Ivonescimab + Chemotherapy for Breast Cancer

Recruiting at 3 trial locations

Overseen By Clinical Trial Navigator

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cedars-Sinai Medical Center

Must not be taking: Anticoagulants, Immunosuppressants, Live vaccines

Disqualifiers: Metastatic disease, Autoimmune diseases, Active infection, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 18 weeks

34 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new treatment combination for patients with early-stage triple-negative breast cancer. The trial combines ivonescimab, a new drug, with standard chemotherapy drugs carboplatin and docetaxel to determine if it helps shrink the cancer before surgery. Patients receive this treatment every three weeks for six cycles. Those diagnosed with triple-negative breast cancer and planning to undergo chemotherapy before surgery might be suitable for this trial. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group of people, offering patients a chance to contribute to important advancements in cancer treatment.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, certain medications like anticoagulants, immunosuppressive drugs, and live vaccines are restricted. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that ivonescimab, when combined with chemotherapy, is generally safe for individuals with triple-negative breast cancer. Studies find that most patients tolerate this treatment well. Specifically, patients experienced a median progression-free survival of over nine months, suggesting the treatment does not cause serious harm during that period. While some side effects may occur, the overall safety appears manageable. This information comes from trials involving patients with similar conditions, providing a positive outlook for those considering participation in a clinical trial like this one. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for breast cancer?

Unlike the standard treatments for breast cancer, which typically involve chemotherapy drugs like doxorubicin or paclitaxel, Ivonescimab is a novel therapy that combines with chemotherapy to enhance its effects. Researchers are excited about Ivonescimab because it is a bispecific antibody, which means it can simultaneously target two different antigens, potentially offering a more precise and powerful attack against cancer cells. This dual-targeting approach could improve treatment outcomes and reduce the likelihood of cancer cells developing resistance. Additionally, the combination with carboplatin and docetaxel might offer a more comprehensive treatment strategy, providing hope for improved effectiveness in managing the disease.

What evidence suggests that ivonescimab combined with chemotherapy might be an effective treatment for early-stage triple negative breast cancer?

Research has shown that combining ivonescimab with chemotherapy yields promising results for treating certain cancers. One study found that this combination reduced the risk of cancer progression or death by 40% in patients with a type of lung cancer compared to another treatment. In this trial, participants will receive a combination of ivonescimab and chemotherapy, specifically carboplatin and docetaxel, to evaluate its effectiveness in treating breast cancer. Previous studies have demonstrated that ivonescimab with chemotherapy allowed patients with advanced triple-negative breast cancer (TNBC) to live without cancer worsening for an average of 9.36 months. This suggests that using ivonescimab with chemotherapy might improve outcomes for patients with TNBC. These findings offer hope for its potential effectiveness in treating early-stage TNBC. ^{2 6 7 8 9}

Who Is on the Research Team?

Yuan Yuan, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for patients with early-stage triple negative breast cancer. Participants must be suitable for chemotherapy and surgery, and willing to provide tissue, blood, and stool samples. Specific eligibility details are not provided but typically include factors like age, health status, and cancer stage.

Inclusion Criteria

I am 18 years old or older.

My breast cancer is triple negative and considered high-risk.

I am fully active and can carry on all pre-disease activities without restriction.

Exclusion Criteria

Known allergy to any components within the study agents and/or their excipients

My cancer has spread to other parts of my body.

Current or recent participation in a study of an investigational agent within 4 weeks of the first dose of treatment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ivonescimab in combination with carboplatin and docetaxel every 3 weeks for 6 cycles

18 weeks

6 visits (in-person, every 3 weeks)

Surgery

Curative intent surgery performed within 6 weeks (maximum 12 weeks) after last dose of chemoimmunotherapy

6-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments for EFS and OS

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Ivonescimab

Trial Overview The trial tests the combination of Ivonescimab with Carboplatin + Docetaxel in a single-arm study over 6 cycles every 3 weeks. Patients will also undergo surgery post-treatment to assess the primary endpoint of pathological response.

How Is the Trial Designed?

Group I: Carboplatin and Ivonescimab Experimental Treatment 3 Interventions

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).

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Summit Therapeutics

Industry Sponsor

Trials

18

Recruited

4,500+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07017673

NCT07017673 | Phase II Trial of Ivonescimab in ... The trial is designed to test the safety and efficacy of adding ivonescimab in patients with early TNBC undergoing neoadjuvant chemotherapy with carboplatin and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12519357/

Neoadjuvant stereotactic body radiotherapy combined with ... This study aims to assess the safety and efficacy of SBRT combined with chemotherapy and Ivonescimab, potentially improving pCR rates and long- ...

3. smmttx.com smmttx.com/pressrelease/ivonescimab-with-chemotherapy-reduced-the-risk-of-disease-progression-or-death-by-40-compared-to-tislelizumab-pd-1-inhibitor-plus-chemotherapy-in-1l-treatment-of-patients-with-squamous-nsclc-in-the/

Ivonescimab with Chemotherapy Reduced the Risk ... Ivonescimab with Chemotherapy Reduced the Risk of Disease Progression or Death by 40% Compared to Tislelizumab (PD-1 Inhibitor) Plus ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1556086424024213

Brief Report: Ivonescimab Combined With Etoposide Plus ... Ivonescimab in combination with etoposide and carboplatin was well tolerated and found to have promising antitumor activity in extensive-stage SCLC.

5. cancernetwork.com cancernetwork.com/view/ivonescimab-chemo-combo-yields-positive-efficacy-and-safety-results-in-tnbc

Ivonescimab/Chemo Combo Yields Positive Efficacy and ... Ivonescimab with chemotherapy elicited a median progression-free survival of 9.36 months in patients with locally advanced unresectable or metastatic triple- ...

6. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)01814-3/fulltext

347MO The safety and efficacy of ivonescimab in ... Ivonescimab in combination with chemotherapy showed promising anti-tumor activity and tolerable safety as 1L treatment of TNBC.

7. smmttx.com smmttx.com/wp-content/uploads/2024/12/150207425-AK117-203-phase-2-TNBC-poster_L2.pdf

Evaluation of the Safety and Efficacy of Ivonescimab ... At the time of data cutoff, 35 patients had ≥1 post baseline tumor assessment and were included in the efficacy analysis.

8. onclive.com onclive.com/view/dr-wang-on-updated-efficacy-and-safety-data-with-first-line-ivonescimab-plus-chemotherapy-in-tnbc

Dr Wang on Updated Efficacy and Safety Data With First- ... The median progression-free survival (PFS) across the full cohort was 9.36 months (95% CI, 6.24-NE), with a 9-month PFS rate of 61.3% (95% CI, ...

9. akesobio.com akesobio.com/en/media/akeso-news/240918-1/

ESMO 2024 | Akeso's Ivonescimab plus Chemo in First- ... The preliminary data, with only a 10-month median follow-up, revealed that the ivonescimab combination regimen demonstrated excellent efficacy and a favorable ...