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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

Program Status

Recruiting

Phase

Phase 2

Immunotherapy-centered Trial

Yes

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

No

Drugs

Abemaciclib, afatinib, Atezolizumab and PHESGO, Atezolizumab and Talazoparib, Crizotinib, Entrectinib, Larotrectinib, Nivolumab and Ipilimumab, Olaparib, palbociclib, Pembrolizumab, Regorafenib, Sunitinib, Talazoparib, Temsirolimus, Trastuzumab and Pertuzumab, Tucatinib plus Trastuzumab Subcutaneous (SC), Vemurafenib and Cobimetinib, Cotellic, Herceptin, Perjeta, Zelboraf

Tags

MSI-H/ MMRd, MSS/ MMRp

Comments

Includes but is not limited to:
HER2 (ERBB2) CRC arm: Participants receive trastuzumab (Herceptin) and pertuzumab (Perjeta)- dosage, frequency and duration per label (ERBB2 (HER2) amplifications)

BRAF CRC arm: Participants receive vemurafenib (BRAF inhibitor, Zelboraf) and cobimetinib (MEK inhibitor, Cotellic) – dosage, frequency and duration per label BRAFV600E mutations

POLE, POLD1 mutations arm: Participants receive pembrolizumab – dosage, frequency and duration per label

Measurable disease is one of the key inclusion criteria.

Helpful Links

Location Location Status
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama 35294
Recruiting
Cancer Treatment Centers of America-Phoenix
Phoenix, Arizona 85338
Recruiting
Sutter Auburn
Auburn, California 95602
Recruiting
Sutter Alta Bates
Berkeley, California 94705
Recruiting
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
Los Angeles, California 90025
Recruiting
Kaiser Permanente - Oakland Medical Center
Oakland, California 94611
Recruiting
Sutter Palo Alto Medical Foundation: Palo Alto
Palo Alto, California 94301
Recruiting
Kaiser Permanente - Roseville Medical Center
Roseville, California 95661
Recruiting
Sutter Roseville
Roseville, California 95661
Recruiting
Kaiser Permanente - Sacramento Medical Center
Sacramento, California 95814
Recruiting
Sutter Sacramento
Sacramento, California 95816
Recruiting
Kaiser Permanente - South San Francisco Medical Center
San Francisco, California 94080
Recruiting
California Pacific Medical Center Research Institute
San Francisco, California 94115
Recruiting
Kaiser Permanente - San Francisco Medical Center
San Francisco, California 94115
Recruiting
Sutter Cancer Research Consortium
San Francisco, California 94115
Recruiting
Kaiser Permanente - San Jose Medical Center
San Jose, California 95119
Recruiting
Kaiser Permanente - San Leandro Medical Center
San Leandro, California 94577
Recruiting
Kaiser Permanente - Santa Clara Medical Center
Santa Clara, California 95051
Recruiting
Sutter Palo Alto Medical Foundation: Santa Cruz
Santa Cruz, California 95065
Recruiting
Sutter Palo Alto Medical Foundation: Fremont
Santa Cruz, California 994538
Recruiting
Sutter Palo Alto Medical Foundation: Sunnyvale
Sunnyvale, California 94086
Recruiting
Kaiser Permanente - Vallejo Medical Center
Vallejo, California 94589
Recruiting
Kaiser Permanente - Walnut Creek Medical Center
Walnut Creek, California 94596
Recruiting
Saint Vincent's Medical Center (SVMC)
Bridgeport, Connecticut 06606
Recruiting
Hartford Hospital
Hartford, Connecticut 06102
Recruiting
Midstate Medical Center (MSMC)
Meriden, Connecticut 06451
Recruiting
The Hospital of Central Connecticut (HOCC) Cancer Center
New Britain, Connecticut 06053
Recruiting
William W. Backus Hospital
Norwich, Connecticut 06360
Recruiting
Charlotte Hungerford
Torrington, Connecticut 06790
Recruiting
Windham Hospital (WH)
Willimantic, Connecticut 06226
Recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute
Altamonte Springs, Florida 32701
Recruiting
Florida Cancer Specialists South / Sarah Cannon Research Institute
Bonita Springs, Florida 34135
Recruiting
Florida Cancer Specialists South / Sarah Cannon Research Institute
Bradenton, Florida 34211
Recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute
Brandon, Florida 33511
Recruiting
Florida Cancer Specialists South / Sarah Cannon Research Institute
Cape Coral, Florida 33909
Recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute
Clearwater, Florida 33761
Recruiting
Florida Cancer Specialists East / Sarah Cannon Research Institute
Daytona Beach, Florida 32117
Recruiting
Florida Cancer Specialists Panhandle / Sarah Cannon Research Institute
Fleming Island, Florida 32003
Recruiting
Holy Cross Hospital
Fort Lauderdale, Florida 33308
Recruiting
Florida Cancer Specialists South / Sarah Cannon Research Institute
Fort Myers, Florida 33901
Recruiting
Florida Cancer Specialists South / Sarah Cannon Research Institute
Fort Myers, Florida 33905
Recruiting
Florida Cancer Specialists South / Sarah Cannon Research Institute
Fort Myers, Florida 33908
Recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute
Gainesville, Florida 32605
Recruiting
University of Florida Health
Gainesville, Florida 32610
Recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute
Largo, Florida 33770
Recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute
Lecanto, Florida 34461
Recruiting
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida 33136
Recruiting
Florida Cancer Specialists South / Sarah Cannon Research Institute
Naples, Florida 34102
Recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute
Ocala, Florida 34474
Recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute
Orange City, Florida 32763
Recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute
Orlando, Florida 32806
Recruiting
Florida Cancer Specialists South / Sarah Cannon Research Institute
Port Charlotte, Florida 33980
Recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute
Saint Petersburg, Florida 33705
Recruiting
Florida Cancer Specialists South / Sarah Cannon Research Institute
Sarasota, Florida 34232
Recruiting
Florida Cancer Specialists South / Sarah Cannon Research Institute
Sarasota, Florida 34236
Recruiting
Florida Cancer Specialists East / Sarah Cannon Research Institute
Stuart, Florida 34994
Recruiting
Florida Cancer Specialists Panhandle / Sarah Cannon Research Institute
Tallahassee, Florida 32308
Recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute
Tampa, Florida 33607
Recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute
Tavares, Florida 32778
Recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute
The Villages, Florida 32159
Recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute
Trinity, Florida 34655
Recruiting
Florida Cancer Specialists South / Sarah Cannon Research Institute
Venice, Florida 34285
Recruiting
Florida Cancer Specialists South / Sarah Cannon Research Institute
Venice, Florida 34292
Recruiting
Florida Cancer Specialists East / Sarah Cannon Research Institute
Vero Beach, Florida 32960
Recruiting
Florida Cancer Specialists East / Sarah Cannon Research Institute
Wellington, Florida 33414
Recruiting
Florida Cancer Specialists East / Sarah Cannon Research Institute
West Palm Beach, Florida 33401
Recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute
Winter Park, Florida 32789
Recruiting
Cancer Treatment Centers of America - Atlanta
Atlanta, Georgia 30265
Recruiting
Emory University Winship Cancer Institute
Atlanta, Georgia 30322
Recruiting
Gynecologic Oncology and Surgical Specialists at the Lewis Cancer & Research Pavilion
Savannah, Georgia 31405
Recruiting
Lewis Cancer & Research Pavilion at the Melanoma, Skin Cancer & Sarcoma Institute
Savannah, Georgia 31405
Recruiting
Lewis Cancer & Research Pavilion
Savannah, Georgia 31405
Recruiting
Summit Cancer Care
Savannah, Georgia 31405
Recruiting
The Queen's Medical Center (The University of Texas MD Anderson Cancer Center)
Honolulu, Hawaii 96813
Active, not recruiting
Cancer Treatment Centers of America-Chicago
Chicago, Illinois 60099
Recruiting
Community Health Network (The University of Texas MD Anderson Cancer Center)
Indianapolis, Indiana 46250
Recruiting
Harold Alfond Center for Cancer Care
Augusta, Maine 04330
Recruiting
Jackson Laboratory - Maine Cancer Genomics Initiative
Augusta, Maine 04330
Recruiting
Waldo County General Hospital
Belfast, Maine 04915
Recruiting
SMHC Cancer Care and Blood Disorders -Biddeford
Biddeford, Maine 04005
Recruiting
Northern Light Cancer Care
Brewer, Maine 04412
Recruiting
Raish Peavey Haskell Children's Cancer and Treatment Center
Brewer, Maine 04412
Recruiting
MaineHealth Cancer Care -Brunswick
Brunswick, Maine 04011
Recruiting
New England Cancer Specialist
Kennebunk, Maine 04043
Recruiting
York Hopsital Oncology & Infusion Care in Kittery
Kittery, Maine 03904
Recruiting
Stephens Memorial Hospital
Norway, Maine 04268
Recruiting
Penobscot Bay Medical Center
Rockport, Maine 04856
Recruiting
SMHC Cancer Care and Blood Disorders -Sandford
Sanford, Maine 04073
Recruiting
Maine Children's Cancer Program
Scarborough, Maine 04074
Recruiting
Maine Medical Partner's Women's Health
Scarborough, Maine 04074
Recruiting
New England Cancer Specialist
Scarborough, Maine 04074
Recruiting
MaineHealth Cancer Care -South Portland
South Portland, Maine 04106
Recruiting
New England Cancer Specialist
Topsham, Maine 04086
Recruiting
York Hospital Oncology & Infusion Care in Wells
Wells, Maine 04090
Recruiting
York Hospital Oncology & Infusion Care in York
York, Maine 03909
Recruiting
Trinity Health Ann Arbor Hospital
Ann Arbor, Michigan 48106
Recruiting
University of Michigan
Ann Arbor, Michigan 48109
Recruiting
Ascension St. John Hospital
Detroit, Michigan 48236
Recruiting
Genesys Hurley Cancer Institute
Grand Blanc, Michigan 48439
Recruiting
Cancer Research Consortium of West Michigan
Grand Rapids, Michigan 49503
Recruiting
Sparrow Hospital
Lansing, Michigan 48912
Recruiting
Trinity Health Livonia Hospital
Livonia, Michigan 48154
Recruiting
Trinity Health Oakland Hospital
Pontiac, Michigan 48341
Recruiting
Ascension St. Mary's Hospital
Saginaw, Michigan 48601
Recruiting
Michigan Cancer Research Consortium
Traverse City, Michigan 48341
Recruiting
St. John Macomb Oakland Hospital
Warren, Michigan 48093
Recruiting
University of Nebraska Medical Center
Omaha, Nebraska 68198
Recruiting
NH Oncology - Hematology, PA
Concord, New Hampshire 03103
Recruiting
Solinsky Center for Cancer Care
Manchester, New Hampshire 03103
Recruiting
New England Cancer Specialist
Portsmouth, New Hampshire 03801
Recruiting
Lovelace Medical Center - Saint Joseph Square
Albuquerque, New Mexico 87102
Recruiting
Presbyterian Kaseman Hospital
Albuquerque, New Mexico 87110
Recruiting
The University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico 87131
Recruiting
Memorial Medical Center
Las Cruces, New Mexico 88011
Recruiting
Presbyterian Rust Medical Center
Rio Rancho, New Mexico 87124
Recruiting
Northwell Health Monter Cancer Center
Lake Success, New York 11042
Recruiting
Cohen Children's Medical Center
New Hyde Park, New York 11040
Recruiting
Herbert Irving Comprehensive Cancer Center
New York, New York 10032
Recruiting
Manhattan Eye, Ear, and Throat Hospital
New York, New York 10065
Recruiting
Phelps Hospital
Sleepy Hollow, New York 10591
Recruiting
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
Recruiting
Atrium Health's Levine Cancer Institute
Charlotte, North Carolina 28277
Recruiting
Sanford Health- Bismarck
Bismarck, North Dakota 58501
Recruiting
Sanford Health- Fargo
Fargo, North Dakota 58122
Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
Recruiting
Kettering Health
Kettering, Ohio 45429
Recruiting
West Chester Hospital
West Chester, Ohio 45069
Recruiting
Providence Health & Services
Portland, Oregon 97213
Recruiting
Lehigh Valley Health Network
Allentown, Pennsylvania 18103
Recruiting
Lehigh Valley Hospital- Muhlenberg
Bethlehem, Pennsylvania 18017
Recruiting
Pocono Medical Center
East Stroudsburg, Pennsylvania 18301
Recruiting
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania 18201
Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
Recruiting
SC Cancer Specialists at St. Joseph's/Candler Bluffton
Bluffton, South Carolina 29910
Recruiting
St. Joseph's/Candler Smith
Bluffton, South Carolina 29910
Recruiting
Summit Cancer Care at St. Josph's/Candler Bluffton
Bluffton, South Carolina 29910
Recruiting
South Carolina Cancer Specialists
Hilton Head Island, South Carolina 29926
Recruiting
Sanford Cancer Center Oncology Clinic and Pharmacy
Sioux Falls, South Dakota 57104
Recruiting
Tennessee Oncology - Nashville / Sarah Cannon Research Institute
Nashville, Tennessee 37203
Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
Recruiting
Cedar City Hospital, SW Cancer Clinic, Sandra Maxwell Cancer Center
Cedar City, Utah 84720
Recruiting
Dixie Regional Medical Center-River Road Campus
Saint George, Utah 84770
Recruiting
Intermountain Healthcare
Salt Lake City, Utah 84107
Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia 22042
Recruiting
Swedish Cancer Institute
Seattle, Washington 98104
Recruiting
Aurora Cancer Care - Burlington
Burlington, Wisconsin 53105
Recruiting
Aurora Health Care - Germantown Health Center
Germantown, Wisconsin 53022
Recruiting
Aurora Cancer Care - Grafton
Grafton, Wisconsin 53024
Recruiting
Aurora BayCare Medical Center
Green Bay, Wisconsin 54311
Recruiting
Aurora Cancer Care - Kenosha South
Kenosha, Wisconsin 53142
Recruiting
Aurora Bay Area Medical Center
Marinette, Wisconsin 54143
Recruiting
Aurora Cancer Care Milwaukee
Milwaukee, Wisconsin 53209
Recruiting
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin 53215
Recruiting
Aurora Sinai Medical Center
Milwaukee, Wisconsin 53223
Recruiting
Aurora West Allis Medical Center
Milwaukee, Wisconsin 53227
Recruiting
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin 54904
Recruiting
Aurora Cancer Care - Racine
Racine, Wisconsin 53406
Recruiting
Vince Lombardi Cancer Center
Sheboygan, Wisconsin 53081
Recruiting
Aurora Medical Center in Summit
Summit, Wisconsin 53066
Recruiting
Vince Lombardi Cancer Clinic - Two Rivers
Two Rivers, Wisconsin 54241
Recruiting
Aurora Cancer Care - Milwaukee West
Wauwatosa, Wisconsin 53226
Recruiting

Contacts

Pam Mangat, MS
Contact
www.tapur.org tapur@asco.org

Inclusion Criteria

Inclusion Criteria:

12 years of age or older (*Restrictions apply. Not all therapies are available for patients 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.

Exclusion Criteria

Exclusion Criteria:

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

NCT ID

NCT02693535

Date Trial Added

2016-02-26

Updated Date

2024-01-18