To determine whether MCS110 antibody therapy improves the efficacy of carboplatin and gemcitabine (carbo/gem) in advanced TNBC patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Highlands Oncology Group
Fayetteville, Arkansas, United States
Progression Free Survival (PFS) as Per RECIST v1.1 (by Local Investigator Assessment)
PFS Results presented for all MCS110 treated patients (with and without day 8 dose), in line with phase 2 study design.
Time frame: 4 years
Free MCS110 : Derived Pharmacokinetics (PK) Parameters: AUCtau
AUC tau derived from day 0 to 21 (cycle 1) from day 0 to 21 (cycle 4) Cycle duration is 21 days
Time frame: day 21 (end cycle 1); day 84 (end cycle 4)
Free MCS110 : Derived Pharmacokinetics (PK) Parameters: Cmax
Time frame: day 21 (end cycle 1); day 84 (end cycle 4)
Cmax Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)
day 21 (end cycle 1); day 84 (end cycle 4)
Time frame: day 21, day 84
AUClast Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)
day 21 (end cycle 1); day 84 (end cycle 4)
Time frame: day 21, day 84
Total Colony Stimulation Factor -1 (CSF-I) Circulating Levels
results expressed as a the ratio change from baseline expressed in percentage. Cycle duration is 21 days. These Biomarker Analyses were performed for MCS110 treated patients only.
Time frame: baseline, day 1, 4, 15, 22, 43, 64, 85, 106, 127, 148
Serum C-terminal Telopeptide of Type I Collagen (CTX-I)
results expressed as a the ratio change from baseline expressed in percentage. Cycle duration is 21 days. Biomarker Analyses performed for MCS110 treated patients only.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 13 more locations
Time frame: baseline, day 2, 4, 15, 22, 43, 64, 85, 106, 127, 148
Tumor Response Per RECIST v1.1 (by Local Investigator Assessment)
CR: complete response. PR: partial response. SD: stable disease: CBR: clinical benefit rate =CR + PR + SD lasting at least for 6 months. ORR = CR + PR. Efficacy Results presented for all MCS110 treated patients (with and without day 8 dose), in line with phase 2 study design.
Time frame: 4 years
Tumor Response Per RECIST v1.1 (by Local Investigator Assessment) Duration of Response
CR: complete response. PR: partial response. SD: stable disease: CBR: clinical benefit rate =CR + PR + SD lasting at least for 6 months. ORR = CR + PR. Efficacy Results presented for all MCS110 treated patients (with and without day 8 dose), in line with phase 2 study design.
Time frame: 4 years
Number of Patients With at Least One MCS110 Dose Reduction, and Number of Patients With at Least One MCS110 Dose Interruption
patients treated with MCS110 only
Time frame: 4 years
MCS110 Dose Intensity
Relative dose intensity by categories. Patients treated with MCS110 only. The dose intensity measures the dose actually taken versus the planned dose, and is expressed in percentage: \<50%: less than 50 % of the planned dose received; 50-\<75 %: dose received is 50% or more, but less than 75 %; 75-\<90 %: dose received is 75% or more, but less than 90%; 90-\<110 %: dose received is 90% or more, but less than 110%
Time frame: 4 years
Tumor Associated Macrophage (TAM) and Tumor Infiltrating Lymphocyte (TIL) Content in Pre- and Post-dose Tumor Biopsies.
results expressed as a the ratio change from baseline expressed in percentage: Biopsies were taken at baseline and between Day 29 and Day 43. Patients treated with MCS110 only
Time frame: Baseline, Day 29-43
Circulating Monocytes Cells in Blood
Cycle duration is 21 days results expressed in percentage of cells. Only 1 arm reported as results were available for 1 patient only.
Time frame: day 15, 29, 43, 50