24.0122:  Study Title:  SPECT-CT GUIDED ELECTIVE CONTRALATERAL NECK TREATMENT (SELECT) FOR PATIENTS WITH LATERALIZED OROPHARYNGEAL CANCER: A PHASE III RANDOMIZED CONTROLLED TRIAL 

Principal Investigator: Neal Dunlap, MD 

Phase:  III 

Description:  This study is being done to answer the following question:Is the chance of cancer spreading or returning the same if radiotherapy to the neck is guided, by using a special imaging study called lymph node mapping (lymphatic mapping) Single Photon Emission Computed Tomography (SPECT-CT), compared to the usual treatment when radiotherapy is given to both sides of the neck? 

ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT05451004?term=NCT05451004&rank=1

24.0108:  A Phase II Randomized Trial of Adjuvant Therapy with Pembrolizumab after Resection of Recurrent or Second Primary Head and Neck Squamous Cell Carcinoma with High Risk Features. 

Principal Investigator: Neal Dunlap, MD 

Phase:  II 

Description:  This phase II trial studies the effect of pembrolizumab alone compared to the usual approach (chemotherapy [cisplatin and carboplatin] plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head and neck cancer that is not from metastasis (primary). Radiation therapy uses high energy radiation or protons to kill tumor cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Carboplatin is also in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. 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. Giving pembrolizumab alone after surgery may work better than the usual approach in shrinking recurrent or primary head and neck squamous cell carcinoma.

More Info: https://clinicaltrials.gov/study/NCT04671667?term=NCT04671667&rank=1

23.0820:  Study Title:  BelieveIT-201- A Randomized, Phase 2, Open-label Trial of TransCon TLR7-8 Agonist in Combination with Pembrolizumab, TransCon TLR7-8 Agonist in Combination with TransCon IL-2 Beta-Y, or Pembrolizumab Monotherapy as Neoadjuvant Therapy in Participants with Stage III-IV A Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC). 

Principal Investigator: Daniel Vinh, MD 

Phase:  II 

Description:  The purpose of this trial is to evaluate the safety and efficacy of TransCon TLR7/8 Agonist, TransCon IL-2 β/γ, and pembrolizumab given prior to curative intent surgery in treatment of participants with newly diagnosed Stage III/IVA resectable locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC). After surgery, participants will receive local standard-of-care treatment and will be followed for safety, efficacy, and survival for up to 2 years.This trial contains a safety run-in to evaluate the safety and tolerability of the two treatment arms: Arm A (TransCon TLR7/8 Agonist plus pembrolizumab) and Arm B (TransCon TLR7/8 Agonist plus TransCon IL-2 β/γ). The safety run-in will be followed by the randomized Phase 2, open-label part of the trial comparing the safety, efficacy and survival of treatment Arm A or Arm B compared to treatment Arm C (pembrolizumab monotherapy). 

ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT05980598?term=NCT05980598&rank=1

23.0742:  Study Title:  An open-label, first-in-human, dose-escalation monotherapy, safety, and expansion study of SRF114 in patients with advanced solid tumors 

Principal Investigator: Rebecca Redman, MD 

Phase:  I/II 

Description:  This is a Phase 1/2, open-label, first-in-human, dose-escalation and expansion study of SRF114, a monoclonal antibody that targets CCR8, as a monotherapy in patients with advanced solid tumors, that will be conducted in 2 parts:Part A: SRF114 monotherapy dose-escalation portion of the study will enroll approximately 30 patients with advanced solid tumors.Part B: SRF114 monotherapy expansion cohort(s) will evaluate the safety, efficacy, tolerability, pharmacokinetics, and pharmacodynamics of SRF114 in indication specific cohort(s). Up to approximately 40 patients will be enrolled. 

ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT05635643?term=NCT05635643&rank=1

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

22.0722:  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 

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

19.0260: 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.