drugset / Trial / NCT02693535
TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer
Phase 2
Recruiting
4200 enrolled
American Society of Clinical Oncology
AstraZeneca · collabBayer · collabBoehringer Ingelheim · collabBristol-Myers Squibb · collabEli Lilly and Company · collabGenentech, Inc. · collabMerck Institute for Therapeutic Research · collabNovartis · collabPfizer · collabSeattle Genetics (now a wholly owned subsidiary of Pfizer) · collabTaiho Oncology, Inc. · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug. NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). \*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\* Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org/news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress. \*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*
Timeline
- Start
- 2016-03-14
- Primary completion
- 2027-12-31
- Completion
- 2028-12-31
Outcome
Mixed primary results
paper CONCLUSION: Pertuzumab plus trastuzumab met prespecified criteria to declare a signal of activity PMID 38748939 ↗
paper CONCLUSION: Sunitinib did not meet prespecified criteria to declare a signal of antitumor activity PMID 38354330 ↗
Publications
- Veljovich DS, Rothe M, Garrett-Mayer E, Ali-Ahmad HM, Naumann RW, Siedel J, Chan JK, Gregory A, Pisick E, Adesunloye B, Arend RC, Bell M, Frimer M, Tawfik B, Thota R, Tsimberidou AM, Mangat PK, Hinshaw DC, Gregory A, Grantham GN, Halabi S, Schilsky RL. Palbociclib in Patients With Ovarian Cancer With CDKN2A Alterations: Results From the Targeted Agent and Profiling Utilization Registry Study. JCO Precis Oncol. 2026 Jul;10(7):e2600456. doi: 10.1200/PO-26-00456. Epub 2026 Jul 15.
- Cobain EF, Rothe M, Garrett-Mayer E, Cannon TL, Chan JK, Mileham KF, Adesunloye B, Calfa CJ, Alese OB, Butler KY, Dib EG, Pisick E, Bell M, Klute KA, Mehmi I, Meric-Bernstam F, Mangat PK, Hinshaw DC, Gregory A, Grantham GN, Halabi S, Schilsky RL. Nivolumab Plus Ipilimumab in Patients With Solid Tumors With High Tumor Mutation Burden: Results From the Targeted Agent and Profiling Utilization Registry Study. JCO Precis Oncol. 2026 Apr;10(4):e2501205. doi: 10.1200/PO-25-01205. Epub 2026 Apr 30.
- Pisick E, Rothe M, Garrett-Mayer E, Srkalovic G, Chan JK, Calfa CJ, Leath CA 3rd, Marr AS, Gold PJ, Crane EK, Moyers JT, Yost Butler K, Gaba A, Thota R, Harnden KK, Alese OB, Jain A, Rueter J, Gill S, George TJ, Frimer M, Kayali F, Mangat PK, Hinshaw DC, Gregory A, Grantham GN, Halabi S, Schilsky RL. Temsirolimus in Patients With Solid Tumors With PIK3CA Mutations: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study. JCO Precis Oncol. 2026 Apr;10(4):e2500985. doi: 10.1200/PO-25-00985. Epub 2026 Apr 22.
- Carrizosa DR, Rothe M, Mangat PK, Garrett-Mayer E, Behl D, Adesunloye B, Pisick E, Beekman KW, Dotan E, Akce M, Alese OB, Sahai V, Klute KA, Aragon-Ching JB, Cooper KA, Thota R, Meric-Bernstam F, Hosein PJ, Maestas EC, Moyers JT, Powell S, Zhao S, Hobbs E, Rueter J, Sohal DPS, Taylor MA, Hinshaw DC, Gregory A, Grantham GN, Halabi S, Schilsky RL. Olaparib in Patients With Solid Tumors With ATM Alterations: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study. JCO Precis Oncol. 2026 Jan;10:e2500716. doi: 10.1200/PO-25-00716. Epub 2026 Jan 15.
- Al Baghdadi T, Rothe M, Mangat PK, Garrett-Mayer E, Crysler OV, Mileham KF, Farrington LC, Adesunloye B, Dublis SA, Astsaturov I, Calfa CJ, Bleeker J, Khalil M, Thota R, Cannon TL, Alese OB, Gold PJ, Hafez N, Baron AD, Meric-Bernstam F, Hobbs E, Marr AS, Rueter J, Tawfik B, Hinshaw DC, Gregory A, Grantham GN, Halabi S, Schilsky RL. Olaparib in Patients With Solid Tumors With BRCA1/2 Alterations: Results From The Targeted Agent and Profiling Utilization Registry (TAPUR) Study. JCO Precis Oncol. 2025 Oct;9:e2500649. doi: 10.1200/PO-25-00649. Epub 2025 Oct 16.
- Mangat PK, Kirkwood MK, Hinshaw DC, Garrett-Mayer E, Schilsky RL. Prevalence of targetable genomic alterations among a diverse population participating in the ASCO TAPUR Study. NPJ Precis Oncol. 2025 Jul 3;9(1):222. doi: 10.1038/s41698-025-00962-1.
- Worden FP, Pisick E, Rothe M, Mangat PK, Garrett-Mayer E, Khalil MF, Carrizosa DR, Bauman JR, Leidner RS, Duvivier HL, Fu S, Park MS, Yost KJ, Calfa CJ, Marr AS, Balmanoukian AS, Behl D, Cannon TL, Nabell L, Powell SF, Thota R, Hinshaw DC, Gregory A, Grantham GN, Halabi S, Schilsky RL. Palbociclib in Patients With Head and Neck Cancer and Other Tumors With CDKN2A Alterations: Results From the Targeted Agent and Profiling Utilization Registry Study. JCO Precis Oncol. 2024 Oct;8:e2400477. doi: 10.1200/PO-24-00477. Epub 2024 Oct 16.
- Schuetze S, Rothe M, Mangat PK, Garrett-Mayer E, Meric-Bernstam F, Calfa CJ, Farrington LC, Livingston MB, Wentzel K, Behl D, Kier Y, Marr AS, von Mehren M, Press JZ, Thota R, Grantham GN, Gregory A, Hinshaw DC, Halabi S, Schilsky RL. Palbociclib in Patients With Soft Tissue Sarcoma With CDK4 Amplifications: Results From the Targeted Agent and Profiling Utilization Registry Study. JCO Precis Oncol. 2024 Jul;8:e2400219. doi: 10.1200/PO.24.00219.
- Srkalovic G, Rothe M, Mangat PK, Garrett-Mayer E, Ahn ER, Brouse G, Chan J, Mehmi I, Khalil M, Duvivier HL, Gaba A, Leuva H, Thota R, Yost KJ, Grantham GN, Gregory A, Hinshaw DC, Halabi S, Schilsky RL. Talazoparib in Patients With Solid Tumors With BRCA1/2 Mutation: Results From the Targeted Agent and Profiling Utilization Registry Study. JCO Precis Oncol. 2024 Jun;8:e2400026. doi: 10.1200/PO.24.00026.
- Cannon TL, Rothe M, Mangat PK, Garrett-Mayer E, Chiu VK, Hwang J, Vijayvergia N, Alese OB, Dib EG, Duvivier HL, Klute KA, Sahai V, Ahn ER, Bedano P, Behl D, Sinclair S, Thota R, Urba WJ, Yang ES, Grantham GN, Hinshaw DC, Gregory A, Halabi S, Schilsky RL. Pertuzumab Plus Trastuzumab in Patients With Biliary Tract Cancer With ERBB2/3 Alterations: Results From the Targeted Agent and Profiling Utilization Registry Study. J Clin Oncol. 2024 Sep 20;42(27):3228-3237. doi: 10.1200/JCO.23.02078. Epub 2024 May 15.
- Perez JK, Kleber J, Rothe M, Mangat P, Garrett-Mayer E, Schilsky RL. Concordance in Molecular Tumor Board Case Reviews in the ASCO TAPUR Study. JCO Precis Oncol. 2024 Mar;8:e2300615. doi: 10.1200/PO.23.00615.
- Calfa CJ, Rothe M, Mangat PK, Garrett-Mayer E, Ahn ER, Burness ML, Gogineni K, Rohatgi N, Al Baghdadi T, Conlin A, Gaba A, Hamid O, Krishnamurthy J, Gavini NJ, Gold PJ, Rodon J, Rueter J, Thota R, Grantham GN, Hinshaw DC, Gregory A, Halabi S, Schilsky RL. Sunitinib in Patients With Breast Cancer With FGFR1 or FGFR2 Amplifications or Mutations: Results From the Targeted Agent and Profiling Utilization Registry Study. JCO Precis Oncol. 2024 Feb;8:e2300513. doi: 10.1200/PO.23.00513.
- Meric-Bernstam F, Rothe M, Mangat PK, Garrett-Mayer E, Gutierrez R, Ahn ER, Cannon TL, Powell S, Krauss JC, Reynolds CM, von Mehren M, Behl D, Calfa CJ, Duvivier HL, Kaplan HG, Livingston MB, Sharma MR, Urba WJ, Grantham GN, Hinshaw DC, Gregory A, Halabi S, Schilsky RL. Cobimetinib Plus Vemurafenib in Patients With Solid Tumors With BRAF Mutations: Results From the Targeted Agent and Profiling Utilization Registry Study. JCO Precis Oncol. 2023 Sep;7:e2300385. doi: 10.1200/PO.23.00385.
- Rohatgi N, Rothe M, Mangat PK, Garrett-Mayer E, Meric-Bernstam F, Pisick E, Alese OB, Reynolds CM, Thota R, Vaccaro GM, von Mehren M, Arend RC, Chiu VK, Duvivier HL, Gold PJ, Hack K, Marr AS, Winer A, Grantham GN, Hinshaw DC, Gregory A, Halabi S, Schilsky RL. Nivolumab Plus Ipilimumab in Patients With Solid Tumors With ATM Mutations: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study. JCO Precis Oncol. 2023 Sep;7:e2300279. doi: 10.1200/PO.23.00279.
- Duvivier HL, Rothe M, Mangat PK, Garrett-Mayer E, Ahn ER, Al Baghdadi T, Alva AS, Dublis SA, Cannon TL, Calfa CJ, Li R, Behl D, Chiu VK, Gold PJ, Marr AS, Mileham KF, Powell SF, Rodon J, Thota R, Grantham GN, Gregory A, Hinshaw DC, Halabi S, Schilsky RL. Pembrolizumab in Patients With Tumors With High Tumor Mutational Burden: Results From the Targeted Agent and Profiling Utilization Registry Study. J Clin Oncol. 2023 Nov 20;41(33):5140-5150. doi: 10.1200/JCO.23.00702. Epub 2023 Aug 10.
- Mangat PK, Garrett-Mayer E, Perez JK, Schilsky RL. The Targeted Agent and Profiling Utilization Registry Study: A pragmatic clinical trial. Clin Trials. 2023 Dec;20(6):699-707. doi: 10.1177/17407745231182013. Epub 2023 Jul 25.
- Ganti AK, Rothe M, Mangat PK, Garrett-Mayer E, Dib EG, Duvivier HL, Ahn ER, Behl D, Borghaei H, Balmanoukian AS, Gaba A, Li R, Osei-Boateng K, Thota R, Grantham GN, Gregory A, Halabi S, Schilsky RL. Pertuzumab Plus Trastuzumab in Patients With Lung Cancer With ERBB2 Mutation or Amplification: Results From the Targeted Agent and Profiling Utilization Registry Study. JCO Precis Oncol. 2023 Jun;7:e2300041. doi: 10.1200/PO.23.00041.
- Ahn ER, Rothe M, Mangat PK, Garrett-Mayer E, Ali-Ahmad HM, Chan J, Maitland ML, Patel SR, Reese Z, Balmanoukian AS, Drescher CW, Li R, Tsimberidou AM, Leath CA 3rd, O'Lone R, Grantham GN, Halabi S, Schilsky RL. Pertuzumab Plus Trastuzumab in Patients With Endometrial Cancer With ERBB2/3 Amplification, Overexpression, or Mutation: Results From the TAPUR Study. JCO Precis Oncol. 2023 Apr;7:e2200609. doi: 10.1200/PO.22.00609.
- Yang ES, Halabi S, Rothe M, Garrett-Mayer E, Mangat PK, Pisick E, Dib E, Burgess EF, Zakem M, Rohatgi N, Bilen MA, O'Lone R, Grantham GN, Schilsky RL. Olaparib in Patients With Metastatic Prostate Cancer With BRCA1/2 Mutation: Results From the TAPUR Study. JCO Precis Oncol. 2023 Feb;7:e2200505. doi: 10.1200/PO.22.00505.
- Gupta R, Meric-Bernstam F, Rothe M, Garrett-Mayer E, Mangat PK, D'Andre S, Ahn ER, O'Lone R, Halabi S, Grantham GN, Schilsky RL. Pertuzumab Plus Trastuzumab in Patients With Colorectal Cancer With ERBB2 Amplification or ERBB2/3 Mutations: Results From the TAPUR Study. JCO Precis Oncol. 2022 Oct;6:e2200306. doi: 10.1200/PO.22.00306.
- Alva AS, Mangat PK, Garrett-Mayer E, Halabi S, Hansra D, Calfa CJ, Khalil MF, Ahn ER, Cannon TL, Crilley P, Fisher JG, Haslem DS, Shrestha S, Antonelli KR, Butler NL, Warren SL, Rygiel AL, Ranasinghe S, Bruinooge SS, Schilsky RL. Pembrolizumab in Patients With Metastatic Breast Cancer With High Tumor Mutational Burden: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study. J Clin Oncol. 2021 Aug 1;39(22):2443-2451. doi: 10.1200/JCO.20.02923. Epub 2021 Apr 12.
- Fisher JG, Tait D, Garrett-Mayer E, Halabi S, Mangat PK, Schink JC, Alvarez RH, Veljovich D, Cannon TL, Crilley PA, Pollock T, Calfa CJ, Al Baghdadi T, Thota R, Fleming N, Cotta JA, Rygiel AL, Warren SL, Schilsky RL. Cetuximab in Patients with Breast Cancer, Non-Small Cell Lung Cancer, and Ovarian Cancer Without KRAS, NRAS, or BRAF Mutations: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study. Target Oncol. 2020 Dec;15(6):733-741. doi: 10.1007/s11523-020-00753-7.
- Al Baghdadi T, Garrett-Mayer E, Halabi S, Mangat PK, Rich P, Ahn ER, Chai S, Rygiel AL, Osayameh O, Antonelli KR, Islam S, Bruinooge SS, Schilsky RL. Sunitinib in Patients with Metastatic Colorectal Cancer (mCRC) with FLT-3 Amplification: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study. Target Oncol. 2020 Dec;15(6):743-750. doi: 10.1007/s11523-020-00752-8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | — | — |
| Subject | Atezolizumab | Monoclonal antibody | — | — |
| Subject | Cobimetinib | Small molecule | — | — |
| Subject | Dabrafenib | Small molecule | — | — |
| Subject | Futibatinib | Small molecule | — | — |
| Subject | Ipilimumab | Monoclonal antibody | — | — |
| Subject | Nivolumab | Monoclonal antibody | — | — |
| Subject | Olaparib | Small molecule | — | — |
| Subject | Pertuzumab | Monoclonal antibody | — | — |
| Subject | Sunitinib | Small molecule | — | Oral |
| Subject | Talazoparib | Small molecule | — | — |
| Subject | Trametinib | Small molecule | — | — |
| Subject | Trastuzumab | Monoclonal antibody | — | — |
| Subject | Trastuzumab | Monoclonal antibody | — | Subcutaneous |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | — | — |
| Subject | Tucatinib | Small molecule | — | — |
| Subject | Vemurafenib | Small molecule | — | — |