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- View the latest TAPUR Study news press releases with information about study progress, growth, and collaborations.
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 |
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The tables below display cohorts that have been closed or expanded to stage II as of October 08, 2019.
Closed Cohorts
| Treatment | Cancer | Variant | Findings | Publications/Presentations |
|---|---|---|---|---|
| Cetuximab | Breast | KRAS, NRAS, BRAF wild type | Negative | Poster Presentation - 2019 AACR Annual Meeting - April 2, 2019 |
| Bronchus and lung | KRAS, NRAS, BRAF wild type | Negative | ||
| Palbociclib | Gallbladder and bile ducts | CDKN2A loss or mutation | Negative | Poster Presentation - 2018 ASCO Annual Meeting - June 4, 2018 |
| Pancreatic | CDKN2A loss or mutation | Negative | Published Manuscript - JCO Precision Oncology - August 14, 2019 Poster Presentation - 2018 ASCO Annual Meeting - June 4, 2018 |
|
| Non-small cell lung (NSCLC) | CDKN2A alterations | Positive | Poster Presentation - 2019 ASCO Annual Meeting - June 2, 2019 | |
| Sunitinib | Colorectal | FLT-3 mutation or amplification | Negative | Poster Presentation - 2019 AACR Annual Meeting - April 2, 2019 |
| Pertuzumab + Trastuzumab | Colorectal | ERBB2/ERBB3 mutation | Pending | Pending |
| Pembrolizumab | Metastatic breast | High tumor mutational burden | Positive | Poster Presentation - 2019 ASCO Annual Meeting - June 2, 2019 |
| Colorectal | High tumor mutational burden | Pending | Pending | |
| Vemurafenib + Cobimetinib | Colorectal | BRAF_V600E/D/K/R mutation | Pending | Pending |
Expanded Cohorts
| Treatment | Cancer | Variant |
|---|---|---|
| Cetuximab | Ovarian | KRAS, NRAS, BRAF wild type |
| Nivolumab + Ipilimumab | Breast | BRCA1/BRCA2 mutation |
| Ovarian | BRCA1/BRCA2 mutation | |
| Pancreatic | 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 | 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 | |
| Ovarian | ERBB2/ERBB3 amplification, mutation or overexpression | |
| Sunitinib | Breast | FGFR1 mutation or amplification |
| Gallbladder and bile ducts | FGFR2 mutation or amplification | |
| Vemurafenib + Cobimetinib | Gallbladder and Bile Ducts | BRAF_V600E/D/K/R mutation |