CURE’s Clinical Trial Corner: October 2020

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

Non-Small Cell Lung Cancer

Calithera Biosciences announced that the first patient has been treated in the phase 2 KEAPSAKE clinical trial of the investigational glutaminase inhibitor CB-839 (telaglenastat) to treat patients with stage 4 non-squamous non-small cell lung cancer (NSCLC).

The KEAPSAKE trial is assessing the safety and activity of the investigational inhibitor in combination with Keytruda (pembrolizumab), carboplatin and Alimta (pemetrexed) for the firstline treatment of patients with non-squamous NSCLC whose disease expresses a KEAP1 or NRF tumor mutation.

Trial researchers are expected to enroll approximately 120 patients, who will be randomized to receive study drug or placebo in combination with the triplet therapy. Measuring progression-free survival will be the main goal of the study.

“Therapies that inhibit glutaminase in tumors with KEAP1/NRF2 pathway activation could have a meaningful clinical impact for a substantial percentage of people with NSCLC,” said Calithera’s CEO Susan Molineaux in a press release.

Ovarian Cancer and Mesothelioma

MaxCyte announced the expansion of an ongoing phase 1 intraperitoneal delivery and dose-escalation trial of MCY-M11 to treat patients with relapsed-refractory ovarian cancer and malignant peritoneal mesothelioma.

An anti-mesothelin CAR-PBMC cell therapy candidate, MCY-M11 is currently being investigated as a treatment for people with high mesothelin expressing solid tumors.

The study authors are aiming to assess the intraperitoneal delivery of MCY-M11 at escalating doses in additional patients with relapsed/refractory ovarian cancer and malignant peritoneal mesothelioma within the expanded cohort. With the addition of a preconditioning regimen of cyclophosphamide prior to MCY-M11 infusion.

“We are very pleased with the progress of this first-in-human trial to date, and have great hopes that we are moving closer towards bringing a more effective immunotherapeutic option for patients with solid tumors,” said MaxCyte’s chief medical officer Dr. Claudio Dansky Ullmann in a press release.

HR-Positive, HER2-Negative Advanced Breast Cancer

A ctDNA test, Signatera, will be used for treatment monitoring and the assessment of minimal residual disease in a multi-center clinical trial that is analyzing Ibrance (palbociclib) for the treatment of HR-positive, HER2-negative advanced breast cancer when administered with an aromatase inhibitor or Faslodex (fulvestrant), according to the test’s manufacturer, Natera.

“Detecting relapse before it becomes clinically symptomatic requires a test with high sensitivity and specificity,” said lead study investigator Dr. Lajos Pusztai, co-leader of the Genetics, Genomics and Epigenetics Research Program at Yale Cancer Center, in a press release. "Signatera enables us to confidently identify patients with molecular relapse when the disease burden is so low that it is undetectable with imaging. The trial will test if early intervention at this stage could delay or avert a clinical relapse."

Head and Neck Cancer

The first patient has been dosed in a phase 3 trial of Debio 1143 (xevinapant) versus placebo when combined with chemoradiotherapy to treat high-risk patients with locally advanced squamous cell carcinoma of the head and neck, according to the agent’s manufacturer, Debiopharm.

Approximately 700 patients across 25 countries are expected to be enrolled on the randomized, double-blind, placebo-controlled trial. The start of this trial follows positive results of a 3-year follow-up analysis of a phase 2 trial which demonstrated Debio 1143 induced superior and statistically significant locoregional control, progression-free survival and overall survival vs. the placebo control group.

"The launch of the TrilynX trial follows several key 2020 milestones in the development of xevinapant including the FDA (Food and Drug Administration) breakthrough designation in February and the recent presentation this fall of our clinically meaningful three-year, phase 2 data at the ESMO (European Society of Medical Oncology) virtual congress,” said Debiopharm’s CEO Bertrand Ducrey in a press release. “We expect that this large-scale trial will confirm the strong outcomes observed in phase 2, bring us a step further towards positively impacting the lives of high-risk head & neck cancer patients.”

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