Head and Neck Clinical Trials
To find new and better ways to treat patients with cancer, the doctors at the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) conduct clinical trials.
These research studies test new drugs, treatments or approaches. A clinical trial is offered to patients only after much research has gone into developing a new treatment option.
Doctors and scientist often use trials to find out:
- If a new treatment is safe and effective
- What dose of a new treatment to use and how to provide it
- Whether the new treatment is better than existing treatments
People volunteer to be part of a clinical trial. Sometimes a trial allows patients to receive a treatment option several years before it is widely available. Some patients enjoy knowing that they are helping to advance cancer research.
For more information about clinical trials at UMGCCC, see What Are Clinical Trials?
Because cancer research is a large part of UMGCCC's mission, our head and neck cancer experts offer several clinical trials. Below are the current head and neck cancer clinical trials open at UMGCCC with a brief summary of information about each.
To search for other open trials at UMGCCC, see our Clinical Trials Database.
Current Head and Neck Clinical Trials
1910GCCC | The AIM-HN and SEQ-HN Study: A 2 Cohort, Non-comparative, Pivotal Study Evaluating the Efficacy of Tipifarnib in Patients with Head and Neck Squamous Cell Carcinoma (HNSCC) with HRAS Mutations (AIM-HN) and the Impact of HRAS Mutations on Response to First Line Systemic Therapies for HNSCC (SEQ-HN)
Principal Investigator: Ranee Mehra, MD
Brief Summary: An international, multicenter, open-label, 2 cohort, non-comparative, pivotal study evaluating the efficacy of tipifarnib in HRAS mutant HNSCC (AIM-HN). The first cohort will assess the objective response rate (ORR) of tipifarnib in subjects with HNSCC with HRAS mutations. The second study cohort, SEQ-HN, is an observational sub-study and includes 2 types of patients: (1) the historical record of first line therapy in subjects with HRAS mutant HNSCC participating in Cohort 1 in whom first line outcome data are available and (2) matched control HNSCC patients in whom HRAS mutations were not identified (wild type HRAS HNSCC) and who consent to provide first line outcome data and additional follow up.
Learn More: Find contact and eligibility information for this clinical trial.
1922GCCC | Phase 2 Study of Pembrolizumab and Bavituximab for Progressive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
Principal Investigator: Ranee Mehra, MD
Brief Summary: This phase II single arm study is being done to determine if bavituximab could potentially synergize with PD-1 inhibitor therapy to generate an effective anti-tumor immune response in patients with recurrent/metastatic squamous cell head and neck cancer (HNSCC) who progressed on a PD-1 inhibitor.
Learn More: Find contact and eligibility information for this clinical trial.
19152GCCC | Phase 2 Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC (VERSATILE002)
Principal Investigator: Ranee Mehra, MD
Brief Summary: Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC (VERSATILE002)
PDS0101 is a novel T-cell immunotherapy delivered subcutaneously that has been shown to stimulate high levels of HPV16-specific T cells within patients by activating multiple immune pathways. These HPV-specific T cells then target tumors such as head and neck cancers that are caused by HPV infection. This study will explore in a preliminary manner whether combination treatment with PDS0101 plus pembrolizumab will improve clinical efficacy. Subjects will be enrolled into either the checkpoint inhibitor (CPI) naïve cohort or the CPI refractory cohort.
Learn More: Find contact and eligibility information for this clinical trial.
20110GCC | A single-arm, single-stage phase II trial of Selective Avoidance of nodal VolumEs at minimal Risk (SAVER) in the contralateral neck of patients with p16-positive oropharynx cancer
Principal Investigator: Matthew Witek, MD
Brief Summary: This is a phase II, non-randomized, therapeutic trial with the primary objective to determine the efficacy of reduced contralateral (C/L) elective nodal treatment volumes in preventing C/L recurrences at 2 years in patients with p16 positive oropharyngeal squamous cell carcinoma undergoing definitive or adjuvant RT.
Learn More: Find contact and eligibility information for this clinical trial.
2070GCCC | 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 and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and immunotherapy (PD-1/PD-L1 inhibitors) (LEAP-009)
Principal Investigator: Ranee Mehra, MD
Brief Summary: This study is designed to assess the safety and efficacy of lenvatinib in combination with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and a programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor. The primary hypothesis is that lenvatinib + pembrolizumab is superior to SOC chemotherapy with respect to ORR per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review.
Learn More: Find contact and eligibility information for this clinical trial.
2083GCCC | Phase II trial of androgen deprivation therapy (ADT) and pembrolizumab for advanced stage androgen receptor-positive salivary gland carcinoma
Principal Investigator: Ranee Mehra, MD
Brief Summary: A Phase II, multi-center, single-arm, non-blinded study combining androgen deprivation therapy (ADT) and pembrolizumab for patients with metastatic or locally recurrent androgen receptor-positive salivary gland carcinoma, not amenable to surgery or radiation.
Learn More: Find contact and eligibility information for this clinical trial.
A091802 | Phase II randomized trial of avelumab plus cetuximab versus avelumab alone in advanced cutaneous squamous cell carcinoma of the skin (cSCC)
Principal Investigator: Ranee Mehra, MD
Brief Summary: This phase II trial studies how well avelumab with or without cetuximab work in treating patients with skin squamous cell cancer that has spread to other places in the body. Immunotherapy with monoclonal antibodies, such as avelumab and cetuximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Learn More: Find contact and eligibility information for this clinical trial.
Make an Appointment
The head and neck cancer team sees patients at a variety of locations in downtown Baltimore near and inside the University of Maryland Greenebaum Comprehensive Cancer Center.
To make an appointment with one of our specialists, please visit Locations and Appointments.
