Clinical Research Directory

A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers

Background: Often, metastatic human papillomavirus (HPV) associated cancers cannot be cured. They also do not respond well to treatment. Some forms of colon cancer also have poor responses to treatment. Researchers want to see if a new drug treatment can help people with these types of cancers. Objective: To find a safe dose of entinostat in combination with PDS01ADC and bintrafusp alfa and to see if this treatment will cause tumors to shrink. Eligibility: Adults ages 18 and older who have cervical, oropharyngeal, anal, vulvar, vaginal, penile, squamous cell rectal, or another cancer that may be associated with HPV infection or microsatellite stable small bowel or colorectal cancer. Design: Participants will be screened with a medical history and physical exam. Their ability to do daily activities will be assessed. They may have imaging scans of the brain and/or chest, abdomen, and pelvis. They may have nuclear bone scans. They will have an electrocardiogram to test heart function. They will have blood and urine tests. They may have a tumor biopsy. Participants with skin lesions may have them photographed. Some screening tests will be repeated during the study. Treatment will be done in 28-day cycles. Participants will get bintrafusp alfa through an intravenous catheter every 2 weeks. They will get PDS01ADC as an injection under the skin every 4 weeks. They will take entinostat by mouth once a week. They will complete a medicine diary. Participants will get treatment for 2 years. They will have 1-2 follow-up visits in the 30 days after treatment ends. Then they will be contacted every 6 months to check on their health.

BALSTILIMAB on Viral Clearance in HPV+ Oropharyngeal Cancer Patients

This study aims to leverage this unique property of HPV+ OPC to detect possible minimal residual disease represented by persistent viral detection after the completion of definitive treatment. The study will offer adjuvant immune therapy to patients with persistent viral detection and evaluate the clearance of viral load. It will evaluate the rate of viral clearance with immune therapy and establish the link between viral clearance and long-term disease control.

SPECT-CT Guided ELEctive Contralateral Neck Treatment for Patients With Lateralized Oropharyngeal Cancer

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?

Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-escalation (NeoScorch HN)

The NeoScorch HN study is a single institution multisite phase II trial including 3 cohorts of 25 patients each for patients with newly diagnosed locoregionally advanced, histologically confirmed, head and neck cancer eligible for curative-intent treatment, who will receive neo-adjuvant chemoimmunotherapy-based treatment as well as standard of care adjuvant treatment. The three cohorts include three different aspects of surgical de-escalation in head and neck cancer. The first cohort includes human papillomavirus independent (HPV-) squamous cell carcinoma of the head and neck. The second cohort includes HPV-associated head and neck cancer with radiographic evidence of extranodal extension in neck lymphadenopathy. The third cohort specifically includes malignancies of the sinonasal cavity and skull base which have a propensity for invasion of the orbit, skull base, and maxilla. Surgical treatment of all three of these cohorts has significant morbidity including swallowing, speech, and vision among others.

A Study of Reduced Radiation Therapy and Standard-of-Care Chemotherapy in People With HPV-Positive Throat Cancer

The purpose of this study is to find out if lower doses of radiation may help reduce the side effects of radiation therapy in combination with standard-of-care chemotherapy in people with HPV-positive throat cancer. The chemotherapy drugs used in this study include cisplatin, carboplatin, and 5-fluorouracil (5- FU), paclitaxel and abraxane- (Albumin-bound Paclitaxel).

Depression and Adherence in Head and Neck Cancer

Primary Objectives: * Develop and pilot test an innovative intervention to determine its feasibility and acceptability to patients. Recruitment rate, patient satisfaction, attendance, questionnaire completion rates and the reliability and validity of the questionnaires will be assessed. * Conduct preliminary analyses on the efficacy of the intervention in improving patients' depression. Evaluate whether depression levels in patients receiving the intervention decreases, and whether the decrease is greater among those who complete more sessions. * Test the relationship between patients' depression levels and adherence to swallowing rehabilitation and to dental preventive maintenance regimens.

Enhancing Self Care Among Oral Cancer Survivors: The Empowered Survival Trial

Project's goal is evaluate an online tool the research team created called Empowered Survivor (ES) against a free online self-management intervention developed for cancer survivors by the National Cancer Institute and the American Cancer Society called Springboard Beyond Cancer.

TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck

This is a single-arm Phase II study of adjuvant radiation for locally advanced p16+ oropharyngeal squamous cell carcinoma. The main purpose of this research is to determine the likelihood of cancer growing back in the throat or in the neck two years after completion of radiation if lower doses of radiation are used to a smaller area of the head and neck region than is currently used in standard of care.

A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)

Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have very good outcomes. Patients' treatment responses depend more on their individual cancer characteristics and personal risk factors than on the specific type of treatment they receive. However, the different treatments used for this cancer can cause significant side effects. Because outcomes are often favorable regardless of treatment type, reducing treatment-related side effects should be a priority when choosing care. Studies have reported that lowering radiation doses for some patients can reduce side effects while still effectively controlling the cancer. Patients with this type of head and neck cancer typically receive either surgery or radiation as their first treatment. For patients who receive surgery first, radiation to the surgical area and nearby neck lymph nodes is often recommended afterward. In these patients, the study will test whether lowering the radiation dose to low-risk lymph nodes on the side of the neck opposite the tumor can reduce side effects while still effectively controlling the cancer (Method A). For patients who receive radiation as their first treatment, the study will test one or both of two radiation approaches aimed at reducing both short-term and long-term side effects. These approaches include reduced lymph node radiation (Method A, described above) and a tumor dose reduction approach (Method B), which lowers the radiation dose delivered directly to the tumor. Information such as tumor size, the number of cancerous or suspicious lymph nodes, and risk factors like smoking history will be used to determine which patients may be eligible for reduced lymph node radiation (Method A), reduced tumor radiation (Method B), or both. Patients who may qualify for tumor dose reduction (Method B), either alone or combined with Method A, will need an additional blood test called a circulating tumor DNA (ctDNA) test to determine eligibility. The ctDNA test measures small amounts of tumor-related DNA in the blood, which are often elevated at the time of diagnosis. Studies have shown that cancer is more likely to return when ctDNA levels remain positive after treatment. This study will evaluate whether ctDNA levels measured before and during treatment can help identify patients who can safely receive lower radiation doses to the tumor (Method B). Overall, this study aims to safely evaluate two radiation de-escalation approaches in order to lessen short- and long-term side effects while maintaining excellent cancer control.

HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers

Background: For some cancers associated with human papillomavirus (HPV), standard treatments are not helpful. Researchers want to see if a vaccine for HPV combined with a drug called M7824 (MSB0011359C) has a better effect on these cancers than when they work alone. Objective: To find a safe dose of HPV vaccine alone or combined with M7824. Also, to test if either HPV vaccine alone or combined with M7824 causes a better immune response. Eligibility: People ages 18 and older with locally advanced or metastatic HPV associated cancer (Phase I) or stage II or III p16-positive oropharyngeal cancer (Phase II) Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests Possible photos of skin lesions Computed tomography (CT), magnetic resonance imaging (MRI), or nuclear bone scan: Participants will lie in a machine that takes pictures of the body. For the CT scan, they may have a contrast agent injected into a vein. Participants may have up to 2 tumor biopsies. For participants in Phase II, this may be performed with a thin tube placed through the nose into the airway. Participants will receive the HPV vaccine alone or with M7824. For participants on the Phase II, they will receive two doses of HPV vaccine under the skin either alone or with M7824 as an infusion spaced two weeks apart. This will be done prior to their planned chemoradiation or surgery. For participants on the Phase I, they will get the HPV vaccine injected under the skin 2 to 3 times in the first month. Then they will have a booster every 4 weeks. They will receive M7824 as an infusion into a vein every 2 weeks. Treatment will last up to 1 year. After they stop treatment, participants will have a visit within 4 weeks. They will then be contacted for long-term follow-up every year, for the rest of their lives. ...

De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma

The purpose of this study is to find out whether radiotherapy to some of the lymph node areas can be safely omitted to decrease side effects without increasing the risk of the tumour coming back.

Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring

This trial will evaluate the possible benefits and the performance of liquid biopsies in HPV-associated cancer treatment monitoring. This study aims to find a combination of an adequately sensitive and specific sampling method and biomarkers for early risk stratification of disease recurrence.

Surgery With or Without Neoadjuvant Treatment of SBRT Plus Chemoimmunotherapy in Resectable Locally Advanced Oral and HPV-unrelated Oropharyngeal Squamous Cell Carcinoma

The objective of this study is to evaluate the efficacy of neoadjuvant stereotactic body radiation therapy (SBRT) in combination with chemotherapy and immunotherapy, prior to radical surgery, in enhancing the 2-year event-free survival rate and overall survival rate in patients diagnosed with locally advanced oral or HPV-unrelated oropharyngeal cancer.

Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)

Investigators seek to determine the sensitivity and specificity of a combined HPV 16 DNA and host gene methylation oral biomarker panel to distinguish early Oropharyngeal Cancer (OPC) cases from controls among 100 early and 100 late disease pre-treatment OPC cases, and 200 controls matched by sex, age, race/ethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh).

EValuating the Safety Of De-escaLated Head and Neck Irradiation in HPV positivE Oropharynx Cancer in Non-smokers/Minimal Smokers

A prospective, observational study evaluating the durability of local/regional control of previously published de-escalated radiotherapy protocols for patients with P16 positive oropharynx cancers who have minimal nicotine exposure who are not current uses (\< 10 pack year smoking history; \< 10 year history of any nicotine product \[electronic cigarette, chewing tobacco\]). Quality of Life measures will also be collected.

Toripalimab in Combination With Standard Treatment for Human Papillomavirus (HPV) Positive Throat Cancer

This is a single-center phase 2 study of to test how well the combination of toripalimab with chemotherapy followed by TORS or risk and response stratified de-escalated (chemo)radiotherapy works in patients with in HPV16+ locoregionally advanced oropharyngeal cancer (OPC).

A Phase II Study for p16+ Oropharyngeal Cancer PerSonalized De-escalation Treatment at University of MIchigan (CuSToMIze)

Single center, non-randomized Phase II study enrolling Stage I-II p16+ oropharyngeal cancer patients to one of two de-escalation treatment paradigms: (1) receive surgery followed by observation or risk-adjusted adjuvant radiation (+/-chemo), or (2) individualized adaptive definitive chemoradiation (CRT).

Primary Radiotherapy Versus Primary Surgery for HPV-Associated Oropharyngeal Cancer

The goal of this randomized treatment de-escalation study is to formally compare outcomes in HPV related oropharyngeal cancer tumors treated with a primary radiotherapy versus a primary surgical approach, to provide a high level of evidence to guide the selection of treatment options for a subsequent phase III trial

Integrated Cancer Repository for Cancer Research

The iCaRe2 is a multi-institutional resource created and maintained by the Fred \& Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.

Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer

The goal of this clinical research study is to compare the use of MRI simulations to plan different doses of intensity modulated radiotherapy (IMRT) to the standard IMRT dose in patients with low risk human papilloma virus positive oropharyngeal cancer. This is an investigational study. MRI simulations and radiation therapy are delivered using FDA-approved and commercially available methods. The use of MRI imaging to plan the dose is investigational. Up to 90 participants will be enrolled in this study. All will take part at MD Anderson.

Using CircuLating Tumor DNA to Risk Adapt Post-Operative Therapy for HPV-associated Oropharyngeal Cancer

This is a single institution phase II study that will enroll patients with T0-3N0-2 p16-positive oropharyngeal squamous cell carcinoma (OSCC) undergoing resection of all gross visible disease at the primary site and in the lymph nodes.

Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer

The purpose of this study is to compare any good or bad effects of using pembrolizumab (an experimental drug) and radiation therapy (RT), compared to using cisplatin chemotherapy and radiation therapy (RT) in the treatment of patients with head and neck squamous cell carcinoma (HNSCC).

A Study Using Human Papillomavirus (HPV) DNA Testing to Detect HPV-Related Oropharyngeal Cancer (OPC)

The researchers think that a blood test (NavDx®) may be able to identify cancer early by looking for circulating DNA from Human Papillomavirus/HPV. Circulating DNA are small pieces of genes that are released into the bloodstream. The purpose of this study is to find out whether using this blood test to test for HPV DNA will help detect HPV-related Oropharyngeal Cancer/OPC.

Men and Women Offering Understanding of Throat HPV

This study will screen people for oncogenic oral Human Papillomavirus (HPV) infection and antibodies to form a cohort of people who may be at increased risk of HPV-oropharyngeal cancer (HPV-OPC). The investigators will follow these individuals prospectively to evaluate oncogenic oral HPV persistence, risk factors, and biomarkers for persistence.