14 recruiting, 9 active not recruiting, 4 completed, 4 terminated. 21 Phase 2, 11 Phase 1, 4 Phase 3, 3 Not applicable, 2 Phase 4.
Follow Metastatic Head and Neck Squamous Cell Carcinoma: new trials by email Literature Review of Metastatic Head and Neck Squamous Cell Carcinoma trials Research Report on Metastatic Head and Neck Squamous Cell Carcinoma
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 |
|---|---|---|---|---|---|---|
| Low Dose, Reduced Frequency Nivolumab for the Treatment of Unresectable or Metastatic Cancer, AFFORD IO Trial Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging - Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 | Phase 2 | Not yet recruiting | Fred Hutchinson Cancer Center | 50 | 2026-12-01 | 2026-09-17 |
| Pharmacokinetic Study of Pembrolizumab and Its Impact on Immunity and the Tumor Microenvironment, Which May Explain the Efficacy of Post-immunotherapy Chemotherapy. Blood sampling, Tumor biopsies for biobank establishment (optional) - Non-Small Cell Lung Carcinoma (NSCLC), Metastatic Head and Neck Squamous Cell Carcinoma | Phase 4 | Not yet recruiting | Centre Antoine Lacassagne | 110 | 2026-10-01 | 2026-09-15 |
| A Study Evaluating Ficerafusp Alfa (BCA101) QW in Combination With Pembrolizumab vs Alternative Ficerafusp Alfa Dosing in 1L R or M HNSCC Ficerafusp alfa, Pembrolizumab (KEYTRUDA®) - Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma | Phase 2 | Recruiting | Bicara Therapeutics | 160 | 2026-09-01 | 2026-10-13 |
| Morning Versus Afternoon Administration of Immunotherapy for the Treatment of Advanced or Metastatic Solid Tumors, The Knight SHIFT Study Biospecimen Collection, Immune Checkpoint Inhibitor - Advanced Biliary Tract Carcinoma, Advanced Head and Neck Squamous Cell Carcinoma | Phase 4 | Recruiting | OHSU Knight Cancer Institute | 160 | 2026-04-24 | 2026-10-13 |
| Study Evaluating [18F]NOTA-ABY030 for Safety and Tolerability of Indeterminate Primary and/or Metastatic Disease in Head and Neck Squamous Cell Carcinoma Cetuximab (EGFR inhibitor), 18F-NOTA-ABY-030, Positron Emission Tomography (PET) - SCC - Squamous Cell Carcinoma, Radiotracer | Phase 1 | Recruiting | Vanderbilt-Ingram Cancer Center | 25 | 2026-04-24 | 2026-05-11 |
| Remote Audiometry to Monitor for Treatment-Related Hearing Loss in Patients With H&N SCC Receiving Cisplatin and/or Radiation Audiometric Test, Interview - Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Cutaneous Squamous Cell Carcinoma of the Head and Neck | Not applicable | Recruiting | Emory University | 118 | 2025-08-25 | 2026-07-16 |
| TMV Vaccine Therapy Alone and With Pembrolizumab for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer Autologous Tumor Membrane Vesicles Vaccine, Biospecimen Collection, Computed Tomography - Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma | Phase 1 | Recruiting | Emory University | 40 | 2025-05-08 | 2026-03-04 |
| Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment Biospecimen Collection, Cetuximab, Computed Tomography - Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma | Phase 3 | Recruiting | National Cancer Institute (NCI) | 158 | 2025-03-27 | 2026-10-19 |
| FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC Ficerafusp alfa, Pembrolizumab (KEYTRUDA®), Placebo - Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma | Phase 2 / Phase 3 | Recruiting | Bicara Therapeutics | 650 | 2025-01-28 | 2026-10-02 |
| A Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab Evofosfamide, Zalifrelimab, Balstilimab - Metastatic Prostate Cancer, Metastatic Head and Neck Squamous Cell Carcinoma | Phase 1 / Phase 2 | Recruiting | ImmunoGenesis | 71 | 2025-01-08 | 2025-01-21 |
| Lovastatin and Pembrolizumab for the Treatment of Patients With Recurrent or Metastatic Head and Neck Cancer, LAPP Trial Biospecimen Collection, Computed Tomography, Lovastatin - Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Human Papillomavirus-Related Neck Squamous Cell Carcinoma of Unknown Primary | Phase 2 | Recruiting | Emory University | 28 | 2024-12-09 | 2026-02-11 |
| Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program Home Health Encounter, Nivolumab, Patient Monitoring - Advanced Esophageal Squamous Cell Carcinoma, Advanced Renal Cell Carcinoma | Phase 2 | Recruiting | Mayo Clinic | 50 | 2024-04-30 | 2026-10-02 |
| Losartan, Pembrolizumab and Stereotactic Body Radiation Therapy for the Treatment of Patients With Locally Recurrent, Refractory or Oligometastatic Head and Neck Squamous Cell Carcinoma Losartan, Pembrolizumab, Stereotactic Body Radiation Therapy - Locally Recurrent Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma | Phase 1 | Recruiting | University of California, Davis | 24 | 2023-12-07 | 2026-03-12 |
| Home Sleep Apnea Machine in Evaluating Obstructive Sleep Apnea in Patients With Stage III-IV Head and Neck Cancer Monitoring Device, Quality-of-Life Assessment, Questionnaire Administration - Locally Advanced Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma | Not applicable | Withdrawn | Barbara Ann Karmanos Cancer Institute | 2023-07-25 | 2023-10-04 | |
| Combining Radiation Therapy With Immunotherapy for the Treatment of Metastatic Squamous Cell Carcinoma of the Head and Neck Carboplatin, Cisplatin, Computed Tomography - Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma | Phase 3 | Active not recruiting | ECOG-ACRIN Cancer Research Group | 290 | 2023-06-08 | 2026-09-14 |
| (89Zr Panitumumab) With PET/CT for Diagnosing Metastases in Patients With Head and Neck Squamous Cell Carcinoma Panitumumab, Zirconium Zr 89 Panitumumab, Positron Emission Tomography - Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma | Phase 1 | Recruiting | Eben Rosenthal | 60 | 2023-05-09 | 2026-05-08 |
| Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers Atezolizumab, Bevacizumab, Biospecimen Collection - Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma | Phase 2 / Phase 3 | Active not recruiting | National Cancer Institute (NCI) | 430 | 2023-03-13 | 2026-10-01 |
| INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma INCAGN01876, retifanlimab - Metastatic Head and Neck Squamous Cell Carcinoma, Advanced Malignancies | Phase 2 | Withdrawn | Incyte Biosciences International Sàrl | 2023-03-01 | 2023-09-15 | |
| BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study Biopsy Procedure, Biospecimen Collection, Cabozantinib S-malate - Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Phase 2 | Recruiting | National Cancer Institute (NCI) | 150 | 2022-12-06 | 2026-10-20 |
| Testing the Addition of an Anti-cancer Drug, Ipatasertib, to the Usual Immunotherapy Treatment (Pembrolizumab) in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck Biopsy Procedure, Biospecimen Collection, Computed Tomography - Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma | Phase 2 | Active not recruiting | National Cancer Institute (NCI) | 52 | 2022-07-26 | 2026-09-21 |
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Squamous Cell Carcinoma of Head and Neck (35) · Carcinoma (9) · Hypopharyngeal Neoplasms (9) · Laryngeal Neoplasms (9) · Mouth Neoplasms (9) · Carcinoma, Non-Small-Cell Lung (7) · Melanoma (7) · Oropharyngeal Neoplasms (7) · Carcinoma, Transitional Cell (5) · Lung Neoplasms (5) · Neoplasm Metastasis (5) · Carcinoma, Renal Cell (4) · Nasopharyngeal Carcinoma (4) · Carcinoma, Hepatocellular (3) · Head and Neck Neoplasms (3)
Neoplasms by Histologic Type (35) · Neoplasms by Site (35) · Neoplasms, Glandular and Epithelial (35) · Neoplasms (34) · Carcinoma, Squamous Cell (33) · Head and Neck Neoplasms (32) · Carcinoma (26) · Respiratory Tract Diseases (18) · Respiratory Tract Neoplasms (16) · Otorhinolaryngologic Diseases (11) · Laryngeal Diseases (9) · Mouth Diseases (9) · Otorhinolaryngologic Neoplasms (9) · Pharyngeal Diseases (9) · Pharyngeal Neoplasms (9)
pembrolizumab (15) · Magnetic Resonance Spectroscopy (12) · Specimen Handling (9) · Carboplatin (6) · Cetuximab (5) · (225)Ac-DOTA-c(RGDyK) (3) · Biopsy (3) · Cisplatin (3) · Immunoglobulin G (3) · Nivolumab (3) · Paclitaxel (3) · Radiosurgery (3) · Taxes (3) · 1,2-diaminocyclohexaneplatinum II citrate (2) · Disulfides (2)
National Cancer Institute (NCI) (5) · M.D. Anderson Cancer Center (4) · Emory University (3) · Mayo Clinic (3) · Bicara Therapeutics (2) · Barbara Ann Karmanos Cancer Institute (1) · Centre Antoine Lacassagne (1) · Chase Heaton, MD (1) · ECOG-ACRIN Cancer Research Group (1) · Eben Rosenthal (1) · Fred Hutchinson Cancer Center (1) · ImmunoGenesis (1) · Incyte Biosciences International Sàrl (1) · Marcelo Bonomi (1) · Novartis Pharmaceuticals (1)
United States (31) · Australia (2) · Canada (2) · France (2) · Singapore (2) · South Korea (2) · Taiwan (2) · United Kingdom (2) · Argentina (1) · Austria (1) · Belgium (1) · Brazil (1) · China (1) · Czechia (1) · Germany (1)
Aarti Bhatia (1) · Ammar Sukari, M.D. (1) · Chase Heaton, MD (1) · Chenping Zhang, M.D. (1) · Cristina P. Rodriguez (1) · David J Sher (1) · Dong M. Shin, MD, FACP, FAAAS (1) · Douglas Adkins, M.D. (1) · Eben Rosenthal, MD (1) · George Blumenschein, MD (1) · Jacob S Thomas (1) · Jason M Johnson (1) · Jay Reddy (1) · Marcelo R Bonomi, MD (1) · Maria K Gule-Monroe (1)
P30CA138292 (3), U10CA180820 (2), K24DC022077 (1), N01CM00070 (1), P30CA015704 (1), P30CA016058 (1), P30CA016672 (1), P30CA022453 (1), P30CA093373 (1), R01CA262123 (1), U01CA076576 (1), U10CA180821 (1), U10CA180888 (1), UM1CA186712 (1), UM1CA186717 (1)