A PHASE 1B/2 STUDY TO EVALUATE SAFETY AND ANTI TUMOR ACTIVITY OF AVELUMAB IN COMBINATION WITH THE POLY(ADENOSINE DIPHOSPHATE [ADP]-RIBOSE) POLYMERASE (PARP) INHIBITOR TALAZOPARIB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS
Description
Brief Summary
Avelumab in combination with talazoparib will be investigated in patients with locally
advanced (primary or recurrent) or metastatic solid tumors, including non-small cell lung
cancer (NSCLC), triple negative breast cancer (TNBC), hormone receptor positive (HR+) breast
cancer, recurrent platinum sensitive ovarian cancer, urothelial cancer (UC), and castration
resistant prostate cancer (CRPC).
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, including non-small cell lung
cancer (NSCLC), triple negative breast cancer (TNBC), hormone receptor positive (HR+) breast
cancer, recurrent platinum sensitive ovarian cancer, urothelial cancer (UC), and castration
resistant prostate cancer (CRPC).
Phase
N/AInclusion and Exclusion Criteria
- Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumors that are not amenable for treatment with curative intent in adult patients with: NSCLC, TNBC, HR+ breast cancer, recurrent platinum sensitive ovarian cancer, UC, CRPC, and other advanced solid tumors with a BRCA or ATM gene defect
- Mandatory primary or metastatic tumor biopsy. If archival tumor tissue is available from a biopsy/surgery the tumor tissue may be submitted without repeating a tumor biopsy during the screening period.
- Minimum age in Japan is 20 years.
- ECOG performance status 0 or 1.
- Resolved acute effects of prior therapy
- Adequate bone marrow, renal, and liver function.
- Negative serum pregnancy test at screening.
- Pregnant, breastfeeding females or female patients able to have children must agree to use highly effective method of contraception throughout the study and for at least 30 days after the last dose of avelumab and for at least 7 months after the last dose of talazoparib; fertile male patients must use a condom during treatment and for at least 4 months after the last dose of talazoparib.
- Signed and dated informed consent.
- Prior treatment with a PARP inhibitor.
- Prior immunotherapy with IL-2, IFN-
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.