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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
Date last updated
13/05/2025
Titles & IDs
Public title
Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma.
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Scientific title
A Phase 2 Platform Study of Novel Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma
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Secondary ID [1]
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2024-513121-22
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Secondary ID [2]
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GS-US-699-7184
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Universal Trial Number (UTN)
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Trial acronym
VELOCITY-HNSCC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Head and Neck Squamous Cell Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Head and neck
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Substudy-01: Objective response rate (ORR)
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Assessment method [1]
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ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 using investigator assessments.
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Timepoint [1]
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Up to 36 months
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Primary outcome [2]
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Substudy-01: Progression-free survival (PFS)
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Assessment method [2]
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PFS is defined as the time from the date of randomization until the first date of documented progressive disease (PD) or death from any cause, whichever occurs first, as measured by RECIST v1.1 using investigator assessments.
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Timepoint [2]
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Up to 36 months
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Secondary outcome [1]
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Substudy-01: Duration of Response (DOR)
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Assessment method [1]
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DOR is defined as the time from the date of the first documented response until the first date of documented PD or death from any cause, whichever occurs first, as measured by RECIST v1.1 using investigator assessments.
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Timepoint [1]
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Up to 36 months
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Secondary outcome [2]
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Substudy-01: Progression-Free Survival at 6 Months (PFS6)
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Assessment method [2]
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PFS6 is defined as the proportion of participants alive and PD-free from date of randomization until 6 months as measured by RECIST v1.1 using investigator assessments.
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Timepoint [2]
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Up to 6 months
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Secondary outcome [3]
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Substudy-01: Overall Survival (OS)
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Assessment method [3]
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OS is defined as the time from the date of randomization until the date of death from any cause.
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Timepoint [3]
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Up to 36 months
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Secondary outcome [4]
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Substudy-01: Overall Survival at 6 Months (OS6)
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Assessment method [4]
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OS6 is defined as the proportion of participants alive at 6 months from the date of randomization, respectively.
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Timepoint [4]
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Up to 6 months
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Secondary outcome [5]
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Substudy-01: Overall Survival at 12 Months (OS12)
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Assessment method [5]
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OS12 is defined as the proportion of participants alive at 12 months from the date of randomization, respectively.
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Timepoint [5]
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Up to 12 months
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Secondary outcome [6]
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Substudy-01: Disease Control Rate (DCR)
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Assessment method [6]
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DCR is defined as the proportion of participants who achieve a CR, PR, or stable disease (SD) as measured by RECIST v1.1 using investigator assessments.
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Timepoint [6]
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Up to 36 months
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Secondary outcome [7]
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Substudy-01: Time to Progression (TTP)
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Assessment method [7]
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TTP, defined as the time from randomization until the first date of documented PD as measured by RECIST v1.1 using investigator assessments
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Timepoint [7]
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Up to 36 months
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Secondary outcome [8]
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Substudy-01: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Related TEAEs
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Assessment method [8]
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Timepoint [8]
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First dose date up to 24 months plus 100 days
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Secondary outcome [9]
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Substudy-01: Percentage of Participants Experiencing Clinical Laboratory Abnormalities
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Assessment method [9]
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Timepoint [9]
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First dose date up to 24 months plus 100 days
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/02/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2026
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash Health - Clayton
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Recruitment hospital [2]
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Alfred Health - Melbourne
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Recruitment hospital [3]
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ICON Cancer Center - Kurralta Park
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Recruitment hospital [4]
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Westmead Hospital - Sydney
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment postcode(s) [3]
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5037 - Kurralta Park
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Recruitment postcode(s) [4]
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2145 - Sydney
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Missouri
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Country [2]
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United States of America
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State/province [2]
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Tennessee
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United States of America
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State/province [3]
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Texas
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Country [4]
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China
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State/province [4]
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Chengdu
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Country [5]
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China
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State/province [5]
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Hangzhou
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Country [6]
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China
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State/province [6]
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Nanning
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Country [7]
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China
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State/province [7]
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Shanghai
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Country [8]
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China
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State/province [8]
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Wuhan
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Country [9]
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France
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State/province [9]
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Pessac
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Country [10]
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Italy
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State/province [10]
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Milano
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Italy
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State/province [11]
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Napoli
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Country [12]
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Malaysia
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State/province [12]
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Sarawak
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Spain
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State/province [13]
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Sevilla
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Country [14]
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Taiwan
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State/province [14]
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Kaohsiung City
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Country [15]
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Taiwan
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State/province [15]
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Kaohsiung
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Country [16]
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Taiwan
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State/province [16]
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Taichung
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Taiwan
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State/province [17]
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Taipei City
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Country [18]
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Taiwan
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State/province [18]
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Taoyuan
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Country [19]
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United Kingdom
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State/province [19]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Arcus Biosciences, Inc.
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Master protocol: The main goal of this master clinical study is to evaluate the efficacy and safety of multiple novel combination therapies in participants with head and neck squamous cell carcinoma (HNSCC) in various substudies.
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Trial website
https://clinicaltrials.gov/study/NCT06727565
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gilead Study Director
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Address
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Gilead Sciences
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Gilead Clinical Study Information Center
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Address
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Country
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Phone
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1-833-445-3230 (GILEAD-0)
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Fax
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Email
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[email protected]
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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
Download to PDF