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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



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


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

Gemcitabine Hydrochloride and Cisplatin with or without Nab-Paclitaxel in Treating Patients with Newly Diagnosed Advanced Biliary Tract Cancers

Multiple Cancer Types

This phase III trial studies how well gemcitabine hydrochloride and cisplatin given with or without nab-paclitaxel work in treating patients with newly diagnosed biliary tract cancers that have spread to other places in the body (advanced). Chemotherapy drugs, such as gemcitabine hydrochloride, cisplatin, and nab-paclitaxel, 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 known if giving gemcitabine hydrochloride and cisplatin with or without nab-paclitaxel may work better at treating biliary tract cancers.
Liver, Pancreatic
III
Goff, Laura
NCT03768414
ECOGGIS1815

Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients with Relapsed or Refractory Germ Cell Tumors

Multiple Cancer Types

This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement (relapsed) or did not respond to treatment (refractory). Chemotherapy drugs, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, 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. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumors.
Germ Cell (Pediatrics), Pediatrics
III
Borinstein, Scott
NCT02375204
COGA031102

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

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

M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)

Multiple Cancer Types

The main purpose of this study is to evaluate safety and efficacy in participants treated with concomitant chemoradiation therapy (cCRT) plus M7824 followed by M7824 compared to cCRT plus placebo followed by durvalumab.
Lung, Non Small Cell
II
Osmundson, Evan
NCT03840902
VICCTHO1917

A Study of Chemo Only Versus Chemo Plus Nivo With or Without BMS-986205, Followed by Post- Surgery Therapy With Nivo or Nivo and BMS-986205 in Patients With MIBC

Bladder

A study to evaluate nivolumab + chemotherapy or nivolumab / BMS-986205 + chemotherapy followed by continued Immuno-Oncology therapy after radical cystectomy (RC) compared with neoadjuvant standard of care (SOC) chemotherapy alone in patients with muscle-invasive bladder cancer (MIBC)
Bladder
III
Davis, Nancy
NCT03661320
VICCURO18152

Testing Platinum-based Chemotherapy after Surgery in Triple-Negative Breast Cancers

Breast

This phase III trial compares the effect of cisplatin or carboplatin (platinum based chemotherapy) to capecitabine after surgery for the treatment of residual triple-negative breast cancer. Chemotherapy drugs, such as cisplatin, carboplatin, 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. At present, upon completion of chemotherapy and surgery, the standard of care for patients with triple-negative breast cancer is observation. However, recent studies have shown that giving capecitabine after completion of chemotherapy and surgery is a better treatment than receiving no treatment and also that platinum-based chemotherapy after surgery could prevent residual triple-negative breast cancer from returning. This trial is being done to find out whether addition of a platinum agent after completion of surgery will provide a higher disease free survival benefit than capecitabine in treating patients with residual triple-negative breast cancer.
Breast
III
Mayer, Ingrid
NCT02445391
ECOGBREEA1131

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