NCT04986852

Olinvacimab With Pembrolizumab in Patients With mTNBC

A Phase II, Open-Label, Multicenter Study of Olinvacimab in Combination With Pembrolizumab in Patients With Metastatic Triple-Negative Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: PharmAbcine · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The objective is to evaluate the efficacy and safety of Olinvacimab in combination with Pembrolizumab in patients with mTNBC.

Detailed description

After being informed about the study and potential risks, all patients will complete informed consent form in written. During 2 weeks screening period, investigator will evaluate patient eligibility and if it meet with protocol, patient will enrolled. 1 cycle treatment is perform on D1, D8, D15 to inject Olinvacimab and Pembrolizumab, it can be repeated upto 35 cycles.

Conditions

• Metastatic Triple-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Olinvacimab	Treatment with Olinvacimab and Pembrolizumab is to be continued until disease progression, the development of unacceptable toxicity or patient's withdrawal of consent. Maximum duration of treatment will be 35 cycles (approximately 2 years).

Timeline

• Start date: 2021-09-30
• Primary completion: 2024-12-03
• Completion: 2024-12-03
• First posted: 2021-08-03
• Last updated: 2025-12-30

Locations

1 site across 1 country: Australia