Trial Title:
Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
NCT ID:
NCT06082167
Condition:
Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Pembrolizumab
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Zanzalintinib
Description:
Specified doses on specified days
Arm group label:
Zanzalintinib + Pembrolizumab
Other name:
XL092
Intervention type:
Drug
Intervention name:
Zanzalintinib-matched Placebo
Description:
Specified doses on specified days
Arm group label:
Zanzalintinib-Matched Placebo + Pembrolizumab
Other name:
XL092-matched Placebo
Intervention type:
Biological
Intervention name:
Pembrolizumab
Description:
Specified doses on specified days
Arm group label:
Zanzalintinib + Pembrolizumab
Arm group label:
Zanzalintinib-Matched Placebo + Pembrolizumab
Other name:
Keytruda®
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.
Criteria for eligibility:
Criteria:
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.
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Exelixis Clinical Site #2
Address:
City:
Fullerton
Zip:
92835
Country:
United States
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #1
Address:
City:
Orange City
Zip:
32763
Country:
United States
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #19
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #62
Address:
City:
Des Moines
Zip:
50309
Country:
United States
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #4
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #3
Address:
City:
Shirley
Zip:
11967
Country:
United States
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #43
Address:
City:
Roanoke
Zip:
24014
Country:
United States
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site # 47
Address:
City:
Ciudad Autonoma de Buenos Aire
Zip:
C1015ABO
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #53
Address:
City:
Ciudad Autonoma de Buenos Aire
Zip:
C1056ABJ
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #64
Address:
City:
Córdoba
Zip:
X5008HHW
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #57
Address:
City:
Port Macquarie
Zip:
2444
Country:
Australia
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site # 46
Address:
City:
Adelaide
Zip:
5000
Country:
Australia
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #39
Address:
City:
Murdoch
Zip:
6150
Country:
Australia
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #42
Address:
City:
Salzburg
Zip:
5020
Country:
Austria
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #22
Address:
City:
Bruxelles
Zip:
1200
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #14
Address:
City:
Libramont
Zip:
6800
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #37
Address:
City:
Sint-Niklaas
Zip:
9100
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #68
Address:
City:
Passo Fundo
Zip:
99010-260
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #65
Address:
City:
Santo André
Zip:
09060-650
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Exelixis Clinical #Site 67
Address:
City:
São Paulo
Zip:
04014-002
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #25
Address:
City:
Plovdiv
Zip:
4004
Country:
Bulgaria
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #15
Address:
City:
Sofia
Zip:
1330
Country:
Bulgaria
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #11
Address:
City:
Sofia
Zip:
1527
Country:
Bulgaria
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #54
Address:
City:
Sofia
Zip:
1797
Country:
Bulgaria
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #33
Address:
City:
Santiago
Zip:
13127
Country:
Chile
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #52
Address:
City:
Santiago
Zip:
7500859
Country:
Chile
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #38
Address:
City:
Santiago
Zip:
8331143
Country:
Chile
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #50
Address:
City:
Talca
Zip:
3465586
Country:
Chile
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #51
Address:
City:
Valdivia
Zip:
5090000
Country:
Chile
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #40
Address:
City:
Viña Del Mar
Zip:
2540364
Country:
Chile
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #49
Address:
City:
Nový Jičín
Zip:
74101
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #58
Address:
City:
Olomouc
Zip:
77900
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #34
Address:
City:
Prague
Zip:
14059
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #48
Address:
City:
Praha
Zip:
15006
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #36
Address:
City:
Praha
Zip:
18081
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #28
Address:
City:
Marseille
Zip:
13005
Country:
France
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #16
Address:
City:
Bordeaux
Zip:
33075
Country:
France
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #44
Address:
City:
Rennes
Zip:
35042
Country:
France
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #66
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #26
Address:
City:
Paris
Zip:
75013
Country:
France
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #21
Address:
City:
Candiolo
Zip:
10060
Country:
Italy
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #35
Address:
City:
Brescia
Zip:
25124
Country:
Italy
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #45
Address:
City:
Catania
Zip:
95123
Country:
Italy
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #55
Address:
City:
Milano
Zip:
20141
Country:
Italy
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #18
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #10
Address:
City:
Verona
Zip:
37134
Country:
Italy
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #7
Address:
City:
Busan
Zip:
49267
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #30
Address:
City:
Suwon-si
Zip:
16247
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #17
Address:
City:
Suwon
Zip:
16499
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #9
Address:
City:
Yangsan
Zip:
50612
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #8
Address:
City:
Jeonju
Zip:
54907
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #13
Address:
City:
Busan
Zip:
49201
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #5
Address:
City:
Seoul
Zip:
3722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #63
Address:
City:
Seoul
Zip:
5505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #12
Address:
City:
Seoul
Zip:
6273
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #6
Address:
City:
Seoul
Zip:
6591
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #29
Address:
City:
Seoul
Zip:
8308
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #61
Address:
City:
Putrajaya
Zip:
62250
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #60
Address:
City:
Kuala Lumpur
Zip:
50586
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #24
Address:
City:
Cluj-Napoca
Zip:
400641
Country:
Romania
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #20
Address:
City:
Craiova
Zip:
200542
Country:
Romania
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #23
Address:
City:
Košice
Zip:
04191
Country:
Slovakia
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #27
Address:
City:
Trnava
Zip:
91775
Country:
Slovakia
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #32
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #59
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #31
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #41
Address:
City:
Zaragoza
Zip:
50009
Country:
Spain
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #56
Address:
City:
Chiangmai
Zip:
50200
Country:
Thailand
Status:
Recruiting
Start date:
June 7, 2024
Completion date:
March 2028
Lead sponsor:
Agency:
Exelixis
Agency class:
Industry
Source:
Exelixis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06082167
