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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

ConditionsLymphoma, Non-HodgkinMultiple MyelomaAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorAmerican Society of Clinical Oncology

About this trial

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 [email protected], 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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Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 (except under the circumstance in which the TAPUR arm is designed to provide additional evidence to support an existing FDA indication).

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/

Disqualifiers

Absolute neutrophil count ≥ 1500 µl

Hemoglobin ≥ 9.0 g/dl

Platelets ≥ 75,000/µl

Total bilirubin < 2.0 mg/ dl, except in patients with Gilbert's Syndrome

Trial design

Design model

Single group

Treatments tested in this trial

  • Sunitinib (CLOSED TO ENROLLMENT)

    Drug

    drug

  • Trastuzumab and Pertuzumab (CLOSED TO ENROLLMENT)

    Drug

    drug

  • Vemurafenib and Cobimetinib (CLOSED TO ENROLLMENT)

    Drug

    drug

  • Olaparib (CLOSED TO ENROLLMENT)

    Drug

    drug

  • Nivolumab and Ipilimumab (CLOSED TO ENROLLMENT)

    Drug

    drug

  • Abemaciclib (CLOSED TO ENROLLMENT)

    Drug

    drug

  • Talazoparib (CLOSED TO ENROLLMENT)

    Drug

    drug

  • Atezolizumab and Talazoparib (CLOSED TO ENROLLMENT)

    Drug

    drug

  • Tucatinib plus Trastuzumab Subcutaneous (SC) (CLOSED TO ENROLLMENT)

    Drug

    drug

  • Futibatinib

    Drug

    drug

  • Dabrafenib plus Trametinib

    Drug

    Drug

  • Fam-Trastuzumab Deruxtecan-Nxki (TDxD)

    Drug

    Drug

Treatment groups

4,200 Participants
are divided into 12 treatment groups

12

Treatment groups

See each treatment group below.

Group A: Group 5 (CSF1R,PDGFR,VEGFR)Other 1 intervention
Group B: Group 8 (ERBB2)Other 1 intervention
Group C: Group 9 (BRAF V600E/D/K/R)Other 1 intervention
Group D: Group 14 (BRCA1/2; ATM)Other 1 intervention
Group E: Group 16 (MSI-H, high mutational load and others)Other 1 intervention
Group F: Group 17 (CDKN2A, CDK4, CDK6)Other 1 intervention
Group G: Group 19 (BRCA1/2, PALB2)Other 1 intervention
Group H: Group 21 (BRCA1/2, PALB2, ATM, and others)Other 1 intervention
Group I: Group 24 (ERBB2)Other 1 intervention
Group J: Group 25Other 1 intervention
Group K: Group 26 (BRAF V600 E mutation )Other 1 intervention
Group L: Group 27 (ERBB2 amplification, ERBB2 (HER2) IHC2+ or IHC3+ overexpression)Other 1 intervention

Trial outcomes

Primary outcomes

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

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.

Time frame
Assessed at 16 weeks of treatment

Secondary outcomes

1

Overall survival (OS)

OS will be estimated using the Kaplan-Meier method

Time frame
Duration of survival from registration on study until death from any cause, assessed throughout end of study, up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

American Society of Clinical Oncology

Lead sponsor

AstraZeneca

Collaborator

Bayer

Collaborator

Bristol-Myers Squibb

Collaborator

Eli Lilly and Company

Collaborator

Genentech, Inc.

Collaborator

Pfizer

Collaborator

Taiho Oncology, Inc.

Collaborator

Novartis

Collaborator

Merck Institute for Therapeutic Research

Collaborator

Boehringer Ingelheim

Collaborator

Seattle Genetics (now a wholly owned subsidiary of Pfizer)

Collaborator

Source ClinicalTrials.gov
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