Treatment Resistance Following Anti-cancer Therapies

Stopped early · Not applicable

Conditions studied: Disease Progression

In brief

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.

Key facts

Study ID

NCT04436120

Run by

Pfizer

People needed

38

Starts

2019-02-13

Expected to finish

2020-12-14

Last updated by the study team

2024-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumors treated as follows:
• 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.

You may not qualify if…

• Tumor biopsy taken from a bone or an irradiated target lesion.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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