Treatment Resistance Following Anti-cancer Therapies

NCT04436120 | Terminated Results

• 3 other identifiers: A9001502TRANSLATE2018-003612-45
• Study Type: interventional
• Target: 38
• Locations: 5 countries
• Sites: 33

Brief 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.

Conditions

Disease Progression

Keywords

Non Small Cell Lung Cancer; Renal Cell Carcinoma; HR+ HER2- Breast Cancer; Castrate-Resistant Prostate Cancer; Germline mutated BRCA, HER2- Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Change in the Frequency of Gene Alterations Between Pre-treatment Tumor Samples (Archival) and Post-progression (De Novo) Tumor Biopsies

  Change in frequency is calculated by (frequency in de novo samples) - (frequency in archival samples). The frequency of each gene alteration is calculated as number of patients who harbored the alteration divided by the total number of patients in the cohort. Only gene alterations with variant allele frequency of 5% or greater were included in the analysis. Two different sequencing techniques were applied so 2 analysis sets were repeated for each cohort: targeted panel next-generation sequencing (NGS) and whole exome sequencing NGS.

  Through study completion, approximately 3 months

Secondary Outcomes (7)

• Number of Participants With Fully Evaluable Archival and Post-Progression Tumor Biopsy by Cohort

  Through study completion, approximately 3 months

• Overall Agreement Rate of Gene Alterations Between Post-Progression Tumor Biopsy and Blood NGS Results

  Through study completion, approximately 3 months

• Change in Frequency of RB1 Gene Alterations Between Pre-Treatment Archival and Post-Progression Samples

  Through study completion, approximately 3 months

• Percentage of Participants Who Carried the RB1 Gene Alterations in Post-Progression Blood cfDNA

  Through study completion, approximately 3 months

• Change in Frequency of AR Gene Alterations Between Pre-Treatment Archival and Post-Progression Samples

  Through study completion, approximately 3 months

Study Arms (1)

Tumor biopsy and blood draw

OTHER

Tumor biopsy and blood draw

Procedure: De novo tumor tissue biopsy; Procedure: Research blood draws

Interventions

De novo tumor tissue biopsy PROCEDURE

De novo tissue biopsy performed following disease progression

Tumor biopsy and blood draw

Research blood draws PROCEDURE

Blood biospecimens collected following disease progression

Tumor biopsy and blood draw

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (33)

Southern Cancer Center, P.C.

Daphne, Alabama, 36526, United States

Location

Southern Cancer Center, PC

Mobile, Alabama, 36607, United States

Location

Southern Cancer Center, PC

Mobile, Alabama, 36608, United States

Location

Alaska Urological Institute dba Alaska Clinical Research Center

Anchorage, Alaska, 99503, United States

Location

Arizona Oncology Associates, PC-HOPE

Tucson, Arizona, 85704, United States

Location

Arizona Oncology Associates, PC - HOPE

Tucson, Arizona, 85711, United States

Location

The Oncology Institute of Hope Innovation

Glendale, California, 91204, United States

Location

The Oncology Institute of Hope Innovation

Long Beach, California, 90805, United States

Location

UCI Medical Center-Chao Family Comprehensive Cancer Center

Orange, California, 92868-3201, United States

Location

The Oncology Institute of Hope Innovation

Santa Ana, California, 92705, United States

Location

Sansum Clinic

Santa Barbara, California, 93105, United States

Location

Sansum Clinic

Solvang, California, 93463, United States

Location

The Oncology Institute of Hope and Innovation

Whittier, California, 90602, United States

Location

ICRI-Administrative and Supplies Only

Whittier, California, 90603, United States

Location

Woodlands Medical Specialists PA

Pensacola, Florida, 32503, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Clínica Viedma S.A.

Viedma, Río Negro Province, 8500, Argentina

Location

Sanatorio de la Mujer

Rosario, Santa Fe Province, S2000ORE, Argentina

Location

Hospital Britanico de Buenos Aires

CABA, C1280AEB, Argentina

Location

Centro de Educacion Medica e Investigaciones Clinicas"Norberto Quirno" CEMIC

Ciudad Autónoma de Bs As, C1431FWO, Argentina

Location

Grand Hôpital de Charleroi - Site Notre Dame

Charleroi, 6000, Belgium

Location

AZ Maria Middelares

Ghent, 9000, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

Hôpital de Jolimont

Haine-Saint-Paul, 7100, Belgium

Location

Clinique Saint-Pierre Ottignies

Ottignies, 1340, Belgium

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Hôpitaux Civils de Colmar, Centre Hospitalier Louis Pasteur

Colmar, 68024, France

Location

CHU Henri Mondor

Créteil, 94010, France

Location

Hôpital La Croix du Sud

Quint-Fonsegrives, 31130, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Hopital Bégin

Saint-Mandé, 94160, France

Location

Royal Cornwall Hospital

Cornwall, TR1 3IJ, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Disease Progression; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Limitations and Caveats

Because of given challenges with study enrollment that were compounded by the global COVID-19 pandemic, and the observed high failure rate of tumor biospecimen analyses due to limitations in sample quality and quantity, the study was terminated in October 2020, which was not due to safety concerns or regulatory interactions. For endpoints with no data collected, no results can be disclosed.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 17, 2020
• Study Start: February 13, 2019
• Primary Completion: December 14, 2020
• Study Completion: December 14, 2020
• Last Updated: December 3, 2024
• Results First Posted: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (17); AR (4); BE (5); FR (6); GB (1)