CURE’s Clinical Trial Corner: April 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.

Liver Cancer

Sirtex Medical recently announced that the Food and Drug Administration (FDA) approved the DOORwaY90 trial, which aims to assess the safety and efficacy of selective internal radiation therapy (SIRT) using the company’s SIR-Spheres® Y-90 resin microspheres in patients with unresectable hepatocellular carcinoma.

The SIRT with SIR-Spheres® Y-90 resin microspheres, according to a news release from Sirtex, is a prescription device for the treatment of inoperable liver tumors which delivers high doses of high-energy beta radiation directly to the tumors. Interventional radiologists administer the therapy via a catheter into the liver arteries that supply blood to the tumors. The procedure aims to target the cancer cells, while sparing healthy tissue.

“Our therapy is used for treatment in HCC in more than 50 countries, with years of safety and efficacy,” Sirtex’s CEO Kevin Smith said in the release. “The DOORwaY90 Study has the potential to expand the FDA-approved indication for use of SIR-Spheres in the U.S., which would mark an incredible achievement in patient care.”

The single-arm study is expected to enroll 100 patients across 15 cancer centers in the United States. The study population is expected to consist of patients with stage a, b1 and b2 disease who are ineligible for resection or ablation.

Skin Cancer

The first patient has been dosed in a phase 2 study evaluating the safety and efficacy of Pvsripo alone or combined with a programmed cell death protein-1/ligand 1 (PD-1/L1) inhibitor in patients with melanoma who are resistant to these therapies, according to a news release from the agent’s manufacturer, Istari Oncology.

Pvsripo is a viral immunotherapy that activates the innate and adaptive immune system to stimulate the production of a functional, systemic anticancer CD8-positive T-cell responses, according to the release.

The open-label, phase 2, multicenter randomized LUMINOS-102 trial is expected to evaluate objective response rates, durability of responses, progression-free survival and overall survival over a 24-month period. An interim analysis is planned once the trial has accrued 20 patients and they have been treated for three months.

“Being based on the poliovirus vaccine, our team was intrigued by the potential for Pvsripo to leverage an immunological recall response to fight cancer in patients who have been vaccinated against polio. This and other unique mechanisms as well as the responses seen in the phase 1 trial encouraged us to get involved in LUMINOS-102,” Dr. Ding Wang, director of the phase 1 program and associate director of Clinical Trials Office at Henry Ford Cancer Institute in Detroit, said in the release. “LUMINOS-102 will build on these data and further evaluate the ability of Pvsripo to generate a systemic immune response, important for patients with unresectable anti–PD-1 refractory melanoma. We’re proud to be the first site to treat a participant and looking forward to continuing enrollment.”

The trial is expected to be conducted across more than 20 cancer centers in the United States, including the Henry Ford Cancer Institute.

COVID-19

The first patient has been dosed in a study aimed at assessing the benefit of interleukin-7 (IL-7) in patients with cancer who have contracted COVID-19, the Cancer Research Institute announced.

The phase 2 multi-center trial, known as ILIAD-7US-O, is expected to review the benefit of RevImmune’s CYT107 in approximately 48 patients with cancer. The trial, according to a news release, would be the first to test an IL-7 drug in those with cancer who also have COVID-19.

“This partnership allows (Cancer Research Institute) to apply RevImmune’s promising IL-7 agent in a novel setting of patients with both cancer and COVID-19, potentially offering a way to strengthen the immune system’s ability to fend off the SARS-CoV-2 coronavirus, mitigate symptoms of COVID-19, and improve overall outcomes for people living with cancer and COVID,” Jay Campbell, the managing director of Cancer Research Institute’s Venture Fund and Anna-Maria Kellen Clinical Accelerator, in a news release.

Brain Cancer

The Ivy Brain Tumor Center recently announced the dosing of its first patient in a phase 0 trial of a noninvasive drug-device combination for patients with recurrent glioblastoma and other high-grade gliomas.

The first-in-patient trial aims to assess sonodynamic therapy using a magnetic resonance-guided focused ultrasound technology in combination with a novel therapy, according to a news release.

“This novel modality may prove to be an indispensable new tool for patients, families and physicians racing against what is often a fatal disease and one that has not seen an FDA-approved drug in decades,” Shwetal Mehta, deputy director and chief operating officer of the Ivy Brain Tumor Center, said in the release. “The noninvasive aspect of this treatment is particularly unique, as we are always looking to preserve patient quality of life while aggressively treating such tumors.”

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