4200 Participants Needed

Targeted Therapy for Advanced Stage Cancer

(TAPUR Trial)

Recruiting at 189 trial locations
PM
JM
CM
JP
Overseen ByJacqueline Perez, MPH
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: American Society of Clinical Oncology
Must be taking: Targeted therapies
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of 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 TAPUR@asco.org, or if a patient, your nearest participating TAPUR site (see participating centers).\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*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.\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with your doctor or the trial coordinators.

Is pembrolizumab generally safe for humans?

Pembrolizumab has been shown to have a manageable safety profile in various studies, including those for metastatic non-small-cell lung cancer and tumor mutational burden-high solid tumors. Common side effects include immune-related reactions, but these are generally considered manageable.12345

How is the drug Abemaciclib unique in treating advanced stage cancer?

Abemaciclib is unique because it is a CDK4/6 inhibitor that has shown effectiveness in improving progression-free survival in patients with hormone receptor-positive, HER2-negative advanced breast cancer, especially when combined with other therapies like letrozole or fulvestrant.678910

What data supports the effectiveness of the drug combination of cobimetinib and vemurafenib?

Research shows that the combination of cobimetinib and vemurafenib improves progression-free survival in patients with advanced melanoma that has a specific BRAF mutation, compared to using vemurafenib alone.1112131415

Are You a Good Fit for This Trial?

This trial is for people aged 12+ with advanced cancer, such as solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma. Participants must be able to take oral medication, agree to use contraception, and have a specific abnormality in their tumor genes that can be targeted by the study drugs.

Inclusion Criteria

I have an advanced or spreading cancer, multiple myeloma, or B cell lymphoma.
I can swallow and tolerate pills.
I have results from a genetic or protein test for my cancer.
See 6 more

Exclusion Criteria

My cancer can't be measured or found through scans or exams.
I have had brain metastases, but no seizures or major changes in my neurological status in the last 3 months.
I have a primary brain tumor or cancer that has spread to the lining of my brain.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive FDA-approved targeted therapies based on genomic variants for 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Abemaciclib
  • Afatinib
  • Atezolizumab and PHESGO
  • Atezolizumab and Talazoparib
  • Crizotinib
  • Entrectinib
  • Futibatinib
  • Larotrectinib
  • Nivolumab and Ipilimumab
  • Olaparib
  • Palbociclib
  • Pembrolizumab
  • Regorafenib
  • Sunitinib
  • Talazoparib
  • Temsirolimus
  • Trastuzumab and Pertuzumab
  • Tucatinib plus Trastuzumab Subcutaneous (SC)
  • Vemurafenib and Cobimetinib
Trial Overview The TAPUR study tests FDA-approved drugs targeting specific genetic abnormalities in tumors. It aims to learn how these therapies work in real-world settings for patients with advanced stage cancers who show sensitivity to these drugs based on genomic testing.
How Is the Trial Designed?
17Treatment groups
Experimental Treatment
Group I: Group 9 (BRAF V600E/D/K/R)Experimental Treatment1 Intervention
Group II: Group 8 (ERBB2)Experimental Treatment1 Intervention
Group III: Group 6 (mTOR, TSC)Experimental Treatment1 Intervention
Group IV: Group 5 (CSF1R,PDGFR,VEGFR)Experimental Treatment1 Intervention
Group V: Group 4 (CDKN2A, CDK4, CDK6)Experimental Treatment1 Intervention
Group VI: Group 25Experimental Treatment1 Intervention
Group VII: Group 24 (ERBB2)Experimental Treatment1 Intervention
Group VIII: Group 23 (NTRK amplification)Experimental Treatment1 Intervention
Group IX: Group 22 (ROS1 fusion)Experimental Treatment1 Intervention
Group X: Group 21 (BRCA1/2, PALB2, ATM, and others)Experimental Treatment1 Intervention
Group XI: Group 20 (ERBB2)Experimental Treatment1 Intervention
Group XII: Group 19 (BRCA1/2, PALB2)Experimental Treatment1 Intervention
Group XIII: Group 17 (CDKN2A, CDK4, CDK6)Experimental Treatment1 Intervention
Group XIV: Group 16 (MSI-H, high mutational load and others)Experimental Treatment1 Intervention
Group XV: Group 15 (POLE, POLD1)Experimental Treatment1 Intervention
Group XVI: Group 14 (BRCA1/2; ATM)Experimental Treatment1 Intervention
Group XVII: Group 13 (RET,VEGFR1/2/3,KIT,PDGFRฮฒ,RAF-1,BRAF)Experimental Treatment1 Intervention

Abemaciclib is already approved in United States, European Union for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Verzenio for:
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Verzenio for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

American Society of Clinical Oncology

Lead Sponsor

Trials
40
Recruited
148,000+

AstraZeneca

Industry Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from ร‰cole nationale vรฉtรฉrinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from ร‰cole nationale vรฉtรฉrinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Bayer

Industry Sponsor

Trials
2,291
Recruited
25,560,000+
Founded
1863
Headquarters
Leverkusen, Germany
Known For
Pharmaceutical Innovations
Top Products
Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy profile image

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Eli Lilly and Company

Industry Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Genentech, Inc.

Industry Sponsor

Trials
1,578
Recruited
569,000+
Ashley Magargee profile image

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway profile image

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Boehringer Ingelheim

Industry Sponsor

Trials
2,566
Recruited
16,150,000+

Seagen Inc.

Industry Sponsor

Trials
212
Recruited
73,800+
Founded
1997
Headquarters
Bothell, USA
Known For
Antibody-Drug Conjugates
Top Products
Adcetris (brentuximab vedotin), Tukysa (tucatinib), Padcev (enfortumab vedotin-ejfv), Tivdak (tisotumab vedotin-tftv)
Dr. Roger Dansey profile image

Dr. Roger Dansey

Seagen Inc.

Chief Medical Officer since 2018

MD from University of Witwatersrand

David R. Epstein profile image

David R. Epstein

Seagen Inc.

Chief Executive Officer since 2022

BSc in Pharmacy from Rutgers University, MBA from Columbia University

Taiho Oncology, Inc.

Industry Sponsor

Trials
79
Recruited
12,700+

Tim Whitten

Taiho Oncology, Inc.

Chief Executive Officer since 2018

MBA and Pharmacy degree

Harold Keer

Taiho Oncology, Inc.

Chief Medical Officer

MD, PhD

Published Research Related to This Trial

In a study involving 495 patients with advanced BRAF(V600)-mutant melanoma, the combination of cobimetinib and vemurafenib significantly improved median progression-free survival to 12.3 months compared to 7.2 months for the placebo group, indicating a strong efficacy of the treatment.
The combination therapy also resulted in a median overall survival of 22.3 months versus 17.4 months for the placebo group, with a manageable safety profile and no new safety concerns identified during the extended follow-up.
Cobimetinib combined with vemurafenib in advanced BRAF(V600)-mutant melanoma (coBRIM): updated efficacy results from a randomised, double-blind, phase 3 trial.Ascierto, PA., McArthur, GA., Drรฉno, B., et al.[2022]
In a long-term study of 123 patients with advanced nonsquamous NSCLC, the combination of pembrolizumab with pemetrexed-carboplatin significantly improved the objective response rate (58% vs. 33%) and progression-free survival (24.5 months vs. 9.9 months) compared to chemotherapy alone.
Patients who completed 2 years of pembrolizumab treatment had a remarkable 92% survival rate at the data cutoff, indicating a durable clinical benefit, while the safety profile remained manageable with no new safety concerns identified.
Long-Term Overall Survival From KEYNOTE-021 Cohort G: Pemetrexed and Carboplatin With or Without Pembrolizumab as First-Line Therapy for Advanced Nonsquamous NSCLC.Awad, MM., Gadgeel, SM., Borghaei, H., et al.[2021]
In a phase 2 study involving 65 patients with BRAFV600 mutation-positive melanoma and CNS metastases, the combination of atezolizumab with vemurafenib and cobimetinib showed a promising intracranial objective response rate of 42%.
The treatment was associated with significant adverse events, with 68% of patients experiencing grade 3 or worse side effects, highlighting the need for careful monitoring during therapy.
Atezolizumab, vemurafenib, and cobimetinib in patients with melanoma with CNS metastases (TRICOTEL): a multicentre, open-label, single-arm, phase 2 study.Dummer, R., Queirolo, P., Abajo Guijarro, AM., et al.[2023]

Citations

Cobimetinib combined with vemurafenib in advanced BRAF(V600)-mutant melanoma (coBRIM): updated efficacy results from a randomised, double-blind, phase 3 trial. [2022]
Long-Term Overall Survival From KEYNOTE-021 Cohort G: Pemetrexed and Carboplatin With or Without Pembrolizumab as First-Line Therapy for Advanced Nonsquamous NSCLC. [2021]
Atezolizumab, vemurafenib, and cobimetinib in patients with melanoma with CNS metastases (TRICOTEL): a multicentre, open-label, single-arm, phase 2 study. [2023]
Atezolizumab, vemurafenib, and cobimetinib in patients with melanoma with CNS metastases (TRICOTEL): a multicentre, open-label, single-arm, phase 2 study. [2023]
Economic Evaluation of Three BRAF + MEK Inhibitors for the Treatment of Advanced Unresectable Melanoma With BRAF Mutation From a US Payer Perspective. [2023]
First-line pembrolizumab vs chemotherapy in metastatic non-small-cell lung cancer: KEYNOTE-024 Japan subset. [2022]
Safety, Clinical Activity, and Biological Correlates of Response in Patients with Metastatic Melanoma: Results from a Phase I Trial of Atezolizumab. [2020]
First-line pembrolizumab vs chemotherapy in metastatic non-small-cell lung cancer: KEYNOTE-024 Japan subset. [2021]
FDA Approval Summary: Pembrolizumab for the Treatment of Tumor Mutational Burden-High Solid Tumors. [2022]
Safety, recommended dose, efficacy and immune correlates for nintedanib in combination with pembrolizumab in patients with advanced cancers. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
First-Line Abemaciclib Effective in ER+ Breast Cancer. [2019]
Observational study of HR+/HER2- metastatic breast cancer patients treated with abemaciclib in Spain in the Named Patient Use Program (AbemusS). [2023]
Cost-effectiveness analysis of abemaciclib with endocrine therapy (ET) versus ET alone for HR+, HER2-, node-positive, high-risk early breast cancer in Italy. [2023]
14.United Statespubmed.ncbi.nlm.nih.gov
Abemaciclib in Combination With Pembrolizumab for Stage IV KRAS-Mutant or Squamous NSCLC: A Phase 1b Study. [2022]
Health-Related Quality of Life in MONARCH 2: Abemaciclib plus Fulvestrant in Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer After Endocrine Therapy. [2022]
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