Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors
Solid Tumor
Unknown Primary
18 Years and older, Male and Female
B9991032 (primary)
NCI-2018-01421
2018-000345-39
Summary
Avelumab in combination with talazoparib will be investigated in patients with locally
advanced or metastatic solid tumors with a BRCA or ATM defect.
Objectives
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.
Eligibility
- 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.
Treatment Sites in Georgia
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