Neoadjuvant Angiogenesis-Targeting Bispecific Chemoimmunotherapy for TNBC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Kansas Medical Center
About this trial
This study will test the effectiveness of two standard neoadjuvant chemotherapy regimens plus an investigational drug (ivonescimab) that has dual action as both immunotherapy and therapy targeting the tumor's blood supply. This investigational drug is called ivonescimab.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The invasive tumor must be hormone receptor poor, defined as both estrogen receptor (ER) and progesterone receptor staining in ≤ 10% of invasive cancer cells by IHC.
The invasive tumor must be HER2-negative based on the current ASCO-CAP guidelines 79.
Subjects with bilateral synchronous triple-negative breast cancer are eligible if they meet other eligibility criteria.
Not a woman of reproductive potential as defined by institutional standards and treating physician's discretion
Disqualifiers
Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots). Note: Transient hemoptysis associated with diagnostic bronchoscopy is allowed.
Nasal bleeding /epistaxis (bloody nasal discharge is allowed)
Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to starting study treatment. The use of full-dose anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits according to institutional guidelines.
Live vaccines include (but are not limited to) measles, mumps, rubella, varicella/zoster (chicken pox and shingles), yellow fever, rabies, Bacillus-Calmette-Guérin (BCG), typhoid.
Trial design
Design model
Parallel
Treatments tested in this trial
Carboplatin
DrugCommercially available
Docetaxel
DrugCommercially available
Doxorubicin
DrugCommercially available.
Cyclophosphamide
DrugCommercially available.
Ivonescimab
DrugIvonescimab is a bispecific antibody targeting PD-1 and VEGF. Ivonescimab will be supplied for participants by Summit Therapeutics.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Low-sTILs cohort (sTILs <30%)Other 5 interventions
Group B: High-sTILs cohort (sTILs ≥30%)Other 3 interventions
Trial outcomes
Primary outcomes
1
Pathologic complete response (pCR) rate in the breast and axilla in the two treatment arms.
Determine the rates of pathologic complete response (pCR) with ivonescimab-containing neoadjuvant systemic therapy among patients with low and high stromal tumor-infiltrating lymphocytes (sTILs), as evidenced by absence of invasive disease in breast and axillary lymph nodes (ypT0/Tis ypN0) determined by histopathological examination.
Time frame
At time of definitive breast surgerySecondary outcomes
1
Treatment-related adverse events
Assess toxicity of ivonescimab in combination with chemotherapy. Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 6.0.
Time frame
Start of study treatment (cycle 1 day 1) until 30 days after last dose of study treatment (90 days for serious and immune-related adverse events)2
Event-free survival (EFS)
3- and 5-year event-free survival (defined as the time from diagnosis to first recurrence \[invasive ipsilateral breast, invasive local/regional, or distant\] or to breast cancer-related death)
Time frame
Up to 5 years after enrollment3
Overall survival (OS)
3- and 5-year overall survival (defined as the time from diagnosis to death from any cause)
Time frame
Up to 5 years after enrollmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: