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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02435680
• Date of registration: 22/04/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Efficacy Study of MCS110 Given With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC) TNBC
• Scientific title: A Randomized Phase II Study of MCS110 Combined With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)
• Date of first enrolment: August 10, 2015
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02435680
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Australia, Austria, Belgium, Czech Republic, Czechia, France, Germany, Hong Kong, Italy, Korea, Republic of, Spain, Taiwan, Turkey, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Advanced Triple Negative Breast Cancer (TNBC) With High TAMs

Intervention(s)

Drug: MCS110

Drug: carboplatin

Drug: gemcitabine

Primary Outcome(s)

Progression free survival (PFS) as per RECIST v1.1 (by local investigator assessment) [Time Frame: 4 years]

Secondary Outcome(s)

Serum concentration of free MCS110 and derived Pharmacokinetics (PK) parameters: Cmax [Time Frame: 4 years]

Tumor response per RECIST v1.1 (by local investigator assessment) [Time Frame: 4 years]

Plasma concentration of carboplatin, gemcitabine and 2',2'-difluoro-deoxyuridine (dFdU) [Time Frame: 4 years]

Tumor associated macrophage (TAM) and Tumor infiltrating lymphocyte (TIL) content in pre- and post-dose tumor biopsies [Time Frame: 4 years]

Number of participants with adverse events and serioaus adverse events [Time Frame: 4 years]

Serum concentration of free MCS110 and derived Pharmacokinetics (PK) parameters: AUC [Time Frame: 4 years]

Total Colony stimulation factor -1 (CSF-I) circulating levels, serum C-terminal telopeptide of type I collagen (CTX-I) and circulating monocytes [Time Frame: 4 years]

Secondary ID(s)

2015-000179-29

CMCS110Z2201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors