Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
NA
38 participants
INTERVENTIONAL
2019-02-13
2020-12-14
Brief Summary
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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 Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Tumor biopsy and blood draw
Tumor biopsy and blood draw
De novo tumor tissue biopsy
De novo tissue biopsy performed following disease progression
Research blood draws
Blood biospecimens collected following disease progression
Interventions
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De novo tumor tissue biopsy
De novo tissue biopsy performed following disease progression
Research blood draws
Blood biospecimens collected following disease progression
Eligibility Criteria
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Inclusion Criteria
* Non small cell lung carcinoma (NSCLC) monotherapy: Disease progression (PD) on 1st line monotherapy anti PD-1/ L1.
* NSCLC combination: PD on 1st line anti PD-1/ L1 plus standard doublet platinum containing regimen; or PD on 1st-line anti-PD-1/-L1 plus standard doublet platinum-containing regimen followed by continuation of single agent anti-PD-1/-L1).
* Renal cell carcinoma (RCC) with clear cell component: PD on 2nd line monotherapy anti PD-1/ L1; or PD on 1st line combination of doublet anti-PD-1/ L1 with anti-CTLA-4; or PD on 1st-line combination of avelumab with axitinib or pembrolizumab with axitinib.
* HR+ HER2 adenocarcinoma of the breast: PD on 1st line combination of doublet palbociclib with hormonal therapy.
* Castrate resistant adenocarcinoma of the prostate: PD on enzalutamide monotherapy.
* Castrate resistant adenocarcinoma of the prostate: PD on abiraterone in combination with prednisone.
* germline mutated BRCA (gBRCAm), HER2- breast cancer: PD on a PARP inhibitor monotherapy in patients previously treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting.
* Radiographic evidence of PD, including the target lesion being subjected to biopsy for the study, on the most recent regimen that requires a change in anti-cancer treatment.
Exclusion Criteria
* Discontinuation of current or most recent anti cancer therapy due to toxicity and not progressive disease.
* Initiation of new anti-cancer therapy after disease progression prior to planned biopsy.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Southern Cancer Center, P.C.
Daphne, Alabama, United States
Southern Cancer Center, PC
Mobile, Alabama, United States
Southern Cancer Center, PC
Mobile, Alabama, United States
Alaska Urological Institute dba Alaska Clinical Research Center
Anchorage, Alaska, United States
Arizona Oncology Associates, PC-HOPE
Tucson, Arizona, United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States
The Oncology Institute of Hope Innovation
Glendale, California, United States
The Oncology Institute of Hope Innovation
Long Beach, California, United States
UCI Medical Center-Chao Family Comprehensive Cancer Center
Orange, California, United States
The Oncology Institute of Hope Innovation
Santa Ana, California, United States
Sansum Clinic
Santa Barbara, California, United States
Sansum Clinic
Solvang, California, United States
The Oncology Institute of Hope and Innovation
Whittier, California, United States
ICRI-Administrative and Supplies Only
Whittier, California, United States
Woodlands Medical Specialists PA
Pensacola, Florida, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Clínica Viedma S.A.
Viedma, Río Negro Province, Argentina
Sanatorio de la Mujer
Rosario, Santa Fe Province, Argentina
Hospital Britanico de Buenos Aires
CABA, , Argentina
Centro de Educacion Medica e Investigaciones Clinicas"Norberto Quirno" CEMIC
Ciudad Autónoma de Bs As, , Argentina
Grand Hôpital de Charleroi - Site Notre Dame
Charleroi, , Belgium
AZ Maria Middelares
Ghent, , Belgium
UZ Gent
Ghent, , Belgium
Hôpital de Jolimont
Haine-Saint-Paul, , Belgium
Clinique Saint-Pierre Ottignies
Ottignies, , Belgium
Centre Jean Perrin
Clermont-Ferrand, , France
Hôpitaux Civils de Colmar, Centre Hospitalier Louis Pasteur
Colmar, , France
CHU Henri Mondor
Créteil, , France
Hôpital La Croix du Sud
Quint-Fonsegrives, , France
Institut Jean Godinot
Reims, , France
Hopital Bégin
Saint-Mandé, , France
Royal Cornwall Hospital
Cornwall, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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TRANSLATE
Identifier Type: OTHER
Identifier Source: secondary_id
2018-003612-45
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A9001502
Identifier Type: -
Identifier Source: org_study_id