CURE's Clinical Trial Corner: April 2020

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

Multiple Myeloma

HealthTree, an online portal for patients with multiple myeloma, is conducting an observational study to analyze the impact the novel coronavirus (COVID-19) has on those with multiple myeloma. The study is expected to assess the effects of the COVID-19 pandemic on myeloma treatments and outcomes, as well as patient vulnerability.

“The HealthTree platform is designed as a tool to collect patient information in real time and is ideally and uniquely suited to help assess the situation that the novel coronavirus outbreak has created,” Jenny Ahlstrom, founder of the CrowdCare Foundation and HealthTree.org, said in a press release. “With a user base of more than 5,200 patients, the HealthTree platform will provide critical intelligence related to the impact of COVID-19 for myeloma patients and ultimately a broader segment of cancer patients.”

Small-Cell Lung Cancer

The first patient was treated with PLX038 in a phase 1b clinical trial for the treatment of small-cell lung cancer at the National Cancer Institute. The trial is combining PLX038, a long-acting PEGylated SN-38, with the PARP inhibitor Rubraca (rucaparib).

The researchers plan on using a “gapped-schedule” approach to avoid potential accompanying toxicities of the combination.

“The beauty of the gapped-schedule approach is that upon treatment with rucaparib, both SN-38 and rucaparib should be present in the tumor at the same time, so they should act together to exert synergistic anti-cancer effects and enhance synthetic lethality,” Dr. Daniel V. Santi, president and founder of ProLynx said in a press release.

Urothelial Carcinoma

The first patients have been dosed in separate phase 3 and phase 2 trials of infigratinib in two cancer indications.

The phase 3 trial is studying infigratinib for the adjuvant treatment of invasive urothelial carcinoma. Patients with invasive urothelial cancer harboring susceptible FGFR3 genetic alterations who are at high risk of recurrence following surgical resection will be included in the study. Disease-free survival will be the main outcome of the study.

The second trial aims to assess the efficacy of infigratinib in patients who have advanced or metastatic solid tumors that are positive for FGFR1-3 gene fusions/translocations or other FGFR alterations. The main outcome of that study is overall response rate.

Graft-Versus-Host Disease

Under a modified trial protocol, the first patient was treated in a phase 2 trial of leronlimab for the treatment of graft-versus-host disease (GvHD).

“GvHD is a life-threatening complication following bone marrow transplantation in patients with leukemia who have compromised immune systems due to treatment with aggressive cancer therapies,” Dr. Nader Pourhassan, president and chief executive officer of CytoDyn, said in a press release. “Based upon the compelling results in our preclinical studies, we are optimistic about the opportunities for leronlimab to provide a therapy for transplant patients to mitigate GvHD.”

The Food and Drug Administration previously granted orphan drug designation to leronlimab for the prevention of GvHD.