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CDK4/6 Inhibitor

Targeted Therapy for Advanced Stage Cancer (TAPUR Trial)

Phase 2

Recruiting

Research Sponsored by American Society of Clinical Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically-proven locally advanced or metastatic solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma

For orally administered drugs, the patient must be able to swallow and tolerate oral medication

Must not have

Patients whose disease is not measurable or cannot be assessed by radiographic imaging or physical examination

Patients with primary brain tumors or leptomeningeal metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration of survival from registration on study until death from any cause, assessed throughout end of study, up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well different targeted drugs work in treating patients with cancer that has progressed after other treatments and has a genomic variant that makes the tumor respond to the drug.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Side effects vary depending on the drug but may include fatigue, digestive issues, skin reactions, blood count changes, liver function alterations and potential risks associated with targeted cancer therapy like immune system effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have an advanced or spreading cancer, multiple myeloma, or B cell lymphoma.

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I can swallow and tolerate pills.

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I have results from a genetic or protein test for my cancer.

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I am able to get out of my bed or chair and move around.

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My blood tests for organ function are within normal ranges.

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My cancer has a genetic profile that may benefit from specific FDA approved drugs in this study.

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I am 12 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer can't be measured or found through scans or exams.

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I have a primary brain tumor or cancer that has spread to the lining of my brain.

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My cancer has spread to my brain and is getting worse.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ duration of survival from registration on study until death from any cause, assessed throughout end of study, up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~duration of survival from registration on study until death from any cause, assessed throughout end of study, up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of survival from registration on study until death from any cause, assessed throughout end of study, up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate defined as % of participants in a cohort with complete or partial response or with stable disease according to standard response criteria

Secondary study objectives

Overall survival (OS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

17Treatment groups

Experimental Treatment

Group I: Group 9 (BRAF V600E/D/K/R)Experimental Treatment1 Intervention

Participants receive vemurafenib and cobimetinib - dosage, frequency and duration per label; acceptable genomic matches include BRAF V600E/D/K/R mutations

Group II: Group 8 (ERBB2)Experimental Treatment1 Intervention

Participants receive trastuzumab and pertuzumab - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression, and specific ERBB2 mutations

Group III: Group 6 (mTOR, TSC)Experimental Treatment1 Intervention

Participants receive temsirolimus - dosage, frequency and duration per label; acceptable genomic matches include mTOR, TSC1/2, AKT1 mutations

Group IV: Group 5 (CSF1R,PDGFR,VEGFR)Experimental Treatment1 Intervention

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

Group V: Group 4 (CDKN2A, CDK4, CDK6)Experimental Treatment1 Intervention

Participants receive palbociclib - dosage, frequency and duration per label; acceptable genomic matches include CDKN2A loss or mutation, CDK4, CDK6 amplifications, CDKN2B loss or mutation

Group VI: Group 25Experimental Treatment1 Intervention

Participants receive futibatinib- dosage, frequency and duration per label; acceptable genomic matches include FGFR 1,2,3,4 fusion (or other rearrangement) or mutation

Group VII: Group 24 (ERBB2)Experimental Treatment1 Intervention

Participants receive tucatinib plus trastuzumab SC - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression, and specific ERBB2 mutations

Group VIII: Group 23 (NTRK amplification)Experimental Treatment1 Intervention

Participants receive larotrectinib - dosage, frequency and duration per label; acceptable genomic matches include NTRK1/2/3 amplification

Group IX: Group 22 (ROS1 fusion)Experimental Treatment1 Intervention

Participants receive entrectinib - dosage, frequency and duration per label; acceptable genomic matches include any ROS1 fusion

Group X: Group 21 (BRCA1/2, PALB2, ATM, and others)Experimental Treatment1 Intervention

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

Group XI: Group 20 (ERBB2)Experimental Treatment1 Intervention

Participants receive atezolizumab plus PHESGO - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression

Group XII: Group 19 (BRCA1/2, PALB2)Experimental Treatment1 Intervention

Participants receive talazoparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic BRCA1/2 and PALB2 mutations

Group XIII: Group 17 (CDKN2A, CDK4, CDK6)Experimental Treatment1 Intervention

Participants receive abemaciclib - dosage, frequency and duration per label; acceptable genomic matches include CDKN2A loss or mutation, CDK4, CDK6 amplifications, CDKN2B loss or mutation

Group XIV: Group 16 (MSI-H, high mutational load and others)Experimental Treatment1 Intervention

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

Group XV: Group 15 (POLE, POLD1)Experimental Treatment1 Intervention

Participants receive pembrolizumab - dosage, frequency and duration per label; acceptable genomic matches include specific POLE and POLD1 mutations

Group XVI: Group 14 (BRCA1/2; ATM)Experimental Treatment1 Intervention

Participants receive olaparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic BRCA1/2 inactivating mutations; ATM mutations or deletions

Group XVII: Group 13 (RET,VEGFR1/2/3,KIT,PDGFRβ,RAF-1,BRAF)Experimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sunitinib

2014

Completed Phase 3

~4380

Temsirolimus

2008

Completed Phase 2

~1940