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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.

Summary of Cohort Activity in the TAPUR Study

Link to publication: Rationale and Design of the TAPUR Study published in the Journal of Clinical Oncology

The tables below display cohorts that have been closed or expanded to stage II as of April 12, 2019.

Closed Cohorts

Treatment Cancer Variant Publications/Presentations
Cetuximab Breast KRAS, NRAS, BRAF wild type Poster Presentation - 2019 AACR Annual Meeting - April 2, 2019
Bronchus and lung KRAS, NRAS, BRAF wild type
Palbociclib Gallbladder and bile ducts CDKN2A loss or mutation Poster Presentation -  2018 ASCO Annual Meeting - June 4, 2018
Pancreatic CDKN2A loss or mutation Published Manuscript - JCO Precision Oncology - August 14, 2019
Poster Presentation -  2018 ASCO Annual Meeting - June 4, 2018
Non-small cell lung (NSCLC) CDKN2A alterations Poster Presentation2019 ASCO Annual Meeting - June 2, 2019
Sunitinib Colorectal FLT-3 mutation or amplification Poster Presentation - 2019 AACR Annual Meeting - April 2, 2019
Pertuzumab + Trastuzumab Colorectal ERBB2/ERBB3 mutation Pending
Pembrolizumab Metastatic breast High tumor mutational burden Poster Presentation2019 ASCO Annual Meeting - June 2, 2019

Expanded Cohorts

Treatment Cancer Variant
Cetuximab Ovarian KRAS, NRAS, BRAF wild type
Nivolumab + Ipilimumab Breast BRCA1/BRCA2 mutation
Ovarian BRCA1/BRCA2 mutation
Olaparib Breast Somatic or germline inactivating mutations in BRCA1 or BRCA2
Bronchus and lung Somatic or germline inactivating mutations in BRCA1 or BRCA2
Colorectal ATM mutation or deletion
Gallbladder and bile ducts Somatic or germline inactivating mutations in BRCA1 or BRCA2
Prostate Somatic or germline inactivating mutations in BRCA1 or BRCA2
Pancreatic Somatic or germline inactivating mutations in BRCA1 or BRCA2
Uterine Somatic or germline inactivating mutations in BRCA1 or BRCA2
Palbociclib Bronchus and lung CDKN2A loss or mutation
Bronchus and lung CCND1 amplification
Soft tissue sarcoma CDK4 amplification
Head and neck CDKN2A loss or mutation
Ovarian CDKN2A loss or mutation
Soft tissue sarcoma CDKN2A loss or mutation
Pembrolizumab Breast High tumor mutational burden
Colorectal High tumor mutational burden 
Esophagus High tumor mutational burden
Ovarian High tumor mutational burden
Pancreatic High tumor mutational burden
Uterine High tumor mutational burden
Pertuzumab + Trastuzumab Colorectal ERBB2 amplification
Bladder ERBB2/ERBB3 amplification, mutation or overexpression
Bronchus and lung ERBB2/ERBB3 amplification, mutation or overexpression
Gallbladder and bile ducts ERBB2/ERBB3 amplification, mutation or overexpression
Uterine  ERBB2/ERBB3 amplification, mutation or overexpression
Sunitinib Breast FGFR1 mutation or amplification
Gallbladder and bile ducts FGFR2 mutation or amplification
Vemurafenib + Cobimetinib Colorectal BRAF_V600E mutation