Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06082167




Registration number
NCT06082167
Ethics application status
Date submitted
9/10/2023
Date registered
13/10/2023
Date last updated
5/08/2024

Titles & IDs
Public title
Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Scientific 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
Secondary ID [1] 0 0
EU CTR: 2023-506308-24-00
Secondary ID [2] 0 0
XL092-305
Universal Trial Number (UTN)
Trial acronym
STELLAR-305
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Squamous Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Zanzalintinib
Treatment: Drugs - Zanzalintinib-matched Placebo
Treatment: Other - Pembrolizumab

Experimental: Zanzalintinib + Pembrolizumab - Subjects with R/M HNSCC will receive zanzalintinib + pembrolizumab

Placebo comparator: Zanzalintinib-Matched Placebo + Pembrolizumab - Subjects with R/M HNSCC will receive zanzalintinib-matched placebo + pembrolizumab


Treatment: Drugs: Zanzalintinib
Specified doses on specified days

Treatment: Drugs: Zanzalintinib-matched Placebo
Specified doses on specified days

Treatment: Other: Pembrolizumab
Specified doses on specified days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by Blinded Independent Radiology Committee (BIRC)
Timepoint [1] 0 0
Approximately 28 months after the first subject is randomized
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Approximately 40 months after the first subject is randomized
Secondary outcome [1] 0 0
PFS per RECIST 1.1 by Investigator
Timepoint [1] 0 0
Approximately 28 months after the first subject is randomized
Secondary outcome [2] 0 0
Objective Response Rate (ORR) per RECIST 1.1 by BIRC and Investigator
Timepoint [2] 0 0
Approximately 28 months after the first subject is randomized
Secondary outcome [3] 0 0
Duration of Response (DOR) Per RECIST 1.1 by BIRC and Investigator
Timepoint [3] 0 0
Approximately 28 months after the first subject is randomized

Eligibility
Key inclusion criteria
* Histologically or cytologically-confirmed R/M HNSCC that is considered incurable by local therapy.

* Subjects should not have had prior systemic therapy administered in the recurrent or metastatic setting. Systemic therapy which was completed more than 6 months prior to randomization if given as part of multimodal treatment for locally advanced disease is allowed.
* The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, and larynx.
* PD-L1 expression level Combined Positive Score (CPS) = 1 by immunohistochemistry (IHC) testing.
* Have human papilloma virus (HPV) testing result for oropharyngeal cancer defined as p16 IHC testing.
* Measurable disease according to RECIST 1.1 determined by the Investigator.
* Tumor samples (archival or fresh tumor biopsy) are required. If archival tissue is unavailable, must provide fresh tumor tissue biopsy prior to randomization.
* Recovery to baseline or = Grade 1 severity (CTCAE v5) from adverse events (AEs) related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
* Age 18 years or older on the day of consent.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Adequate organ and marrow function.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Nasopharynx, salivary gland or occult primary site (regardless of p16 status).
* Has disease that is suitable for local therapy administered with curative intent.
* Has received prior therapy with zanzalintinib, any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
* Life expectancy < 3 months.
* Had progressive disease within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.
* Radiation therapy for bone metastases within 2 weeks, any other radiation therapy within 4 weeks prior to randomization.
* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to randomization.
* Positive hepatitis B surface antigen (HBsAg) test.
* Positive hepatitis C virus (HCV) antibody test.
* Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to randomization. Complete wound healing from major or minor surgery must have occurred at least prior to randomization.
* Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per electrocardiogram (ECG) within 28 days before randomization.
* Pregnant or lactating females.
* Administration of a live, attenuated vaccine within 30 days before randomization.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2028
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Exelixis Clinical Site #57 - Port Macquarie
Recruitment hospital [2] 0 0
Exelixis Clinical Site # 46 - Adelaide
Recruitment hospital [3] 0 0
Exelixis Clinical Site #39 - Murdoch
Recruitment postcode(s) [1] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Iowa
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Virginia
Country [8] 0 0
Argentina
State/province [8] 0 0
Ciudad Autonoma de Buenos Aire
Country [9] 0 0
Argentina
State/province [9] 0 0
Córdoba
Country [10] 0 0
Austria
State/province [10] 0 0
Salzburg
Country [11] 0 0
Belgium
State/province [11] 0 0
Bruxelles
Country [12] 0 0
Belgium
State/province [12] 0 0
Libramont
Country [13] 0 0
Belgium
State/province [13] 0 0
Sint-Niklaas
Country [14] 0 0
Brazil
State/province [14] 0 0
Rio Grande Do Sul
Country [15] 0 0
Brazil
State/province [15] 0 0
Sao Paulo
Country [16] 0 0
Brazil
State/province [16] 0 0
São Paulo
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Plovdiv
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Sofia
Country [19] 0 0
Chile
State/province [19] 0 0
Santiago
Country [20] 0 0
Chile
State/province [20] 0 0
Talca
Country [21] 0 0
Chile
State/province [21] 0 0
Valdivia
Country [22] 0 0
Chile
State/province [22] 0 0
Viña Del Mar
Country [23] 0 0
Czechia
State/province [23] 0 0
Nový Jicín
Country [24] 0 0
Czechia
State/province [24] 0 0
Olomouc
Country [25] 0 0
Czechia
State/province [25] 0 0
Prague
Country [26] 0 0
Czechia
State/province [26] 0 0
Praha
Country [27] 0 0
France
State/province [27] 0 0
Bouches-du-Rhône
Country [28] 0 0
France
State/province [28] 0 0
Gironde
Country [29] 0 0
France
State/province [29] 0 0
Ille Et Vilaine
Country [30] 0 0
France
State/province [30] 0 0
Val De Marne
Country [31] 0 0
France
State/province [31] 0 0
Paris
Country [32] 0 0
Italy
State/province [32] 0 0
Torino
Country [33] 0 0
Italy
State/province [33] 0 0
Brescia
Country [34] 0 0
Italy
State/province [34] 0 0
Catania
Country [35] 0 0
Italy
State/province [35] 0 0
Milano
Country [36] 0 0
Italy
State/province [36] 0 0
Napoli
Country [37] 0 0
Italy
State/province [37] 0 0
Verona
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Gangwon-do
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Gyeonggi-do
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Gyeongsangnam-do
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Jeollabuk-do
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Busan
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Seoul
Country [44] 0 0
Malaysia
State/province [44] 0 0
Kuala Lumpur
Country [45] 0 0
Romania
State/province [45] 0 0
Cluj-Napoca
Country [46] 0 0
Romania
State/province [46] 0 0
Craiova
Country [47] 0 0
Slovakia
State/province [47] 0 0
Košice
Country [48] 0 0
Slovakia
State/province [48] 0 0
Trnava
Country [49] 0 0
Spain
State/province [49] 0 0
Madrid
Country [50] 0 0
Spain
State/province [50] 0 0
Zaragoza
Country [51] 0 0
Thailand
State/province [51] 0 0
Chiang Mai

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Exelixis
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a multicenter, randomized, double-blind, controlled Phase 2/3 trial of zanzalintinib in combination with pembrolizumab versus zanzalintinib-matched placebo in combination with pembrolizumab in subjects with PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) incurable by local therapies who have not received prior systemic therapy for recurrent or metastatic disease.
Trial website
https://clinicaltrials.gov/study/NCT06082167
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Exelixis Clinical Trials
Address 0 0
Country 0 0
Phone 0 0
1-888-EXELIXIS (888-393-5494)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06082167