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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06727565




Registration number
NCT06727565
Ethics application status
Date submitted
9/12/2024
Date registered
11/12/2024

Titles & IDs
Public title
Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma.
Scientific title
A Phase 2 Platform Study of Novel Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma
Secondary ID [1] 0 0
2024-513121-22
Secondary ID [2] 0 0
GS-US-699-7184
Universal Trial Number (UTN)
Trial acronym
VELOCITY-HNSCC
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 - Domvanalimab
Treatment: Drugs - Zimberelimab
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Carboplatin

Experimental: Substudy-01:Treatment Group A: Domvanalimab (DOM) + Zimberelimab (ZIM) + Platinum-based Chemotherapy - Participants will receive DOM + ZIM + platinum-based chemotherapy (paclitaxel + carboplatin).

Experimental: Substudy-01: Treatment Group B: Zimberelimab (ZIM) + Platinum-based Chemotherapy - Participants will receive ZIM + platinum-based chemotherapy (paclitaxel + carboplatin).


Treatment: Drugs: Domvanalimab
Administered intravenously

Treatment: Drugs: Zimberelimab
Administered intravenously

Treatment: Drugs: Paclitaxel
Administered intravenously

Treatment: Drugs: Carboplatin
Administered intravenously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Substudy-01: Objective response rate (ORR)
Timepoint [1] 0 0
Up to 36 months
Primary outcome [2] 0 0
Substudy-01: Progression-free survival (PFS)
Timepoint [2] 0 0
Up to 36 months
Secondary outcome [1] 0 0
Substudy-01: Duration of Response (DOR)
Timepoint [1] 0 0
Up to 36 months
Secondary outcome [2] 0 0
Substudy-01: Progression-Free Survival at 6 Months (PFS6)
Timepoint [2] 0 0
Up to 6 months
Secondary outcome [3] 0 0
Substudy-01: Overall Survival (OS)
Timepoint [3] 0 0
Up to 36 months
Secondary outcome [4] 0 0
Substudy-01: Overall Survival at 6 Months (OS6)
Timepoint [4] 0 0
Up to 6 months
Secondary outcome [5] 0 0
Substudy-01: Overall Survival at 12 Months (OS12)
Timepoint [5] 0 0
Up to 12 months
Secondary outcome [6] 0 0
Substudy-01: Disease Control Rate (DCR)
Timepoint [6] 0 0
Up to 36 months
Secondary outcome [7] 0 0
Substudy-01: Time to Progression (TTP)
Timepoint [7] 0 0
Up to 36 months
Secondary outcome [8] 0 0
Substudy-01: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Related TEAEs
Timepoint [8] 0 0
First dose date up to 24 months plus 100 days
Secondary outcome [9] 0 0
Substudy-01: Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Timepoint [9] 0 0
First dose date up to 24 months plus 100 days

Eligibility
Key inclusion criteria
Key

* Histologically or cytologically confirmed r/m squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies.
* No prior systemic therapy for r/m HNSCC. Individuals who had disease progression or recurrence more than 6 months after the last dose of curative intent systemic platinum-containing therapy for locoregionally advanced disease are eligible.
* At least 1 measurable lesion by computed tomography or magnetic resonance imaging that qualifies as a RECIST v1.1 target lesion at baseline.
* Have adequate tumor tissue samples preferably from lesions not irradiated prior to biopsy (acceptable from irradiated lesions if disease progression has been demonstrated in such lesions) to submit for central testing.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Known results from human papillomavirus (HPV) status test (p16 expression) for oropharyngeal carcinoma defined as p16 testing.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Individuals with nasopharyngeal cancer (any histology), squamous cell carcinoma of unknown primary tumors, skin (cutaneous squamous cell carcinoma), paranasal sinuses, and salivary gland.
* Have disease that is suitable for any local therapies with curative intent.
* Individuals who had disease progression or recurrence within 6 months after the last dose of curative intent systemic platinum-containing therapy for locoregionally advanced disease.
* Have a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* Have an active autoimmune disease that required systemic treatment in the past 2 years. (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
* Prior treatment with any of the following within the specific time frame prior to the first dose of study drug:

* Major surgery for any cause or significant traumatic injury within 4 weeks prior to the first dose of study drug. Individuals must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study drug.
* Any noninvestigational anticancer therapy (chemotherapy, biologic therapy, targeted therapy, hormone therapy, or immunotherapy, etc) within 4 weeks prior to the first dose of study drug. Concurrent use for noncancer related condition (eg, hormone replacement therapy) is acceptable.
* Any investigational drugs (drugs not marketed for any indication) within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of study drug.
* Radiation therapy within 2 weeks prior to the first dose of study drug. Individuals must have recovered to Grade = 1 from all radiation-related toxicities, not requiring corticosteroid, and have not experienced radiation pneumonitis.
* Received prior treatment with any anti-PD-1/PD-L1, anti-TIGIT, or other immune checkpoint inhibitors.
* Currently receiving chronic systemic steroids (> 10 mg/day prednisone or its equivalent). Use of topical, inhalational, intranasal, intraocular steroids, and use as premedication for hypersensitivity reactions (eg, IV contrast allergy) are permitted.
* Any unresolved toxicity (Grade = 2) per National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 from prior anticancer therapy or surgical intervention, with the exception of alopecia, vitiligo, and the laboratory toxicities if the laboratory thresholds defined in the inclusion criteria are met. Individuals with Grade = 2 neuropathy are eligible for this study.
* Have an active second malignancy or have had an active second malignancy within 3 years prior to enrollment.
* Have known active central nervous system (CNS) metastases. Individuals with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to enrollment and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastasis and are not requiring use of steroid for at least 14 days prior to the first dose of study drugs.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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
Open (masking not used)
Who is / are masked / blinded?



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
18/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Health - Clayton
Recruitment hospital [2] 0 0
ICON Cancer Center - Kurralta Park
Recruitment hospital [3] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [3] 0 0
2145 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Missouri
Country [2] 0 0
United States of America
State/province [2] 0 0
Tennessee
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
China
State/province [4] 0 0
Chengdu
Country [5] 0 0
China
State/province [5] 0 0
Hangzhou
Country [6] 0 0
China
State/province [6] 0 0
Nanning
Country [7] 0 0
China
State/province [7] 0 0
Shanghai
Country [8] 0 0
China
State/province [8] 0 0
Wuhan
Country [9] 0 0
France
State/province [9] 0 0
Pessac
Country [10] 0 0
Italy
State/province [10] 0 0
Napoli
Country [11] 0 0
Spain
State/province [11] 0 0
Sevilla
Country [12] 0 0
Taiwan
State/province [12] 0 0
Kaohsiung City
Country [13] 0 0
Taiwan
State/province [13] 0 0
Kaohsiung
Country [14] 0 0
Taiwan
State/province [14] 0 0
Taichung
Country [15] 0 0
Taiwan
State/province [15] 0 0
Taipei City
Country [16] 0 0
United Kingdom
State/province [16] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Arcus Biosciences, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gilead Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-833-445-3230 (GILEAD-0)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT06727565