Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT03964532

TALAVE: Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer

TALAVE: A Pilot Trial of Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer

Status
Active Not Recruiting
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
24 (actual)
Sponsor
Georgetown University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a multi-institutional pilot trial for patients with advanced breast cancer. The trial is designed to assess the safety and tolerability of induction talazoparib followed by combination of talazoparib and avelumab. As an exploratory endpoint, the study team will evaluate the immunomodulatory effects of induction talazoparib followed by the combination of talazoparib and avelumab in patients with advanced breast cancer.

Conditions

Interventions

TypeNameDescription
DRUGTalazoparibTalazoparib (formerly MDV3800 and BMN673) is an oral small molecule, selective inhibitor of PARP-1 and PARP-2.
DRUGAvelumabAvelumab (formerly MSB0010718C) is a human immunoglobulin G1 (IgG1) anti-PD-L1 monoclonal antibody131 that utilizes both adaptive and innate immune mechanisms.

Timeline

Start date
2019-04-17
Primary completion
2027-04-01
Completion
2027-04-01
First posted
2019-05-28
Last updated
2026-04-09

Locations

2 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03964532. Inclusion in this directory is not an endorsement.

TALAVE: Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer (NCT03964532) · Clinical Trials Directory