CURE’s Clinical Trial Corner: February 2021

As the cancer treatment landscape continues to expand, patients and their caregivers should be aware of the various clinical trials currently being conducted — including studies they can possibly join.

Prostate Cancer

Bayer and Orion Corporation recently announced the launch of a new phase 3 study to investigate the safety and efficacy of Nubeqa (darolutamide) plus androgen deprivation therapy versus placebo plus androgen deprivation therapy for the treatment of metastatic hormone-sensitive prostate cancer.

“Nubeqa has already shown in men with non-metastatic castration-resistant prostate cancer that it extends metastasis-free and overall survival,” Dr. Scott Z. Fields, senior vice president and head of Oncology Development at Bayer's Pharmaceutical Division, said in a company-issued press release. “Given the encouraging results that we have seen with Nubeqa so far, it is important that we also evaluate the potential of Nubeqa in other stages of prostate cancer that may offer men with (metastatic hormone-sensitive prostate cancer) a new treatment option.”

The new randomized, double-blind, placebo-controlled trial (ARANOTE) is expected to enroll 555 men. The main goal of the study, according to the release, is to assess radiological progression-free survival (the time from treatment to disease progression or worsening).

Multiple Myeloma

Cartesian Therapeutics recently announced the beginning of a phase 2a trial assessing Descartes-11 (an mRNA CAR-T cell therapy) in patients with newly diagnosed, high-risk multiple myeloma.

The manufacturer anticipates enrolling 30 patients with newly diagnosed, high-risk myeloma across multiple cancer centers in the United States. The goal of the study, according to the release, is to assess the safety and early efficacy of the CAR-T cell therapy in patients who have completed a pre-transplant anti-myeloma drug combination regimen but still have residual disease.

“Patients newly diagnosed with high-risk multiple myeloma seldom achieve deep, durable responses after frontline therapy,” Dr. Kenneth Anderson, Kraft Family Professor of Medicine at Harvard Medical School and Program Director of the Jerome Lipper Multiple Myeloma Center and LeBow Institute for Myeloma Therapeutics, said in a company-issued press release. “Integrating a CAR-T cell therapy into our standard of care, without using lymphodepleting chemotherapy, would be a welcome addition to our toolkit for treating this currently incurable disease.”

Urothelial Cancer

Rutgers Cancer Institute of New Jersey has treated its first patient with upper tract urothelial cancer with a recently approved treatment option.

The drug, Jelmyto (mitomycin gel), became the first approved therapy to treat this patient population.

“It’s important to understand the indications for this drug, so visiting a center with expertise in (upper tract urothelial cancer) is essential,” Dr. Saum Ghodoussipour, director of the Bladder and Urothelial Cancer Program at Rutgers Cancer Institute, said in a press release. “While (Jelmyto) gives patients a good non-surgical option, it’s not necessarily for every patient and if there is recurrence after the treatment, the management of (upper tract urothelial cancer) can be complex, requiring multidisciplinary care from urologists, medical oncologists, pathologists and radiologists.”

Lung Cancer

The Addario Lung Cancer Medical Institute and GO2 Foundation for Lung Cancer recently announced the start of a new study to assess the underlying causes of lung cancer diagnoses in people under the age of 40.

The Epidemiology of Young Lung Cancer study aims to survey 250 patients who were diagnosed before they turned 40. The confidential survey will ask questions about a patient’s medical history, demographics, environmental exposures and other lifestyle questions. Participants are also going to be asked to provide a blood sample for further study.

“Patients hold the key to research. Now that we have confirmed that young lung cancer looks different than other lung cancer, discovering the how and why of it through epidemiology will be critical to our ongoing efforts to prevent, diagnose early, and more effectively treat lung cancer in young patients,” Bonnie J. Addario, GO2 Foundation co-founder, board chair, and stage 3b lung cancer survivor, said in a release. “What we learn from young lung cancer will also help unlock answers for the entire lung cancer community.”

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