23.0042:  A Phase 1/2, First-In-Human, Multi-Part, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of DF9001 as a monotherapy and in combination with nivolumab in Patients With Advanced (Unresectable, Recurrent, or Metastatic) Solid Tumors, and Expansion in Selected Indications 

Principal Investigator: Rebecca Redman, MD 

Phase:  I/II 

Description:  DF9001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors that express epidermal growth factor receptor (EGFR). A combination therapy cohort will be opened for enrollment, DF9001 + nivolumab. The second phase will include a dose expansion using the best dose selected from the first phase of the study. Multiple cohorts will be opened with eligible patients having selected solid tumors.

 More info:  https://clinicaltrials.gov/study/NCT05597839?term=NCT05597839&rank=1

22.0978:  A Phase 1, Open-label, Multicenter Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MK-4464 as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced/Metastatic Solid Tumors

Principal Investigator: Rebecca Redman, M.D.

Phase:  I

Description: The purpose of this study is to assess the safety, pharmacokinetics, and preliminary efficacy of MK-4464 as monotherapy and in combination with pembrolizumab in participants with advanced/metastatic solid tumors.

More Info:  https://clinicaltrials.gov/ct2/show/NCT05514444?term=NCT05514444&draw=2&rank=1

22.0722:  A phase II trial of induction and maintenance pembrolizumab and olaparib in locally advanced head and neck squamous cell carcinoma (HNSCC)

Principal Investigator: Rebecca Redman, MD 

Phase:  II 

Description:  The purpose of this research study is to evaluate the effectiveness of using a combination of pembrolizumab and olaparib when given before and after standard chemoradiation therapy in treating locally advanced head and neck squamous cell carcinoma. Pembrolizumab and olaparib are drugs that are approved for head and neck cancer treatment. However, FDA has not approved the use of these two drugs together in treating head and neck cancer. 

ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT05366166?term=NCT05366166&rank=1 

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 

21.0204: A Randomized Trial of an Advanced Pneumatic Compression Device vs. Usual Care for Head and Neck Lymphedema 

Principal Investigator: Neal Dunlap, M

Description: To compare the effectiveness of an APCD to Usual Care in the management of lymphedema and fibrosis (LEF) in head and neck cancer (HNC) survivors.

ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT04797390?term=NCT04797390&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

19.1216:  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

19.0829: 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

19.0260: 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  

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.