Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors

NCT03565991

Last updated date
Study Location
Osaka International Cancer Institute
Osaka-shi, Osaka, 541-8567, Japan
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Locally Advanced or Metastatic Solid Tumors, BRCA 1 Genes
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

- BRCA1, BRCA2 and/or ATM gene defect.

- Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumors that are not amenable for treatment with curative intent

- Availability a tumor tissue sample from a diagnostic biopsy/surgery or a metastatic tumor biopsy.

- Progressive disease at study enrollment.

- Minimum age 18 years (in Japan, minimum age 20 years).

- ECOG performance status 0 or 1.

- Adequate bone marrow, renal and liver function.

- For childbearing female patients, negative serum or urine pregnancy test at screening

- Signed and dated informed consent document.

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


- Prior anti-cancer therapy or radiation therapy within 2 weeks prior to enrolment.
Palliative radiotherapy to metastatic lesion(s) permitted providing that it has been
completed at least 2 days prior to enrolment and no significant toxicity are expected.


- Major surgery within 4 weeks prior to study enrollment.


- Current use of immunosuppressive medication at the time of study enrollment.


- Known prior severe hypersensitivity to investigational products or any component in
their formulations


- Known history of immune-mediated colitis, inflammatory bowel disease, pneumonitis,
pulmonary fibrosis.


- Active or prior autoimmune disease that might deteriorate when receiving an
immunostimulatory agent.


- Prior organ transplantation including allogenic stem-cell transplantation.


- Administration of live attenuated vaccines within 4 weeks of study enrollment.


- Diagnosis of myelodysplastic syndrome.


- Known symptomatic brain metastases requiring steroids.


- Persisting toxicity related to prior therapy Grade >1.


- Known history of HIV or AIDS.


- Positive HBV or HCV test indicating acute or chronic infection.


- Active infection requiring systemic therapy.


- Clinically significant (active) cardiovascular disease: cerebral vascular
accident/stroke or myocardial infarction within 6 months prior to study enrollment;
unstable angina, congestive heart failure or a serious cardiac arrhythmia requiring
medication.


- Diagnosis of any other malignancy within 2 years prior to study enrollment, except for
adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of
the breast, bladder, or cervix, or low-grade prostate cancer or other early-stage
low-risk cancers.


- Pregnant or breastfeeding female patients; female or male patients who are able to
have children who are unable or unwilling to use contraception as outlined in the
protocol.

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Locally Advanced or Metastatic Solid Tumors, BRCA 1 GenesJavelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors
NCT03565991
  1. Osaka-shi, Osaka
  2. Los Angeles, California
  3. Los Angeles, California
  4. Palo Alto, California
  5. Palo Alto, California
  6. Santa Monica, California
  7. Stanford, California
  8. Stanford, California
  9. Alpharetta, Georgia
  10. Athens, Georgia
  11. Atlanta, Georgia
  12. Atlanta, Georgia
  13. Atlanta, Georgia
  14. Atlanta, Georgia
  15. Canton, Georgia
  16. Cumming, Georgia
  17. Decatur, Georgia
  18. Decatur, Georgia
  19. Jonesboro, Georgia
  20. Macon, Georgia
  21. Marietta, Georgia
  22. New Orleans, Louisiana
  23. Boston, Massachusetts
  24. Boston, Massachusetts
  25. Creve Coeur, Missouri
  26. Saint Louis, Missouri
  27. Saint Louis, Missouri
  28. Saint Louis, Missouri
  29. Saint Louis, Missouri
  30. Saint Louis, Missouri
  31. Saint Peters, Missouri
  32. Middletown, New Jersey
  33. Harrison, New York
  34. New York, New York
  35. New York, New York
  36. New York, New York
  37. New York, New York
  38. New York, New York
  39. New York, New York
  40. New York, New York
  41. White Plains, New York
  42. Columbus, Ohio
  43. Columbus, Ohio
  44. Columbus, Ohio
  45. Oklahoma City, Oklahoma
  46. Philadelphia, Pennsylvania
  47. Philadelphia, Pennsylvania
  48. Pittsburgh, Pennsylvania
  49. Pittsburgh, Pennsylvania
  50. Pittsburgh, Pennsylvania
  51. Chattanooga, Tennessee
  52. Chattanooga, Tennessee
  53. Cleveland, Tennessee
  54. Dickson, Tennessee
  55. Franklin, Tennessee
  56. Gallatin, Tennessee
  57. Hermitage, Tennessee
  58. Lebanon, Tennessee
  59. Murfreesboro, Tennessee
  60. Nashville, Tennessee
  61. Nashville, Tennessee
  62. Nashville, Tennessee
  63. Nashville, Tennessee
  64. Nashville, Tennessee
  65. Shelbyville, Tennessee
  66. Smyrna, Tennessee
  67. Houston, Texas
  68. Brussels,
  69. Brussel,
  70. Edegem,
  71. Copenhagen,
  72. Odense C,
  73. Clermont Ferrand,
  74. La Rochelle,
  75. Montpellier Cedex 5,
  76. Torette Di Ancona, AN
  77. Meldola, FC
  78. Monza, MB
  79. Milano, MI
  80. Milano, MI
  81. Napoli,
  82. Roma,
  83. Roma,
  84. Kashiwa, Chiba
  85. Chuo-ku, Tokyo
  86. Tilburg, Noord-brabant
  87. Tilburg, Noord-brabant
  88. Amsterdam, Noord-holland
  89. Rotterdam, Zuid-holland
  90. Pamplona, Navarra
  91. Barcelona,
  92. Barcelona,
  93. Barcelona,
  94. Madrid,
  95. Madrid,
  96. Madrid,
  97. Sevilla,
  98. London,
  99. London,
  100. London,
  101. London,
  102. London,
  103. London,
  104. London,
  105. London,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors
Official Title  ICMJE A PHASE 2 STUDY TO EVALUATE SAFETY AND ANTI-TUMOR ACTIVITY OF AVELUMAB IN COMBINATION WITH TALAZOPARIB IN PATIENTS WITH BRCA OR ATM MUTANT TUMORS JAVELIN BRCA/ATM
Brief Summary Avelumab in combination with talazoparib will be investigated in patients with locally advanced or metastatic solid tumors with a BRCA or ATM defect.
Detailed Description

Avelumab is a human immunoglobulin (Ig)G1 monoclonal antibody (mAb) directed against programmed death ligand 1 (PD-L1). Avelumab selectively binds to PD-L1 and competitively blocks its interaction with programmed death receptor 1 (PD-1), thereby interfering with this key immune checkpoint inhibition pathway. Avelumab is currently being investigated as single agent and in combination with other anti cancer therapies in patients with locally advanced or metastatic solid tumors and various hematological malignancies.

Talazoparib is a potent, orally bioavailable poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor, which is cytotoxic to human cancer cell lines harboring gene mutations that compromise deoxyribonucleic acid (DNA) repair, an effect referred to as synthetic lethality, and by trapping PARP protein on DNA thereby preventing DNA repair, replication, and transcription.

Avelumab in combination with talazoparib will be investigated in patients with locally advanced (primary or recurrent) or metastatic solid tumors with a BReast CAncer susceptibility gene (BRCA)1, or BRCA2, or ataxia telangiectasia mutated (ATM) gene defect.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Single arm study with two cohorts enrolled in parallel.

  • Cohort 1 will enroll patients with locally advanced or metastatic solid tumors with one or more defects in the BRCA1 or BRCA2 genes
  • Cohort 2 will enroll patients with locally advanced or metastatic solid tumors with one or more defects in the ATM gene
Masking: None (Open Label)
Masking Description:
Open label
Primary Purpose: Treatment
Condition  ICMJE
  • Locally Advanced or Metastatic Solid Tumors
  • Genes, BRCA 1
Intervention  ICMJE
  • Drug: Avelumab
    IV treatment
    Other Name: Bavencio
  • Drug: Talazoparib
    Oral treatment
    Other Name: MDV3800, BMN 673
Study Arms  ICMJE Experimental: Combination of avelumab and talazoparib
Single arm open label
Interventions:
  • Drug: Avelumab
  • Drug: Talazoparib
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 22, 2020)
202
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2018)
200
Estimated Study Completion Date  ICMJE December 2, 2022
Estimated Primary Completion Date March 8, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BRCA1, BRCA2 and/or ATM gene defect.
  • Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumors that are not amenable for treatment with curative intent
  • Availability a tumor tissue sample from a diagnostic biopsy/surgery or a metastatic tumor biopsy.
  • Progressive disease at study enrollment.
  • Minimum age 18 years (in Japan, minimum age 20 years).
  • ECOG performance status 0 or 1.
  • Adequate bone marrow, renal and liver function.
  • For childbearing female patients, negative serum or urine pregnancy test at screening
  • Signed and dated informed consent document.

Exclusion Criteria:

  • Prior anti-cancer therapy or radiation therapy within 2 weeks prior to enrolment. Palliative radiotherapy to metastatic lesion(s) permitted providing that it has been completed at least 2 days prior to enrolment and no significant toxicity are expected.
  • Major surgery within 4 weeks prior to study enrollment.
  • Current use of immunosuppressive medication at the time of study enrollment.
  • Known prior severe hypersensitivity to investigational products or any component in their formulations
  • Known history of immune-mediated colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis.
  • Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
  • Prior organ transplantation including allogenic stem-cell transplantation.
  • Administration of live attenuated vaccines within 4 weeks of study enrollment.
  • Diagnosis of myelodysplastic syndrome.
  • Known symptomatic brain metastases requiring steroids.
  • Persisting toxicity related to prior therapy Grade >1.
  • Known history of HIV or AIDS.
  • Positive HBV or HCV test indicating acute or chronic infection.
  • Active infection requiring systemic therapy.
  • Clinically significant (active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months prior to study enrollment; unstable angina, congestive heart failure or a serious cardiac arrhythmia requiring medication.
  • Diagnosis of any other malignancy within 2 years prior to study enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast, bladder, or cervix, or low-grade prostate cancer or other early-stage low-risk cancers.
  • Pregnant or breastfeeding female patients; female or male patients who are able to have children who are unable or unwilling to use contraception as outlined in the protocol.
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Denmark,   France,   Italy,   Japan,   Netherlands,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03565991
Other Study ID Numbers  ICMJE B9991032
2018-000345-39 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
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 August 2020

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