Actively Recruiting
Phase II Trial of Ivonescimab in Combination With Carboplatin + Docetaxel in Patients With Early-Stage Triple Negative Breast Cancer
Led by Cedars-Sinai Medical Center · Updated on 2026-04-02
34
Participants Needed
4
Research Sites
379 weeks
Total Duration
On this page
Sponsors
C
Cedars-Sinai Medical Center
Lead Sponsor
S
Summit Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single arm phase II trial combination of ivonescimab and carbo-docetaxel every 3 weeks for 6 cycles in patients with early-stage triple negative breast cancer. The trial is designed to test the safety and efficacy of adding ivonescimab in patients with early TNBC undergoing neoadjuvant chemotherapy with carboplatin and docetaxel. Patients will receive ivonescimab 20 mg/kg IV on Day 1 of each cycle, and carboplatin AUC6 and docetaxel 75 mg/m2 on Day 1 of each cycle for 6 cycles. Cycles will be 21 days for a total of 6 cycles. Curative intent surgery will be performed within 6 weeks (maximum 12 weeks) time frame upon completion of last dose of chemoimmunotherapy. The surgical pathology information will be used for assessment of pathological response, which serve as the primary endpoint of this study. Patients will undergo assessment at baseline, C1D1 of each cycle and end of treatment visit for collection of treatment-emergent adverse events, evaluated by CTCAE v5.0. Patient reported outcomes will be collected at cycles 1, 4, and 6, and at EOT. All study patients will be followed for at least 5 years for EFS and OS follow up. Research biopsies, peripheral blood and stool samples will be collected at the following time points: baseline, C4D1 (+/-14 days), and surgery (+/-14 days). Baseline and EOT breast MRI will be performed as standard of care for assessment of clinical response. Mid treatment breast ultrasound (C4D1 +/-14 days) will be repeated as standard of care to assess clinical response to treatment. Mid-treatment C4D1 tumor biopsy may be omitted if the primary tumor is no longer visible or the tumor deemed too small for biopsy by radiologist.
CONDITIONS
Official Title
Phase II Trial of Ivonescimab in Combination With Carboplatin + Docetaxel in Patients With Early-Stage Triple Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status 0 or 1
- Diagnosed with high-risk early-stage triple negative breast cancer defined by ER 60;10%, PR 60;10%, and HER2 negative
- Clinical stage 60;T1cN0 or any T, N1-2
- Planned treatment with neoadjuvant chemotherapy and immune checkpoint inhibitor before surgery
- Adequate organ function including ANC 60;1500/mm3, platelets 60;100,000/mm3, hemoglobin 60;9.0 g/dL, bilirubin, AST, ALT, creatinine clearance, and clotting times within specified limits
- Negative pregnancy test within 14 days prior to treatment for women of childbearing potential
- Female participants not pregnant, not breastfeeding, and either not of childbearing potential or willing to use effective contraception during study and for 120 days after last dose
- Male participants agree to use contraception during treatment and for 120 days after last dose
- Ability to provide informed consent and comply with study requirements
You will not qualify if you...
- Evidence of metastatic disease
- Participation in another investigational study within 4 weeks before treatment
- History of bleeding disorders or significant bleeding risk within 4 weeks before treatment
- Uncontrolled hypertension with repeated high blood pressure despite therapy
- Pregnant or breastfeeding women
- Known allergy to study drugs or their components
- History of autoimmune diseases, certain prior cancers, pneumonitis requiring steroids, active infections including HIV, active Hepatitis B or C, active tuberculosis
- Recent serious cardiac events or unstable vascular disease within 12 months
- Prolonged QTc interval >480 msec
- Prior bone marrow or solid organ transplantation
- Recent gastrointestinal complications including ulcers, fistulas, abscesses, bleeding within 6 months
- History of serious thromboembolic events within 12 months
- Acute COPD exacerbation within 4 weeks
- Prior cancer treatments or surgeries that conflict with current study
- Use of prohibited therapies including certain immunosuppressive drugs and live vaccines
- Major surgery within 28 days before treatment or within 4 weeks after first dose
- Any condition deemed unsafe for study participation by investigator
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
Cedars-Sinai Medical Center Beverly Hills
Los Angeles, California, United States, 90211
Actively Recruiting
3
Huntington Cancer Center, an Affiliate of CS Cancer
Pasadena, California, United States, 91105
Not Yet Recruiting
4
Hunt Cancer Institute, an Affiliate of CS Cancer
Torrance, California, United States, 90505
Actively Recruiting
Research Team
C
Clinical Trial Navigator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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