Olinvacimab With Pembrolizumab in Patients With mTNBC

  • STATUS
    Recruiting
  • End date
    Aug 30, 2026
  • participants needed
    36
  • sponsor
    PharmAbcine
Updated on 25 March 2022

Summary

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

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.

Details
Condition Metastatic Triple-Negative Breast Cancer
Treatment Olinvacimab
Clinical Study IdentifierNCT04986852
SponsorPharmAbcine
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Female patients ≥19 years old
Histologically proven metastatic triple-negative breast cancer irrespective of PD-L1 status
Histological or cytological diagnosis of relapsed/metastatic triple receptor negative breast cancer (TNBC).TNBC is defined negatively expression of estrogen(ER), progesterone(PR) and human epidermal receptor-2(HER2). If there is a pathology report of the metastasis, take the histopathology of the metastases as standard. Negative of ER and PR is defined as expression of ER, PR<1% of the tumor cells by immunohistochemistry (IHC). HER2-negative is defined as a score of 0 and 1+ by IHC, or IHC 2+ & fluorescent in situ hybridization (FISH) negative. If the ER2 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
Has received one or two prior lines 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. 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 patient with creatinine levels >1.5 × institutional ULN 9) 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) 10) Participants who are HBsAg positive are eligible if they have received HBV antiviral 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 11) 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 12) The patient should provide written
informed consent

Exclusion Criteria

A patient who meets any of the following criteria is excluded from participating in this
study
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 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 -Common Terminology Criteria for Adverse
events (NCI-CTCAE v5.0) grade 1 or baseline from AEs due to previous therapy (patient
with ≤ Grade 2 neuropathy or alopecia may be eligible)
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 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 or the implantation of
intrauterine system (IUD)
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 enrolment. 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 enrolment
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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