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
- Conditions
- Lymphoma, Non-HodgkinMultiple MyelomaAdvanced Solid Tumors
- Interventions
- Drug: SunitinibDrug: Vemurafenib and CobimetinibDrug: PalbociclibDrug: Nivolumab and IpilimumabDrug: AbemaciclibDrug: Atezolizumab and PHESGODrug: Atezolizumab and TalazoparibDrug: FutibatinibDrug: Trastuzumab and PertuzumabDrug: Tucatinib plus Trastuzumab Subcutaneous (SC)Drug: TalazoparibDrug: TemsirolimusDrug: RegorafenibDrug: OlaparibDrug: PembrolizumabDrug: EntrectinibDrug: Larotrectinib
- Registration Number
- NCT02693535
- Lead Sponsor
- American Society of Clinical Oncology
- 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).
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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.
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- Detailed Description
The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3791
-
12 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)
-
Patients must have acceptable organ function as defined below. However, as noted above, drug-specific inclusion/exclusion criteria specified in the protocol appendix for each agent will take precedence for this and all inclusion criteria:
- 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 leptomeningeal metastases are excluded.
- Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within the 3 months prior to registration. All patients with previously treated brain metastases must be clinically stable for at least 1 month after completion of treatment and off steroid treatment for one month prior to study enrollment.
- Patients with known progressive brain metastases are eligible but additional eligibility criteria apply.
Note: there are additional exclusion criteria that may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group 5 (CSF1R,PDGFR,VEGFR) Sunitinib 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 Group 9 (BRAF V600E/D/K/R) Vemurafenib and Cobimetinib Participants receive vemurafenib and cobimetinib - dosage, frequency and duration per label; acceptable genomic matches include BRAF V600E/D/K/R mutations Group 4 (CDKN2A, CDK4, CDK6) Palbociclib Participants receive palbociclib - dosage, frequency and duration per label; acceptable genomic matches include CDKN2A loss or mutation, CDK4, CDK6 amplifications, CDKN2B loss or mutation Group 16 (MSI-H, high mutational load and others) Nivolumab and Ipilimumab 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 Group 17 (CDKN2A, CDK4, CDK6) Abemaciclib Participants receive abemaciclib - dosage, frequency and duration per label; acceptable genomic matches include CDKN2A loss or mutation, CDK4, CDK6 amplifications, CDKN2B loss or mutation Group 20 (ERBB2) Atezolizumab and PHESGO Participants receive atezolizumab plus PHESGO - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression Group 21 (BRCA1/2, PALB2, ATM, and others) Atezolizumab and Talazoparib 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 Group 25 Futibatinib Participants receive futibatinib- dosage, frequency and duration per label; acceptable genomic matches include FGFR 1,2,3,4 fusion (or other rearrangement) or mutation Group 8 (ERBB2) Trastuzumab and Pertuzumab Participants receive trastuzumab and pertuzumab - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression, and specific ERBB2 mutations Group 24 (ERBB2) Tucatinib plus Trastuzumab Subcutaneous (SC) Participants receive tucatinib plus trastuzumab SC - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression, and specific ERBB2 mutations Group 19 (BRCA1/2, PALB2) Talazoparib Participants receive talazoparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic BRCA1/2 and PALB2 mutations Group 6 (mTOR, TSC) Temsirolimus Participants receive temsirolimus - dosage, frequency and duration per label; acceptable genomic matches include mTOR, TSC1/2, AKT1 mutations Group 13 (RET,VEGFR1/2/3,KIT,PDGFRβ,RAF-1,BRAF) Regorafenib 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 Group 14 (BRCA1/2; ATM) Olaparib Participants receive olaparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic BRCA1/2 inactivating mutations; ATM mutations or deletions Group 15 (POLE, POLD1) Pembrolizumab Participants receive pembrolizumab - dosage, frequency and duration per label; acceptable genomic matches include specific POLE and POLD1 mutations Group 22 (ROS1 fusion) Entrectinib Participants receive entrectinib - dosage, frequency and duration per label; acceptable genomic matches include any ROS1 fusion Group 23 (NTRK amplification) Larotrectinib Participants receive larotrectinib - dosage, frequency and duration per label; acceptable genomic matches include NTRK1/2/3 amplification
- Primary Outcome Measures
Name Time Method Objective Response Rate defined as % of participants in a cohort with complete or partial response or with stable disease according to standard response criteria Assessed at 16 weeks of treatment 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.
- Secondary Outcome Measures
Name Time Method Overall survival (OS) Duration of survival from registration on study until death from any cause, assessed throughout end of study, up to 3 years OS will be estimated using the Kaplan-Meier method
Trial Locations
- Locations (128)
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Cancer Treatment Centers of America-Phoenix
🇺🇸Phoenix, Arizona, United States
Sutter Auburn
🇺🇸Auburn, California, United States
Sutter Alta Bates
🇺🇸Berkeley, California, United States
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
🇺🇸Los Angeles, California, United States
Kaiser Permanente - Oakland Medical Center
🇺🇸Oakland, California, United States
Sutter Palo Alto Medical Foundation: Palo Alto
🇺🇸Palo Alto, California, United States
Kaiser Permanente - Roseville Medical Center
🇺🇸Roseville, California, United States
Sutter Roseville
🇺🇸Roseville, California, United States
Kaiser Permanente - Sacramento Medical Center
🇺🇸Sacramento, California, United States
Sutter Sacramento
🇺🇸Sacramento, California, United States
Kaiser Permanente - South San Francisco Medical Center
🇺🇸San Francisco, California, United States
California Pacific Medical Center Research Institute
🇺🇸San Francisco, California, United States
Kaiser Permanente - San Francisco Medical Center
🇺🇸San Francisco, California, United States
Sutter Cancer Research Consortium
🇺🇸San Francisco, California, United States
Kaiser Permanente - San Jose Medical Center
🇺🇸San Jose, California, United States
Kaiser Permanente - San Leandro Medical Center
🇺🇸San Leandro, California, United States
Kaiser Permanente - Santa Clara Medical Center
🇺🇸Santa Clara, California, United States
Sutter Palo Alto Medical Foundation: Santa Cruz
🇺🇸Santa Cruz, California, United States
Sutter Palo Alto Medical Foundation: Fremont
🇺🇸Santa Cruz, California, United States
Sutter Palo Alto Medical Foundation: Sunnyvale
🇺🇸Sunnyvale, California, United States
Kaiser Permanente - Vallejo Medical Center
🇺🇸Vallejo, California, United States
Kaiser Permanente - Walnut Creek Medical Center
🇺🇸Walnut Creek, California, United States
Saint Vincent's Medical Center (SVMC)
🇺🇸Bridgeport, Connecticut, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Midstate Medical Center (MSMC)
🇺🇸Meriden, Connecticut, United States
The Hospital of Central Connecticut (HOCC) Cancer Center
🇺🇸New Britain, Connecticut, United States
William W. Backus Hospital
🇺🇸Norwich, Connecticut, United States
Charlotte Hungerford
🇺🇸Torrington, Connecticut, United States
Windham Hospital (WH)
🇺🇸Willimantic, Connecticut, United States
Florida Cancer Specialists North / Sarah Cannon Research Institute
🇺🇸Winter Park, Florida, United States
Florida Cancer Specialists South / Sarah Cannon Research Institute
🇺🇸Venice, Florida, United States
Florida Cancer Specialists East / Sarah Cannon Research Institute
🇺🇸West Palm Beach, Florida, United States
Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
University of Florida Health
🇺🇸Gainesville, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Cancer Treatment Centers of America - Atlanta
🇺🇸Atlanta, Georgia, United States
Emory University Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Gynecologic Oncology and Surgical Specialists at the Lewis Cancer & Research Pavilion
🇺🇸Savannah, Georgia, United States
Lewis Cancer & Research Pavilion at the Melanoma, Skin Cancer & Sarcoma Institute
🇺🇸Savannah, Georgia, United States
Lewis Cancer & Research Pavilion
🇺🇸Savannah, Georgia, United States
Summit Cancer Care
🇺🇸Savannah, Georgia, United States
The Queen's Medical Center (The University of Texas MD Anderson Cancer Center)
🇺🇸Honolulu, Hawaii, United States
Cancer Treatment Centers of America-Chicago
🇺🇸Chicago, Illinois, United States
Community Health Network (The University of Texas MD Anderson Cancer Center)
🇺🇸Indianapolis, Indiana, United States
Harold Alfond Center for Cancer Care
🇺🇸Augusta, Maine, United States
Jackson Laboratory - Maine Cancer Genomics Initiative
🇺🇸Augusta, Maine, United States
Waldo County General Hospital
🇺🇸Belfast, Maine, United States
SMHC Cancer Care and Blood Disorders -Biddeford
🇺🇸Biddeford, Maine, United States
Northern Light Cancer Care
🇺🇸Brewer, Maine, United States
Raish Peavey Haskell Children's Cancer and Treatment Center
🇺🇸Brewer, Maine, United States
MaineHealth Cancer Care -Brunswick
🇺🇸Brunswick, Maine, United States
New England Cancer Specialist
🇺🇸Portsmouth, New Hampshire, United States
York Hopsital Oncology & Infusion Care in Kittery
🇺🇸Kittery, Maine, United States
Stephens Memorial Hospital
🇺🇸Norway, Maine, United States
Penobscot Bay Medical Center
🇺🇸Rockport, Maine, United States
SMHC Cancer Care and Blood Disorders -Sandford
🇺🇸Sanford, Maine, United States
Maine Children's Cancer Program
🇺🇸Scarborough, Maine, United States
Maine Medical Partner's Women's Health
🇺🇸Scarborough, Maine, United States
MaineHealth Cancer Care -South Portland
🇺🇸South Portland, Maine, United States
York Hospital Oncology & Infusion Care in Wells
🇺🇸Wells, Maine, United States
York Hospital Oncology & Infusion Care in York
🇺🇸York, Maine, United States
Trinity Health Ann Arbor Hospital
🇺🇸Ann Arbor, Michigan, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Ascension St. John Hospital
🇺🇸Detroit, Michigan, United States
Genesys Hurley Cancer Institute
🇺🇸Grand Blanc, Michigan, United States
Cancer Research Consortium of West Michigan
🇺🇸Grand Rapids, Michigan, United States
Sparrow Hospital
🇺🇸Lansing, Michigan, United States
Trinity Health Livonia Hospital
🇺🇸Livonia, Michigan, United States
Trinity Health Oakland Hospital
🇺🇸Pontiac, Michigan, United States
Ascension St. Mary's Hospital
🇺🇸Saginaw, Michigan, United States
Michigan Cancer Research Consortium
🇺🇸Traverse City, Michigan, United States
St. John Macomb Oakland Hospital
🇺🇸Warren, Michigan, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
NH Oncology - Hematology, PA
🇺🇸Concord, New Hampshire, United States
Solinsky Center for Cancer Care
🇺🇸Manchester, New Hampshire, United States
Lovelace Medical Center - Saint Joseph Square
🇺🇸Albuquerque, New Mexico, United States
Presbyterian Kaseman Hospital
🇺🇸Albuquerque, New Mexico, United States
The University of New Mexico Comprehensive Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Memorial Medical Center
🇺🇸Las Cruces, New Mexico, United States
Presbyterian Rust Medical Center
🇺🇸Rio Rancho, New Mexico, United States
Northwell Health Monter Cancer Center
🇺🇸Lake Success, New York, United States
Cohen Children's Medical Center
🇺🇸New Hyde Park, New York, United States
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
Manhattan Eye, Ear, and Throat Hospital
🇺🇸New York, New York, United States
Staten Island University Hospital
🇺🇸New York, New York, United States
Phelps Hospital
🇺🇸Sleepy Hollow, New York, United States
Lineberger Comprehensive Cancer Center
🇺🇸Chapel Hill, North Carolina, United States
Atrium Health's Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
Sanford Health- Bismarck
🇺🇸Bismarck, North Dakota, United States
Sanford Health- Fargo
🇺🇸Fargo, North Dakota, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
Kettering Health
🇺🇸Kettering, Ohio, United States
West Chester Hospital
🇺🇸West Chester, Ohio, United States
Providence Health & Services
🇺🇸Portland, Oregon, United States
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
Lehigh Valley Hospital- Muhlenberg
🇺🇸Bethlehem, Pennsylvania, United States
Pocono Medical Center
🇺🇸East Stroudsburg, Pennsylvania, United States
Lehigh Valley Hospital-Hazleton
🇺🇸Hazleton, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
SC Cancer Specialists at St. Joseph's/Candler Bluffton
🇺🇸Bluffton, South Carolina, United States
St. Joseph's/Candler Smith
🇺🇸Bluffton, South Carolina, United States
Summit Cancer Care at St. Josph's/Candler Bluffton
🇺🇸Bluffton, South Carolina, United States
South Carolina Cancer Specialists
🇺🇸Hilton Head Island, South Carolina, United States
Sanford Cancer Center Oncology Clinic and Pharmacy
🇺🇸Sioux Falls, South Dakota, United States
Tennessee Oncology - Nashville / Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Cedar City Hospital, SW Cancer Clinic, Sandra Maxwell Cancer Center
🇺🇸Cedar City, Utah, United States
Dixie Regional Medical Center-River Road Campus
🇺🇸Saint George, Utah, United States
Intermountain Healthcare
🇺🇸Salt Lake City, Utah, United States
Inova Schar Cancer Institute
🇺🇸Fairfax, Virginia, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Aurora Cancer Care - Burlington
🇺🇸Burlington, Wisconsin, United States
Aurora Health Care - Germantown Health Center
🇺🇸Germantown, Wisconsin, United States
Aurora Cancer Care - Grafton
🇺🇸Grafton, Wisconsin, United States
Aurora BayCare Medical Center
🇺🇸Green Bay, Wisconsin, United States
Aurora Cancer Care - Kenosha South
🇺🇸Kenosha, Wisconsin, United States
Aurora Bay Area Medical Center
🇺🇸Marinette, Wisconsin, United States
Aurora Cancer Care Milwaukee
🇺🇸Milwaukee, Wisconsin, United States
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Aurora West Allis Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Vince Lombardi Cancer Clinic - Oshkosh
🇺🇸Oshkosh, Wisconsin, United States
Aurora Cancer Care - Racine
🇺🇸Racine, Wisconsin, United States
Vince Lombardi Cancer Center
🇺🇸Sheboygan, Wisconsin, United States
Aurora Medical Center in Summit
🇺🇸Summit, Wisconsin, United States
Vince Lombardi Cancer Clinic - Two Rivers
🇺🇸Two Rivers, Wisconsin, United States
Aurora Cancer Care - Milwaukee West
🇺🇸Wauwatosa, Wisconsin, United States