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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



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 Study of Duvelisib in Combination With Pembrolizumab in Head and Neck Cancer

Multiple Cancer Types

This study will assess the safety and preliminary efficacy of duvelisib in combination with pembrolizumab in subjects with recurrent or metastatic (R / M) head and neck squamous cell carcinoma (HNSCC).
Head/Neck, Phase I
I/II
Gibson, Mike
NCT04193293
VICCHNP19109

Nivolumab and Ipilimumab in Treating Patients with Esophageal and Gastroesophageal Junction Adenocarcinoma Undergoing Surgery

Multiple Cancer Types

This phase II / III trial studies the usefulness of treatment with nivolumab and ipilimumab in addition to standard of care chemotherapy and radiation therapy in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery. Immunotherapy with antibodies, such as nivolumab and ipilimumab, may remove the brake on the body’s immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy and radiation therapy may reduce the tumor size and the amount of normal tissue that needs to be removed during surgery. A combined treatment with nivolumab and ipilimumab, chemotherapy, and radiation therapy might be more effective in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery.
Esophageal, Gastric/Gastroesophageal
II/III
Gibson, Mike
NCT03604991
ECOGGIEA2174

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

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

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 in patients with recurrent / metastatic head and neck squamous cell carcinoma (HNSCC).
Head/Neck, Phase I
I
Gibson, Mike
NCT03978689
VICCPHI1981

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

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

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

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