Phase II Trial of Ivonescimab in Combination With Carboplatin + Docetaxel in Patients With Early-Stage Triple Negative Breast Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT07017673
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Early Stage Triple-Negative Breast Carcinoma
  • TNBC
  • TNBC - Triple-Negative Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ivonescimab — DRUG
    Drug: Ivonescimab Dose: 20 mg/kg Route: IV infusion over 60 minutes Frequency: Q3W Duration: 6 cycles (Each cycle is 21 days)
  • Carboplatin — DRUG
    Drug: Carboplatin Dose: AUC6 Route: IV infusion Frequency: Q3W Duration: 6 cycles (Each cycle is 21 days)
  • Docetaxel — DRUG
    Drug: Docetaxel Dose: 75 mg/m\^2 Route: IV infusion over 60 minutes Frequency: Q3W Duration: 6 cycles (Each cycle is 21 days)

Study Details

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.

Key Dates

Start date
Jul 25, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Nov 30, 2032

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Carboplatin and Ivonescimab
    Carboplatin AUC6 and docetaxel 75 mg/m2 every 3 weeks x 6 cycles plus ivonescimab 20 mg/kg iv every 3 weeks x 6 cycles. Each cycle is 21 days. Trial interventions may be administered up to 3 days before or after the scheduled Day 1 of each cycle due to administrative reasons (after all safety assessments have been completed).

Primary Outcome Measure

Pathological complete response (pCR) rate [ Time Frame: 6 months (From cycle 1 day 1 till surgery) ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Clinical Trial Recruitment Navigator
[email protected]
3104232133
Yuan Yuan, MD, PhD (PRINCIPAL_INVESTIGATOR)
Cedars-Sinai Medical Center Beverly HillsLos AngelesCalifornia90211
Clinical Trial Recruitment Navigator
[email protected]
3104232133
Jin Sun Bitar, MD (SUB_INVESTIGATOR)
Stephen Shiao, MD, PhD (SUB_INVESTIGATOR)
Dorothy Park, MD (SUB_INVESTIGATOR)
Maryliza El-Masry, MD (SUB_INVESTIGATOR)
Philomena McAndrew, MD (SUB_INVESTIGATOR)
Huntington Cancer Center, an Affiliate of CS CancerPasadenaCalifornia91105
Clinical Trial Recruitment Navigator
[email protected]
310-423-2133
Niki Tank, MD (SUB_INVESTIGATOR)
Tina Wang, MD (SUB_INVESTIGATOR)
Tiffany Shaw, MD (SUB_INVESTIGATOR)
Hunt Cancer Institute, an Affiliate of CS CancerTorranceCalifornia90505
Sarah Valdez
[email protected]
310-750-3300
Swati Sikaria, MD (SUB_INVESTIGATOR)
David Chan, MD (SUB_INVESTIGATOR)
Vanessa Dickey, MD (SUB_INVESTIGATOR)
Hugo Hool, MD (SUB_INVESTIGATOR)
Andrew Horodner, MD (SUB_INVESTIGATOR)
Syed Jilani, MD (SUB_INVESTIGATOR)
Thomas Lowe, MD (SUB_INVESTIGATOR)
Justin Tiulim, MD (SUB_INVESTIGATOR)

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