Last reviewed · How we verify
NCT04815720: KEYNOTE-B84
Pepinemab in Combination With Pembrolizumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
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.
24 July 2024
Quick facts
| Lead sponsor | Vaccinex Inc. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 49 |
| Start date | 9 August 2021 |
| Primary completion | 24 July 2024 |
| Estimated completion | 24 July 2024 |
| Sites | 15 locations across United States |
Drugs / interventions tested
- pepinemab + pembrolizumab — full drug profile →
Conditions studied
- Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC) — all drugs for Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC) →
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):
-
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 -
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT04815720
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Vaccinex Inc. trials
Trials by the same sponsor.
- NCT05102721 — Trial of Immunotherapy With Avelumab and Pepinemab As Second Line For Patients With Metastatic Pancreatic Adenocarcinoma · Phase 1, PHASE2 · active not recruiting
- NCT04381468 — SEMA4D Blockade Safety and Brain Metabolic Activity in Alzheimer's Disease (AD) · Phase 1, PHASE2 · completed
- NCT03268057 — VX15/2503 in Combination With Avelumab in Advanced Non-small Cell Lung Cancer · Phase 1, PHASE2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04815720 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vaccinex Inc.
- Last refreshed: 8 January 2025
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