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Combination Treatment of PDS0101 and Pembrolizumab

Phase 3

Recurrent Head and Neck Cancer | Monoclonal antibody | Oncology |PDS Biotechnology Corporation|Last Updated: Apr 6, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment252
FDA Designations
FAST_TRACK
Clinical trial landscape

Combination Treatment of PDS0101 and Pembrolizumab · 1 trial · 5 indications

Phase 3 1
NCT06790966Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell CarcinomaRecurrent Head and Neck Cancer
ACTIVE NOT_RECRUITING252 Analytics
PHASE3ACTIVE NOT_RECRUITING
Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Recurrent Head and Neck CancerUnlock trial analytics
Study Endpoints
Primary Endpoints
Overall Survival (OS)
Up to 54 months

OS is defined as the time from randomization until death from any cause.

Progression-Free Survival (PFS)
Up to 18 months

PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. PFS will be based on RECIST 1.1 as assessed by BICR.

Secondary Endpoints
Objective Response Rate (ORR)
Up to 27 months
Disease Control Rate (DCR)
Up to 27 months
Duration of Response (DOR)
Up to 27 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Interventional ArmEXPERIMENTALPDS0101 + Pembrolizumab
Control ArmACTIVE_COMPARATORPembrolizumab
Interventions
NameTypeDescription
Combination Treatment of PDS0101 and PembrolizumabCOMBINATION_PRODUCT* Pembrolizumab (IV) every 3 weeks for up to 35 Cycles * PDS0101 (SC) during Cycles 1, 2, 3, 4, and 12
Pembrolizumab MonotherapyDRUGPembrolizumab (IV) every 3 weeks for up to 35 cycles.
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: 1. Subject (or legally acceptable representative, if applicable) provides written informed consent for the study. 2. Subject is ≥18 years of age on the day of signing the informed consent. 3. Have a history of histologically- or cytologically-confirmed diagnosis of recurrent and...

Countries:United States
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Competitive Landscape -Head and Neck Cancer 153 trials (matched to "Recurrent Head and Neck Cancer")
Recent Changes (Last 90 Days)
HIGHMay 26, 2026NCT06790966Enrollment: 351 → 252
LOWMay 24, 2026NCT06790966studyFirstPostDate: changed