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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02435680




Registration number
NCT02435680
Ethics application status
Date submitted
22/04/2015
Date registered
6/05/2015
Date last updated
26/06/2019

Titles & IDs
Public title
Efficacy Study of MCS110 Given With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)
Scientific title
A Randomized Phase II Study of MCS110 Combined With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)
Secondary ID [1] 0 0
2015-000179-29
Secondary ID [2] 0 0
CMCS110Z2201
Universal Trial Number (UTN)
Trial acronym
TNBC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Triple Negative Breast Cancer (TNBC) With High TAMs 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MCS110
Treatment: Drugs - carboplatin
Treatment: Drugs - gemcitabine

Experimental: Arm 1: MCS110+carboplatin+gemcitabine - MCS110+carboplatin+gemcitabine

Active Comparator: Arm 2: carboplatin+gemcitabine - carboplatin+gemcitabine


Treatment: Drugs: MCS110
taken by I.V

Treatment: Drugs: carboplatin
taken by I.V

Treatment: Drugs: gemcitabine
taken by I.V

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression free survival (PFS) as per RECIST v1.1 (by local investigator assessment)
Timepoint [1] 0 0
4 years
Secondary outcome [1] 0 0
Number of participants with adverse events and serioaus adverse events
Timepoint [1] 0 0
4 years
Secondary outcome [2] 0 0
Serum concentration of free MCS110 and derived Pharmacokinetics (PK) parameters: AUC
Timepoint [2] 0 0
4 years
Secondary outcome [3] 0 0
Serum concentration of free MCS110 and derived Pharmacokinetics (PK) parameters: Cmax
Timepoint [3] 0 0
4 years
Secondary outcome [4] 0 0
Plasma concentration of carboplatin, gemcitabine and 2',2'-difluoro-deoxyuridine (dFdU)
Timepoint [4] 0 0
4 years
Secondary outcome [5] 0 0
Total Colony stimulation factor -1 (CSF-I) circulating levels, serum C-terminal telopeptide of type I collagen (CTX-I) and circulating monocytes
Timepoint [5] 0 0
4 years
Secondary outcome [6] 0 0
Tumor associated macrophage (TAM) and Tumor infiltrating lymphocyte (TIL) content in pre- and post-dose tumor biopsies
Timepoint [6] 0 0
4 years
Secondary outcome [7] 0 0
Tumor response per RECIST v1.1 (by local investigator assessment)
Timepoint [7] 0 0
4 years

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Clayton
Recruitment hospital [2] 0 0
Novartis Investigative Site - Nedlands
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
Austria
State/province [3] 0 0
Salzburg
Country [4] 0 0
Austria
State/province [4] 0 0
Vienna
Country [5] 0 0
Belgium
State/province [5] 0 0
Antwerpen
Country [6] 0 0
Belgium
State/province [6] 0 0
Bruxelles
Country [7] 0 0
Czechia
State/province [7] 0 0
Czech Republic
Country [8] 0 0
France
State/province [8] 0 0
Paris
Country [9] 0 0
France
State/province [9] 0 0
Saint-Herblain Cédex
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Germany
State/province [11] 0 0
Dresden
Country [12] 0 0
Germany
State/province [12] 0 0
Essen
Country [13] 0 0
Germany
State/province [13] 0 0
Kiel
Country [14] 0 0
Hong Kong
State/province [14] 0 0
Hong Kong SAR
Country [15] 0 0
Italy
State/province [15] 0 0
Bologna
Country [16] 0 0
Italy
State/province [16] 0 0
Napoli
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Korea
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Seoul
Country [19] 0 0
Spain
State/province [19] 0 0
Catalunya
Country [20] 0 0
Spain
State/province [20] 0 0
Comunidad Valenciana
Country [21] 0 0
Spain
State/province [21] 0 0
Galicia
Country [22] 0 0
Spain
State/province [22] 0 0
Barcelona
Country [23] 0 0
Spain
State/province [23] 0 0
Madrid
Country [24] 0 0
Taiwan
State/province [24] 0 0
Taipei
Country [25] 0 0
Turkey
State/province [25] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To determine whether MCS110 antibody therapy improves the efficacy of carboplatin and
gemcitabine (carbo/gem) in advanced TNBC patients
Trial website
https://clinicaltrials.gov/show/NCT02435680
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications