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NCT04815720: KEYNOTE-B84

Pepinemab in Combination With Pembrolizumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Completed Phase 1, PHASE2 Last updated 8 January 2025
What this trial tests

Phase 1, PHASE2 trial testing pepinemab + pembrolizumab in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC) in 49 participants. Completed in 24 July 2024.

Timeline
9 August 2021
Primary endpoint
24 July 2024
24 July 2024

Quick facts

Lead sponsorVaccinex Inc.
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment49
Start date9 August 2021
Primary completion24 July 2024
Estimated completion24 July 2024
Sites15 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Vaccinex Inc. — full company profile →

Who can join

Adults 18 to 100, any sex, with Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the study is to evaluate the safety and tolerability of pepinemab in combination with pembrolizumab as first-line treatment and determine a recommended Phase 2 dose (RP2D) in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Novel Systemic Treatment Modalities Including Immunotherapy and Molecular Targeted Therapy for Recurrent and Metastatic Head and Neck Squamous Cell Carcinoma.
    Ghosh S, Shah PA, Johnson FM. · · 2022 · cited 47× · PMID 35887235 · DOI 10.3390/ijms23147889
  2. Review of Current and Future Medical Treatments in Head and Neck Squamous Cell Carcinoma.
    Lee AM, Weaver AN, Acosta P, Harris L, et al · · 2024 · cited 17× · PMID 39456583 · DOI 10.3390/cancers16203488
  3. Overcoming Resistance to Standard-of-Care Therapies for Head and Neck Squamous Cell Carcinomas.
    Gauss C, Stone LD, Ghafouri M, Quan D, et al · · 2024 · cited 10× · PMID 38920648 · DOI 10.3390/cells13121018
  4. Immune biomarkers for head and neck cancer.
    Sobhani N, D'Angelo A, Kugeratski FG, Nguyen T, et al · · 2025 · cited 1× · PMID 41410866 · DOI 10.1007/s00262-025-04233-7

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Other Vaccinex Inc. trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04815720.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing