Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumours

Official Title

A Phase 1b/2 Study To Evaluate Safety And Anti Tumour Activity Of Avelumab In Combination With The Poly(Adenosine Diphosphate [Adp]-Ribose) Polymerase (Parp) Inhibitor Talazoparib In Patients With Locally Advanced Or Metastatic Solid Tumours

Summary:

Avelumab in combination with talazoparib will be investigated in patients with locally advanced (primary or recurrent) or metastatic solid tumours, 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).

Trial Description

Primary Outcome:

  • Dose Limiting Toxicity (DLT)
  • Overall Response (OR)
Secondary Outcome:
  • Serum concentrations of avelumab
  • Anti drug antibody (ADA) levels of avelumab
  • OR
  • PSA Tumour Marker
  • CA-125 Tumour Marker
  • Biomarker PD-L1
  • Genomic
  • Serum concentrations of avelumab
  • Plasma concentrations of talazoparib
  • Plasma concentration of talazoparib
  • Neutralizing antibodies (Nab) levels against avelumab.
  • Time to Tumour Response (TTR)
  • Duration of response (DR)
  • Progression-Free Survival (PFS)
  • Prostate-Specific Antigen (PSA) response
  • Overall Survival (OS)
  • Biomarker Tumour Mutational Burden
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 tumours 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 tumours, 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).

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society