Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Avelumab or Hydroxychloroquine with or without Palbociclib for the Treatment of Stage II-III Breast Cancer, PALAVY Study

Breast

This phase II trial investigates the effect of avelumab or hydroxychloroquine sulfate with or without palbociclib in treating patients with stage II-III breast cancer that is positive for disseminated tumor cells (DTCs) after curative therapy. DTCs are breast cancer cells that are asleep (dormant) in the bone marrow. There are multiple ways in which these cells stay alive, and three of these mechanisms are inhibited by the drugs in this trial. First, dormant cancer cells need a protein signal pathway involving CDK 4/6 to start dividing once they wake up in order to survive as an active cancer cell. Palbociclib works by blocking the CDK 4/6 protein and by doing so may limit the dormant cancer cell from being able to survive. In addition, palbociclib may also help both of the other drugs in the trial to work better. Second, dormant cancer cells also use a process called autophagy to generate their own nutrition, which can allow them to stay asleep. Hydroxychloroquine has been shown to block autophagy, which leads to starvation of the cells. Third, dormant cancer cells are able to hide from the bodys immune system. The immune system sends a type of cell called T cells throughout the body to detect and fight infections and diseasesincluding cancers. One way the immune system controls the activity of T cells is through the PD-1/PD-L1 (programmed cell death protein-1) pathway. However, some cancer cells hide from T-cell attack by taking control of the PD-1/PD-L1 interaction and this stops T cells from attacking cancer cells. Avelumab is an antibody designed to block the PD-1/PD-L1 pathway and helps the immune system in detecting and fighting dormant cancer cells. Because palbociclib, hydroxychloroquine, and avelumab work on the mechanisms that keep the dormant cells alive, taking one or a combination of these drugs may be able to eliminate DTCs.

Disease Sites: Breast

Phase: II

Investigator: Reid, Sonya

NCTID: NCT04841148

Protocol No: VICCBRE2161

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A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema

Head/Neck

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.

Disease Sites: Head/Neck

Phase: N/A

Investigator: Murphy, Barbara

NCTID: NCT04797390

Protocol No: VICCHN2111

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Biomarker-Driven Radiation Therapy Dose Reduction after Transoral Robotic Surgery for the Treatment of HPV-Positive Oropharyngeal Cancer

Head/Neck

This phase II trial tests whether reduced dose radiation therapy after transoral robotic surgery works in treating patients with human papillomavirus (HPV)-positive oropharyngeal cancer. HPV positive oropharyngeal cancer has a better prognosis than oropharyngeal cancer not caused by HPV. A standard of care treatment for HPV positive oropharyngeal cancer is transoral robotic surgery followed by radiation therapy. However, this treatment is associated with many long-term side effects including difficulty swallowing. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving reduced dose radiation therapy after transoral robotic surgery may improve swallowing outcomes and quality of life compared to standard of care dose radiation therapy after transoral robotic surgery.

Disease Sites: Head/Neck

Phase: II

Investigator: Topf, Michael

NCTID: NCT05387915

Protocol No: VICC-ITHAN23125

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A First-in-human Study of PRTH-101 Monotherapy +/- Pembrolizumab in Subjects With Advanced Malignancies

The goal of this Open-Label Study is to evaluate the safety and tolerability of PRTH-101
alone or in combination with pembrolizumab in adults with advance or metastatic solid tumors.

Disease Sites: Not Available

Phase: I

Investigator: Berlin, Jordan

NCTID: NCT05753722

Protocol No: VICC-DTPHI23182

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Ipilimumab, Nivolumab, and Ciforadenant as First-Line Therapy for Stage IV Renal Cell Carcinoma

Multiple Cancer Types

This phase 1b/2 trial tests the safety, side effects, and best dose of ciforadenant in combination with ipilimumab and nivolumab as initial (first-line) therapy for patients with stage IV renal cell carcinoma. Ciforadenant may stimulate the immune system in different ways and stop tumor cells from growing. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ciforadenant in combination with ipilimumab and nivolumab may help control the disease.

Disease Sites: Kidney (Renal Cell), Phase I

Phase: I/II

Investigator: Beckermann, Kathryn

NCTID: NCT05501054

Protocol No: VICCUROP22122

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Sparing Bone Marrow in Patients with Stage IIB-IV Lung Cancer, VMAT Trial

Lung

This phase II trial tests whether designing radiation to avoid bone marrow in the spine (vertebral bone marrow) leads to less reduction of white blood cell counts (lymphopenia) in patients with lung cancer. This sparing technique could lead to better disease control and outcome.

Disease Sites: Lung

Phase: N/A

Investigator: Osmundson, Evan

NCTID: NCT05248256

Protocol No: VICCRAD2189

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