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

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Osaka International Cancer Institute
Osaka-shi, Osaka, 541-8567 Japan
Contact
1-800-718-1021
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.

NCT03565991
Pfizer
Recruiting
Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors

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Locally Advanced or Metastatic Solid Tumors, BRCA 1 Genes
NCT03565991
All Genders
18+
Years
Multiple Sites
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
Brief SummaryAvelumab 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 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2, 2022
Estimated Primary Completion DateMarch 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: Pfizer CT.gov Call Center1-800-718-1021[email protected]pfizer.com
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 CommitteeNot 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/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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