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Olinvacimab With Pembrolizumab in Patients With mTNBC
The objective is to evaluate the efficacy and safety of Olinvacimab in combination with Pembrolizumab in patients with mTNBC.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 19 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2021-09-30
Primary completion: 2025-02-28
Study completion finish: 2026-08-30
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT04986852
Intervention or treatment
DRUG: Olinvacimab
Conditions
- • Metastatic Triple-Negative Breast Cancer
Find a site
Closest Location:
Hollywood Private Hospital
Research sites nearby
Select from list below to view details:
Hollywood Private Hospital
Nedlands, Western Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Olinvacimab (TTAC-0001) 16 mg/kg and Pembrolizumab (Keytruda®) 200 mg
| DRUG: Olinvacimab
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Objective response rate (ORR) | ORR is defined as the proportion of subjects who achieve a best overall response (BOR) of complete response (CR) or partial response (PR). RECIST 1.1 will be used to determine ORR and patients with no post baseline tumor assessments, will be classified as non-responders | Baseline upto 24 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Duration of response (DOR) | DOR is defined as the time between the date of first response (CR or PR) according to RECIST 1.1 to the date of first disease progression, or death due to any cause, whichever occurs first. | Baseline upto 24 months |
Disease control rate (DCR) | DCR is defined as the proportion of subjects who achieve CR, PR, or stable disease (SD) according to RECIST 1.1. | Baseline upto 24 months |
Progression-free survival (PFS) | PFS time is defined as the time from the start date of the study drug administration to date of the first disease progression according to RECIST 1.1, or death due to any cause, whichever occurs first. | Baseline upto 24 months |
Overall survival (OS) | OS time is defined as the time from the start date of the study drug administration to the date of death due to any cause. | Baseline upto 24 months |
Frequently Asked Questions
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
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