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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



A Phase 2 Pilot Study of ADP-A2M4 in Combination with Pembrolizumab in Subjects with Recurrent or Metastatic Head and Neck Cancer

Head/Neck

Head/Neck
II
Gibson, Mike
NCT04408898
VICCHN2034

Multimodality Therapy before and after Surgery in Patients with Squamous Cell Carcinoma of the Head and Neck

Head/Neck

This phase II clinical trial studies how well multimodality therapy works before and after surgery in patients with squamous cell carcinoma of the head and neck. Immunotherapy with monoclonal antibodies, such as durvalumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin, nab-paclitaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving carboplatin, nab-paclitaxel, and durvalumab before surgery and using durvalumab with or without radiation therapy and cisplatin after surgery may kill more tumor cells in patients with head and neck cancer.
Head/Neck
II
Gibson, Mike
NCT03174275
VICCHN1890

Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Head and Neck Cancer

Head/Neck

ADU-CL-20 is an open-label, multicenter Phase 2 clinical trial to evaluate the efficacy and safety of intratumoral ADU-S100 (also referred to as MIW815) administered with pembrolizumab in the first-line setting. The population will consist of adults with PD-L1 positive recurrent or metastatic HNSCC.
Head/Neck
II
Gibson, Mike
NCT03937141
VICCHN1976

Radiation Therapy and Pembrolizumab or Cisplatin in Treating Patients with Stage III / IV p16 Positive Head and Neck Squamous Cell Carcinoma

Head/Neck

This phase II trial studies how well radiation therapy works when given with pembrolizumab or cisplatin in treating patients with stages III / IV p16-positive head and neck squamous cell carcinoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving pembrolizumab during and after radiation therapy or cisplatin during radiation therapy works better in treating participants with head and neck squamous cell carcinoma.
Head/Neck
II
Gibson, Mike
NCT03383094
VICCHN1966

A Phase 1 Study in Patients With HPV+ Recurrent / Metastatic Head and Neck Squamous Cell Carcinoma

Multiple Cancer Types

This is a multi center, open-label, phase 1 dose escalation and expansion study evaluating the safety, anti-tumor effect, and immunogenicity of CUE-101 as monotherapy treatment in second line or CUE-101 Combination Therapy with Pembrolizumab in first line patients with HPV+ Recurrent / Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Head/Neck, Phase I
I
Gibson, Mike
NCT03978689
VICCPHI1981

Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)

Head/Neck

This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III / IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves major pathological response and event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.
Head/Neck
III
Gibson, Mike
NCT03765918
VICCHN1861

Testing Immunotherapy versus Observation in Patients with HPV Throat Cancer

Head/Neck

This phase II / III trials studies whether maintenance immunotherapy (nivolumab) following definitive treatment with radiation and chemotherapy (cisplatin) result in significant improvement in overall survival (time being alive) and progression-free survival (time being alive without cancer) for patients with intermediate risk human papillomavirus (HPV) positive oropharynx cancer (throat cancer) that has spread to nearby tissue or lymph nodes. Drugs used in chemotherapy such as cisplatin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether chemotherapy and radiation therapy followed by maintenance nivolumab therapy works better than chemotherapy and radiation therapy alone in treating patients with HPV positive oropharyngeal cancer.
Head/Neck
II/III
Gibson, Mike
NCT03811015
ECOGHNEA3161

Pembrolizumab Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630 / KEYNOTE-630)

Miscellaneous

This is a randomized, double-blind, study that compares pembrolizumab with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in increasing recurrence free survival (RFS).
Miscellaneous
III
Gibson, Mike
NCT03833167
VICCHN18177

Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy

Head/Neck

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.
Head/Neck
II
Gibson, Mike
NCT03719690
VICCHN18117

Testing the Addition of Radiotherapy to the Usual Treatment (Chemotherapy) for Patients with Esophageal and Gastric Cancer that has Spread to a Limited Number of Other Places in the Body

Multiple Cancer Types

This phase III trial studies how well the addition of radiotherapy to the usual treatment (chemotherapy) works compared to the usual treatment alone in treating patients with esophageal and gastric cancer that has spread to a limited number of other places in the body (oligometastatic disease). Radiotherapy uses high energy x-rays, gamma rays, or protons to kill tumor cells and shrink tumors. Drugs used in usual chemotherapy, such as leucovorin, 5-fluorouracil, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding radiotherapy to the usual chemotherapy may work better compared to the usual chemotherapy alone in treating patients with esophageal and gastric cancer.
Esophageal, Gastric/Gastroesophageal
III
Gibson, Mike
NCT04248452
ECOGGIEA2183

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