Head and Neck Squamous Cell CarcinomaPhase 2VELOCITY-HNSCCNCT06727565
Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status; Substudy-01
A Phase 2 study testing Domvanalimab, Zimberelimab and Paclitaxel in people with Head and Neck Squamous Cell Carcinoma, run by Gilead Sciences at 23 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Domvanalimab, Zimberelimab and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 23 sitesin 9 countries
- Study dates
- 18 Feb 2025to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 16Show fewer
- 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.
Trial locations and contacts
23 sites in 9 countries.
23 sites in 9 countries
China5 sites
Sichuan Cancer Hospital
Chengdu, 610040
Zhejiang Cancer Hospital
Hangzhou, 310005
Guangxi Medical University Cancer Hospital
Nanning, 530012
Shanghai East Hospital
Shanghai, 200120
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, 430030
Australia4 sites
Monash Health
Clayton, Victoria, 3168
ICON Cancer Center
Kurralta Park, South Australia, 5037
Alfred Health
Melbourne, Victoria, 3004
Westmead Hospital
Sydney, New South Wales, 2145
Taiwan4 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
China Medical University Hospital
Taichung, 40402
Taipei Veterans General Hospital
Taipei, 11217
Chang Gung Memorial Hospital, Linkou
Taoyuan, 33308
United States3 sites
The University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
Tennessee Oncology, PLLC - Greco-Hainsworth Centers for Research
Nashville, Tennessee, 37203
Siteman Cancer Center
St Louis, Missouri, 63110
Italy2 sites
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, 80131
United Kingdom2 sites
Barts Health NHS Foundation Trust
London, EC1A 7BE
The Royal Marsden NHS Foundation Trust
London, SW10 9NH
About this study
Official title: VELOCITY-HNSCC Substudy-01: A Phase 2 Study of Novel Combination Therapies in Participants With Previously Untreated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status
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.
Substudy-01 will evaluate the efficacy and safety of novel combination of treatment regimens, domvanalimab (DOM) and zimberelimab (ZIM) combined with chemotherapy vs ZIM combined with chemotherapy.
The primary objective is to assess the efficacy of DOM and ZIM in combination with chemotherapy versus ZIM in combination with chemotherapy.
Read the detailed description
This platform study will begin with a substudy targeting first-line (1L) recurrent or metastatic (r/m) HNSCC regardless of programmed cell death ligand 1 (PD-L1) expression status (Substudy-01), and new substudies may be added in the future targeting different study populations of HNSCC. All substudies evaluating additional drugs will be added in a staggered manner when relevant nonclinical and/or clinical data become available. Additional drugs may also be added to Substudy-01 in the future.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Domvanalimab, Zimberelimab, Paclitaxel, Carboplatin
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DomvanalimabDrug
Administered intravenously
ZimberelimabDrug
Administered intravenously
PaclitaxelDrug
Administered intravenously
CarboplatinDrug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A: Domvanalimab (DOM) + Zimberelimab (ZIM) + Platinum-based Chemotherapy | Experimental | Participants will receive DOM + ZIM + platinum-based chemotherapy (paclitaxel + carboplatin). Receives: Drug: Domvanalimab; Drug: Zimberelimab; Drug: Paclitaxel; Drug: Carboplatin |
| Treatment Group B: Zimberelimab (ZIM) + Platinum-based Chemotherapy | Experimental | Participants will receive ZIM + platinum-based chemotherapy (paclitaxel + carboplatin). Receives: Drug: Zimberelimab; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
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.
Measured: Up to 36 months
Progression-free survival (PFS)
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.
Measured: Up to 36 months
Secondary outcomes (9)
Duration of Response (DOR)
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.
Measured: Up to 36 months
Progression-Free Survival at 6 Months (PFS6)
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.
Measured: Up to 6 months
Overall Survival (OS)
OS is defined as the time from the date of randomization until the date of death from any cause.
Measured: Up to 36 months
Overall Survival at 6 Months (OS6)
OS6 is defined as the proportion of participants alive at 6 months from the date of randomization, respectively.
Measured: Up to 6 months
Overall Survival at 12 Months (OS12)
OS12 is defined as the proportion of participants alive at 12 months from the date of randomization, respectively.
Measured: Up to 12 months
Disease Control Rate (DCR)
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.
Measured: Up to 36 months
Time to Progression (TTP)
TTP, defined as the time from randomization until the first date of documented PD as measured by RECIST v1.1 using investigator assessments
Measured: Up to 36 months
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Related TEAEs
Measured: First dose date up to 24 months plus 100 days
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Measured: First dose date up to 24 months plus 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start18 Feb 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arcus Biosciences, Inc.
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727565
- Sponsor's protocol ID
- GS-US-699-7184-01
- Other IDs
- 2024-513121-22
- Acronym
- VELOCITY-HNSCC
- Status last verified
- Sep 2026
- First submitted
- 9 Dec 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VELOCITY-HNSCC Substudy-01: A Phase 2 Study of Novel Combination Therapies in Participants With Previously Untreated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status
- ClinicalTrials.gov ID
- NCT06727565
- Acronym / sponsor ID
- VELOCITY-HNSCC / GS-US-699-7184-01
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Arcus Biosciences, Inc.
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Substudy-01 will evaluate the efficacy and safety of novel combination of treatment regimens, domvanalimab (DOM) and zimberelimab (ZIM) combined with chemotherapy vs ZIM combined with chemotherapy.
The primary objective is to assess the efficacy of DOM and ZIM in combination with chemotherapy versus ZIM in combination with chemotherapy.
Detailed description
This platform study will begin with a substudy targeting first-line (1L) recurrent or metastatic (r/m) HNSCC regardless of programmed cell death ligand 1 (PD-L1) expression status (Substudy-01), and new substudies may be added in the future targeting different study populations of HNSCC. All substudies evaluating additional drugs will be added in a staggered manner when relevant nonclinical and/or clinical data become available. Additional drugs may also be added to Substudy-01 in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A: Domvanalimab (DOM) + Zimberelimab (ZIM) + Platinum-based Chemotherapy | Experimental | Drug: Domvanalimab, Drug: Zimberelimab, Drug: Paclitaxel, Drug: CarboplatinParticipants will receive DOM + ZIM + platinum-based chemotherapy (paclitaxel + carboplatin). |
| Treatment Group B: Zimberelimab (ZIM) + Platinum-based Chemotherapy | Experimental | Drug: Zimberelimab, Drug: Paclitaxel, Drug: CarboplatinParticipants will receive ZIM + platinum-based chemotherapy (paclitaxel + carboplatin). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DomvanalimabAdministered intravenously | Drug | Treatment Group A: Domvanalimab (DOM) + Zimberelimab (ZIM) + Platinum-based Chemotherapy |
| ZimberelimabAdministered intravenously | Drug | Treatment Group A: Domvanalimab (DOM) + Zimberelimab (ZIM) + Platinum-based Chemotherapy, Treatment Group B: Zimberelimab (ZIM) + Platinum-based Chemotherapy |
| PaclitaxelAdministered intravenously | Drug | Treatment Group A: Domvanalimab (DOM) + Zimberelimab (ZIM) + Platinum-based Chemotherapy, Treatment Group B: Zimberelimab (ZIM) + Platinum-based Chemotherapy |
| CarboplatinAdministered intravenously | Drug | Treatment Group A: Domvanalimab (DOM) + Zimberelimab (ZIM) + Platinum-based Chemotherapy, Treatment Group B: Zimberelimab (ZIM) + Platinum-based Chemotherapy |
Primary outcome
Objective response rate (ORR)
Time frame: Up to 36 months
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.
Progression-free survival (PFS)
Time frame: Up to 36 months
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.
9 secondary outcomes
Duration of Response (DOR)
Time frame: Up to 36 months
Progression-Free Survival at 6 Months (PFS6)
Time frame: Up to 6 months
Overall Survival (OS)
Time frame: Up to 36 months
Overall Survival at 6 Months (OS6)
Time frame: Up to 6 months
Overall Survival at 12 Months (OS12)
Time frame: Up to 12 months
Disease Control Rate (DCR)
Time frame: Up to 36 months
Time to Progression (TTP)
Time frame: Up to 36 months
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Related TEAEs
Time frame: First dose date up to 24 months plus 100 days
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Time frame: First dose date up to 24 months plus 100 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
23 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Domvanalimab, Zimberelimab and Paclitaxel in people with Head and Neck Squamous Cell Carcinoma, run by Gilead Sciences at 23 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in China, Australia, Taiwan, United States, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Up to 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.