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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

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
Trial website
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
druginfo@exelixis.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06082167