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

NCT02693535 | Recruiting Phase 2 DMC

• 1 other identifier: Pro00014171
• Study Type: interventional
• Target: 4,200
• Locations: 1 country
• Sites: 174

Brief 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 TAPUR@asco.org, 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. \*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*

Conditions

Multiple Myeloma; Advanced Solid Tumors; Lymphoma, Non-Hodgkin

Keywords

cancer; off-label; precision medicine; targeted therapy

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate defined as % of participants in a cohort with complete or partial response or with stable disease according to standard response criteria

  Each cohort includes participants with the same tumor type, genomic variant and study drug. For solid tumors, the Response Evaluation Criteria for Solid Tumors (RECIST) criteria will be used, for non-Hodgkin Lymphoma, the Lugano Criteria will be used, and for multiple myeloma, the International Uniform Response Criteria for Multiple Myeloma will be used.

  Assessed at 16 weeks of treatment

Secondary Outcomes (1)

• Overall survival (OS)

  Duration of survival from registration on study until death from any cause, assessed throughout end of study, up to 3 years

Study Arms (15)

Group 4 (CDKN2A, CDK4, CDK6)

OTHER

Participants receive palbociclib - dosage, frequency and duration per label; acceptable genomic matches include CDKN2A loss or mutation, CDK4, CDK6 amplifications, CDKN2B loss or mutation

Drug: Palbociclib

Group 5 (CSF1R,PDGFR,VEGFR)

OTHER

Participants receive sunitinib - dosage, frequency and duration per label; acceptable genomic matches include CSF1R, PDGFR, VEGFR1/2/3, KIT, FLT-3, RET, FGFR1/2/3, VHL amplifications or mutations

Drug: Sunitinib

Group 6 (mTOR, TSC)

OTHER

Participants receive temsirolimus - dosage, frequency and duration per label; acceptable genomic matches include mTOR, TSC1/2, AKT1 mutations

Drug: Temsirolimus

Group 8 (ERBB2)

OTHER

Participants receive trastuzumab and pertuzumab - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression, and specific ERBB2 mutations

Drug: Trastuzumab and Pertuzumab

Group 9 (BRAF V600E/D/K/R)

OTHER

Participants receive vemurafenib and cobimetinib - dosage, frequency and duration per label; acceptable genomic matches include BRAF V600E/D/K/R mutations

Drug: Vemurafenib and Cobimetinib

Group 13 (RET,VEGFR1/2/3,KIT,PDGFRβ,RAF-1,BRAF)

OTHER

Participants receive regorafenib - dosage, frequency and duration per label; acceptable genomic matches include RET, VEGFR1/2/3, KIT, PDGFRβ, RAF-1, BRAF mutations or amplifications

Drug: Regorafenib

Group 14 (BRCA1/2; ATM)

OTHER

Participants receive olaparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic BRCA1/2 inactivating mutations; ATM mutations or deletions

Drug: Olaparib

Group 16 (MSI-H, high mutational load and others)

OTHER

Participants receive nivolumab and ipilimumab - dosage, frequency and duration per label; acceptable genomic matches include MSI high status, high tumor mutational burden, MLH1, MSH2/6, PMS2, EPCAM mutations, specific POLE or POLD1 mutations, BRCA1/2, ATM, MSH3, PMS1, MLH3, EXO1, RFC1/2/3/4/5, PCNA, RPA1/2/3/4, and SSBP1 loss of function mutations

Drug: Nivolumab and Ipilimumab

Group 17 (CDKN2A, CDK4, CDK6)

OTHER

Participants receive abemaciclib - dosage, frequency and duration per label; acceptable genomic matches include CDKN2A loss or mutation, CDK4, CDK6 amplifications, CDKN2B loss or mutation

Drug: Abemaciclib

Group 19 (BRCA1/2, PALB2)

OTHER

Participants receive talazoparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic BRCA1/2 and PALB2 mutations

Drug: Talazoparib

Group 21 (BRCA1/2, PALB2, ATM, and others)

OTHER

Participants receive atezolizumab plus talazoparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic mutations in BRCA1/2, PALB2, ATM, ATR, CHEK2, FANCA, RAD51C, NBN, MLH1, MRE11A, CDK12; positive genomic instability score reported on the Myriad MyChoice CDx test; or Genomic Loss of Heterozygosity (LOH) Score above threshold as reported on a FoundationOne CDx test or another qualifying test for TAPUR with MTB approval

Drug: Atezolizumab and Talazoparib

Group 24 (ERBB2)

OTHER

Participants receive tucatinib plus trastuzumab SC - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression, and specific ERBB2 mutations

Drug: Tucatinib plus Trastuzumab Subcutaneous (SC)

Group 25

OTHER

Participants receive futibatinib- dosage, frequency and duration per label; acceptable genomic matches include FGFR 1,2,3,4 fusion (or other rearrangement) or mutation

Drug: Futibatinib

Group 26 (BRAF V600 E mutation )

OTHER

Participants receive Dabrafenib plus Trametinib - dosage, frequency and duration per label; acceptable genomic matches include BRAF V600 E mutation .

Drug: Dabrafenib plus Trametinib

Group 27 (ERBB2 amplification, ERBB2 (HER2) IHC2+ or IHC3+ overexpression)

OTHER

Participants receive Fam-trastuzumab deruxtecan-nxki (ENHERTU®) - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification, For NSCLC Only-ERBB2 (HER2) IHC2+ or IHC3+ overexpression without ERBB2 amplification)

Drug: Fam-Trastuzumab Deruxtecan-Nxki (TDxD)

Interventions

Palbociclib DRUG

drug

Also known as: Ibrance

Group 4 (CDKN2A, CDK4, CDK6)

Sunitinib DRUG

drug

Also known as: Sutent

Group 5 (CSF1R,PDGFR,VEGFR)

Temsirolimus DRUG

drug

Also known as: Torisel

Group 6 (mTOR, TSC)

Vemurafenib and Cobimetinib DRUG

drug

Also known as: Zelboraf and Cotellic

Group 9 (BRAF V600E/D/K/R)

Regorafenib DRUG

drug

Also known as: Stivarga

Group 13 (RET,VEGFR1/2/3,KIT,PDGFRβ,RAF-1,BRAF)

Trastuzumab and Pertuzumab DRUG

drug

Also known as: Herceptin and Perjeta

Group 8 (ERBB2)

Olaparib DRUG

drug

Also known as: Lynparza

Group 14 (BRCA1/2; ATM)

Nivolumab and Ipilimumab DRUG

drug

Also known as: Opdivo and Yervoy

Group 16 (MSI-H, high mutational load and others)

Abemaciclib DRUG

drug

Also known as: Verzenio

Group 17 (CDKN2A, CDK4, CDK6)

Talazoparib DRUG

drug

Also known as: Talzenna

Group 19 (BRCA1/2, PALB2)

Atezolizumab and Talazoparib DRUG

drug

Also known as: Tecentriq and Talzenna

Group 21 (BRCA1/2, PALB2, ATM, and others)

Tucatinib plus Trastuzumab Subcutaneous (SC) DRUG

drug

Also known as: Tukysa and Herceptin Hylecta

Group 24 (ERBB2)

Futibatinib DRUG

drug

Also known as: Lytgobi

Group 25

Dabrafenib plus Trametinib DRUG

Drug

Also known as: tanfinlar, Mekinist

Group 26 (BRAF V600 E mutation )

Fam-Trastuzumab Deruxtecan-Nxki (TDxD) DRUG

Drug

Also known as: Enhertu

Group 27 (ERBB2 amplification, ERBB2 (HER2) IHC2+ or IHC3+ overexpression)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older (\*Restrictions apply. Not all therapies are available for patients \<18)
• Histologically-proven locally advanced or metastatic solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma who is no longer benefiting from standard anti-cancer treatment or for whom, in the opinion of the treating physician, no such treatment is available or indicated
• Performance status 0-2 (Per Eastern Cooperative Oncology Group (ECOG) criteria)

You may not qualify if:

• Absolute neutrophil count ≥ 1.5 x 106/µl
• Hemoglobin \> 9.0 g/dl
• Platelets \> 75,000/µl
• Total bilirubin \< 2.0 mg/ dl, except in patients with Gilbert's Syndrome
• Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) serum glutamic-pyruvic transaminase (SGPT) \< 2.5 x institutional upper limit of normal (ULN) (or \< 5 x ULN in patients with known hepatic metastases)
• Serum creatinine ≤ 1.5 × ULN or calculated or measured creatinine clearance ≥ 50 mL/min/1.73 m2
• Patients must have disease that can be objectively measured by physical or radiographic exam (per RECIST v1.1 for solid tumor, Lugano criteria for non-Hodgkin lymphoma or International Myeloma Working Group criteria for multiple myeloma), defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or a subcutaneous or superficial lesion that can be measured with calipers by clinical exam. For lymph nodes, the short axis must be ≥15 mm. Patient's whose disease cannot be objectively measured by physical or radiographic examination (e.g., elevated serum tumor marker only, bone-only disease without an identifiable soft tissue component, or patients with only assessable non-measurable disease) are NOT eligible.
• Results must be available from a genomic test or immunohistochemistry (IHC) test for protein expression performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified and College of American Pathologists (CAP)-accredited or New York State accredited (for labs offering services to residents of NY) laboratory. Labs that have registered the test with the NIH Genetic Testing Registry or that provide a report that has been designated as optimized for TAPUR participation are preferred, but not required. The genomic or IHC test used to qualify a patient for participation in TAPUR may have been performed on any specimen of the patient's tumor obtained at any point during the patient's care at the discretion of the patient's treating physician. Genomic assays performed on cell-free DNA in plasma ("liquid biopsies") will also be acceptable if the genomic analysis is performed in a laboratory that meets the criteria described above.
• Ability to understand and the willingness to sign a written informed consent/assent document.
• Have a tumor genomic profile for which single agent treatment with one of the FDA approved targeted anti-cancer drugs included in this study has potential clinical benefit based on the criteria described in protocol.
• For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.
• Because of the risks of drug treatment to the developing fetus, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation, and for four months following completion of study therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study or if she is the partner of a male participant in this study and becomes pregnant while he is participating in this study, she should inform her or her partner's treating physician immediately as well as her obstetrician. Female study patients who become pregnant must immediately discontinue treatment with any study therapy. Male patients should avoid impregnating a female partner. Male study patients, even if surgically sterilized, (i.e. post-vasectomy) must agree to one of the following: practice effective barrier contraception during the entire study treatment period and for a specified amount of time the last dose of study drug, or completely abstain from sexual intercourse.
• Note: TAPUR does not explicitly exclude any type of solid tumor, but the patient must have measurable and evaluable disease per RECIST v1.1.
• Patients whose disease is not measurable or cannot be assessed by radiographic imaging or physical examination (e.g., elevated serum tumor marker only) are not eligible
• Patients with primary brain tumors or new, untreated or progressive leptomeningeal metastases are excluded

Sponsors & Collaborators

• Novartis: collaborator
• Merck Institute for Therapeutic Research: collaborator
• AstraZeneca: collaborator
• American Society of Clinical Oncology: lead
• Bayer: collaborator
• Bristol-Myers Squibb: collaborator
• Eli Lilly and Company: collaborator
• Genentech, Inc.: collaborator
• Pfizer: collaborator
• Taiho Oncology, Inc.: collaborator
• Boehringer Ingelheim: collaborator
• Seattle Genetics (now a wholly owned subsidiary of Pfizer): collaborator

Study Sites (174)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

RECRUITING

Cancer Treatment Centers of America-Phoenix

Phoenix, Arizona, 85338, United States

RECRUITING

Sutter Auburn

Auburn, California, 95602, United States

RECRUITING

Sutter Alta Bates

Berkeley, California, 94705, United States

RECRUITING

The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate

Los Angeles, California, 90025, United States

RECRUITING

Kaiser Permanente - Oakland Medical Center

Oakland, California, 94611, United States

RECRUITING

Sutter Palo Alto Medical Foundation: Palo Alto

Palo Alto, California, 94301, United States

RECRUITING

Kaiser Permanente - Roseville Medical Center

Roseville, California, 95661, United States

RECRUITING

Sutter Roseville

Roseville, California, 95661, United States

RECRUITING

Kaiser Permanente - Sacramento Medical Center

Sacramento, California, 95814, United States

RECRUITING

Sutter Sacramento

Sacramento, California, 95816, United States

RECRUITING

Kaiser Permanente - South San Francisco Medical Center

San Francisco, California, 94080, United States

RECRUITING

California Pacific Medical Center Research Institute

San Francisco, California, 94115, United States

RECRUITING

Kaiser Permanente - San Francisco Medical Center

San Francisco, California, 94115, United States

RECRUITING

Sutter Cancer Research Consortium

San Francisco, California, 94115, United States

RECRUITING

Kaiser Permanente - San Jose Medical Center

San Jose, California, 95119, United States

RECRUITING

Kaiser Permanente - San Leandro Medical Center

San Leandro, California, 94577, United States

RECRUITING

Sutter Sansum Clinic

Santa Barbara, California, 93105, United States

RECRUITING

Kaiser Permanente - Santa Clara Medical Center

Santa Clara, California, 95051, United States

RECRUITING

Sutter Palo Alto Medical Foundation: Santa Cruz

Santa Cruz, California, 95065, United States

RECRUITING

Sutter Palo Alto Medical Foundation: Fremont

Santa Cruz, California, 994538, United States

RECRUITING

Sutter Palo Alto Medical Foundation: Sunnyvale

Sunnyvale, California, 94086, United States

RECRUITING

Kaiser Permanente - Vallejo Medical Center

Vallejo, California, 94589, United States

RECRUITING

Kaiser Permanente - Walnut Creek Medical Center

Walnut Creek, California, 94596, United States

RECRUITING

Saint Vincent's Medical Center (SVMC)

Bridgeport, Connecticut, 06606, United States

RECRUITING

Hartford Hospital

Hartford, Connecticut, 06102, United States

RECRUITING

Midstate Medical Center (MSMC)

Meriden, Connecticut, 06451, United States

RECRUITING

The Hospital of Central Connecticut (HOCC) Cancer Center

New Britain, Connecticut, 06053, United States

RECRUITING

William W. Backus Hospital

Norwich, Connecticut, 06360, United States

RECRUITING

Charlotte Hungerford

Torrington, Connecticut, 06790, United States

RECRUITING

Windham Hospital (WH)

Willimantic, Connecticut, 06226, United States

RECRUITING

Florida Cancer Specialists North / Sarah Cannon Research Institute

Altamonte Springs, Florida, 32701, United States

ACTIVE NOT RECRUITING

University of Miami/Sylvester Cancer Institute - Aventura

Aventura, Florida, 33180, United States

RECRUITING

Florida Cancer Specialists South / Sarah Cannon Research Institute

Bonita Springs, Florida, 34135, United States

ACTIVE NOT RECRUITING

Florida Cancer Specialists South / Sarah Cannon Research Institute

Bradenton, Florida, 34211, United States

ACTIVE NOT RECRUITING

Florida Cancer Specialists North / Sarah Cannon Research Institute

Brandon, Florida, 33511, United States

ACTIVE NOT RECRUITING

Florida Cancer Specialists South / Sarah Cannon Research Institute

Cape Coral, Florida, 33909, United States

ACTIVE NOT RECRUITING

Florida Cancer Specialists North / Sarah Cannon Research Institute

Clearwater, Florida, 33761, United States

ACTIVE NOT RECRUITING

University of Miami/Sylvester Cancer Institute - Lennar

Coral Gables, Florida, 33146, United States

RECRUITING

University of Miami/Sylvester Cancer Institute - Deerfield Beach

Deerfield Beach, Florida, 33442, United States

RECRUITING

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

RECRUITING

Florida Cancer Specialists South / Sarah Cannon Research Institute

Fort Myers, Florida, 33901, United States

ACTIVE NOT RECRUITING

Florida Cancer Specialists South / Sarah Cannon Research Institute

Fort Myers, Florida, 33905, United States

ACTIVE NOT RECRUITING

Florida Cancer Specialists South / Sarah Cannon Research Institute

Fort Myers, Florida, 33908, United States

ACTIVE NOT RECRUITING

Florida Cancer Specialists North / Sarah Cannon Research Institute

Gainesville, Florida, 32605, United States

ACTIVE NOT RECRUITING

University of Florida Health

Gainesville, Florida, 32610, United States

RECRUITING

Florida Cancer Specialists North / Sarah Cannon Research Institute

Largo, Florida, 33770, United States

ACTIVE NOT RECRUITING

Florida Cancer Specialists North / Sarah Cannon Research Institute

Lecanto, Florida, 34461, United States

ACTIVE NOT RECRUITING

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

RECRUITING

University of Miami/Sylvester Cancer Institute - Alex's Place

Miami, Florida, 33136, United States

RECRUITING

University of Miami/Sylvester Cancer Institute - Griffin Cancer Research Building

Miami, Florida, 33136, United States

RECRUITING

University of Miami/Sylvester Cancer Institute - Kendall

Miami, Florida, 33176, United States

RECRUITING

University of Miami/Sylvester Cancer Institute - Sole Mia

Miami, Florida, 33181, United States

RECRUITING

Florida Cancer Specialists South / Sarah Cannon Research Institute

Naples, Florida, 34102, United States

ACTIVE NOT RECRUITING

Florida Cancer Specialists North / Sarah Cannon Research Institute

Ocala, Florida, 34474, United States

ACTIVE NOT RECRUITING

Florida Cancer Specialists North / Sarah Cannon Research Institute

Orange City, Florida, 32763, United States

ACTIVE NOT RECRUITING

Florida Cancer Specialists North / Sarah Cannon Research Institute

Orlando, Florida, 32806, United States

ACTIVE NOT RECRUITING

University of Miami/Sylvester Cancer Institute - Plantation

Plantation, Florida, 33324, United States

RECRUITING

Florida Cancer Specialists South / Sarah Cannon Research Institute

Port Charlotte, Florida, 33980, United States

ACTIVE NOT RECRUITING

Florida Cancer Specialists South / Sarah Cannon Research Institute

Sarasota, Florida, 34232, United States

ACTIVE NOT RECRUITING

Florida Cancer Specialists South / Sarah Cannon Research Institute

Sarasota, Florida, 34236, United States

ACTIVE NOT RECRUITING

Florida Cancer Specialists North / Sarah Cannon Research Institute

St. Petersburg, Florida, 33701, United States

ACTIVE NOT RECRUITING

Florida Cancer Specialists North / Sarah Cannon Research Institute

Tampa, Florida, 33607, United States

ACTIVE NOT RECRUITING

Florida Cancer Specialists North / Sarah Cannon Research Institute

Tavares, Florida, 32778, United States

ACTIVE NOT RECRUITING

Florida Cancer Specialists North / Sarah Cannon Research Institute

The Villages, Florida, 32159, United States

ACTIVE NOT RECRUITING

Florida Cancer Specialists North / Sarah Cannon Research Institute

Trinity, Florida, 34655, United States

ACTIVE NOT RECRUITING

Florida Cancer Specialists South / Sarah Cannon Research Institute

Venice, Florida, 34285, United States

ACTIVE NOT RECRUITING

Florida Cancer Specialists South / Sarah Cannon Research Institute

Venice, Florida, 34292, United States

ACTIVE NOT RECRUITING

Florida Cancer Specialists North / Sarah Cannon Research Institute

Winter Park, Florida, 32789, United States

ACTIVE NOT RECRUITING

Cancer Treatment Centers of America - Atlanta

Atlanta, Georgia, 30265, United States

RECRUITING

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Gynecologic Oncology and Surgical Specialists at the Lewis Cancer & Research Pavilion

Savannah, Georgia, 31405, United States

RECRUITING

Lewis Cancer & Research Pavilion at the Melanoma, Skin Cancer & Sarcoma Institute

Savannah, Georgia, 31405, United States

RECRUITING

Lewis Cancer & Research Pavilion

Savannah, Georgia, 31405, United States

RECRUITING

Summit Cancer Care

Savannah, Georgia, 31405, United States

RECRUITING

The Queen's Medical Center - POB I

Honolulu, Hawaii, 96813, United States

RECRUITING

The Queen's Medical Center - Punchbowl

Honolulu, Hawaii, 96813, United States

RECRUITING

The Queen's Medical Center - Kuakini

Honolulu, Hawaii, 96817, United States

RECRUITING

The Queen's Medical Center - West Oahu

‘Ewa Beach, Hawaii, 96706, United States

RECRUITING

Cancer Treatment Centers of America-Chicago

Chicago, Illinois, 60099, United States

RECRUITING

Community Health Network (The University of Texas MD Anderson Cancer Center)

Indianapolis, Indiana, 46250, United States

RECRUITING

Harold Alfond Center for Cancer Care

Augusta, Maine, 04330, United States

RECRUITING

Jackson Laboratory - Maine Cancer Genomics Initiative

Augusta, Maine, 04330, United States

RECRUITING

Waldo County General Hospital

Belfast, Maine, 04915, United States

RECRUITING

SMHC Cancer Care and Blood Disorders -Biddeford

Biddeford, Maine, 04005, United States

RECRUITING

Northern Light Cancer Care

Brewer, Maine, 04412, United States

RECRUITING

Raish Peavey Haskell Children's Cancer and Treatment Center

Brewer, Maine, 04412, United States

RECRUITING

MaineHealth Cancer Care -Brunswick

Brunswick, Maine, 04011, United States

RECRUITING

New England Cancer Specialist

Kennebunk, Maine, 04043, United States

RECRUITING

York Hopsital Oncology & Infusion Care in Kittery

Kittery, Maine, 03904, United States

RECRUITING

Stephens Memorial Hospital

Norway, Maine, 04268, United States

RECRUITING

Penobscot Bay Medical Center

Rockport, Maine, 04856, United States

RECRUITING

SMHC Cancer Care and Blood Disorders -Sandford

Sanford, Maine, 04073, United States

RECRUITING

Maine Children's Cancer Program

Scarborough, Maine, 04074, United States

RECRUITING

Maine Medical Partner's Women's Health

Scarborough, Maine, 04074, United States

RECRUITING

New England Cancer Specialist

Scarborough, Maine, 04074, United States

RECRUITING

MaineHealth Cancer Care -South Portland

South Portland, Maine, 04106, United States

RECRUITING

New England Cancer Specialist

Topsham, Maine, 04086, United States

RECRUITING

York Hospital Oncology & Infusion Care in Wells

Wells, Maine, 04090, United States

RECRUITING

York Hospital Oncology & Infusion Care in York

York Village, Maine, 03909, United States

RECRUITING

Trinity Health Ann Arbor Hospital

Ann Arbor, Michigan, 48106, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

ACTIVE NOT RECRUITING

Henry Ford Health Saint John Hospital

Detroit, Michigan, 48236, United States

RECRUITING

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

RECRUITING

Cancer Research Consortium of West Michigan

Grand Rapids, Michigan, 49503, United States

RECRUITING

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, 48912, United States

RECRUITING

Trinity Health Livonia Hospital

Livonia, Michigan, 48154, United States

RECRUITING

Trinity Health Oakland Hospital

Pontiac, Michigan, 48341, United States

RECRUITING

MyMichigan Medical Center Saginaw

Saginaw, Michigan, 48601, United States

RECRUITING

Michigan Cancer Research Consortium

Traverse City, Michigan, 48341, United States

RECRUITING

Henry Ford Health Warren Hospital

Warren, Michigan, 48093, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

NH Oncology - Hematology, PA

Concord, New Hampshire, 03103, United States

RECRUITING

Solinsky Center for Cancer Care

Manchester, New Hampshire, 03103, United States

RECRUITING

New England Cancer Specialist

Portsmouth, New Hampshire, 03801, United States

RECRUITING

Lovelace Medical Center - Saint Joseph Square

Albuquerque, New Mexico, 87102, United States

RECRUITING

Presbyterian Kaseman Hospital

Albuquerque, New Mexico, 87110, United States

RECRUITING

The University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, 87131, United States

RECRUITING

Memorial Medical Center

Las Cruces, New Mexico, 88011, United States

RECRUITING

Presbyterian Rust Medical Center

Rio Rancho, New Mexico, 87124, United States

RECRUITING

Northwell Health Monter Cancer Center

Lake Success, New York, 11042, United States

RECRUITING

Northern Westchester Hospital

Mount Kisco, New York, 10549, United States

RECRUITING

Cohen Children's Medical Center

New Hyde Park, New York, 11040, United States

RECRUITING

Manhattan Eye, Ear, and Throat Hospital

New York, New York, 10065, United States

RECRUITING

Staten Island University Hospital

New York, New York, 10305, United States

RECRUITING

Queens Cancer Center

Rego Park, New York, 11374, United States

RECRUITING

Phelps Hospital

Sleepy Hollow, New York, 10591, United States

RECRUITING

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Atrium Health's Levine Cancer Institute

Charlotte, North Carolina, 28277, United States

RECRUITING

Sanford Health- Bismarck

Bismarck, North Dakota, 58501, United States

RECRUITING

Sanford Health- Fargo

Fargo, North Dakota, 58122, United States

RECRUITING

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

Kettering Health

Kettering, Ohio, 45429, United States

RECRUITING

West Chester Hospital

West Chester, Ohio, 45069, United States

RECRUITING

Providence Health & Services

Portland, Oregon, 97213, United States

RECRUITING

Lehigh Valley Hospital - Cedar Crest

Allentown, Pennsylvania, 18103, United States

RECRUITING

Lehigh Valley Hospital- Muhlenberg

Bethlehem, Pennsylvania, 18017, United States

RECRUITING

Pocono Medical Center

East Stroudsburg, Pennsylvania, 18301, United States

RECRUITING

Lehigh Valley Hospital-Hazleton

Hazleton, Pennsylvania, 18201, United States

RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

SC Cancer Specialists at St. Joseph's/Candler Bluffton

Bluffton, South Carolina, 29910, United States

RECRUITING

St. Joseph's/Candler Smith

Bluffton, South Carolina, 29910, United States

RECRUITING

Summit Cancer Care at St. Josph's/Candler Bluffton

Bluffton, South Carolina, 29910, United States

RECRUITING

South Carolina Cancer Specialists

Hilton Head Island, South Carolina, 29926, United States

RECRUITING

Sanford Cancer Center Oncology Clinic and Pharmacy

Sioux Falls, South Dakota, 57104, United States

RECRUITING

Tennessee Oncology - Nashville / Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Cedar City Hospital, SW Cancer Clinic, Sandra Maxwell Cancer Center

Cedar City, Utah, 84720, United States

RECRUITING

Intermountain Healthcare

Salt Lake City, Utah, 84107, United States

RECRUITING

Dixie Regional Medical Center-River Road Campus

St. George, Utah, 84770, United States

RECRUITING

Inova Schar Cancer Institute

Fairfax, Virginia, 22042, United States

RECRUITING

Northwest Medical Specialties

Bonney Lake, Washington, 98391, United States

RECRUITING

Northwest Medical Specialties

Federal Way, Washington, 98003, United States

RECRUITING

Northwest Medical Specialties

Gig Harbor, Washington, 98332, United States

RECRUITING

Northwest Medical Specialties

Olympia, Washington, 98502, United States

RECRUITING

Northwest Medical Specialties

Puyallup, Washington, 98373, United States

RECRUITING

Swedish Cancer Institute

Seattle, Washington, 98104, United States

RECRUITING

Northwest Medical Specialties

Tacoma, Washington, 98405, United States

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Aurora Cancer Care - Burlington

Burlington, Wisconsin, 53105, United States

RECRUITING

Aurora Health Care - Germantown Health Center

Germantown, Wisconsin, 53022, United States

RECRUITING

Aurora Cancer Care - Grafton

Grafton, Wisconsin, 53024, United States

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Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311, United States

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Aurora Cancer Care - Kenosha South

Kenosha, Wisconsin, 53142, United States

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Aurora Bay Area Medical Center

Marinette, Wisconsin, 54143, United States

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Aurora Cancer Care Milwaukee

Milwaukee, Wisconsin, 53209, United States

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Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

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Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53223, United States

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Aurora West Allis Medical Center

Milwaukee, Wisconsin, 53227, United States

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Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, 54904, United States

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Aurora Cancer Care - Racine

Racine, Wisconsin, 53406, United States

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Vince Lombardi Cancer Center

Sheboygan, Wisconsin, 53081, United States

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Aurora Medical Center in Summit

Summit, Wisconsin, 53066, United States

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Vince Lombardi Cancer Clinic - Two Rivers

Two Rivers, Wisconsin, 54241, United States

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Aurora Cancer Care - Milwaukee West

Wauwatosa, Wisconsin, 53226, United States

RECRUITING

Related Publications (20)

• 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.

  PMID: 41538762 DERIVED

• 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.

  PMID: 41100773 DERIVED

• 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.

  PMID: 40610648 DERIVED

• 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.

  PMID: 39413339 DERIVED

• 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.

  PMID: 39013131 DERIVED

• 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.

  PMID: 38865672 DERIVED

• 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.

  PMID: 38748939 DERIVED

• 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.

  PMID: 38564684 DERIVED

• 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.

  PMID: 38354330 DERIVED

• 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.

  PMID: 38096472 DERIVED

• 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.

  PMID: 38039429 DERIVED

• 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.

  PMID: 37561967 DERIVED

• 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.

  PMID: 37489819 DERIVED

• 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.

  PMID: 37315265 DERIVED

• 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.

  PMID: 37027810 DERIVED

• 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.

  PMID: 36753688 DERIVED

• 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.

  PMID: 36315917 DERIVED

• 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.

  PMID: 33844595 DERIVED

• 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.

  PMID: 33090333 DERIVED

• 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.

  PMID: 33068284 DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Multiple Myeloma; Neoplasms

Interventions

palbociclib; Sunitinib; temsirolimus; Trastuzumab; pertuzumab; Vemurafenib; cobimetinib; regorafenib; olaparib; Nivolumab; Ipilimumab; abemaciclib; talazoparib; atezolizumab; tucatinib; futibatinib; dabrafenib; trametinib

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Central Study Contacts

Pam Mangat, MS

CONTACT

www.tapur.org; tapur@asco.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: February 26, 2016
• Study Start: March 14, 2016
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-04

Locations

US (174)