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TerminatedNot applicableNCT04436120
Official study title

Treatment Resistance Following Anti-cancer Therapies

Study summary

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.

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Key things to know

Main goalOther

This describes the study’s primary purpose.

What is being studiedDe novo tumor tissue biopsy and Research blood draws

The study team can explain what participation involves.

Who it may be forDisease Progression

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 3, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?33 U.S. locations

Locations may change over time.

Who runs it?Pfizer

Study sponsor

01
Study overview

What this study is about

Purpose
Other
Study type
Interventional
Phase
Not applicable
Sponsor
Pfizer
Interventions being studied
Procedure: De novo tumor tissue biopsy; Procedure: Research blood draws
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Study topics
After prior treatment→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Southern Cancer Center, P.C.Daphne, Alabama
  • Southern Cancer Center, PCMobile, Alabama
  • Southern Cancer Center, PCMobile, Alabama
  • Alaska Urological Institute dba Alaska Clinical Research CenterAnchorage, Alaska
  • Arizona Oncology Associates, PC-HOPETucson, Arizona
  • Arizona Oncology Associates, PC - HOPETucson, Arizona
  • The Oncology Institute of Hope InnovationGlendale, California
  • The Oncology Institute of Hope InnovationLong Beach, California
  • UCI Medical Center-Chao Family Comprehensive Cancer CenterOrange, California
  • The Oncology Institute of Hope InnovationSanta Ana, California
  • Sansum ClinicSanta Barbara, California
  • Sansum ClinicSolvang, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 3, 2024. Always confirm current availability with the study team.

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