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

NCT07017673 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IIT2024-09-YUAN-NeoIVO
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 4

Brief Summary

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

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

Keywords

Ivonescimab; Carboplatin; Docetaxel; Neoadjuvant chemotherapy; TNBC; High-risk early stage TNBC

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (pCR) rate

  Pathological complete response (pCR) will be defined as the absence of invasive disease in the breast and lymph nodes at the time of SOC curative-intent surgery. This will be assessed at time of surgery. Pathological responses will be evaluated using residual cancer burden (RCB) classifier defined by ASCO/CAP guideline.

  6 months (From cycle 1 day 1 till surgery)

Secondary Outcomes (5)

• To determine the overall safety of ivonescimab in combination with carboplatin and docetaxel in patients with early-stage TNBC by CTCAE v5.0.

  9 months (From Cycle 1 until 90 days post last dose of study treatment)

• Event-free survival (EFS)

  From cycle 1 day 1 till end of follow up (up to 5 years)

• Overall survival (OS)

  From cycle 1 day 1 till end of follow up (up to 5 years)

• Patient-reported outcomes (PRO)

  9 months

• Patient-reported outcomes (PRO)

  9 months

Study Arms (1)

Carboplatin and Ivonescimab

EXPERIMENTAL

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).

Drug: Ivonescimab; Drug: Carboplatin; Drug: Docetaxel

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 and Ivonescimab

Carboplatin DRUG

Drug: Carboplatin Dose: AUC6 Route: IV infusion Frequency: Q3W Duration: 6 cycles (Each cycle is 21 days)

Carboplatin and Ivonescimab

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)

Carboplatin and Ivonescimab

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years of age
• ECOG ≤ 1
• High-risk early stage triple negative breast cancer (TNBC), defined by ER≤10%, PR≤10% and HER2 negative (by IHC or FISH), per ASCO/CAP guidelines
• Clinically ≥T1cN0, or any T, N1-2
• Plan to receive neoadjuvant chemotherapy and immune checkpoint inhibitor before surgery as standard-of-care treatment
• Adequate organ function as defined in the following. Specimens must be collected within 14 days prior to the start of study treatment.
• ANC ≥ 1,500/mm3
• Platelets ≥ 100,000/mm3
• Hemoglobin ≥ 9.0 g/dL.
• Total serum bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 x ULN
• AST \< 3 x ULN
• ALT \< 3 x ULN
• Creatinine clearance ≥ 30 mL/min
• INR or PT, aPTT \< 1.5 x ULN
• Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 14 days of start of study treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Note: If egg harvesting was completed prior to enrollment, the pregnancy test may be falsely positive and the PI will assess and determine eligibility for these cases.

You may not qualify if:

• Evidence of metastatic disease.
• Is currently participating in or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
• History of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms or risk within 4 weeks prior to start of study treatment, including but not limited to:
• 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, in the opinion of the treating investigator, prior to start of study treatment is not allowed. The use of full-dose anticoagulants is permitted as long as the INR or activated partial thromboplastin time (aPTT) is within therapeutic limits according to the medical standard of the enrolling institution.
• Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy
• Women who are or are planning to become pregnant or breastfeed
• Known allergy to any of the components within the study agents and/or their excipients
• Medical history and concurrent diseases
• Autoimmune diseases
• Any prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least three years
• History of (non-infectious) pneumonitis that required steroids or has current pneumonitis
• Active infection requiring systemic therapy
• Known history of Human Immunodeficiency Virus (HIV) infection

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Summit Therapeutics: collaborator

Study Sites (4)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Cedars-Sinai Medical Center Beverly Hills

Los Angeles, California, 90211, United States

RECRUITING

Huntington Cancer Center, an Affiliate of CS Cancer

Pasadena, California, 91105, United States

NOT YET RECRUITING

Hunt Cancer Institute, an Affiliate of CS Cancer

Torrance, California, 90505, United States

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Carboplatin; Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Yuan Yuan, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trial Navigator

CONTACT

3104232133; cancer.trial.info@cshs.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): November 1, 2032
• Last Updated: April 2, 2026

Record last verified: 2026-04

Locations

US (4)