Treatment Resistance Following Anti-cancer Therapies

NCT04436120

Last updated date
Study Location
Johnston Hematology and Oncology of Clayton
Clayton, North Carolina, 27520, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Disease Progression
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Disease ProgressionTreatment Resistance Following Anti-cancer Therapies
NCT04436120
  1. Clayton, North Carolina
  2. Durham, North Carolina
  3. Henderson, North Carolina
  4. Laurinburg, North Carolina
  5. Lumberton, North Carolina
  6. Lumberton, North Carolina
  7. Smithfield, North Carolina
  8. Tours Cedex 09,
  9. Daphne, Alabama
  10. Mobile, Alabama
  11. Mobile, Alabama
  12. Anchorage, Alaska
  13. Tucson, Arizona
  14. Tucson, Arizona
  15. Camarillo, California
  16. Glendale, California
  17. Long Beach, California
  18. Orange, California
  19. Oxnard, California
  20. Santa Ana, California
  21. Santa Barbara, California
  22. Ventura, California
  23. Whittier, California
  24. Whittier, California
  25. Aurora, Colorado
  26. Boulder, Colorado
  27. Colorado Springs, Colorado
  28. Denver, Colorado
  29. Denver, Colorado
  30. Englewood, Colorado
  31. Lakewood, Colorado
  32. Littleton, Colorado
  33. Lone Tree, Colorado
  34. Longmont, Colorado
  35. Parker, Colorado
  36. Pueblo, Colorado
  37. Thornton, Colorado
  38. Pensacola, Florida
  39. Omaha, Nebraska
  40. Omaha, Nebraska
  41. Papillion, Nebraska
  42. Charleston, South Carolina
  43. Seattle, Washington
  44. Seattle, Washington
  45. Caba, Buenos Aires
  46. Viedma, RIO Negro
  47. Rosario, Santa FE
  48. Rosario, Santa FÉ
  49. San Migeuel De Tucuman, Tucuman
  50. San Miguel de Tucuman, Tucuman
  51. Caba,
  52. Ciudad Autónoma de Bs As,
  53. Krems,
  54. Bonheiden,
  55. Charleroi,
  56. Gent,
  57. Gent,
  58. Haine-Saint-Paul,
  59. Hasselt,
  60. Namur,
  61. Ottignies,
  62. Wilrijk,
  63. Clermont Ferrand,
  64. Colmar,
  65. Créteil,
  66. Créteil,
  67. Dijon,
  68. Lyon Cedex 09,
  69. Nancy,
  70. Quint Fonsegrives,
  71. Reims Cedex,
  72. Saint Grégoire,
  73. Saint-Mande,
  74. Wuerselen,
  75. Santiago de Compostela, A Coruna
  76. Barcelona,
  77. Cáceres,
  78. Málaga,
  79. Cornwall,
  80. Taunton,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Treatment Resistance Following Anti-cancer Therapies
Official Title  ICMJE TREATMENT RESISTANCE FOLLOWING ANTI-CANCER THERAPIES (TRANSLATE)
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.

Detailed Description

Background: Development of new cancer treatments requires better understanding of why tumors develop resistance to standard-of-care (SOC) therapies. However, post-progression tumor biopsies are not routinely collected, limiting the tissue available to characterize mechanisms of treatment resistance. The TRANSLATE clinical study is specifically designed to address these critical gaps.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Disease Progression
Intervention  ICMJE
  • Procedure: De novo tumor tissue biopsy
    De novo tissue biopsy performed following disease progression
  • Procedure: Research blood draws
    Blood biospecimens collected following disease progression
Study Arms  ICMJE Tumor biopsy and blood draw
Tumor biopsy and blood draw
Interventions:
  • Procedure: De novo tumor tissue biopsy
  • Procedure: Research blood draws
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 16, 2020)
550
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 18, 2021
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Argentina,   Austria,   Belgium,   France,   Germany,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04436120
Other Study ID Numbers  ICMJE A9001502
TRANSLATE ( Other Identifier: Alias Study Number )
2018-003612-45 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP