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Metastatic Triple-Negative Breast CancerPhase 2NCT04986852

Olinvacimab With Pembrolizumab in Patients With mTNBC

A Phase 2 study testing Olinvacimab in people with Metastatic Triple-Negative Breast Cancer, run by PharmAbcine at 1 site in Australia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The objective is to evaluate the efficacy and safety of Olinvacimab in combination with Pembrolizumab in patients with mTNBC. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Metastatic Triple-Negative Breast Cancer
What is being tested?
Olinvacimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteAustralia
Study dates
30 Sep 2021to 3 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients ≥19 years old
  • Histologically proven mTNBC* irrespective of PD-L1 status.
  • Histological or cytological diagnosis of relapsed/metastatic TNBC. TNBC is defined by the negative expression of estrogen receptors (ER), progesterone receptors and human epidermal receptor-2 (HER2). If there is a pathology report of the metastasis, take the histopathology of the metastases as standard. Negative for ER and progesterone receptors is defined as the expression of ER and progesterone receptors in <1% of the tumor cells by immunohistochemistry (IHC). HER2-negative is defined as a score of 0 and 1+ by IHC, or IHC 2+ and fluorescence in situ hybridization (FISH) negative. If the HER2 test result is 0 or 1+ by IHC, FISH detection is optional, but the result must be negative.
  • Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
  • Note: If submitting unstained cut slides, newly cut slides should be submitted to the testing laboratory within 14 days from the date slides are cut
  • Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
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  • Has received at least one prior line of systemic therapy for metastatic or inoperable locally advanced TNBC. Patients who have failed adjuvant chemo within 12 months should be considered as fulfilling a line of systemic therapy.
  • No previous therapy with anti-VEGF, anti-VEGFR or anti-PD-1 antibody for their metastatic disease. The use of anti-VEGF, anti-VEGFR, anti-PD-1 or anti-PD-L1 antibody in neoadjuvant or adjuvant setting will be allowed if there was no progression of disease within 6 months after the completion of treatment.
  • 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:
  • Hematologic tests
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Platelets ≥ 100 x 109/L
  • Haemoglobin ≥ 9.0 g/dL (This must be met without packed red blood cell (pRBC) transfusion within the prior 2 weeks. Participants can be on stable dose of erythropoietin, e.g. ≥ approximately 3 months)
  • Blood coagulation tests
  • Prothrombin time (PT) ≤ 1.5 x Upper limit of normal (UNL)
  • Activated partial thromboplastin time (aPTT) ≤ 1.5 x UNL
  • Hepatic function tests
  • Total bilirubin ≤ 1.5 x UNL
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN in case of liver metastasis)
  • Renal function test - Creatinine ≤1.5 × ULN or creatinine clearance (CrCl) ≥30 mL/min for patients with creatinine levels >1.5 × institutional ULN
  • HIV-infected participants must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease defined as:
  • Participants on ART must have a CD4+ T cell count >350 cells/mm3 at time of screening
  • Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 copies/mL or the lower limit of qualification (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks prior to screening
  • Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks prior to study entry (day 1)
  • 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.
  • Note: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.
  • Hepatitis B screening tests are not required unless:
  • Known history of HBV infection
  • As mandated by local health authority
  • Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening.
  • Note: Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.
  • Hepatitis C screening tests are not required unless:
  • Known history of HCV infection
  • As mandated by local health authority
  • The patient should provide written informed consent

Who cannot join

  • 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.
  • Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
  • Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment
  • Treatment with systemic chemotherapy, hormonal therapy, immunotherapy or biologic therapy within 4 weeks or five half-lives (which is shorter) prior to the baseline visit
  • Has received prior radiotherapy within 2 weeks of start of study treatment. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 2-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease
  • Not recovered below National Cancer Institute (NCI) CTCAE (v5.0) Grade 1 or baseline from AEs due to previous therapy (patient with ≤ Grade 2 neuropathy or alopecia may be eligible)
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  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive 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 (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. (Note: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ [e.g., breast carcinoma, cervical cancer in situ] controlled by curative therapy are not excluded).
  • 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 (schizophrenia, major depressive disorder, bipolar disorder etc.) or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study. Treated depression with ongoing antidepressant medication is not an exclusion criterion
  • Female who is pregnant* or lactating and of childbearing potential who does not agree to a reliable and adequate method of contraceptiona.
  • A women of childbearing potential (WOCBP) must agree to use contraception during the treatment period and for at least 6 months (for females) after the last dose of study treatment.
  • aAdequate contraception allowed in this trial is as follows
  • Hormonal contraceptives such as combined oral contraceptive pill
  • Intrauterine devices (IUD) or the implantation of intrauterine system
  • Blockage methods (spermicides and condoms/spermicides and [vaginal] diaphragm for contraception, vaginal sponges or cervical cap)
  • Sterilization surgery such as tubal ligation in females *A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Uncontrolled hypertension (systolic blood pressure [SBP]> 150 or diastolic blood pressure [DBP]> 90 mmHg) or seizure
  • Class III or IV heart failure by New York Heart Association (NYHA) classification
  • Requiring therapeutic anticoagulation treatment (prophylactic therapy with low-molecular weight heparin is allowed)
  • Serious Grade 4 venous thromboembolic event including pulmonary embolism
  • Moderate to severe proteinuria as demonstrated by urine dipstick for proteinuria ≥2+. For patients with ≥2+ proteinuria on dipstick urinalysis, a urine protein: creatinine (UPC) ratio will be determined, or a 24-hour urine collection will be done. Patients with a UPC ratio <1 or a 24-hour urine protein <1 gram are eligible.
  • 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. (If the participant had major surgery, the participant must have recovered adequately from the procedure and/or any complications from the surgery prior to starting study intervention).
  • 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. Seasonal flu vaccines that do not contain live virus are permitted
  • Have had a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Hollywood Private Hospital

    Nedlands, Western Australia, 6009

Other trials in Australia

About this study

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

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

Read the 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.

Being tested
Olinvacimab
Keywords
Olinvacimab, Pembrolizumab
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OlinvacimabDrug

    Also called Pembrolizumab

    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).

Study groups in NCT04986852
Study groupRoleWhat they receive
Olinvacimab (TTAC-0001) 16 mg/kg and Pembrolizumab (Keytruda®) 200 mgExperimental* Olinvacimab (TTAC-0001) 16 mg/kg on D1, D8 and D15 * Pembrolizumab (Keytruda®) 200 mg on D1 Cycle: 3 weeks (21 days per cycle)
Receives: Drug: Olinvacimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline upto 24 months

Secondary outcomes (4)

  1. 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.

    Measured: Baseline upto 24 months

  2. 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.

    Measured: Baseline upto 24 months

  3. 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.

    Measured: Baseline upto 24 months

  4. 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.

    Measured: Baseline upto 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2021
  2. Study start30 Sep 2021
  3. Primary completion3 Dec 2024
  4. Study completion3 Dec 2024

Why it stopped: Subject recruitment issues and follow-up study plans

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Patient will be assigned as sequentially with serial screening/ enrollment number.
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04986852
Sponsor's protocol ID
PMC_TTAC-0001_06 / KEYNOTE-C14
Other IDs
MK-3475-B37
Status last verified
Dec 2025
First submitted
7 Jul 2021
Last updated
30 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Olinvacimab in people with Metastatic Triple-Negative Breast Cancer, run by PharmAbcine at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Subject recruitment issues and follow-up study plans). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Baseline upto 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04986852.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.

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