Olinvacimab With Pembrolizumab in Patients With mTNBC

NCT04986852 | Terminated Phase 2

• 2 other identifiers: PMC_TTAC-0001_06 / KEYNOTE-C14MK-3475-B37
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Triple-Negative Breast Cancer

Keywords

Olinvacimab; Pembrolizumab

Outcome Measures

Primary Outcomes (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

  Baseline upto 24 months

Secondary Outcomes (4)

• Duration of response (DOR)

  Baseline upto 24 months

• Disease control rate (DCR)

  Baseline upto 24 months

• Progression-free survival (PFS)

  Baseline upto 24 months

• Overall survival (OS)

  Baseline upto 24 months

Other Outcomes (8)

• ORR evaluated by iRECIST criteria:

  Baseline upto 24 months

• DOR evaluated by iRECIST criteria:

  Baseline upto 24 months

• DCR evaluated by iRECIST criteria:

  Baseline upto 24 months

Study Arms (1)

Olinvacimab (TTAC-0001) 16 mg/kg and Pembrolizumab (Keytruda®) 200 mg

EXPERIMENTAL

* Olinvacimab (TTAC-0001) 16 mg/kg on D1, D8 and D15 * Pembrolizumab (Keytruda®) 200 mg on D1 Cycle: 3 weeks (21 days per cycle)

Drug: Olinvacimab

Interventions

Olinvacimab DRUG

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).

Also known as: Pembrolizumab

Olinvacimab (TTAC-0001) 16 mg/kg and Pembrolizumab (Keytruda®) 200 mg

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• 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.
• 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

Sponsors & Collaborators

• PharmAbcine: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Hollywood Private Hospital

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

olinvacimab; pembrolizumab

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Claire Beecroft, Ph.D, MD

  Hollywood Private Hospital, Australia

  PRINCIPAL INVESTIGATOR

• Dhanusha Sabanathan, Ph.D, MD

  Macquarie University, Australia

  PRINCIPAL INVESTIGATOR

• Brenton Seidl, Ph.D, MD

  University of Sunshine Coast, Australia

  PRINCIPAL INVESTIGATOR

• Daphne Day, Ph.D, MD

  Monash Medical Centre, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: It is open label study, so investigator and participant can know what is treated.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patient will be assigned as sequentially with serial screening/ enrollment number.

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: August 3, 2021
• Study Start: September 30, 2021
• Primary Completion: December 3, 2024
• Study Completion: December 3, 2024
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)