TAPUR Study Analysis Plan and Current Status

The TAPUR Study is a phase II, non-randomized, open-label clinical trial that aims to define signals of drug activity. Participants are enrolled in cohorts defined by tumor type, genomic alteration, and study drug. Initially, up to 10 participants are enrolled in a cohort and assessed for treatment response or lack of tumor growth for at least 16 weeks. If fewer than 2 participants have a successful outcome, the cohort is permanently closed to further enrollment. If two or more participants have successful outcomes, the cohort is expanded to enroll an additional 18 participants. Once complete data from a cohort become available, the TAPUR Study Data and Safety Monitoring Board (DSMB) will review the cohort results. A signal of drug activity will be declared if at least 7 of the 28 participants experience a treatment response or a lack of tumor growth for at least 16 weeks. ASCO will then publish these study findings in peer-reviewed journals to inform clinical practice and future research.

Rationale and Design of the TAPUR Study (published in JCO Precision Oncology, 2018).

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Summary of Cohort Activity in the TAPUR Study

The tables below display cohorts that have been closed or expanded to Stage II as of March 22, 2024.

Closed Cohorts

*During data validation and verification for the manuscript, one patient that was originally reported as having a response in the 2021 AACR Annual Meeting presentation of this cohort was found instead to have no response. Efficacy findings were updated as a result.

Expanded Cohorts