Olinvacimab With Pembrolizumab in Patients With mTNBC
PHASE2TERMINATED
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
- Female patients ≥19 years old
- Histologically proven mTNBC irrespective of PD-L1 status.
- Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
- Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology.
- Has received at least one prior line of systemic therapy for metastatic or inoperable locally advanced TNBC.
- No previous therapy with anti-VEGF, anti-VEGFR or anti-PD-1 antibody for their metastatic disease.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate hematologic, renal, and hepatic function tests performed within 7 days prior to initiation of study treatment.
- HIV-infected participants must be on anti-retroviral therapy and have a well-controlled HIV infection/disease.
- Participants who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
- Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening.
- The patient should provide written informed consent
Exclusion criteria
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
- Has known active CNS metastases and/or carcinomatous meningitis.
- Treatment with systemic chemotherapy, hormonal therapy, immunotherapy or biologic therapy within 4 weeks or five half-lives prior to the baseline visit.
- Has received prior radiotherapy within 2 weeks of start of study treatment.
- Not recovered below National Cancer Institute (NCI) CTCAE (v5.0) Grade 1 or baseline from AEs due to previous therapy.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy within 7 days prior the first dose of study drug.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years.
- Has a known additional malignancy that is progressing or has required active treatment within the past 2 years.
- Has a history of (non-infectious) pneumonitis/interstitial lung diseases that required steroids or current pneumonitis/interstitial lung disease.
- Has an active infection requiring systemic antibiotics.
- HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
- Active psychiatric disorder or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
- Female who is pregnant or lactating and of childbearing potential who does not agree to a reliable and adequate method of contraception.
- Uncontrolled hypertension (systolic blood pressure > 150 or diastolic blood pressure > 90 mmHg) or seizure.
- Class III or IV heart failure by New York Heart Association classification.
- Requiring therapeutic anticoagulation treatment.
- Serious Grade 4 venous thromboembolic event including pulmonary embolism.
- Moderate to severe proteinuria as demonstrated by urine dipstick for proteinuria ≥2+.
- History of abdominal fistula or gastrointestinal perforation, or serious GI bleeding within 6 months.
- History of severe arterial thromboembolic event within 12 months of start of study drug.
- Major surgery within 4 weeks prior to initiation of study treatment.
- A known history of severe hypersensitivity (≥Grade 3) to study drugs and/or any of its excipients.
- Has had an allogenic tissue/solid organ transplant.
- Unable to participate in the trial according to the investigator's decision.
- Have received a live vaccine within 30 days prior to enrollment.
- Have had a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: FEMALE
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE2
Study ID
NCT04986852
Intervention or treatment
DRUG: Olinvacimab
Conditions
- Metastatic Triple-Negative Breast Cancer
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Hollywood Private Hospital
Select from list below to view details:
Hollywood Private Hospital
Nedlands, Western Australia, Australia
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Who is running the clinical trial?
P
PharmAbcine
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
| Measure | Description | 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
| Measure | Description | 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 |
Are you running this trial?If you're a clinic or sponsor, you can claim this study.
References
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