HEAD AND NECK CANCER

22.0237: RANDOMIZED PHASE II/III TRIAL OF RADIATION WITH HIGH-DOSE CISPLATIN (100 MG/M2) EVERY THREE WEEKS VERSUS RADIATION WITH LOW-DOSE WEEKLY CISPLATIN (40 MG/M2) FOR PATIENTS WITH LOCOREGIONALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK (SCCHN)

Principal Investigator: Rebecca Redman, MD

Phase: II

Description:  This phase II/III trial compares the effect of the combination of high-dose cisplatin every three weeks and radiation therapy versus low-dose cisplatin weekly and radiation therapy for the treatment of patients with locoregionally advanced head and neck cancer. Chemotherapy drugs, 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 x-rays to kill tumor cells and shrink tumors. This study is being done to find out if low-dose cisplatin given weekly together with radiation therapy is the same or better than high-dose cisplatin given every 3 weeks together with radiation therapy in treating patients with head and neck cancer.

More information: https://clinicaltrials.gov/ct2/show/NCT05050162?term=NCT05050162&draw=2&rank=1

22.0094: PHASE I TRIAL WITH EXPANSION COHORT OF DNA-PK INHIBITION AND IMRT IN CISPLATIN-INELIGIBLE PATIENTS WITH STAGE 3-4 LOCAL-REGIONALLY ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMA (HNSCC)

Principal Investigator: Rebecca Redman, MD

Phase: I

Description: This phase I trial investigates the side effects and best dose of peposertib when given together with radiation therapy in treating patients with head and neck cancer that has spread to other places in the body (advanced) who cannot take cisplatin. Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This trial aims to see whether adding peposertib to radiation therapy is safe and works well in treating patients with head and neck cancer.

More information: https://clinicaltrials.gov/ct2/show/NCT04533750?term=NCT04533750&draw=2&rank=1

21.0920: A PHASE 1 OPEN-LABEL, MULTICENTER, DOSE-RANGING STUDY TO INVESTIGATE SAFETY AND TOLERABILITY, EFFICACY, PHARMACOKINETICS, PHARMACODYNAMICS, AND IMMUNOGENICITY OF MT-6402 IN SUBJECTS WITH ADVANCED SOLID CANCER THAT EXPRESSES PD-L1

Principal Investigator: Rebecca Redman, MD

Phase: I

Description: This is a Phase I first-in-human, open-label, dose escalation and dose expansion study of MT-6402 that will be conducted in two parts. Part A is designed to estimate the maximum tolerated dose (MTD) and Part B is designed to identify the RP2D.

More information: https://clinicaltrials.gov/ct2/show/NCT04795713?term=NCT04795713&draw=2&rank=1 

20.1144:  A PHASE 2 STUDY OF ALX148 IN COMBINATION WITH PEMBROLIZUMAB AND  CHEMOTHERAPY IN PATIENTS WITH ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMA(ASPEN-04)

Principal Investigator: Rebecca Redman, MD

Phase:  II

Description: This is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of evorpacept (ALX148) + pembrolizumab + 5FU and platinum and of pembrolizumab + 5FU and platinum alone in patients with metastatic or unresectable, recurrent HNSCC who have not yet been treated for their advanced disease. The study comprises of an initial safety lead-in followed by a randomized portion.

More info:  https://clinicaltrials.gov/ct2/show/NCT04675333?term=NCT04675333&draw=2&rank=1

 

20.0749: RANDOMIZED PHASE II/III TRIAL OF SENTINEL LYMPH NODE BIOPSY VERSUS ELECTIVE NECK DISSECTION FOR EARLY-STAGE ORAL CAVITY CANCER

Principal Investigator: Neal Dunlap, MD

Phase:  II/III

Description:  This phase II/III trial studies how well sentinel lymph node biopsy works and compares sentinel lymph node biopsy surgery to standard neck dissection as part of the treatment for early-stage oral cavity cancer. Sentinel lymph node biopsy surgery is a procedure that removes a smaller number of lymph nodes from your neck because it uses an imaging agent to see which lymph nodes are most likely to have cancer. Standard neck dissection, such as elective neck dissection, removes many of the lymph nodes in your neck. Using sentinel lymph node biopsy surgery may work better in treating patients with early-stage oral cavity cancer compared to standard elective neck dissection.

More info: https://clinicaltrials.gov/ct2/show/NCT04333537?term=NCT04333537&draw=1&rank=1

 

13.0369:  RANDOMIZED PHASE II/III TRIAL OF ADJUVANT RADIATION THERAPY WITH CISPLATIN, DOCETAXEL-CETUXIMAB, OR CISPLATIN-ATEZOLIZUMAB IN PATHOLOGIC HIGH-RISK SQUAMOUS CELL CANCER OF THE HEAD AND NECK

Principal Investigator: Neal Dunlap, MD

Phase:  III

Description:  This phase II/III trial studies how well radiation therapy works when given together with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous cell). Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to compare the usual treatment (radiation therapy with cisplatin chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy, and using the usual treatment plus an immunotherapy drug, atezolizumab.

More info:  https://clinicaltrials.gov/ct2/show/NCT01810913?term=NCT01810913&draw=2&rank=1

 

19.1211:  A Phase 3, randomized, placebo-controlled, double-blind clinical study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) to evaluate the safety and efficacy of pembrolizumab and lenvatinib as 1L intervention in a PD-L1 selected population of participants with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) (LEAP-010).

Principal Investigator: Rebecca Redman, MD

Phase:  III

Description:  This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma.

More info:  https://clinicaltrials.gov/ct2/show/NCT04199104?term=NCT04199104&draw=2&rank=1

 

19.1216:  A Phase II/III Randomized Study of Maintenance Nivolumab versus Observation in Patients with Locally Advanced, Intermediate Risk HPV Positive OPCA

Principal Investigator: Rebecca Redman, MD

Phase:  III

Description:  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 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.

More info: https://clinicaltrials.gov/ct2/show/NCT03811015?term=NCT03811015&draw=2&rank=1

 

19.0698:  Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer

Principal Investigator: Rebecca Redman, M.D.

Phase:  I

Description: This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab. The study will be conducted in two parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.

More Info:  https://clinicaltrials.gov/ct2/show/NCT03674567?term=NCT03674567&draw=2&rank=1

 

19.0829: A randomized phase II/III trial of de-intensified radiation therapy for patients with early stage, P16-postivite, non-smoking associated oropharyngeal cancer

Principal Investigator: Neal Dunlap, MD

Phase: II

Description: This phase II/III trial studies how well a reduced dose of radiation therapy works with nivolumab compared to cisplatin in treating patients with human papillomavirus (HPV)-positive oropharyngeal cancer that is early in its growth and may not have spread to other parts of the body (early-stage), and is not associated with smoking. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. 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. 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. This trial is being done to see if a reduced dose of radiation therapy and nivolumab works as well as standard dose radiation therapy and cisplatin in treating patients with oropharyngeal cancer.

More info: https://clinicaltrials.gov/ct2/show/NCT03952585?term=NCT03952585&rank=1

 

19.0269: 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)       

Principal Investigator: Neal Dunlap, M.D.     

Description:  This randomized phase II trial studies how well chemotherapy before surgery and radiation therapy works compared to surgery and radiation therapy alone in treating patients with nasal and paranasal sinus cancer that can be removed by surgery. Drugs used in chemotherapy, such as docetaxel, cisplatin, and carboplatin 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 chemotherapy before surgery and radiation therapy may make the tumor smaller and reduce the amount of normal tissue that needs to be removed and treated with radiation.    

Phase: II     

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT03493425?term=NCT03493425&rank=1 

 

19.0260: Phase II Randomized Trial of Radiotherapy with or without Cisplatin for Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN) with TP53 Sequencing       

Principal Investigator:  Rebecca Redman, M.D.

Description: This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IVA squamous cell carcinoma of the head and neck who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. 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 if radiation therapy is more effective with or without cisplatin in treating patients with squamous cell carcinoma of the head and neck.     

Phase: II     

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT02734537?term=NCT02734537&rank=1 

 

18.1104: 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     

Principal Investigator:  Neal Dunlap, M.D. 

Description:  This phase II trial with a safety run-in component will evaluate whether the addition of pembrolizumab to Stereotactic Body Radiation Therapy (SBRT) re-irradiation will improve the progression-free survival for patients with recurrent or new second primary Head and Neck Squamous Cell Carcinoma (HNSCC).    

Phase:  II    

Additional Information: https://clinicaltrials.gov/ct2/show/NCT03546582?term=NCT03546582&rank=1 

 

18.0336:  A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes
(LN-144 or LN-145) in Patients with Solid Tumors    

Principal Investigator:  Jason A Chesney, MD, PhD

Description:  A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel)/LN-145 in combination with pembrolizumab. TIL as a single-therapy will be evaluated with LN-145 only.    

Phase: II     

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT03645928?term=NCT03645928&rank=1 
 

 16.0568 - Molecular Analysis for Therapy Choice (MATCH).

Principal Investigator: Vivek Sharma, M.D., F.A.C.P.

Description: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.

Phase: II

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02465060?term=eay131&rank=1

 

08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the Brown Cancer Center (Previous Lung Repository).

Principal Investigator: Rebecca Redman, M.D.

Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.

 

20.0685:  NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study

Principal Investigator: Rebecca Redman, MD

Description:  This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.

More info:  https://clinicaltrials.gov/ct2/show/NCT04387656?term=NCT04387656&draw=2&rank=1