Head and Neck Squamous Cell Carcinoma

Oncology
29
Pipeline Programs
27
Companies
26
Clinical Trials
7 recruiting
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
6
5
11
0
5
2
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
960%
Small Molecule
640%
+ 15 programs with unclassified modality

On Market (2)

Approved therapies currently available

Boehringer Ingelheim
GILOTRIFApproved
afatinib
Boehringer Ingelheim
Kinase Inhibitor [EPC]oral2013
E
LENVIMAApproved
lenvatinib
Eisai
Kinase Inhibitor [EPC]oral2015

Competitive Landscape

24 companies ranked by most advanced pipeline stage

Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
2 programs
1
1
1
AFATINIBPhase 3Small Molecule1 trial
BI 770371Phase 11 trial
Active Trials
NCT06806852Recruiting90Est. Jul 2027
NCT01427478Completed134Est. May 2021
E
EisaiChina - Liaoning
2 programs
2
1
LenvatinibPhase 3Small Molecule1 trial
LenvatinibPhase 3Small Molecule1 trial
Active Trials
NCT04199104Completed511Est. Mar 2025
NCT05523323Completed112Est. Mar 2025
M&
Merck & Co.RAHWAY, NJ
2 programs
1
1
LenvatinibPhase 3Small Molecule
PembrolizumabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT03383094Active Not Recruiting126Est. Dec 2027
Alliance Pharmaceuticals
1 program
1
GabapentinPhase 31 trial
Active Trials
NCT06992427Recruiting228Est. Apr 2031
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
2 programs
1
1
CemiplimabPhase 2Monoclonal Antibody1 trial
AbemaciclibPhase 1/2Small Molecule1 trial
Active Trials
NCT03655444Terminated6Est. Aug 2020
NCT06855212Recruiting21Est. Mar 2028
Novartis
NovartisBASEL, Switzerland
2 programs
1
1
BuparlisibPhase 2Small Molecule1 trial
LJM716Phase 1/21 trial
Active Trials
NCT02143622Withdrawn0Est. Aug 2018
NCT01852292Terminated157Est. Mar 2017
GS
Gilead SciencesFOSTER CITY, CA
2 programs
2
MagrolimabPhase 2Monoclonal Antibody1 trial
MagrolimabPhase 2Monoclonal Antibody
Active Trials
NCT04854499Terminated193Est. Oct 2024
Cue Biopharma
Cue BiopharmaBOSTON, MA
1 program
1
CUE-101Phase 21 trial
Active Trials
NCT07172256Not Yet Recruiting30Est. Feb 2031
Siemens Healthineers
Siemens HealthineersGermany - Forchheim
1 program
1
DE-HyARTPhase 21 trial
Active Trials
NCT06087614RecruitingEst. Apr 2028
Arcus Biosciences
1 program
1
DomvanalimabPhase 2Monoclonal Antibody
Acrivon Therapeutics
Acrivon TherapeuticsMA - Watertown
1 program
1
GemcitabinePhase 21 trial
Active Trials
NCT06597565RecruitingEst. Aug 2028
Bristol Myers Squibb
1 program
1
NivolumabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT04848116Active Not Recruiting24Est. Sep 2026
IO Biotech
IO BiotechCOPENHAGEN, Denmark
1 program
1
PembrolizumabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT05977907Recruiting30Est. Oct 2028
ImmunityBio
ImmunityBioSAN DIEGO, CA
1 program
1
AvelumabPhase 1/2Monoclonal Antibody1 trial
Active Trials
NCT03169764Withdrawn0Est. Dec 2021
City Therapeutics
City TherapeuticsMA - Cambridge
1 program
1
DurvalumabPhase 1/2Monoclonal Antibody1 trial
Active Trials
NCT02643303CompletedEst. Feb 2022
Nektar Therapeutics
Nektar TherapeuticsSAN FRANCISCO, CA
1 program
1
NKTR-255Phase 1/21 trial
Active Trials
NCT04616196CompletedEst. Mar 2023
AbbVie
AbbVieNORTH CHICAGO, IL
1 program
1
ABBV-221Phase 11 trial
Active Trials
NCT02365662Terminated46Est. Mar 2018
Bicara Therapeutics
1 program
1
BCA101Phase 1
Takeda
TakedaTOKYO, Japan
1 program
1
TAK-676Phase 11 trial
Active Trials
NCT06062602Completed15Est. Nov 2022
T-Therapeutics
T-TherapeuticsUK - Cambridge
1 program
1
TadalafilPhase 11 trial
Active Trials
NCT02544880CompletedEst. Jun 2021
Xencor
XencorPASADENA, CA
1 program
1
XmAb®808Phase 11 trial
Active Trials
NCT05585034CompletedEst. May 2025
Alpha Tau Medical
Alpha Tau MedicalJERUSALEM, Israel
1 program
Diffusing Alpha Radiation Emitters TherapyN/A1 trial
Active Trials
NCT05047094Recruiting48Est. Jun 2027
Knight Therapeutics
Knight TherapeuticsQC - Montréal
1 program
Medical Device Qardio® smart scale Usage and EvaluationN/A1 trial
Active Trials
NCT05457478Terminated2Est. Sep 2023
Genomics
GenomicsUK - Oxford
1 program
OncoPrism-HNSCC™N/A1 trial
Active Trials
NCT05296135Withdrawn0Est. Feb 2025

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
Alliance PharmaceuticalsGabapentin
EisaiLenvatinib
EisaiLenvatinib
Boehringer IngelheimAFATINIB
Cue BiopharmaCUE-101
Eli Lilly and CompanyCemiplimab
Acrivon TherapeuticsGemcitabine
Siemens HealthineersDE-HyART
IO BiotechPembrolizumab
Gilead SciencesMagrolimab
Bristol Myers SquibbNivolumab
Merck & Co.Pembrolizumab
NovartisBuparlisib
Nektar TherapeuticsNKTR-255
Eli Lilly and CompanyAbemaciclib

Showing 15 of 26 trials with date data

Clinical Trials (26)

Total enrollment: 1,773 patients across 26 trials

High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer

Start: Jun 2025Est. completion: Apr 2031228 patients
Phase 3Recruiting

A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010/LEAP-010)-China Extension

Start: Oct 2020Est. completion: Mar 2025112 patients
Phase 3Completed

A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010) (KEYNOTE-010)

Start: Feb 2020Est. completion: Mar 2025511 patients
Phase 3Completed

Evaluation of Afatinib in Maintenance Therapy in Squamous Cell Carcinoma of the Head and Neck

Start: Sep 2011Est. completion: May 2021134 patients
Phase 3Completed

CUE-101with Pembrolizumab for LA-HPV+HNSCCs

Start: Feb 2026Est. completion: Feb 203130 patients
Phase 2Not Yet Recruiting

Phase II Study of Neoadjuvant Cetuximab and Cemiplimab in Patients Undergoing Surgery for HNSCC

Start: Feb 2025Est. completion: Mar 202821 patients
Phase 2Recruiting

A Phase II Study of ACR-368 and Low Dose Gemcitabine in R/M HNSCC

Start: Sep 2024Est. completion: Aug 2028
Phase 2Recruiting

Dose Escalation Using Hypoxia-adjusted Radiotherapy

Start: Apr 2024Est. completion: Apr 2028
Phase 2Recruiting

Neoadjuvant Pembrolizumab and IO102-103 for Squamous Cell Carcinoma of the Head and Neck (SCCHN).

Start: Dec 2023Est. completion: Oct 202830 patients
Phase 2Recruiting

Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma

Start: Sep 2021Est. completion: Oct 2024193 patients
Phase 2Terminated

Neoadjuvant Targeting of Myeloid Cell Populations in Combination With Nivolumab in Head & Neck Ca

Start: Apr 2021Est. completion: Sep 202624 patients
Phase 2Active Not Recruiting

Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer

Start: Mar 2018Est. completion: Dec 2027126 patients
Phase 2Active Not Recruiting

Study of Efficacy and Safety of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel in Recurrent or Metastatic Head and Neck Cancer Previously Pre-treated With a Platinum Therapy

Start: Oct 2013Est. completion: Mar 2017157 patients
Phase 2Terminated

Study of NKTR 255 in Combination With Cetuximab in Solid Tumors

Start: Oct 2020Est. completion: Mar 2023
Phase 1/2Completed

Abemaciclib + Nivolumab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed or Recurred Within Six Months After Platinum-based Chemotherapy

Start: May 2019Est. completion: Aug 20206 patients
Phase 1/2Terminated

QUILT-3.047: NANT Head and Neck Squamous Cell Carcinoma (HNSCC) Vaccine: Combination Immunotherapy in Subjects With HNSCC Who Have Progressed on or After Chemotherapy and PD-1/PD-L1 Therapy

Start: Dec 2017Est. completion: Dec 20210
Phase 1/2Withdrawn

A Study of Tremelimumab and IV Durvalumab Plus Poly-ICLC in Subjects With Biopsy-accessible Cancers

Start: Dec 2016Est. completion: Feb 2022
Phase 1/2Completed

Study of Efficacy and Safety of LJM716 and Cetuximab in Head and Neck Squamous Cell Carcinoma Patients

Start: Mar 2015Est. completion: Aug 20180
Phase 1/2Withdrawn

A Study to Test Whether Treatment With BI 770371 in Combination With Pembrolizumab With or Without Cetuximab Helps People With Head and Neck Cancer Compared With Pembrolizumab Alone

Start: May 2025Est. completion: Jul 202790 patients
Phase 1Recruiting

Phase 1, First-in-human, Dose-finding and Expansion Study to Evaluate XmAb®808 in Combination With Pembrolizumab in Advanced Solid Tumors

Start: Dec 2022Est. completion: May 2025
Phase 1Completed

PBI-MST-01(NCT04541108) Substudy TAK-02: Intratumoral Microdosing of TAK-676 in HNSCC

Start: Jul 2021Est. completion: Nov 202215 patients
Phase 1Completed

PDE5 Inhibition Via Tadalafil to Enhance Anti-Tumor Mucin 1 (MUC1) Vaccine Efficacy in Patients With HNSCC

Start: Apr 2016Est. completion: Jun 2021
Phase 1Completed

A Study Evaluating Safety and Pharmacokinetics of ABBV-221 in Subjects With Advanced Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor

Start: Jan 2015Est. completion: Mar 201846 patients
Phase 1Terminated
NCT05457478Knight TherapeuticsMedical Device Qardio® smart scale Usage and Evaluation

The Use of "Smart" Body-Weight Scales for Weight and Nutritional Monitoring in Patients With Head and Neck Cancer Undergoing Radiation Therapy

Start: Jan 2023Est. completion: Sep 20232 patients
N/ATerminated
NCT05047094Alpha Tau MedicalDiffusing Alpha Radiation Emitters Therapy

A Safety and Efficacy Study for Combinational Treatment of DaRT and Check Point Inhibitor for Recurrent Unresectable or mHNSCC

Start: Nov 2021Est. completion: Jun 202748 patients
N/ARecruiting
NCT05296135GenomicsOncoPrism-HNSCC™

Predicting Immunotherapy Efficacy in Head and Neck Squamous Cell Cancer

Start: Feb 2020Est. completion: Feb 20250
N/AWithdrawn

Related Jobs in Oncology

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

5 late-stage (Phase 3) programs — potential near-term approvals
7 actively recruiting trials targeting 1,773 patients
27 companies competing in this space