Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors
NCT03565991
ABOUT THIS STUDY
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- 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.
- 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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Descriptive Information | |||||||
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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.
Masking Description: Open label Primary Purpose: Treatment
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Combination of avelumab and talazoparib
Single arm open label Interventions:
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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 | 202 | ||||||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | September 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |