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Domvanalimab

Phase 2

Head and Neck Squamous Cell Carcinoma | Small molecule | Oncology |Gilead Sciences, Inc.|Last Updated: Jun 1, 2026

Success Probability
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Trial Design
RandomizedCONTROLLED
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical trial landscape

Domvanalimab · 2 trials · 2 indications

Phase 2 2
NCT06727565Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status; Substudy-01Head and Neck Squamous Cell Carcinoma
ACTIVE NOT_RECRUITING100 Analytics
NCT05676931Study With Various Immunotherapy Treatments in Participants With Lung CancerAdvanced Non-Small Cell Lung Cancer
ACTIVE NOT_RECRUITING400 Analytics
PHASE2ACTIVE NOT_RECRUITING
Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status; Substudy-01
Head and Neck Squamous Cell CarcinomaUnlock trial analytics
PHASE2ACTIVE NOT_RECRUITING
Study With Various Immunotherapy Treatments in Participants With Lung Cancer
Advanced Non-Small Cell Lung CancerUnlock trial analytics
Study Endpoints
Primary Endpoints
Objective response rate (ORR)
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)
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.

Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Up to 58 months
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Up to 58 months
Secondary Endpoints
Duration of Response (DOR)
Up to 36 months
Progression-Free Survival at 6 Months (PFS6)
Up to 6 months
Overall Survival (OS)
Up to 36 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment Group A: Domvanalimab (DOM) + Zimberelimab (ZIM) + Platinum-based ChemotherapyEXPERIMENTALParticipants will receive DOM + ZIM + platinum-based chemotherapy (paclitaxel + carboplatin).
Treatment Group B: Zimberelimab (ZIM) + Platinum-based ChemotherapyEXPERIMENTALParticipants will receive ZIM + platinum-based chemotherapy (paclitaxel + carboplatin).
A1: Domvanalimab + ZimberelimabEXPERIMENTALDomvanalimab and Zimberelimab, both administered by IV infusion
A2: Domvanalimab + ZimberelimabEXPERIMENTALDomvanalimab and Zimberelimab, both administered by IV infusion
A3: Quemliclustat + ZimberelimabEXPERIMENTALQuemliclustat and Zimberelimab, both administered by IV infusion
B1: Quemliclustat + Zimberelimab + Platinum Doublet ChemotherapyEXPERIMENTALQuemliclustat, zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
B2: Domvanalimab + Zimberelimab + Platinum Doublet ChemotherapyEXPERIMENTALDomvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet ChemotherapyEXPERIMENTALDomvanalimab, Quemliclustat, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
B4: Domvanalimab + Zimberelimab + Platinum Doublet ChemotherapyEXPERIMENTALDomvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
B5: Domvanalimab + Zimberelimab + Platinum Doublet ChemotherapyEXPERIMENTALDomvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
C1: Quemliclustat + Zimberelimab + DocetaxelEXPERIMENTALQuemliclustat, Zimberelimab, and Docetaxel, all administered by IV infusion
C2: Domvanalimab + Zimberelimab + DocetaxelEXPERIMENTALDomvanalimab, Zimberelimab, and Docetaxel, all administered by IV infusion
Interventions
NameTypeDescription
DomvanalimabDRUGAdministered intravenously
ZimberelimabDRUGAdministered intravenously
PaclitaxelDRUGAdministered intravenously
CarboplatinDRUGAdministered intravenously
QuemliclustatDRUGAdministered as specified in the treatment arm
DocetaxelDRUGAdministered as specified in the treatment arm
Platinum-Based DoubletDRUGAdministered as specified in the treatment arm
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites23

Key Inclusion Criteria: * 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 m...

Countries:United StatesAustraliaChinaFranceItalyMalaysiaSpainTaiwanUnited KingdomGeorgiaPolandSouth Korea
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Recent Changes (Last 90 Days)
LOWJun 2, 2026NCT05676931lastUpdatePostDate: changed
LOWJun 2, 2026NCT05676931lastUpdatePostDate: changed
LOWJun 2, 2026NCT05676931lastUpdatePostDate: changed
LOWMay 26, 2026NCT06727565primaryCompletionDate: changed
LOWMay 26, 2026NCT05676931primaryCompletionDate: changed
LOWMay 24, 2026NCT05676931studyFirstPostDate: changed
LOWMay 24, 2026NCT06727565studyFirstPostDate: changed