Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Carboplatin

Antimetabolites

MCS110

carboplatin

gemcitabine

Novartis Pharmaceuticals

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

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

A Randomized Phase II Study of MCS110 Combined With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

PFS Results presented for all MCS110 treated patients (with and without day 8 dose), in line with phase 2 study design.

AUC tau derived from day 0 to 21 (cycle 1) from day 0 to 21 (cycle 4) Cycle duration is 21 days

day 21 (end cycle 1); day 84 (end cycle 4)

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.

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.

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.

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%

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

Cycle duration is 21 days results expressed in percentage of cells. Only 1 arm reported as results were available for 1 patient only.

MCS110 + Carbo/Gem

MCS110 With C1D8@Dose + Carbo/Gem

All MCS110 + @Carbo/Gem Patients

Carbo/Gem

All@Patients

experimental. MCS110 10mg/kg intravenous infusion on day 1.

MCS110+Carboplatin+Gemcitabine

experimental.MCS110 10mg/kg intravenous infusion on days 1 \& 8

MCS110 With C1D8 Dose + Carboplatin +Gemcitabine

comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8

Carboplatin+Gemcitabine

Total

Age, Continuous

Sex: Female, Male

Caucasian

Asian

Unknown

Other

Race/Ethnicity, Customized

Study Director

experimental. all MCS110 treated patients, with 10mg/kg intravenous infusion, on day 1 and days 1 \& 8

All MCS110+Carboplatin+Gemcitabine

full analysis set: all MCS110 treated patients versus comparator

Progression Free Survival (PFS) as Per RECIST v1.1 (by Local Investigator Assessment)

day 21

day 84

Free MCS110 : Derived Pharmacokinetics (PK) Parameters: AUCtau

Free MCS110 : Derived Pharmacokinetics (PK) Parameters: Cmax

Cmax Carboplatin Day 21

Cmax Carboplatin Day 84

Cmax Gemcitabine Day 21

Cmax Gemcitabine Day 84

Cmax dFdU Day 21

Cmax dFdU Day 84

Cmax Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)

AUC Carboplatin Day 21

AUC Carboplatin Day 84

AUC Gemcitabine Day 21

AUC Gemcitabine Day 84

AUC dFdU Day 21

AUC dFdU Day 84

AUClast Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)

Day 1

Day 4

Day 15

Day 22 (cycle 2 day 1)

Day 43 (cycle 3 day 1)

Day 64 (cycle 4 day 1)

Day 85 (cycle 5 day 1)

Day 106 (cycle 6 day 1)

Day 127 (cycle 7 day 1)

Day 148 (cycle 8 day 1)

Safety set - MCS110 treated patients only

Total Colony Stimulation Factor -1 (CSF-I) Circulating Levels

Day 2

Serum C-terminal Telopeptide of Type I Collagen (CTX-I)

Non-CR/ Non-progressive disease

progressive disease

unknown

clinical benefit rate

Tumor Response Per RECIST v1.1 (by Local Investigator Assessment)

Tumor Response Per RECIST v1.1 (by Local Investigator Assessment) Duration of Response

MCS110 dose reduction

MCS110 dose interruption

Number of Patients With at Least One MCS110 Dose Reduction, and Number of Patients With at Least One MCS110 Dose Interruption

<50%

50-<75%

75-<90%

90-<110%

MCS110 Dose Intensity

CD163

Tumor Associated Macrophage (TAM) and Tumor Infiltrating Lymphocyte (TIL) Content in Pre- and Post-dose Tumor Biopsies.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy Study of MCS110 Given With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)	NCT02435680	Advanced Triple...	MCS110 carboplatin gemcitabine	18 Years -	Novartis
Efficacy Study of MCS110 Given With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)	NCT02435680	Advanced Triple...	MCS110 carboplatin gemcitabine	18 Years -	Novartis

Spots Global Cancer Trial Database for advanced triple negative breast cancer (tnbc) with high tams