CURE's Cancer Clinical Trial Corner: August 2019

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.

Here is a list of the recent trial initiations that occurred in August.

Gastric or Gastroesophageal Cancer

Oncologie, Inc. and Merck have entered a clinical collaboration to evaluate the combination use of bavituximab (PGN401) plus Keytruda (pembrolizumab) to treat patients with advanced gastric or gastroesophageal cancer. The trial is a phase 2, single arm, open-label study that will determine the efficacy of the combination in those who have failed at least one line of treatment. The study is expected to enroll approximately 80 patients in the U.S., United Kingdom, Korea and Taiwan, starting in the second half of this year.

Skin Cancer

The George Washington University Cancer Center the first global site for a clinical trial for patients with high-risk cutaneous squamous cell carcinoma. The study, sponsored by Regeneron in collaboration with Sanofi, is designed to determine the disease-free survival (the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer) among patients who received treatment with Libtayo (cemiplimab) compared with placebo after surgery and radiation therapy. The study is estimated to enroll over 400 participants worldwide.

Pancreatic Cancer

Soricimed Biopharma Inc. has activated an investigator-initiated clinical trial at The University of Texas MD Anderson Cancer Center — designed to evaluate SOR-C13 in late-stage pancreatic cancer. The single arm, open-label phase 1b study will refine the dosing regimen and further explore the agent’s safety and efficacy in late-stage solid tumor cancer. It is expected to enroll approximately 36 patients with advanced solid tumor cancers, with an emphasis on enrolling those patients with late-stage pancreatic cancer. The initial dose escalation cohorts will then be followed by an expansion cohort to monitor clinical response.

Advanced Solid Tumors

In the phase 1b COSMIC-021 trial — designed to evaluate the combination use of Cabometyx (cabozantinib) and Tecentriq (atezolizumab) in patients with locally advanced or metastatic solid tumors – two original cohorts are being expanded and four new cohorts are being added.

Based on encouraging preliminary activity, the original immunotherapy-refractory non-small cell lung cancer and metastatic castration-resistant prostate cancer cohorts are being expanded to 80 patients each. The two new expansion cohorts will evaluate the combination of Cabometyx and Tecentriq in patients with metastatic castration-resistant prostate cancer who have received prior Xtandi (enzalutamide) or Zytiga (abiraterone) therapy, with or without prior docetaxel therapy. The two new exploratory cohorts designed to evaluate single-agent Cabometyx and single-agent Tecentriq in patients with metastatic castration-resistant prostate cancer are being added to determine the individual contribution of each therapy.

The trial now includes 20 expansion cohorts and four exploratory cohorts and aims to enroll up to 1,732 patients with advanced or metastatic solid tumors such as renal cell carcinoma, urothelial carcinoma and more.

Prostate Cancer

Anixa Biosciences, Inc., the VA Maryland Health Care System's Baltimore VA Medical Center and the Baltimore Research and Education Foundation have teamed up to conduct the ongoing prostate cancer Cchek study that seeks to advance the Check™ liquid biopsy for prostate cancer. Enrollment of men who are at risk for prostate cancer in this yearlong study was expected to begin this month. and will include in a yearlong study.

Brain Metastases

Memorial Sloan Kettering Cancer Center will investigate the potential use of GDC-0084 in combination with radiotherapy to treat cancer that has spread to the brain in a phase 1 trial. Patients will be genetically tested for a specific alteration in the PI3K pathway, and only those with a relevant mutation will be enrolled. The trial is expected to recruit 18 to 30 patients and will take about two years to complete. The first part will aim to determine the maximum tolerated dose of GDC-0084, and once that dose has been determined, the second part of the study will enroll an additional 12 patients at that dose to explore preliminary signals of efficacy.