Clinical Trials for Head and Neck Cancer

201307100

Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered with Concurrent Cisplatin versus Docetaxel versus Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of the Head and Neck (RTOG 1216) Phase II/III Principal Investigator…

201405089

Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA) Phase II/III Principal Investigator Adkins, Douglas Disease Site Lip, Oral Cavity and…

201503060

Phase II Trial of Mitomycin C in Patients with Incurable p16 Positive Oropharyngeal and p16 Negative Head and Neck Squamous Cell Carcinoma (HNSCC) Resistant to Standard Therapies Phase II Principal Investigator Oppelt, Peter Disease Site…

201712132

A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA…

201802150

Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Stage III-IVB Head and Neck Cancer with a Contraindication to Cisplatin Phase II/III Principal Investigator Adkins, Douglas…

201805158

Phase II randomized trial of neo-adjuvant chemotherapy followed by surgery and post-operative radiation versus surgery and post-operative radiation for organ preservation of T3 and T4a nasal and paranasal sinus squamous cell carcinoma (NPNSCC) Phase II…

201808015

KEYSTROKE: A RANDOMIZED PHASE II STUDY OF PEMBROLIZUMAB (KEYTRUDA®) PLUS STEREOTACTIC RE-IRRADIATION VERSUS SBRT ALONE FOR LOCOREGIONALLY RECURRENT OR SECOND PRIMARY HEAD AND NECK CARCINOMA Phase II Principal Investigator Thorstad, Wade Disease Site Larynx; Lip,…

201902011

Phase II Randomized Trial of Radiotherapy with Concurrent and Adjuvant Pembrolizumab (Keytruda®) Versus Concurrent Chemotherapy in Patients with Advanced/Intermediate-Risk p16+ Head and Neck Squamous Cell Carcinoma (KEYCHAIN Trial) Phase II Principal Investigator Adkins, Douglas Disease…

201904155

A phase 1b/2a, open label study to evaluate anti-tumor efficacy and safety of rhIL-7-hyFc (NT-I7) in combination with anti-PD-L1 (atezolizumab) in patients with anti-PD-1/PD-L1 naïve or relapsed/refractory high-risk skin cancers Phase I/II Principal Investigator Ansstas,…

201905108

A Phase 1, First-In-Human, Open-label, Dose Escalation and Expansion Study of CUE-101 Monotherapy In Patients with HPV+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Phase I Principal Investigator Adkins, Douglas Disease Site Larynx;…

201905156

A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab Versus Placebo after Surgery and Radiation Therapy in Patients with High Risk Cutaneous Squamous Cell Carcinoma Phase III Principal Investigator Ansstas, George Disease Site Other Skin Learn…

201908206

A Randomized Phase II/III Trial of De-intensified Radiation Therapy for Patients with Early-Stage, p16-Positive, Non-Smoking Associated Oropharyngeal Cancer Phase II/III Principal Investigator Thorstad, Wade Disease Site Lip, Oral Cavity and Pharynx Learn more about this…

201909006

A Phase I/II Study of HB-201 Monotherapy or in Combination with Nivolumab in Patients with Human Papillomavirus 16 Positive (HPV 16+) Confirmed Cancers Phase I/II Principal Investigator Adkins, Douglas Disease Site Cervix; Larynx; Lip, Oral…

201911180

A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES OF PF-06940434 IN PATIENTS WITH ADVANCED OR METASTATIC SOLID TUMORS Phase I Principal Investigator Adkins, Douglas Disease Site Corpus Uteri; Esophagus;…

201912097

A Phase 1 Open Label, Multi-Arm, Multicenter Study of MK-4830 as Monotherapy and in Combination with Pembrolizumab for Participants with Advanced Solid Tumors Phase I Principal Investigator Adkins, Douglas Disease Site Anus; Bones and Joints;…

202001160

A Phase 1, Multicenter, Open-label, Dose-Exploration and Dose-Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 650 in Subjects With Advanced Solid Tumors Phase I (Cancer Control) Principal Investigator Govindan, Ramaswamy Disease Site…

202005122

First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1046 in subjects with malignant solid tumors Phase I/II Principal Investigator Ward, Jeffrey Disease Site Anus; Bones and Joints; Breast; Cervix; Colon; Corpus Uteri;…

202006127

Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-TIM-3 Monoclonal Antibody BGB-A425 in Combination with Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients with Advanced Solid Tumors Phase I/II Principal Investigator Adkins, Douglas…

202006132

Phase I/II, Two-Part, Multicenter First-in-Human Study of DS-7300a in Subjects with Advanced Solid Malignant Tumors Phase I/II (Cancer Control) Principal Investigator Adkins, Douglas Disease Site Esophagus; Ill-Defined Sites; Larynx; Lip, Oral Cavity and Pharynx; Lung;…

202006135

A Phase 2, randomized, open-label three-arm clinical study to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3475) versus standard of care chemotherapy and lenvatinib monotherapy in participants with recurrent/metastatic head…

202006183

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Cemiplimab Versus the Combination of Cemiplimab with ISA101b in the Treatment of Subjects With HPV16-Positive Oropharyngeal Cancer (OPC) Phase II Principal Investigator Adkins, Douglas Disease Site Lip,…

202008158

A randomized, double-blind placebo-controlled, Phase 3 study of Debio 1143 in combination with platinum-based chemotherapy and standard fractionation intensity-modulated radiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck, suitable for…

202011142

Phase II Study of cemiplimab, an anti-PD-1 monoclonal antibody, and ISA101b vaccine in patients with recurrent/metastatic HPV16 positive Oropharyngeal Cancer who have experienced disease progression with prior anti-PD-1 therapy Phase II Principal Investigator Adkins, Douglas…

202011174

Tazemetostat and Pembrolizumab in Patients with Pembrolizumab- or Nivolumab-Resistant, Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma: A Phase 1-2 Trial Phase I/II Principal Investigator Adkins, Douglas Disease Site Larynx; Lip, Oral Cavity and Pharynx…

202012053

A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune…

202103112

The BURAN Study of Buparlisib (AN2025) In Combination with Paclitaxel Compared to Paclitaxel Alone, in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Phase III (Cancer Control) Principal Investigator Adkins, Douglas Disease…

202104114

A Phase 2 Study of Magrolimab Combination Therapy in Patients with Head and Neck Squamous Cell Carcinoma Phase II (Cancer Control) Principal Investigator Adkins, Douglas Disease Site Larynx; Lip, Oral Cavity and Pharynx Learn more…

202104144

Olaparib in Combination with Pembrolizumab and Carboplatin as First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma: A Single-Arm, Phase 2 Trial Phase II Principal Investigator Adkins, Douglas Disease Site Larynx; Lip, Oral…

202104189

A Phase 1b/2 Study of the Combination of Pepinemab and Pembrolizumab in Patients with Advanced, Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Phase I/II Principal Investigator Adkins, Douglas Disease Site Larynx;…

202105128

nab-Paclitaxel in Combination with Nivolumab to Treat Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma that Progressed on a PD-1 or PD-L1 Inhibitor: A Single-Arm, Phase 2 Trial Phase II Principal Investigator Adkins, Douglas Disease…

202106015

Non-Randomized Phase 2 Trial of Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients with Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma Phase II Principal Investigator Adkins, Douglas Disease Site…

202106025

A Phase 1, Multicenter, Single Agent Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of CPO-100 in Adult Patients with Advanced Solid Tumors Phase I (Cancer Control) Principal Investigator Adkins,…

202106026

A Phase 1, Open-Label, Dose Finding Study of CC-95251, a Monoclonal Antibody Directed Against SIRP-alpha, Alone and in Combination with Cetuximab or Rituximab in Subjects with Advanced Solid and Hematologic Cancers Phase I (Cancer Control)…

202107012

A Phase II Randomized Trial of Adjuvant Therapy with Pembrolizumab after Resection of Recurrent/Second Primary Head and Neck Squamous Cell Carcinoma with High Risk Features Phase II Principal Investigator Jackson, Ryan Disease Site Larynx; Lip,…

202108011

A Phase 1/2 open-label, biomarker-defined cohort trial to evaluate the safety, determine the recommended combination dosing, and assess early antitumor activity of tipifarnib and alpelisib for the treatment of adult participants who have HRAS-overexpressing and/or…

202108163

TACTI-003 (Two ACTive Immunotherapeutics): A multicenter, open label, randomized, Phase II trial to investigate a soluble LAG-3 fusion protein, eftilagimod alpha (efti; IMP321) in combination with pembrolizumab (PD-1 antagonist) for first line treatment of subjects…

202108203

Palbociclib and Cetuximab versus Cetuximab Monotherapy for Patients with CDKN2A-altered, HPV-unrelated Head and Neck Squamous Cell Carcinoma who Experienced Disease Progression on a PD-1/L1 Inhibitor: A Multicenter, Open-Label, Randomized Phase 3 Trial Phase III Principal…

202111001

A Phase 1a/1b Dose Escalation/Expansion Study of TTX-080, an HLA-G Antagonist, as Monotherapy and in Combination with Pembrolizumab or Cetuximab in Patients with Advanced Solid Refractory/Resistant Malignancies Phase I Principal Investigator Adkins, Douglas Disease Site…