Efficacy Study of MCS110 Given With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)

Completed · Phase 2

Conditions studied: Advanced Triple Negative Breast Cancer (TNBC) With High TAMs

In brief

To determine whether MCS110 antibody therapy improves the efficacy of carboplatin and gemcitabine (carbo/gem) in advanced TNBC patients

Key facts

Study ID

NCT02435680

Run by

Novartis Pharmaceuticals

People needed

50

Starts

2015-08-10

Expected to finish

2020-03-23

Last updated by the study team

2021-06-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Adult women (≥ 18 years of age) with advanced TNBC.
• Histological or cytological evidence of estrogen-receptor negative (ER-), progesterone receptor negative (PgR-) and human epidermal growth factor-2 receptor negative (HER2-) Breast Cancer by local laboratory testing, based on last available tumor tissue.
• ER/PgR negativity to follow local guidelines
• If IHC HER2 2+, a negative FISH test is required
• A pre-treatment tumor biopsy demonstrating high TAM content as assessed per the central laboratory
• Patients must have:
• At least one measurable lesion per RECIST 1.1. (Note: Measurable lesions include lytic or mixed (lytic + blastic) bone lesions, with an identifiable soft tissue component that meets the measurability criteria)

You may not qualify if…

• Prior chemotherapy for advanced BC. Previous adjuvant/neoadjuvant chemotherapy is allowed (carboplatin, cisplatin or gemcitabine only if > 12 months has passed since last administration).
• Therapy for underlying malignancy within 2 weeks prior to start of study treatment:
• Chemotherapy, biologic therapy (antibodies and biologically targeted small molecules)
• Radiotherapy
• Major surgery
• Patients receiving concomitant immunosuppressive agents or chronic corticosteroids (≥10 mg of prednisone or equivalent) at the time of first study dose.
• Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening.
• Known history of human immunodeficiency virus or active infection with hepatitis virus or any uncontrolled active systemic infection.
• Patients with the following laboratory values during screening and on Day 1 predose:
• Absolute Neutrophil Count (ANC) < 1.5x109/L
• Hemoglobin < 9 g/dL
• Platelets < 100x109/L
• Serum creatinine > 1.5 x ULN
• Serum total bilirubin > 1.5 x ULN
• AST/SGOT and ALT/SGPT > 3.0 x ULN

Where it is running

• Highlands Oncology Group — Fayetteville, Arkansas, United States
• Massachusetts General Hospital Cancer Center SC — Boston, Massachusetts, United States
• Novartis Investigative Site — Nedlands, Western Australia, Australia
• Novartis Investigative Site — Salzburg, Austria
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Saint-Herblain Cédex, France
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Dresden, Germany
• Novartis Investigative Site — Essen, Germany
• Novartis Investigative Site — Hong Kong SAR, Hong Kong
• Novartis Investigative Site — Bologna, Italy
• Novartis Investigative Site — Naples, Italy
• Novartis Investigative Site — Seoul, Korea, South Korea
• Novartis Investigative Site — Seoul, South Korea
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Santiago de Compostela, Galicia, Spain
• Novartis Investigative Site — Barcelona, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Taipei, Taiwan
• Novartis Investigative Site — Istanbul, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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