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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

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

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	Active, not recruiting
Florida Cancer Specialists South / Sarah Cannon Research Institute Bonita Springs, Florida 34135	Active, not recruiting
Florida Cancer Specialists South / Sarah Cannon Research Institute Bradenton, Florida 34211	Active, not recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute Brandon, Florida 33511	Active, not recruiting
Florida Cancer Specialists South / Sarah Cannon Research Institute Cape Coral, Florida 33909	Active, not recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute Clearwater, Florida 33761	Active, not recruiting
Florida Cancer Specialists East / Sarah Cannon Research Institute Daytona Beach, Florida 32117	Active, not recruiting
Holy Cross Hospital Fort Lauderdale, Florida 33308	Recruiting
Florida Cancer Specialists South / Sarah Cannon Research Institute Fort Myers, Florida 33901	Active, not recruiting
Florida Cancer Specialists South / Sarah Cannon Research Institute Fort Myers, Florida 33905	Active, not recruiting
Florida Cancer Specialists South / Sarah Cannon Research Institute Fort Myers, Florida 33908	Active, not recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute Gainesville, Florida 32605	Active, not recruiting
University of Florida Health Gainesville, Florida 32610	Recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute Largo, Florida 33770	Active, not recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute Lecanto, Florida 34461	Active, not recruiting
University of Miami Sylvester Comprehensive Cancer Center Miami, Florida 33136	Recruiting
Florida Cancer Specialists South / Sarah Cannon Research Institute Naples, Florida 34102	Active, not recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute Ocala, Florida 34474	Active, not recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute Orange City, Florida 32763	Active, not recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute Orlando, Florida 32806	Active, not recruiting
Florida Cancer Specialists South / Sarah Cannon Research Institute Port Charlotte, Florida 33980	Active, not recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute Saint Petersburg, Florida 33705	Active, not recruiting
Florida Cancer Specialists South / Sarah Cannon Research Institute Sarasota, Florida 34232	Active, not recruiting
Florida Cancer Specialists South / Sarah Cannon Research Institute Sarasota, Florida 34236	Active, not recruiting
Florida Cancer Specialists East / Sarah Cannon Research Institute Stuart, Florida 34994	Active, not recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute Tampa, Florida 33607	Active, not recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute Tavares, Florida 32778	Active, not recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute The Villages, Florida 32159	Active, not recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute Trinity, Florida 34655	Active, not recruiting
Florida Cancer Specialists South / Sarah Cannon Research Institute Venice, Florida 34285	Active, not recruiting
Florida Cancer Specialists South / Sarah Cannon Research Institute Venice, Florida 34292	Active, not recruiting
Florida Cancer Specialists East / Sarah Cannon Research Institute Vero Beach, Florida 32960	Active, not recruiting
Florida Cancer Specialists East / Sarah Cannon Research Institute Wellington, Florida 33414	Active, not recruiting
Florida Cancer Specialists East / Sarah Cannon Research Institute West Palm Beach, Florida 33401	Active, not recruiting
Florida Cancer Specialists North / Sarah Cannon Research Institute Winter Park, Florida 32789	Active, not 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
Staten Island University Hospital New York, New York 10305	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
3. Platelets > 75,000/µl
4. Total bilirubin < 2.0 mg/ dl, except in patients with Gilbert's Syndrome
5. 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)
6. 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

2024-12-27