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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 (TAPUR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02693535
Recruitment Status : Recruiting
First Posted : February 26, 2016
Last Update Posted : May 18, 2023
Sponsor:
Collaborators:
AstraZeneca
Bayer
Bristol-Myers Squibb
Eli Lilly and Company
Genentech, Inc.
Merck Sharp & Dohme LLC
Pfizer
Boehringer Ingelheim
Seagen Inc.
Taiho Oncology, Inc.
Information provided by (Responsible Party):
American Society of Clinical Oncology

Study Description
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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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Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Multiple Myeloma Advanced Solid Tumors Drug: Palbociclib Drug: Sunitinib Drug: Temsirolimus Drug: Trastuzumab and Pertuzumab Drug: Vemurafenib and Cobimetinib Drug: Regorafenib Drug: Olaparib Drug: Pembrolizumab Drug: Nivolumab and Ipilimumab Drug: Abemaciclib Drug: Talazoparib Drug: Atezolizumab and PHESGO Drug: Atezolizumab and Talazoparib Drug: Entrectinib Drug: Larotrectinib Drug: Tucatinib plus Trastuzumab Subcutaneous (SC) Drug: Futibatinib Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3791 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Actual Study Start Date : March 14, 2016
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Group 4 (CDKN2A, CDK4, CDK6)
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
drug
Other Name: Ibrance
Group 5 (CSF1R,PDGFR,VEGFR)
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
drug
Other Name: Sutent
Group 6 (mTOR, TSC)
Participants receive temsirolimus - dosage, frequency and duration per label; acceptable genomic matches include mTOR, TSC1/2, AKT1 mutations
 Drug: Temsirolimus
drug
Other Name: Torisel
Group 8 (ERBB2)
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
drug
Other Name: Herceptin and Perjeta
Group 9 (BRAF V600E/D/K/R)
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
drug
Other Name: Zelboraf and Cotellic
Group 13 (RET,VEGFR1/2/3,KIT,PDGFRβ,RAF-1,BRAF)
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
drug
Other Name: Stivarga
Group 14 (BRCA1/2; ATM)
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
drug
Other Name: Lynparza
Group 15 (POLE, POLD1)
Participants receive pembrolizumab - dosage, frequency and duration per label; acceptable genomic matches include specific POLE and POLD1 mutations
 Drug: Pembrolizumab
drug
Other Name: Keytruda
Group 16 (MSI-H, high mutational load and others)
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
drug
Other Name: Opdivo and Yervoy
Group 17 (CDKN2A, CDK4, CDK6)
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
drug
Other Name: Verzenio
Group 19 (BRCA1/2, PALB2)
Participants receive talazoparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic BRCA1/2 and PALB2 mutations
 Drug: Talazoparib
drug
Other Name: Talzenna
Group 20 (ERBB2)
Participants receive atezolizumab plus PHESGO - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression
 Drug: Atezolizumab and PHESGO
drug
Other Name: Tecentriq and PHESGO
Group 21 (BRCA1/2, PALB2, ATM, and others)
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
drug
Other Name: Tecentriq and Talzenna
Group 22 (ROS1 fusion)
Participants receive entrectinib - dosage, frequency and duration per label; acceptable genomic matches include any ROS1 fusion
 Drug: Entrectinib
drug
Other Name: Rozlytrek
Group 23 (NTRK amplification)
Participants receive larotrectinib - dosage, frequency and duration per label; acceptable genomic matches include NTRK1/2/3 amplification
 Drug: Larotrectinib
drug
Other Name: Vitrakvi
Group 24 (ERBB2)
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)
drug
Other Name: Tukysa and Herceptin Hylecta
Group 25
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
drug
Other Name: Lytgobi


Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: 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 :
  1. Overall survival (OS) [ Time Frame: 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    1. Absolute neutrophil count ≥ 1.5 x 106/µl
    2. Hemoglobin > 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:

  • 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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02693535


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

Locations
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United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Susan Pruitt    205-975-7265    smpruitt@uabmc.edu   
Principal Investigator: Mehmet Akce, MD         
United States, Arizona
Cancer Treatment Centers of America-Phoenix Recruiting
Phoenix, Arizona, United States, 85338
Contact: Jessica Coats, MS, RN, CCRC    623-207-3899    jessica.coats@ctca-hope.com   
Principal Investigator: Ashish Sangal, MD         
United States, California
Sutter Auburn Recruiting
Auburn, California, United States, 95602
Contact: Kirsten Babski    916-878-4990    BabskiK@sutterhealth.org   
Sutter Alta Bates Recruiting
Berkeley, California, United States, 94705
Contact: Vivian Leong, RN    510-204-3428    leongv@sutterhealth.org   
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate Recruiting
Los Angeles, California, United States, 90025
Contact: Saba Mukarram    310-231-2181    smukarram@theangelesclinic.org   
Principal Investigator: Omid Hamid, MD         
Kaiser Permanente - Oakland Medical Center Recruiting
Oakland, California, United States, 94611
Contact: Desiree Goldstein       desiree.goldstein@kp.org   
Principal Investigator: Jennifer M Suga, MD         
Sutter Palo Alto Medical Foundation: Palo Alto Recruiting
Palo Alto, California, United States, 94301
Contact       clinicaltrials@pamf.org   
Kaiser Permanente - Roseville Medical Center Recruiting
Roseville, California, United States, 95661
Contact: Desiree Goldstein       desiree.goldstein@kp.org   
Principal Investigator: Jennifer M Suga, MD         
Sutter Roseville Recruiting
Roseville, California, United States, 95661
Contact: Kirsten Babski    916-878-4990    BabskiK@sutterhealth.org   
Kaiser Permanente - Sacramento Medical Center Recruiting
Sacramento, California, United States, 95814
Contact: Desiree Goldstein       desiree.goldstein@kp.org   
Principal Investigator: Jennifer M Suga, MD         
Sutter Sacramento Recruiting
Sacramento, California, United States, 95816
Contact: Isabel Rodrigues-Fong    916-454-6628    RodrigI@sutterhealth.org   
Kaiser Permanente - South San Francisco Medical Center Recruiting
San Francisco, California, United States, 94080
Contact: Desiree Goldstein       desiree.goldstein@kp.org   
Principal Investigator: Jennifer M Suga, MD         
California Pacific Medical Center Research Institute Recruiting
San Francisco, California, United States, 94115
Contact    415-600-1654    clinicalresearch@sutterhealth.org   
Principal Investigator: Deepti Behl, MD         
Kaiser Permanente - San Francisco Medical Center Recruiting
San Francisco, California, United States, 94115
Contact: Desiree Goldstein       desiree.goldstein@kp.org   
Principal Investigator: Jennifer M Suga, MD         
Sutter Cancer Research Consortium Recruiting
San Francisco, California, United States, 94115
Contact: Laurel Brechtel    415-600-1654    BrechtLa@cpmcri.org   
Principal Investigator: Stacy D'Andre, MD         
Kaiser Permanente - San Jose Medical Center Recruiting
San Jose, California, United States, 95119
Contact: Desiree Goldstein       desiree.goldstein@kp.org   
Principal Investigator: Jennifer M Suga, MD         
Kaiser Permanente - San Leandro Medical Center Recruiting
San Leandro, California, United States, 94577
Contact: Desiree Goldstein       desiree.goldstein@kp.org   
Principal Investigator: Jennifer M Suga, MD         
Kaiser Permanente - Santa Clara Medical Center Recruiting
Santa Clara, California, United States, 95051
Contact: Desiree Goldstein       desiree.goldstein@kp.org   
Principal Investigator: Jennifer M Suga, MD         
Sutter Palo Alto Medical Foundation: Santa Cruz Recruiting
Santa Cruz, California, United States, 95065
Contact       clinicaltrials@pamf.org   
Sutter Palo Alto Medical Foundation: Fremont Recruiting
Santa Cruz, California, United States, 994538
Contact       clinicaltrials@pamf.org   
Sutter Palo Alto Medical Foundation: Sunnyvale Recruiting
Sunnyvale, California, United States, 94086
Contact       clinicaltrials@pamf.org   
Kaiser Permanente - Vallejo Medical Center Recruiting
Vallejo, California, United States, 94589
Contact: Desiree Goldstein       desiree.goldstein@kp.org   
Principal Investigator: Jennifer M. Suga, MD         
Kaiser Permanente - Walnut Creek Medical Center Recruiting
Walnut Creek, California, United States, 94596
Contact: Desiree Goldstein       desiree.goldstein@kp.org   
Principal Investigator: Jennifer M Suga, MD         
United States, Connecticut
Saint Vincent's Medical Center (SVMC) Recruiting
Bridgeport, Connecticut, United States, 06606
Contact    860-972-4700    CancerResearchSupport@hhchealth.org   
Principal Investigator: Wylie Hosmer, MD         
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06002
Contact    860-972-4700    CancerResearchSupport@hhchealth.org   
Midstate Medical Center (MSMC) Recruiting
Meriden, Connecticut, United States, 06451
Contact    860-972-4700    CancerResearchSupport@hhchealth.org   
Principal Investigator: Wylie Hosmer, MD         
The Hospital of Central Connecticut (HOCC) Cancer Center Recruiting
New Britain, Connecticut, United States, 06053
Contact    860-972-4700    CancerResearchSupport@hhchealth.org   
Principal Investigator: Wylie Hosmer, MD         
William W. Backus Hospital Recruiting
Norwich, Connecticut, United States, 06360
Contact    860-972-4700    CancerResearchSupport@hhchealth.org   
Principal Investigator: Wylie Hosmer, MD         
Charlotte Hungerford Recruiting
Torrington, Connecticut, United States, 06790
Contact    860-972-4700    CancerResearchSupport@hhchealth.org   
Principal Investigator: Wylie Hosmer, MD         
Windham Hospital (WH) Recruiting
Willimantic, Connecticut, United States, 06226
Contact    860-972-4700    CancerResearchSupport@hhchealth.org   
Principal Investigator: Wylie Hosmer, MD         
United States, Florida
Holy Cross Hospital Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Stephanie Couch    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi, MD         
Florida Cancer Specialists South / Sarah Cannon Research Institute Recruiting
Fort Myers, Florida, United States, 33901
Contact       ClinicalTrials@flcancer.com   
Principal Investigator: Fadi Kayali, MD         
University of Florida Health Recruiting
Gainesville, Florida, United States, 32610
Contact: Nghi Lam, MS    352-265-5329    Nghi.Lam@cancer.ufl.edu   
Principal Investigator: Thomas George, MD         
University of Miami Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Carolina Troche, BS    305-243-1481    cxt582@med.miami.edu   
Principal Investigator: Carmen Calfa, MD         
Florida Cancer Specialists North / Sarah Cannon Research Institute Recruiting
Saint Petersburg, Florida, United States, 33705
Contact       ClinicalTrials@flcancer.com   
Principal Investigator: David Wright, MD         
Florida Cancer Specialists Panhandle / Sarah Cannon Research Institute Recruiting
Tallahassee, Florida, United States, 32308
Contact       ClinicalTrials@flcancer.com   
Principal Investigator: Viralkumar Bhanderi, MD         
Florida Cancer Specialists East / Sarah Cannon Research Institute Recruiting
West Palm Beach, Florida, United States, 33401
Contact       ClinicalTrials@flcancer.com   
Principal Investigator: Shachar Peles, MD         
United States, Georgia
Cancer Treatment Centers of America - Atlanta Recruiting
Atlanta, Georgia, United States, 30265
Contact: Mittie Mitchell, RN    770-400-7194    Mittie.Mitchell@ctca-hope.com   
Principal Investigator: Herbert L. Duvivier, MD         
Emory University Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Suzanne Scott    404-778-4083    suzanne.e.scott@emory.edu   
Principal Investigator: Olatunji Alese, MD         
Gynecologic Oncology and Surgical Specialists at the Lewis Cancer & Research Pavilion Recruiting
Savannah, Georgia, United States, 31405
Contact: Stephanie Smith, RN, MSN, OCN    912-819-5723    smiths1@sjchs.org   
Principal Investigator: Mark Taylor, MD         
Lewis Cancer & Research Pavilion at the Melanoma, Skin Cancer & Sarcoma Institute Recruiting
Savannah, Georgia, United States, 31405
Contact: Stephanie Smith, RN, MSN, OCN    912-819-5723    smiths1@sjchs.org   
Principal Investigator: Mark Taylor, MD         
Lewis Cancer & Research Pavilion Recruiting
Savannah, Georgia, United States, 31405
Contact: Stephanie Smith, RN, MSN, OCN    912-819-5723    smiths1@sjchs.org   
Principal Investigator: Mark Taylor, MD         
Summit Cancer Care Recruiting
Savannah, Georgia, United States, 31405
Contact: Stephanie Smith, RN, MSN, OCN    912-819-5723    smiths1@sjchs.org   
Principal Investigator: Mark Taylor, MD         
United States, Hawaii
The Queen's Medical Center (The University of Texas MD Anderson Cancer Center) Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Amanda Eckert, MPH    713-745-8074    ACEckert@mdanderson.org   
Principal Investigator: Funda Meric-Bernstam, MD         
United States, Illinois
Cancer Treatment Centers of America-Chicago Recruiting
Chicago, Illinois, United States, 60099
Contact: Fola Arowora, MS, MPH    847-872-6434    Fola.Arowora@ctca-hope.com   
Principal Investigator: Eugene Ahn, MD         
United States, Indiana
Community Health Network (The University of Texas MD Anderson Cancer Center) Recruiting
Indianapolis, Indiana, United States, 46250
Contact: Amanda Eckert, MPH    713-745-8074    ACEckert@mdanderson.org   
Principal Investigator: Funda Meric-Bernstam, MD         
United States, Maine
Harold Alfond Center for Cancer Care Recruiting
Augusta, Maine, United States, 04330
Contact: Sandra Neptune, BSN, RN    207-626-4811    sandra.neptune@mainegeneral.org   
Principal Investigator: Rachit Kumar, MD         
Jackson Laboratory - Maine Cancer Genomics Initiative Recruiting
Augusta, Maine, United States, 04330
Contact: Petra Helbig, CCRP    207-664-4659    Petra.Helbig@jax.org   
Principal Investigator: Jens Rueter, MD         
Waldo County General Hospital Recruiting
Belfast, Maine, United States, 04915
Contact: Jen Dalton, MHA, BSN, RN    207-294-8291    JDalton@mmc.org   
Principal Investigator: Roger Inhorn, MD         
SMHC Cancer Care and Blood Disorders -Biddeford Recruiting
Biddeford, Maine, United States, 04005
Contact: Jen Dalton    207-294-8291    JDalton@mmc.org   
Principal Investigator: Roger Inhorn, MD         
Northern Light Cancer Care Recruiting
Brewer, Maine, United States, 04412
Contact: Carla Mancini, MHA, BSN, RN    207-973-5581    cmancini@northernlight.org   
Principal Investigator: Sarah Sinclair, MD         
Raish Peavey Haskell Children's Cancer and Treatment Center Recruiting
Brewer, Maine, United States, 04412
Contact: Carla C Mancini, RN, BSN, OCN    207-973-5581    cmancini@northernlight.org   
Principal Investigator: Sarah Sinclair, MD         
MaineHealth Cancer Care -Brunswick Recruiting
Brunswick, Maine, United States, 04011
Contact: Jen Dalton, MHA, BSN, RN    207-294-8291    JDalton@mmc.org   
Principal Investigator: Roger Inhorn, MD         
New England Cancer Specialist Recruiting
Kennebunk, Maine, United States, 04043
Contact: Patricia C Collins    207-303-3422    collip@newecs.org   
Principal Investigator: Christian Thomas, MD         
York Hopsital Oncology & Infusion Care in Kittery Recruiting
Kittery, Maine, United States, 03904
Contact: Brenda i Kiberd, RN    207-361-6115    Brenda.Kiberd@yorkhospital.com   
Principal Investigator: Marilyn McLaughlin, MD         
Stephens Memorial Hospital Recruiting
Norway, Maine, United States, 04268
Contact: Jen Dalton, MHA, BSN, RN    207-294-8291    JDalton@mmc.org   
Principal Investigator: Roger Inhorn, MD         
Penobscot Bay Medical Center Recruiting
Rockport, Maine, United States, 04856
Contact: Jen Dalton, MHA, BSN, RN    207-294-8291    JDalton@mmc.org   
Principal Investigator: Roger Inhorn, MD         
SMHC Cancer Care and Blood Disorders -Sandford Recruiting
Sanford, Maine, United States, 04073
Contact: Jen Dalton, MHA, BSN, RN    207-294-8291    JDalton@mmc.org   
Principal Investigator: Roger Inhorn, MD         
Maine Children's Cancer Program Recruiting
Scarborough, Maine, United States, 04074
Contact: Jen Dalton, MHA, BSN, RN    207-294-8291    JDalton@mmc.org   
Principal Investigator: Roger Inhorn, MD         
Maine Medical Partner's Women's Health Recruiting
Scarborough, Maine, United States, 04074
Contact: Jen Dalton, MHA, BSN, RN    207-294-8291    JDalton@mmc.org   
Principal Investigator: Roger Inhorn, MD         
New England Cancer Specialist Recruiting
Scarborough, Maine, United States, 04074
Contact: Patricia Collins, BA, CCRC    207-303-3422    collip@newecs.org   
Principal Investigator: Christian Thomas, MD         
MaineHealth Cancer Care -South Portland Recruiting
South Portland, Maine, United States, 04106
Contact: Jen Dalton, MHA, BSN, RN    207-294-8291    JDalton@mmc.org   
Principal Investigator: Roger Inhorn, MD         
New England Cancer Specialist Recruiting
Topsham, Maine, United States, 04086
Contact: Patricia C Collins, BA, CCRC    207-303-3422    collip@newecs.org   
Principal Investigator: Christian Thomas, MD         
York Hospital Oncology & Infusion Care in Wells Recruiting
Wells, Maine, United States, 04090
Contact: Brenda Kiberd, RN    207-361-6115    Brenda.Kiberd@yorkhospital.com   
Principal Investigator: Marilyn McLaughlin, MD         
York Hospital Oncology & Infusion Care in York Recruiting
York, Maine, United States, 03909
Contact: Brenda i Kiberd, RN    207-361-6115    Brenda.Kiberd@yorkhospital.com   
Principal Investigator: Marilyn McLaughlin, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Cancer AnswerLine Nurses    800-865-1125    canceranswerline@med.umich.edu   
Principal Investigator: Elie Dib, MD         
St. Joseph Mercy - Brighton Recruiting
Brighton, Michigan, United States, 48114
Contact: Stephanie Couch, BS    734-712-7251    stephanie.couch@stjoeshealth.org   
Principal Investigator: Elie Dib, MD         
St. Joseph Mercy - Canton Recruiting
Canton, Michigan, United States, 48188
Contact: Stephanie Couch, BS    734-712-7251    stephanie.couch@stjoeshealth.org   
Principal Investigator: Elie Dib, MD         
St. Joseph Mercy - Chelsea Recruiting
Chelsea, Michigan, United States, 48118-1370
Contact: Stephanie Couch    734-712-7251    stephanie.couch@stjoeshealth.org   
Principal Investigator: Elie Dib, MD         
Ascension St. John Hospital Recruiting
Detroit, Michigan, United States, 48236
Contact: Stephanie Couch    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Elie Dib, MD         
Genesys Hurley Cancer Institute Recruiting
Grand Blanc, Michigan, United States, 48439
Contact: Stephanie Couch, BS    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Elie Dib, MD         
Cancer Research Consortium of West Michigan Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Connie Szczepanek, RN    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost, MD         
Ascension Borgess Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49009
Contact: Connie Szczepanek, RN    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen Yost, MD         
Sparrow Hospital Recruiting
Lansing, Michigan, United States, 48912
Contact: Stephanie Couch, BS    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Elie Dib, MD         
St. Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
Contact: Stephanie Couch, BS    734-712-7251    stephanie.couch@stjoeshealth.org   
Principal Investigator: Elie Dib, MD         
St. Joseph Mercy Hospital Oakland Recruiting
Pontiac, Michigan, United States, 48341
Contact: Stephanie Couch, BS    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Elie Dib, MD         
Ascension St. Mary's Hospital Recruiting
Saginaw, Michigan, United States, 48601
Contact: Ascension St. M Hospital, BS    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Elie Dib, MD         
Michigan Cancer Research Consortium Recruiting
Traverse City, Michigan, United States, 48341
Contact: Beth LaVasseur, RN, MS    734-712-7251    Beth.LaVasseur@stjoeshealth.org   
Contact    877-590-5995      
Principal Investigator: Philip Stella, MD         
St. John Macomb Oakland Hospital Recruiting
Warren, Michigan, United States, 48093
Contact: Stephanie Couch, BS    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Elie Dib, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Brandie Booker, RN, BSN, OCN    402-559-8197    brandie.booker@unmc.edu   
Principal Investigator: Alissa Marr, MD         
United States, New Hampshire
NH Oncology - Hematology, PA Recruiting
Concord, New Hampshire, United States, 03103
Contact: Ali Fleury    603-314-6888    A.Fleury@nhoh.com   
Principal Investigator: Douglas Weckstein, MD         
Solinsky Center for Cancer Care Recruiting
Manchester, New Hampshire, United States, 03103
Contact: Ali Fleury, BA, CCRP    603-314-6888    A.Fleury@nhoh.com   
Principal Investigator: Douglas Weckstein, MD         
New England Cancer Specialist Recruiting
Portsmouth, New Hampshire, United States, 03801
Contact: Patricia C Collins, BA, CCRC    207-303-3422    collip@newecs.org   
Principal Investigator: Christian Thomas, MD         
United States, New Mexico
Lovelace Medical Center - Saint Joseph Square Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Leslie Byatt    505-925-0366    lpbyatt@salud.unm.edu   
Principal Investigator: Bernard Tawfik, MD         
Presbyterian Kaseman Hospital Recruiting
Albuquerque, New Mexico, United States, 87110
Contact: Monique Robertson, RN    505-559-6100    mrobertso2@phs.org   
Principal Investigator: Bernard Tawfik, MD         
The University of New Mexico Comprehensive Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Kawryn Gustafson, RN    505-925-0380    ksgustafson@salud.unm.edu   
Principal Investigator: Bernard Tawfik, MD         
Memorial Medical Center Recruiting
Las Cruces, New Mexico, United States, 88011
Contact: Kim Hoffman, RN    575-556-6545    kim.hoffman@lpnt.net   
Principal Investigator: Bernard Tawfik, MD         
Presbyterian Rust Medical Center Recruiting
Rio Rancho, New Mexico, United States, 87124
Contact: Andrea Yost    505-253-7878    ayost3@phs.org   
Principal Investigator: Bernard Tawfik, MD         
United States, New York
Northwell Health Monter Cancer Center Recruiting
Lake Success, New York, United States, 11042
Contact: Mary Agnes Templeton    516-734-8979    mtempleton@northwell.edu   
Principal Investigator: Marina Frimer, MD         
Cohen Children's Medical Center Recruiting
New Hyde Park, New York, United States, 11040
Contact: Shreya Seepersaud    718-470-7146    sseepersaud2@northwell.edu   
Principal Investigator: Marina Frimer, MD         
Herbert Irving Comprehensive Cancer Center Recruiting
New York, New York, United States, 10032
Contact: Kim Roman    212-342-3970    Lr2787@cumc.columbia.edu   
Principal Investigator: Alexander Wei, MD         
Manhattan Eye, Ear, and Throat Hospital Recruiting
New York, New York, United States, 10065
Contact: Mary Agnes Templeton    516-734-8979    mtempleton@northwell.edu   
Principal Investigator: Marina Frimer, MD         
United States, North Carolina
Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Cole Cole    919-966-4432    emmie_cole@med.unc.edu   
Principal Investigator: Shetal Patel, MD         
Atrium Health's Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28277
Contact: Kelly Bumgarner, RN, CCRP    704-403-2520    Kelly.Bumgarner@atriumhealth.org   
Principal Investigator: Kathryn F. Mileham, MD, FACP         
United States, North Dakota
Sanford Health- Bismarck Recruiting
Bismarck, North Dakota, United States, 58501
Contact: Peter Kurniali, MD    701-323-5741    peter.kurniali@sanfordhealth.org   
Principal Investigator: Peter Kurniali, MD         
Sanford Health- Fargo Recruiting
Fargo, North Dakota, United States, 58122
Contact: Anu Gaba, MD    701-234-6161    anu.gaba@sanfordhealth.org   
Principal Investigator: Anu Gaba, MD         
United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Alexander Love    513-580-2472    lovea4@ucmail.uc.edu   
Principal Investigator: Trisha Wise-Draper, MD         
Kettering Health Recruiting
Kettering, Ohio, United States, 45429
Contact: Allison Dymacek, BSN, RN    937-395-8367    allison.dymacek@ketteringhealth.org   
Principal Investigator: Malek Safa, MD         
West Chester Hospital Recruiting
West Chester, Ohio, United States, 45069
Contact: Alexander Love    513-580-2472    lovea4@ucmail.uc.edu   
Principal Investigator: Trisha Wise-Draper, MD         
United States, Oregon
Providence Health & Services Recruiting
Portland, Oregon, United States, 97213
Contact: Melissa Pomeroy, RN, BSN, OCN    503-215-2714    Melissa.Pomeroy@providence.org   
Principal Investigator: Walter Urba, MD         
United States, Pennsylvania
Lehigh Valley Hospital Recruiting
Allentown, Pennsylvania, United States, 18105
Contact: Stephanie Couch, BS    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi, MD         
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Fathima S Sheriff    215-728-4094    fathima.sheriff@fccc.edu   
Principal Investigator: Margaret von Mehren, MD         
United States, South Carolina
SC Cancer Specialists at St. Joseph's/Candler Bluffton Recruiting
Bluffton, South Carolina, United States, 29910
Contact: Stephanie Smith, RN, MSN, OCN    912-819-5723    smiths1@sjchs.org   
Principal Investigator: Mark Taylor, MD         
St. Joseph's/Candler Smith Recruiting
Bluffton, South Carolina, United States, 29910
Contact: Stephanie Smith, RN, MSN, OCN    912-819-5723    smiths1@sjchs.org   
Principal Investigator: Mark Taylor, MD         
Summit Cancer Care at St. Josph's/Candler Bluffton Recruiting
Bluffton, South Carolina, United States, 29910
Contact: Stephanie Smith, RN, MSN, OCN    912-819-5723    smiths1@sjchs.org   
Principal Investigator: Mark Taylor, MD         
South Carolina Cancer Specialists Recruiting
Hilton Head Island, South Carolina, United States, 29926
Contact: Stephanie Smith, RN, MSN, OCN    912-819-5723    smiths1@sjchs.org   
Principal Investigator: Mark Taylor, MD         
United States, South Dakota
Sanford Cancer Center Oncology Clinic and Pharmacy Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Steven Powell, MD    605-328-5000    steven.powell@sanfordhealth.org   
Principal Investigator: Steven Powell, MD         
United States, Tennessee
Tennessee Oncology - Nashville / Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Ethan Trull    615-329-7274    Ethan.Trull@SarahCannon.com   
Principal Investigator: Meredith McKean, MD, MPH         
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Amanda Eckert, MPH    713-745-8074    ACEckert@mdanderson.org   
Principal Investigator: Funda Meric-Bernstam, MD         
United States, Utah
Intermountain Healthcare Recruiting
Salt Lake City, Utah, United States, 84107
Contact: Tracy Taylor    801-507-3953    tracy.taylor@imail.org   
Contact: Angi Kahrs, CCRP    435-251-4742    Angi.Cox@imail.org   
Principal Investigator: Ramya Thota, M.D.         
Principal Investigator: Derrick Haslem, M.D.         
United States, Virginia
Inova Schar Cancer Institute Recruiting
Fairfax, Virginia, United States, 22042
Contact: Lindsey Tishman, MHA, CCRC    703-970-6488    lindsey.tishman@inova.org   
Principal Investigator: Timothy Cannon, MD         
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Contact: Leah Clemente    206-386-2227    Leah.Clemente@swedish.org   
Principal Investigator: Philip Gold, MD         
United States, Wisconsin
Aurora Cancer Care - Burlington Recruiting
Burlington, Wisconsin, United States, 53105
Contact: Mary Jo Luser, BSN, RN, OCN    414-646-9825    MaryJo.Luser@aah.org   
Principal Investigator: Antony Ruggeri, MD         
Aurora Health Care - Germantown Health Center Recruiting
Germantown, Wisconsin, United States, 53022
Contact: Mary Jo Luser, BSN, RN, OCN    414-646-9825    MaryJo.Luser@aah.org   
Principal Investigator: Antony Ruggeri, MD         
Aurora Cancer Care - Grafton Recruiting
Grafton, Wisconsin, United States, 53024
Contact: Mary Jo Luser, BSN, RN, OCN    414-646-9825    MaryJo.Luser@aah.org   
Principal Investigator: Antony Ruggeri, MD         
Aurora BayCare Medical Center Recruiting
Green Bay, Wisconsin, United States, 54311
Contact: Mary Jo Luser, BSN, RN, OCN    414-646-9825    MaryJo.Luser@aah.org   
Principal Investigator: Antony Ruggeri, MD         
Aurora Cancer Care - Kenosha South Recruiting
Kenosha, Wisconsin, United States, 53142
Contact: Mary Jo Luser, BSN, RN, OCN    414-646-9825    MaryJo.Luser@aah.org   
Principal Investigator: Antony Ruggeri, MD         
Aurora Bay Area Medical Center Recruiting
Marinette, Wisconsin, United States, 54143
Contact: Mary Jo Luser, BSN, RN, OCN    414-646-9825    MaryJo.Luser@aah.org   
Principal Investigator: Antony Ruggeri, MD         
Aurora Cancer Care Milwaukee Recruiting
Milwaukee, Wisconsin, United States, 53209
Contact: Mary Jo M Luser, BSN, RN, OCN    414-646-9825    MaryJo.Luser@aah.org   
Principal Investigator: Antony Ruggeri, MD         
Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Mary Jo M Luser, BSN, RN, OCN    414-646-9825    MaryJo.Luser@aah.org   
Principal Investigator: Antony Ruggeri, MD         
Aurora Sinai Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53223
Contact: Mary Jo Luser, BSN, RN, OCN    414-646-9825    MaryJo.Luser@aah.org   
Principal Investigator: Antony Ruggeri, MD         
Aurora West Allis Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53227
Contact: Mary Jo Luser, BSN, RN, OCN    414-646-9825    MaryJo.Luser@aah.org   
Principal Investigator: Antony Ruggeri, MD         
Vince Lombardi Cancer Clinic - Oshkosh Recruiting
Oshkosh, Wisconsin, United States, 54904
Contact: Mary Jo Luser, BSN, RN, OCN    414-646-9825    MaryJo.Luser@aah.org   
Principal Investigator: Antony Ruggeri, MD         
Aurora Cancer Care - Racine Recruiting
Racine, Wisconsin, United States, 53406
Contact: Mary Jo Luser, BSN, RN, OCN    414-646-9825    MaryJo.Luser@aah.org   
Principal Investigator: Antony Ruggeri, MD         
Vince Lombardi Cancer Center Recruiting
Sheboygan, Wisconsin, United States, 53081
Contact: Mary Jo Luser, BSN, RN, OCN    414-646-9825    MaryJo.Luser@aah.org   
Principal Investigator: Antony Ruggeri, MD         
Aurora Medical Center in Summit Recruiting
Summit, Wisconsin, United States, 53066
Contact: Mary Jo Luser, BSN, RN, OCN    414-646-9825    MaryJo.Luser@aah.org   
Principal Investigator: Antony Ruggeri, MD         
Vince Lombardi Cancer Clinic - Two Rivers Recruiting
Two Rivers, Wisconsin, United States, 54241
Contact: Mary Jo Luser, BSN, RN, OCN    414-646-9825    MaryJo.Luser@aah.org   
Principal Investigator: Antony Ruggeri, MD         
Aurora Cancer Care - Milwaukee West Recruiting
Wauwatosa, Wisconsin, United States, 53226
Contact: Mary Jo Luser, BSN, RN, OCN    414-646-9825    MaryJo.Luser@aah.org   
Principal Investigator: Antony Ruggeri, MD         
Sponsors and Collaborators
American Society of Clinical Oncology
AstraZeneca
Bayer
Bristol-Myers Squibb
Eli Lilly and Company
Genentech, Inc.
Merck Sharp & Dohme LLC
Pfizer
Boehringer Ingelheim
Seagen Inc.
Taiho Oncology, Inc.
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: American Society of Clinical Oncology
ClinicalTrials.gov Identifier: NCT02693535    
Other Study ID Numbers: Pro00014171
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: May 18, 2023
Last Verified: May 2023
Keywords provided by American Society of Clinical Oncology:
cancer
off-label
precision medicine
targeted therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Lymphoma, Non-Hodgkin
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
 Lymphoma
Lymphatic Diseases
Pembrolizumab
Nivolumab
Trastuzumab
Ipilimumab
Atezolizumab
Pertuzumab
Sunitinib
Olaparib
Palbociclib
Temsirolimus
Vemurafenib
Talazoparib
Tucatinib