Clinical Trials

Clinical trial studies targeted therapy for PARP-resistant tumors and chemotherapy-resistant small cell lung cancer

Anish Thomas, M.B.B.S., M.D., Lasker Clinical Research Scholar in the Developmental Therapeutics Branch, is leading a study using a berzosertib-sacituzumab govitecan combination to target ATR, a key protein involved in an alternative DNA repair pathway used by chemotherapy and PARP inhibitor-resistant cancer cells.

brain tissue before exposure to the experimental nanoparticles

Immunotherapy studied in clinical trial for glioblastoma or gliosarcoma

Adults with glioblastoma (GBM) or gliosarcoma may be eligible to participate in a clinical trial at the NIH Clinical Center. GBM and gliosarcoma tumors can suppress the immune system so immune cells cannot work effectively within the brain. Mark Gilbert, M.D., Chief of the Neuro-Oncology Branch, is leading a study to see if this suppression can be reversed with immune checkpoint inhibitors.

Clinical trial evaluates reduced dosing of cyclophosphamide to prevent severe acute graft-versus-host disease

Christopher G. Kanakry, M.D., Lasker Clinical Research Scholar in the Experimental Transplantation and Immunotherapy Branch, is leading a study that may help people with cancers that begin in blood-forming tissue who are at high risk for graft-versus-host disease (GVHD) following bone marrow transplant. This study will evaluate if reduced dosing of cyclophosphamide is effective in preventing severe acute GVHD.

Clinical trial evaluates the effect of Minnelide on advanced pancreatic cancer

Adenosquamous carcinoma of the pancreas (ASCP) is a rare type of pancreatic cancer that is particularly aggressive. Christine Campo Alewine, M.D., Ph.D., Lasker Clinical Research Scholar in the Laboratory of Molecular Biology, is conducting a study to see if the drug Minnelide can effectively treat ASCP.

screenshot of colorectal peritoneal metastasis

Clinical trial studies surgical treatment for adults with peritoneal carcinomatosis

Andrew M. Blakely, M.D., Assistant Research Physician in the Surgical Oncology Program, is leading a surgical study for adults with peritoneal carcinomatosis that tests two chemotherapy treatments, called HIPEC, simulated in a tissue-testing platform.

Areas of the body affected by von Hippel-Lindau (VHL) disease. Credit: NCI Visuals

FDA approves belzutifan, first drug for cancers associated with von Hippel-Lindau disease

On August 13, 2021, the Food and Drug Administration approved belzutifan, a new drug for adult patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC), central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery.

Ramaprasad Srinivasan, M.D., Ph.D., Investigator in the Urologic Oncology Branch (UOB), designed the ongoing study and played a key leadership role as the principal investigator on the cooperative research and development agreement under which NCI served as a site in the study. Belzutifan is now the first and only approved systemic therapy for certain patients with VHL-associated RCC.

VHL disease is a rare, inherited disorder that causes tumors and cysts to grow in certain parts of the body. Patients with this disease have an increased risk of certain types of cancer, especially kidney cancer and pancreatic cancer. The VHL gene was originally identified by Marston Linehan, M.D., and colleagues in the UOB in the 1990s, and the group continues to define the methods for clinical management of VHL disease.

New study tests drug combination for treatment of biliary tract cancer

Biliary tract cancer (BTC) is a cancer that arises from the bile ducts that carry bile, a digestive fluid, through the liver. There are few treatment options for BTC. Tim F. Greten, M.D., Deputy Chief of the Thoracic and GI Malignancies Branch, is leading a study of a drug combination that may prolong survival in adults with BTC.

Clinical trial investigates drug combination for relapsed small cell lung cancers and advanced neuroendocrine cancers

Anish Thomas, M.B.B.S., M.D., Lasker Clinical Research Scholar in the Developmental Therapeutics Branch (DTB), and Jaydira Del Rivero, M.D., Assistant Research Physician in DTB, are heading a trial testing the safety and efficacy of berzosertib, an ATR inhibitor, in combination with lurbinectedin to treat relapsed small cell lung cancer or high-grade neuroendocrine cancers.

A collection of cancer cells surrounded by immune cells

Clinical trial will test triple-drug combination against aggressive colon and HPV-associated cancers

CCR researchers are exploring whether a special cocktail of drugs, which collectively make cancer cells vulnerable and the immune system stronger, will yield better outcomes for patients with difficult-to-treat cancers. Preliminary research in preclinical models suggests that the triple-drug combination is more effective than just one or two of the drugs being administered.

Microscopic image of oral chronic graft-versus-host disease

Collaborative study leads to FDA approval of belumosudil for chronic graft-versus-host disease

The Food and Drug Administration (FDA) approved belumosudil on July 16, 2021, for people 12 years and older with chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy. Chronic GVHD is a complex condition that can be life threatening and occurs when donated stem cells attack healthy tissues in a patient’s body. Steven Z. Pavletic, M.D., M.S., Senior Clinician in the Immune Deficiency Cellular Therapy Program, guided CCR’s involvement in the pivotal consortium study that led to FDA approval of belumosudil. Pavletic was part of the trial clinical leadership at CCR, one of the 28 centers that enrolled study patients. The study found belumosudil to be safe and well-tolerated, and it may have the potential to improve overall patient well-being.

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