of the study sponsor and investigators. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
ClinicalTrials.gov, a resource provided by the U.S. National Library of Medicine (NLM), is a registry and results information database of clinical research studies sponsored or funded by a broad range of public and private organizations around the world. Not all studies listed on ClinicalTrials.gov are funded by the National Institutes of Health (NIH) or other agencies of the U.S. Federal Government. Not all listed studies are regulated and/or reviewed by the U.S. Food and Drug Administration or other governmental entities.
Information on ClinicalTrials.gov is provided by study sponsors and investigators, and they are responsible for ensuring that the studies follow all applicable laws and regulations. NLM staff do not verify the scientific validity or relevance of the submitted information beyond a limited quality control review for apparent errors, deficiencies, or inconsistencies.
Choosing to participate in a study is an important personal decision. Before you participate in a study, discuss all options with your health care provider and other trusted advisors. For more information about participating in clinical studies, see Learn About Clinical Studies, which includes questions that you might want to ask before deciding to participate in a study.
For more information about using the information on ClinicalTrials.gov, please also see Terms and Conditions.
See also the Web Policies and Notices for the NIH web site.
Study Description
Not Provided| Condition or Disease | Intervention/Treatment |
|---|---|
|
|
Study Design
| Study Type | Interventional |
|---|---|
| Anticipated Enrollment | 600 participants |
| Design Allocation | Randomized |
| Interventional Model | Parallel Assignment |
| Masking | Quadruple |
| Primary Purpose | Treatment |
| Official Title | A Phase 2/3, Randomized, Double-Blind, Controlled Study of Zanzalintinib (XL092) in Combination With Pembrolizumab vs Pembrolizumab in First-Line Treatment of Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma |
| Study Start Date | June 7, 2024 |
| Anticipated Primary Completion Date | August 2028 |
| Anticipated Study Completion Date | March 2029 |
Groups and Cohorts
| Group/ Cohort | Intervention/ Treatment |
|---|---|
|
|
|
|
Outcome Measures
Primary Outcome Measures
- Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) [Approximately 33 months after the first subject is randomized] Defined as the time from randomization to the earlier of either radiographic progressive disease (PD) per RECIST 1.1 as determined by the BICR or death from any cause
- Overall Survival (OS) [Approximately 50 months after the first subject is randomized] Defined as the time from randomization to death due to any cause
Secondary Outcome Measures
- PFS per RECIST 1.1 by Investigator [Approximately 33 months after the first subject is randomized] Defined as the time from randomization to the earlier of either radiographic PD per RECIST 1.1 as determined by the Investigator or death from any cause
- Objective Response Rate (ORR) per RECIST 1.1 by the BICR and Investigator [Approximately 33 months after the first subject is randomized] Defined as the proportion of subjects with the best overall response of complete response (CR) or partial response (PR) per RECIST 1.1 as determined by the BICR and Investigator
- Duration of Response (DOR) Per RECIST 1.1 by BICR and Investigator [Approximately 33 months after the first subject is randomized] Defined as the time from the first documentation of objective response (subsequently confirmed at a visit ≥ 28 days later) to disease progression or death due to any cause
Eligibility Criteria
| Ages Eligible for Study | 18 Years and Older (Adult, Older Adult) |
|---|---|
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | No |
| Inclusion Criteria |
|
| Exclusion Criteria |
|
Contacts and Locations
| Sponsors and Collaborators | Exelixis, Merck Sharp & Dohme LLC |
|---|---|
| Merck Sharp & Dohme LLC | |
| Locations |
|
More Information
Additional Relevant MeSH Terms
- Carcinoma
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Neoplasms, Glandular and Epithelial
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Squamous Cell
- Head and Neck Neoplasms
- Neoplasms by Site