Latest News
- 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 December 18, 2020.
Closed Cohorts
| Treatment | Cancer | Variant | Findings | Publications/Presentations |
|---|---|---|---|---|
| Cetuximab | Breast | KRAS, NRAS, BRAF wild type | Negative |
Published Manuscript - Targeted Oncology - October 22, 2020 |
| Bronchus and lung | KRAS, NRAS, BRAF wild type | Negative | ||
| Ovarian | KRAS, NRAS, BRAF wild type | Negative | ||
| Nivolumab + Ipilimumab | Colorectal | ATM mutation | Pending | Pending |
| Ovarian Cancer | BRCA1/BRCA2 mutation | Pending | Pending | |
| Olaparib | Colorectal | ATM mutation or deletion | Pending | Pending |
| Prostate | BRCA1/BRCA2 mutation | Positive | Poster Presentation - 2020 ASCO Virtual Meeting - May 29, 2020 | |
| Pancreatic | BRCA1/BRCA2 mutation | Positive | Poster Presentation - 2020 ASCO Virtual Meeting - May 29, 2020 | |
| Palbociclib | Gallbladder and bile ducts | CDKN2A loss or mutation | Negative | Published Manuscript - JCO Precision Oncology - August 14, 2019 Poster Presentation - 2018 ASCO Annual Meeting - June 4, 2018 |
| Head and neck | CDKN2A loss or mutation | Pending | Pending | |
| 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 | Published Manuscript - JCO Precision Oncology - June 25, 2020 Poster Presentation - 2019 ASCO Annual Meeting - June 2, 2019 |
|
| Soft tissue sarcoma | CDK4 amplification | Pending | Pending | |
| Pertuzumab + Trastuzumab | Colorectal | ERBB2/ERBB3 mutation | Pending | Pending |
| Colorectal | ERBB2 amplification or overexpression | Positive | Poster Presentation - 2020 ASCO GI Cancers Symposium in San Francisco, CA - January 25, 2020 | |
| Bronchus and lung | ERBB2/ERBB3 amplification, mutation or overexpression | Pending | Pending | |
| Uterine | ERBB2/ERBB3 amplification, mutation or overexpression | Pending | Pending | |
| Pembrolizumab | Metastatic breast | High tumor mutational burden | Positive | Poster Presentation - 2019 ASCO Annual Meeting - June 2, 2019 |
| Colorectal | High tumor mutational burden | Positive | Poster Presentation - 2020 ASCO GI Cancers Symposium in San Francisco, CA - January 25, 2020 | |
| Sunitinib | Breast | FGFR1 mutation or amplification | Pending | Pending |
| Colorectal | FLT-3 mutation or amplification | Negative |
Published Manuscript - Targeted Oncology - October 17, 2020 |
|
| Vemurafenib + Cobimetinib | Colorectal | BRAF_V600E/D/K/R mutation | Positive | Poster Presentation - 2020 ASCO GI Cancers Symposium in San Francisco, CA - January 25, 2020 |
Expanded Cohorts
| Treatment | Cancer | Variant |
|---|---|---|
| Nivolumab + Ipilimumab | Breast | BRCA1/BRCA2 mutation |
| Breast | High tumor mutational burden | |
| Pancreatic | BRCA1/BRCA2 mutation | |
| Colorectal | BRCA1/BRCA2 mutation | |
| Pancreatic | ATM mutation | |
| Breast | ATM mutation | |
| Olaparib | Breast | Somatic or germline inactivating mutations in BRCA1 or BRCA2 |
| Bronchus and lung | Somatic or germline inactivating mutations in BRCA1 or BRCA2 | |
| Bronchus and lung | ATM mutation or deletion | |
| Gallbladder and bile ducts | Somatic or germline inactivating mutations in BRCA1 or BRCA2 | |
| Pancreatic | ATM mutation or deletion | |
| Uterine | Somatic or germline inactivating mutations in BRCA1 or BRCA2 | |
| Palbociclib | Bronchus and lung | CCND1 amplification |
| Soft tissue sarcoma | CDKN2A loss or mutation | |
| Ovarian | CDKN2A loss or mutation | |
| Bone and Cartilage | CDKN2A loss or mutation | |
| Pembrolizumab | Esophagus | High tumor mutational burden |
| Gallbladder and bile ducts | High tumor mutational burden | |
| Ovarian | High tumor mutational burden | |
| Pancreatic | High tumor mutational burden | |
| Uterine | High tumor mutational burden | |
| Pertuzumab + Trastuzumab | Bladder | ERBB2/ERBB3 amplification, mutation or overexpression |
| Gallbladder and bile ducts | ERBB2/ERBB3 amplification, mutation or overexpression | |
| Head and Neck | ERBB2/ERBB3 amplification, mutation or overexpression | |
| Ovarian | ERBB2/ERBB3 amplification, mutation or overexpression | |
| Pancreatic | ERBB2/ERBB3 amplification, mutation or overexpression | |
| Regorafenib | Bronchus and lung | BRAF mutation or amplification |
| Sunitinib | Colorectal | FGFR1 mutation or amplification |
| Gallbladder and bile ducts | FGFR2 mutation or amplification | |
| Temsirolimus | Uterine cancer | PIK3CA mutation |
| Vemurafenib + Cobimetinib | Gallbladder and Bile Ducts | BRAF_V600E/D/K/R mutation |