39 recruiting, 22 completed, 11 active not recruiting, 11 unknown. 46 Phase 2, 36 Phase 1, 7 Phase 3, 5 Early Phase 1, 4 Not applicable.
Follow HNSCC: new trials by email Literature Review of HNSCC trials Research Report on HNSCC
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| MTX-531-001 Phase 1 Study in Advanced Solid Tumors MTX-531 - Solid Tumors (Phase 1), HNSCC | Phase 1 | Not yet recruiting | MEKanistic Therapeutics, Inc. | 71 | 2026-10-20 | 2026-10-15 |
| Window Trial of Intratumoral (IT) Neoadjuvant Fluorescently Labelled Nivolumab (nivo800) in Head and Neck Squamous Cell Carcinoma (HNSCC) Nivolumab-IRDye800 - HNSCC, SCC - Squamous Cell Carcinoma | Early Phase 1 | Recruiting | Vanderbilt-Ingram Cancer Center | 18 | 2026-09-30 | 2026-10-19 |
| A Phase 1, First-in-Human (FIH), Open-Label, Dose-Escalation and Dose Expansion Study of the Peptide Drug Conjugate (PDC), TS-104, as a Monotherapy in Subjects With Select Advanced Solid Tumors TS-104 - NSCLC (Non-small Cell Lung Cancer), HNSCC | Phase 1 | Recruiting | TwoStep Therapeutics, Inc. | 74 | 2026-09-02 | 2026-09-30 |
| Adebrelimab Combined With Dalpiciclib Isethionate Plus Chemotherapy for Neoadjuvant Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma Adebrelimab Injection, Dalpiciclib Isethionate, Cisplatin - HNSCC | Phase 2 | Not yet recruiting | Tianjin Medical University Cancer Institute and Hospital | 32 | 2026-09-01 | 2026-08-21 |
| A Phase II Study to Evaluate the Efficacy and Safety of SKB571 in Recurrent or Metastatic HNSCC Participants SKB571, Pembrolizumab, carboplatin - HNSCC | Phase 2 | Recruiting | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | 120 | 2026-07-27 | 2026-09-09 |
| Safety and Feasibility of Nivolumab-IRDye800CW in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC) Nivo800, Nivolumab - Hnscc, Head and Neck | Phase 1 | Recruiting | Vanderbilt-Ingram Cancer Center | 40 | 2026-07-03 | 2026-10-16 |
| Induction Chemoimmunotherapy Followed by Deescalated Definitive Radiotherapy in Head and Neck Cancer Camrelizumab, Platinum-based Chemotherapy plus PD-1 inhibitor, De-escalated Radiotherapy - Head and Neck Squamous Cell Carcinoma, Locally Advanced Head and Neck Cancer | Phase 2 | Active not recruiting | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | 180 | 2026-06-12 | 2026-08-28 |
| Proton Versus Photon Therapy in Head and Neck Squamous Cell Carcinomas. Proton Radiotherapy - HNSCC | Phase 3 | Recruiting | Oslo University Hospital | 400 | 2026-04-28 | 2026-05-15 |
| A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC EPI-326 - Epidermal Growth Factor, Epidermal Growth Factor Receptor | Phase 1 | Recruiting | EpiBiologics | 110 | 2026-03-31 | 2026-10-14 |
| Nano-Carbon Iron Suspension Injection Combined With Radiotherapy for Solid Tumors Phase II Clinical Trial Carbon Nanoparticle Iron Suspension for Injection - HNSCC, Soft Tissue Cancer | Phase 2 | Not yet recruiting | Sichuan Enray Pharmaceutical Sciences Company | 52 | 2026-03-27 | 2026-03-24 |
| Objective Response Rate of Ivonescimab With Chemotherapy in Locally Advanced Resectable Oral and Oropharyngeal Squamous Cell Carcinoma Ivonescimab（AK112，a PD-1/VEGF bispecific antibody） - HNSCC, OSCC | Recruiting | Zhujiang Hospital | 20 | 2026-01-26 | 2026-07-07 | |
| DCSZ11 in Combination With Standard Therapy in Advanced or Metastatic Solid Tumors Low Dose DCSZ11, Medium Dose DCSZ11, High Dose DCSZ11 - DCSZ11, Solid Tumors | Phase 1 / Phase 2 | Recruiting | West China Hospital | 9 | 2025-12-16 | 2026-03-11 |
| Neutrophil Biomarker Test for Predicting Clinical Benefit From Immunotherapy Based on Flow Cytometry Analysis Blood sample collection - Non Small Cell Lung Cancer (NSCLC), Melanoma (Skin Cancer) | Not yet recruiting | OncoHost Ltd. | 600 | 2025-11-15 | 2025-11-24 | |
| Study of TI-0093 Injection With Recurrent/Metastatic HPV-16 Positive Solid Tumors therapeutic tumor vaccine - HPV 16+ Recurrent or Metastatic Cancer, HNSCC | Phase 1 | Recruiting | Therorna | 12 | 2025-11-11 | 2025-11-24 |
| A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors NRM-823 - HNSCC, ESCC | Phase 1 | Recruiting | Normunity AccelCo, Inc. | 150 | 2025-10-30 | 2026-08-18 |
| Finotonlimab Combined With Stapokibart in the Treatment of Recurrent/Metastatic HNSCC Stapokibart and Finotonlimab - HNSCC | Phase 1 | Recruiting | Beijing Tongren Hospital | 10 | 2025-10-09 | 2026-05-04 |
| A Study of GV20-0251 in Advanced or Refractory Solid Tumors GV20-0251 - HCC - Hepatocellular Carcinoma, Cholangiocarcinoma | Phase 1 | Recruiting | West China Hospital | 10 | 2025-09-04 | 2025-11-24 |
| High-Resolution PET-CT Imaging for Surgical Margin Visualization Intra-op PET/CT Specimen Scanner - Cancer, Solid Malignant Tumors | Not applicable | Recruiting | Vanderbilt-Ingram Cancer Center | 50 | 2025-09-03 | 2026-05-08 |
| A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors ALX2004 - NSCLC (Advanced Non-small Cell Lung Cancer), HNSCC | Phase 1 | Recruiting | ALX Oncology Inc. | 170 | 2025-08-18 | 2026-09-30 |
| A Phase I/II Trial of HCB101 in Combination With Pembrolizumab for Patients With Platinum-Refractory, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (SirH&N Trial) HCB101, Pembrolizumab - HNSCC | Phase 1 / Phase 2 | Recruiting | Taipei Veterans General Hospital, Taiwan | 50 | 2025-08-13 | 2026-07-06 |
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Squamous Cell Carcinoma of Head and Neck (97) · Head and Neck Neoplasms (29) · Melanoma (11) · Carcinoma, Squamous Cell (10) · Colorectal Neoplasms (10) · Mouth Neoplasms (9) · Neoplasm Metastasis (9) · Carcinoma, Non-Small-Cell Lung (8) · Endometrial Neoplasms (6) · Stomach Neoplasms (6) · Uterine Cervical Neoplasms (6) · Carcinoma, Renal Cell (5) · Esophageal Neoplasms (5) · Neoplasms (5) · Triple Negative Breast Neoplasms (5)
Carcinoma (97) · Neoplasms by Histologic Type (97) · Neoplasms by Site (97) · Neoplasms, Glandular and Epithelial (97) · Neoplasms (92) · Carcinoma, Squamous Cell (87) · Head and Neck Neoplasms (68) · Digestive System Diseases (18) · Digestive System Neoplasms (18) · Female Urogenital Diseases (17) · Female Urogenital Diseases and Pregnancy Complications (17) · Skin Diseases (17) · Skin and Connective Tissue Diseases (17) · Urogenital Diseases (17) · Gastrointestinal Diseases (16)
pembrolizumab (20) · Cisplatin (9) · Carboplatin (7) · Nivolumab (7) · Cetuximab (5) · Radiotherapy (5) · tislelizumab (4) · Afatinib (3) · Paclitaxel (3) · abemaciclib (3) · atezolizumab (3) · cemiplimab (3) · durvalumab (3) · Alpelisib (2) · Biological Factors (2)
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (6) · Groupe Oncologie Radiotherapie Tete et Cou (5) · Vanderbilt-Ingram Cancer Center (4) · West China Hospital (4) · Seoul National University Hospital (3) · University of Arizona (3) · Chang Gung Memorial Hospital (2) · Dan Zandberg (2) · ImmVira Pharma Co. Ltd (2) · Immutep S.A.S. (2) · Kura Oncology, Inc. (2) · Memorial Sloan Kettering Cancer Center (2) · Sichuan Cancer Hospital and Research Institute (2) · University of Chicago (2) · A2 Biotherapeutics Inc. (1)
United States (44) · China (23) · South Korea (9) · France (8) · Germany (8) · Australia (7) · Spain (7) · Taiwan (6) · United Kingdom (6) · Netherlands (5) · Belgium (4) · Canada (3) · Greece (3) · Italy (3) · Norway (3)
Everett Vokes, MD (2) · Julie E. Bauman, MD, MPH (2) · Lara Dunn, MD (2) · Xingchen Peng (2) · Andreas Dietz, Prof. Dr. (1) · Assuntina Sacco, M.D. (1) · Benjamin Frey, PD Dr. Dr. (1) · Bhumsuk Keam (1) · Chad Zender, MD (1) · Chia-Hsun Hsieh, PhD (1) · Chukwuemeka Ikpeazu, MD (1)
PMID 15331400, PMID 15975518, PMID 22786655, PMID 25517747, PMID 25877891, PMID 26363010, PMID 28671670, PMID 29763414, PMID 30656676, PMID 31138217, PMID 33125944, PMID 33560478, PMID 33756515, PMID 33986123, PMID 33989559, PMID 34188163, PMID 34321321, PMID 34528763, PMID 36124629, PMID 36761750, PMID 36977289, PMID 37699162, PMID 38842838, PMID 39403626, PMID 40048190, PMID 40721981, PMID 41527715, PMID 41721376, PMID 41996633, PMID 42140743, PMID 42185750, PMID 42289363
2017 (1), 2018 (1), 2023 (1), P30CA023074 (1), P50CA097190 (1), R01CA236546 (1)