Last updated on September 2020

Treatment Resistance Following Anti-cancer Therapies

Brief description of study

The TRANSLATE study aims to better understand why tumors become resistant to standard anti-cancer therapies.

New tumor biopsy and blood samples are collected after disease progression on standard-of-care anti-cancer treatment and compared to the initial (archival) tumor biopsy sample taken from the same patient.

Annotated reports of results from clinical Next Generation Sequencing (NGS) gene panel tests of both tumor and blood are sent directly from the testing lab to the study physician for discussion with the patient during the study.

Patients may participate in interventional treatment clinical trials at the same time as participating in the TRANSLATE study.

Primary data will be publicly available after the study to support further research.

Detailed Study Description

Background: Development of new cancer treatments requires better understanding of why tumors develop resistance to standard-of-care (SOC) therapies. However, post-progression tumor biopsies are not routinely collected, limiting the tissue available to characterize mechanisms of treatment resistance. The TRANSLATE clinical study is specifically designed to address these critical gaps.

Trial design: TRANSLATE is a global, multicenter, translational study designed to collect and compare archival pre-treatment tumor tissue with paired de novo tumor and blood samples obtained following disease progression on SOC therapies, targeting therapeutically important areas of cancer biology.

Eligible Tumor Type and Most Recent SOC Therapy:

  • Non-small-cell lung and Anti-PD-1/-L1 monotherapy
  • Non-small-cell lung and Anti-PD-1/-L1 + platinum
  • Clear cell renal cell carcinoma and Anti-PD-1/-L1 monotherapy
  • Clear cell renal cell carcinoma and Doublet anti-PD-1/-L1 + anti-CTLA-4
  • Clear cell renal cell carcinoma and Pembrolizumab + axitinib
  • Clear cell renal cell carcinoma and Avelumab + axitinib
  • HR+ HER2- breast and Palbociclib + hormonal therapy
  • germline mutated BRCA breast and Olaparib or talazoparib monotherapy
  • Castration-resistant prostate and Enzalutamide
  • Castration-resistant prostate and Abiraterone + prednisone

Eligibility criteria include adults with locally advanced or metastatic tumors; radiographic evidence of progressive disease during the most recent SOC regimen; sufficient archival tumor tissue; and a post-progression tumor lesion that is safely accessible for a new biopsy.

The results from clinical NGS panel testing may help inform subsequent treatment plan or identification of relevant interventional clinical trials.

Patients are enrolled after disease progression on SOC and before change in treatment and participate in 3 study visits within approximately 3 months.

Next-generation sequencing results from analysis of tumor tissue and blood will be returned to the study physician and patient for review at a subsequent study visit within this timeframe.

The primary endpoint is the change in frequency of gene alterations between pre-treatment and post-progression tumor biopsies. Secondary endpoints address prioritized scientific hypotheses specific to each target area of biology and indication.

Primary data will be publicly available after the study to support further research.

Sponsored by Pfizer Inc.; EudraCT: 2018-003612-45.

Clinical Study Identifier: NCT04436120

Find a site near you

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Sansum Clinic

Santa Barbara, CA United States
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Rocky Mountain Cancer Centers

Colorado Springs, CO United States
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Rocky Mountain Cancer Centers

Englewood, CO United States
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Rocky Mountain Cancer Centers

Littleton, CO United States
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Rocky Mountain Cancer Centers

Lone Tree, CO United States
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Woodlands Medical Specialists

Pensacola, FL United States
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Charleston Oncology, P.A.

Charleston, SC United States
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Centro Medico San Roque SRL

San Miguel de Tucuman, Argentina
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UZ Gent

Gent, Belgium
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H pital de Jolimont

Haine-Saint-Paul, Belgium
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Centre Jean Perrin

Clermont Ferrand, France
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H pital La Croix du Sud

Quint Fonsegrives, France
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Hopital B gin

Saint-Mande, France
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Royal Cornwall Hospital

Cornwall, United Kingdom
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Musgrove Park Hospital

Taunton, United Kingdom
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Duke Cancer Network

Durham, NC United States
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DLP Maria Parham Hospital

Henderson, NC United States
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Scotland Memorial Hospital

Laurinburg, NC United States
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Johnston Cancer Center

Smithfield, NC United States
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Urologie Bonn-Rhein-Sieg

Bonn-Bad Godesberg, Germany
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Recruitment Status: Open

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