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Treatment Resistance Following Anti-cancer Therapies
Treatment Resistance Following Anti-cancer Therapies

NCT04436120

TerminatedNA

Sponsor: Pfizer

Conditions: Disease Progression

Interventions: De novo tumor tissue biopsy, Research blood draws

Countries: United States, Argentina, Belgium, France, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
Locations (33)
  • Daphne, Alabama, United States
  • Mobile, Alabama, United States
  • Mobile, Alabama, United States
  • Anchorage, Alaska, United States
  • Tucson, Arizona, United States
  • Tucson, Arizona, United States
  • Glendale, California, United States
  • Long Beach, California, United States
  • Orange, California, United States
  • Santa Ana, California, United States
  • Santa Barbara, California, United States
  • Solvang, California, United States
  • Whittier, California, United States
  • Whittier, California, United States
  • Pensacola, Florida, United States
  • Seattle, Washington, United States
  • Seattle, Washington, United States
  • Viedma, Río Negro Province, Argentina
  • Rosario, Santa Fe Province, Argentina
  • CABA, Argentina
  • Ciudad Autónoma de Bs As, Argentina
  • Charleroi, Belgium
  • Ghent, Belgium
  • Ghent, Belgium
  • Haine-Saint-Paul, Belgium
  • Ottignies, Belgium
  • Clermont-Ferrand, France
  • Colmar, France
  • Créteil, France
  • Quint-Fonsegrives, France
  • + 3 more on CT.gov