CURE’s Clinical Trial Corner: November 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.

Acute Myeloid Leukemia

Rafael Pharmaceuticals announced that more than 100 patients have been enrolled in its phase 3 Armada 2000 clinical trial.

The open-label, randomized, multicenter trial is assessing the safety and efficacy of CPI-613 (devimistat) in combination with high-dose cytarabine and mitoxantrone in patients with relapsed or refractory acute myeloid leukemia (AML), compared to high-dose cytarabine and mitoxantrone.

“The five-year survival rate for adult patients with refractory or relapsed AML is 25% or less, and treatment options that have made a significant impact in improving these rates, have not been identified,” said Dr. Jorge Cortes, director of the Georgia Cancer Center at Augusta University and principal investigator of the Armada 2000 trial, in a press release. “I continue to remain hopeful with each patient enrolled that we can give those diagnosed more options to fight this devastating disease.”

Pancreatic Cancer

An ongoing clinical trial evaluating telaglenastat in combination with Ibrance (palbociclib) is being expanded, according to telaglenastat’s manufacturer, Calithera Biosciences, to include an additional cohort of patients with pancreatic ductal adenocarcinoma whose tumors harbor both KRAS and CDKN2A mutations.

“There is a strong rationale to target KRAS and CDKN2A mutated tumors with the combination of (Ibrance) and telaglenastat,” said Calithera’s president and CEO Susan Molineaux in a release. “Mutations in CDKN2A lead to upregulation of both CDK4/6 activity and glutamine utilization in cancer cells. By inhibiting these activities simultaneously with the telaglenastat-(Ibrance) combination, we hope to have a measurable impact on pancreatic cancer, which still has very few viable treatment options.”

The aim of the additional cohort is to evaluate the safety and anti-tumor activity of the combination, according to the release.

Anal Cancer

A trial that aims to assess the efficacy of Opdivo (nivolumab) in combination with standard chemotherapy for patients with anal cancer associated with human papillomavirus (HPV) is now open and accepting patients, according to a press release.

The trial, EA2176, is the first randomized phase 3 trial ever to be conducted in patients with advanced cancer of the anal canal.

The researchers aim to enroll 205 patients in the U.S. who have inoperable squamous cell anal cancer that has spread to other parts of the body.

“The InterAAct trial established the combination of carboplatin and paclitaxel as the standard initial chemotherapy treatment for inoperable anal cancer,” said lead investigator Dr. Cathy Eng, of Vanderbilt-Ingram Cancer Center, in the release. “Now, we are taking the next step for patients, and exploring whether the addition of immunotherapy to standard chemotherapy will extend progression-free survival.”

Diffuse Large B-Cell Lymphoma

Genmab announced that it will begin a phase 3 trial of the fully human IgG1-bispecific antibody epcoritamab in patients with diffuse large b-cell lymphoma (DLBCL).

“In collaboration with AbbVie, we have planned a broad, expansive, accelerated epcoritamab clinical development plan to maximize the potential of this promising bispecific antibody, with the ultimate goal of bringing new differentiated treatment options as soon as possible to patients. We look forward to the data from this first phase 3 trial, especially for relapsed or refractory DLBCL patients, as it remains an area of high unmet medical need,” said Genmab’s CEO Jan van de Winkel in the release.

The randomized, open-label study is expected to include around 480 patients with relapsed or refractory DLBCL who failed or are ineligible for autologous stem cell transplant. Measuring overall survival is the main goal of the study.

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