NCT03383094 is a Phase 2 clinical trial of Pembrolizumab in Head and Neck Squamous Cell Carcinoma, sponsored by Loren Mell, MD.

Who is sponsoring NCT03383094?

NCT03383094 is sponsored by Loren Mell, MD.

What drugs are being tested in NCT03383094?

Interventions in NCT03383094: Pembrolizumab, Radiation therapy, Cisplatin.

What condition does NCT03383094 study?

NCT03383094 studies Head and Neck Squamous Cell Carcinoma, Cancer, Cancer of Head and Neck, Cancer, Advanced, Cancer, Metastatic, Tumor, Tumor Recurrence, Tumor Neck, Tumor Metastasis, Oral Cancer, Oropharyngeal Cancer, Oropharynx Cancer, Oropharynx Cancer, Stage III, Oropharynx Cancer, Recurrent, Oropharynx Cancer, Metastatic.

Is NCT03383094 still recruiting?

NCT03383094 is currently active, enrolled. Last updated 7 October 2025.

Last reviewed 2025-10-07 · How we verify

NCT03383094

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer

Active, enrolled Phase 2 Last updated 7 October 2025

What this trial tests

Phase 2 trial testing Pembrolizumab in Head and Neck Squamous Cell Carcinoma in 126 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

15 March 2018

Primary endpoint
31 December 2026

31 December 2027

Quick facts

Lead sponsor	Loren Mell, MD
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	126
Start date	15 March 2018
Primary completion	31 December 2026
Estimated completion	31 December 2027
Sites	6 locations across United States

Drugs / interventions tested

Pembrolizumab (pembrolizumab) — full drug profile →
Radiation therapy — full drug profile →
Cisplatin (cisplatin) — full drug profile →

Conditions studied

Head and Neck Squamous Cell Carcinoma — all drugs for Head and Neck Squamous Cell Carcinoma →
Cancer — all drugs for Cancer →
Cancer of Head and Neck — all drugs for Cancer of Head and Neck →
Cancer, Advanced — all drugs for Cancer, Advanced →

Sponsor

Loren Mell, MD

Who can join

18 and older, any sex, with Head and Neck Squamous Cell Carcinoma or Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to compare any good or bad effects of using pembrolizumab (an experimental drug) and radiation therapy (RT), compared to using cisplatin chemotherapy and radiation therapy (RT) in the treatment of patients with head and neck squamous cell carcinoma (HNSCC).

Publications & conference data

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

The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of squamous cell carcinoma of the head and neck (HNSCC).
Cohen EEW, Bell RB, Bifulco CB, Burtness B, et al · · 2019 · cited 528× · PMID 31307547 · DOI 10.1186/s40425-019-0662-5
Tumor Immunity and Immunotherapy for HPV-Related Cancers.
Shamseddine AA, Burman B, Lee NY, Zamarin D, et al · · 2021 · cited 140× · PMID 33990345 · DOI 10.1158/2159-8290.cd-20-1760
Tumor microenvironment: an evil nexus promoting aggressive head and neck squamous cell carcinoma and avenue for targeted therapy.
Bhat AA, Yousuf P, Wani NA, Rizwan A, et al · · 2021 · cited 119× · PMID 33436555 · DOI 10.1038/s41392-020-00419-w
Immune Modulation of Head and Neck Squamous Cell Carcinoma and the Tumor Microenvironment by Conventional Therapeutics.
Miyauchi S, Kim SS, Pang J, Gold KA, et al · · 2019 · cited 107× · PMID 30814108 · DOI 10.1158/1078-0432.ccr-18-0871
Combining Radiotherapy With Anti-angiogenic Therapy and Immunotherapy; A Therapeutic Triad for Cancer?
Goedegebuure RSA, de Klerk LK, Bass AJ, Derks S, et al · · 2018 · cited 76× · PMID 30692993 · DOI 10.3389/fimmu.2018.03107
Immune Evasion by Head and Neck Cancer: Foundations for Combination Therapy.
Horton JD, Knochelmann HM, Day TA, Paulos CM, et al · · 2019 · cited 65× · PMID 30961829 · DOI 10.1016/j.trecan.2019.02.007
Combining Radiation and Immune Checkpoint Blockade in the Treatment of Head and Neck Squamous Cell Carcinoma.
Manukian G, Bar-Ad V, Lu B, Argiris A, et al · · 2019 · cited 57× · PMID 30895168 · DOI 10.3389/fonc.2019.00122
Consensuses, controversies, and future directions in treatment deintensification for human papillomavirus-associated oropharyngeal cancer.
Kang JJ, Yu Y, Chen L, Zakeri K, et al · · 2023 · cited 52× · PMID 36305841 · DOI 10.3322/caac.21758

Verify or expand the search:

Other trials of Pembrolizumab

Trials testing the same drug.

NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
NCT07275216 — Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Stand · Phase 2 · not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
NCT06724042 — Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors · Phase 1 · not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer · Phase 3 · not yet recruiting

Other recruiting trials for Head and Neck Squamous Cell Carcinoma

Currently open trials in the same condition.

NCT06980038 — Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone i · Phase 2 · recruiting
NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types · Phase 1 · recruiting
NCT06995508 — Olanzapine for Managing Anorexia in Head and Neck Cancer Patients Undergoing Chemoradiation, MACRO Trial · Phase 2 · recruiting
NCT07254585 — SYS6010 Combined With Enlonstobart In Recurrent Or Metastatic Head And Neck Squamous Cell Carcinoma · Phase 2 · recruiting
NCT07514754 — Galenos 2 Immunonutrition in Head and Neck, Lung, and Rectal Cancer Patients · NA · recruiting

Other Loren Mell, MD trials

Trials by the same sponsor.

NCT04359199 — QUantitative Assessment of Swallowing After Radiation (QUASAR) · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03383094 (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 Loren Mell, MD
Last refreshed: 7 October 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/NCT03383094.

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