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Investigators plan to enroll approximately 90 patients with squamous cell carcinoma of the head and neck, as well as metastatic bladder and non-small cell lung cancer.
Keytruda (pembrolizumab) plus an investigational cancer immunotherapy have been administered to the first patient enrolled on a clinical trial assessing the combination’s safety and efficacy as a first-line treatment option for patients with a variety of cancers, according to the investigational drug’s manufacturer, IO Biotech.
The phase 2 study, known as IOB-022/KN-D38, is a basket trial, which is a practice used to investigate a new drug in patients who have different types of cancer that all have the same mutation or biomarker.
In fact, researchers have been increasingly utilizing basket trials over the past several years as they could prompt a paradigm shift across many cancer types and lead to more “tumor-agnostic” drug approvals from the Food and Drug Administration.
Investigators plan to enroll approximately 90 patients onto the IOB-022/KN-D38 trial to assess the combination’s ability to treat metastatic non-small cell lung cancer, squamous cell carcinoma of the head or neck and metastatic bladder cancer.
All eligible patients can receive treatment for up to two years.
The main aim of the trial is to evaluate the overall response rate (percentage of partial or complete responses to treatment) among those enrolled on the trial. Additionally, the investigators plan to review data regarding duration of response (defined as first observed treatment response until disease progression or death), progression-free survival (time from first treatment to first documented disease progression or death from any cause) as well as overall survival (time from start of treatment until death from any cause) and the presence of side effects.
“Initiating this study with IO102-IO103 further progresses our late-stage development program,” Mai-Britt Zocca, president and CEO of IO Biotech, said in the press release. “We believe IO102-IO103 has the potential to show utility for multiple cancer indications. We look forward to expanding our dataset in these additional indications.”
Those enrolled onto the trial must have a tumor that expresses the PD-L1 protein. Patients in the non-small cell lung cancer group cannot have known sensitizing EGFR or ALK mutations.
The study is expected to be completed by November 2024.
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