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 (TAPUR)
Lymphoma, Non-Hodgkin, Multiple Myeloma, Advanced Solid Tumors
About this trial
This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring cancer, off-label, precision medicine, targeted therapy
Eligibility Criteria
Inclusion Criteria:
- 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 physicial or radiographic exam or evaluable disease (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 computed tomography (CT) scan, Magnetic Resonance Imaging (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. Patients who have assessable disease by physical or radiographic examination but do not meet these definitions of measurable disease are eligible and will be considered to have evaluable disease. 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:
- 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
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer CenterRecruiting
- Cancer Treatment Centers of America-PhoenixRecruiting
- Sutter AuburnRecruiting
- Sutter Alta BatesRecruiting
- The Angeles Clinic and Research Institute, A Cedars-Sinai AffiliateRecruiting
- Kaiser Permanente - Oakland Medical CenterRecruiting
- Sutter Palo Alto Medical Foundation: Palo AltoRecruiting
- Kaiser Permanente - Roseville Medical CenterRecruiting
- Sutter RosevilleRecruiting
- Kaiser Permanente - Sacramento Medical CenterRecruiting
- Sutter SacramentoRecruiting
- Kaiser Permanente - South San Francisco Medical CenterRecruiting
- California Pacific Medical Center Research InstituteRecruiting
- Kaiser Permanente - San Francisco Medical CenterRecruiting
- Sutter Cancer Research ConsortiumRecruiting
- Kaiser Permanente - San Jose Medical CenterRecruiting
- Kaiser Permanente - San Leandro Medical CenterRecruiting
- Kaiser Permanente - Santa Clara Medical CenterRecruiting
- Sutter Palo Alto Medical Foundation: Santa CruzRecruiting
- Sutter Palo Alto Medical Foundation: FremontRecruiting
- Sutter Palo Alto Medical Foundation: SunnyvaleRecruiting
- Kaiser Permanente - Vallejo Medical CenterRecruiting
- Kaiser Permanente - Walnut Creek Medical CenterRecruiting
- Saint Vincent's Medical Center (SVMC)Recruiting
- Hartford HospitalRecruiting
- Midstate Medical Center (MSMC)Recruiting
- The Hospital of Central Connecticut (HOCC) Cancer CenterRecruiting
- William W. Backus HospitalRecruiting
- Charlotte HungerfordRecruiting
- Windham Hospital (WH)Recruiting
- Florida Cancer Specialists North / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists South / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists South / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists North / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists South / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists North / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists East / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists Panhandle / Sarah Cannon Research InstituteRecruiting
- Holy Cross HospitalRecruiting
- Florida Cancer Specialists South / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists South / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists South / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists North / Sarah Cannon Research InstituteRecruiting
- University of Florida HealthRecruiting
- Florida Cancer Specialists North / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists North / Sarah Cannon Research InstituteRecruiting
- University of Miami Sylvester Comprehensive Cancer CenterRecruiting
- Florida Cancer Specialists South / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists North / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists North / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists North / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists South / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists North / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists South / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists South / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists East / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists Panhandle / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists North / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists North / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists North / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists North / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists South / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists South / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists East / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists East / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists East / Sarah Cannon Research InstituteRecruiting
- Florida Cancer Specialists North / Sarah Cannon Research InstituteRecruiting
- Cancer Treatment Centers of America - AtlantaRecruiting
- Emory University Winship Cancer InstituteRecruiting
- Gynecologic Oncology and Surgical Specialists at the Lewis Cancer & Research PavilionRecruiting
- Lewis Cancer & Research Pavilion at the Melanoma, Skin Cancer & Sarcoma InstituteRecruiting
- Lewis Cancer & Research PavilionRecruiting
- Summit Cancer CareRecruiting
- The Queen's Medical Center (The University of Texas MD Anderson Cancer Center)
- Cancer Treatment Centers of America-ChicagoRecruiting
- Community Health Network (The University of Texas MD Anderson Cancer Center)Recruiting
- Harold Alfond Center for Cancer CareRecruiting
- Jackson Laboratory - Maine Cancer Genomics InitiativeRecruiting
- Waldo County General HospitalRecruiting
- SMHC Cancer Care and Blood Disorders -BiddefordRecruiting
- Northern Light Cancer CareRecruiting
- Raish Peavey Haskell Children's Cancer and Treatment CenterRecruiting
- MaineHealth Cancer Care -BrunswickRecruiting
- New England Cancer SpecialistRecruiting
- York Hopsital Oncology & Infusion Care in KitteryRecruiting
- Stephens Memorial HospitalRecruiting
- Penobscot Bay Medical CenterRecruiting
- SMHC Cancer Care and Blood Disorders -SandfordRecruiting
- Maine Children's Cancer ProgramRecruiting
- Maine Medical Partner's Women's HealthRecruiting
- New England Cancer SpecialistRecruiting
- MaineHealth Cancer Care -South PortlandRecruiting
- New England Cancer SpecialistRecruiting
- York Hospital Oncology & Infusion Care in WellsRecruiting
- York Hospital Oncology & Infusion Care in YorkRecruiting
- Trinity Health Ann Arbor HospitalRecruiting
- University of MichiganRecruiting
- Ascension St. John HospitalRecruiting
- Genesys Hurley Cancer InstituteRecruiting
- Cancer Research Consortium of West MichiganRecruiting
- Sparrow HospitalRecruiting
- Trinity Health Livonia HospitalRecruiting
- Trinity Health Oakland HospitalRecruiting
- Ascension St. Mary's HospitalRecruiting
- Michigan Cancer Research ConsortiumRecruiting
- St. John Macomb Oakland HospitalRecruiting
- University of Nebraska Medical CenterRecruiting
- NH Oncology - Hematology, PARecruiting
- Solinsky Center for Cancer CareRecruiting
- New England Cancer SpecialistRecruiting
- Lovelace Medical Center - Saint Joseph SquareRecruiting
- Presbyterian Kaseman HospitalRecruiting
- The University of New Mexico Comprehensive Cancer CenterRecruiting
- Memorial Medical CenterRecruiting
- Presbyterian Rust Medical CenterRecruiting
- Northwell Health Monter Cancer CenterRecruiting
- Cohen Children's Medical CenterRecruiting
- Herbert Irving Comprehensive Cancer CenterRecruiting
- Manhattan Eye, Ear, and Throat HospitalRecruiting
- Phelps HospitalRecruiting
- Lineberger Comprehensive Cancer CenterRecruiting
- Atrium Health's Levine Cancer InstituteRecruiting
- Sanford Health- BismarckRecruiting
- Sanford Health- FargoRecruiting
- University of Cincinnati Medical CenterRecruiting
- Kettering HealthRecruiting
- West Chester HospitalRecruiting
- Providence Health & ServicesRecruiting
- Lehigh Valley Health NetworkRecruiting
- Lehigh Valley Hospital- MuhlenbergRecruiting
- Pocono Medical CenterRecruiting
- Lehigh Valley Hospital-HazletonRecruiting
- Fox Chase Cancer CenterRecruiting
- SC Cancer Specialists at St. Joseph's/Candler BlufftonRecruiting
- St. Joseph's/Candler SmithRecruiting
- Summit Cancer Care at St. Josph's/Candler BlufftonRecruiting
- South Carolina Cancer SpecialistsRecruiting
- Sanford Cancer Center Oncology Clinic and PharmacyRecruiting
- Tennessee Oncology - Nashville / Sarah Cannon Research InstituteRecruiting
- The University of Texas MD Anderson Cancer CenterRecruiting
- Cedar City Hospital, SW Cancer Clinic, Sandra Maxwell Cancer CenterRecruiting
- Dixie Regional Medical Center-River Road CampusRecruiting
- Intermountain HealthcareRecruiting
- Inova Schar Cancer InstituteRecruiting
- Swedish Cancer InstituteRecruiting
- Aurora Cancer Care - BurlingtonRecruiting
- Aurora Health Care - Germantown Health CenterRecruiting
- Aurora Cancer Care - GraftonRecruiting
- Aurora BayCare Medical CenterRecruiting
- Aurora Cancer Care - Kenosha SouthRecruiting
- Aurora Bay Area Medical CenterRecruiting
- Aurora Cancer Care MilwaukeeRecruiting
- Aurora St. Luke's Medical CenterRecruiting
- Aurora Sinai Medical CenterRecruiting
- Aurora West Allis Medical CenterRecruiting
- Vince Lombardi Cancer Clinic - OshkoshRecruiting
- Aurora Cancer Care - RacineRecruiting
- Vince Lombardi Cancer CenterRecruiting
- Aurora Medical Center in SummitRecruiting
- Vince Lombardi Cancer Clinic - Two RiversRecruiting
- Aurora Cancer Care - Milwaukee WestRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm 15
Arm 16
Arm 17
Other
Other
Other
Other
Other
Other
Other
Other
Other
Other
Other
Other
Other
Other
Other
Other
Other
Group 4 (CDKN2A, CDK4, CDK6)
Group 5 (CSF1R,PDGFR,VEGFR)
Group 6 (mTOR, TSC)
Group 8 (ERBB2)
Group 9 (BRAF V600E/D/K/R)
Group 13 (RET,VEGFR1/2/3,KIT,PDGFRβ,RAF-1,BRAF)
Group 14 (BRCA1/2; ATM)
Group 15 (POLE, POLD1)
Group 16 (MSI-H, high mutational load and others)
Group 17 (CDKN2A, CDK4, CDK6)
Group 19 (BRCA1/2, PALB2)
Group 20 (ERBB2)
Group 21 (BRCA1/2, PALB2, ATM, and others)
Group 22 (ROS1 fusion)
Group 23 (NTRK amplification)
Group 24 (ERBB2)
Group 25
Participants receive palbociclib - dosage, frequency and duration per label; acceptable genomic matches include CDKN2A loss or mutation, CDK4, CDK6 amplifications, CDKN2B loss or mutation
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
Participants receive temsirolimus - dosage, frequency and duration per label; acceptable genomic matches include mTOR, TSC1/2, AKT1 mutations
Participants receive trastuzumab and pertuzumab - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression, and specific ERBB2 mutations
Participants receive vemurafenib and cobimetinib - dosage, frequency and duration per label; acceptable genomic matches include BRAF V600E/D/K/R mutations
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
Participants receive olaparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic BRCA1/2 inactivating mutations; ATM mutations or deletions
Participants receive pembrolizumab - dosage, frequency and duration per label; acceptable genomic matches include specific POLE and POLD1 mutations
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
Participants receive abemaciclib - dosage, frequency and duration per label; acceptable genomic matches include CDKN2A loss or mutation, CDK4, CDK6 amplifications, CDKN2B loss or mutation
Participants receive talazoparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic BRCA1/2 and PALB2 mutations
Participants receive atezolizumab plus PHESGO - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression
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
Participants receive entrectinib - dosage, frequency and duration per label; acceptable genomic matches include any ROS1 fusion
Participants receive larotrectinib - dosage, frequency and duration per label; acceptable genomic matches include NTRK1/2/3 amplification
Participants receive tucatinib plus trastuzumab SC - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression, and specific ERBB2 mutations
Participants receive futibatinib- dosage, frequency and duration per label; acceptable genomic matches include FGFR 1,2,3,4 fusion (or other rearrangement) or mutation