18 and older, female only, with Advanced Triple Negative Breast Cancer (TNBC) With High TAMs. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression Free Survival (PFS) as Per RECIST v1.1 (by Local Investigator Assessment)Primary· 4 years
PFS Results presented for all MCS110 treated patients (with and without day 8 dose), in line with phase 2 study design.
Group
Value
95% CI
All MCS110+Carboplatin+Gemcitabine
5.6
4.5 – 8.7
Carboplatin+Gemcitabine
5.5
3.5 – 7.5
Free MCS110 : Derived Pharmacokinetics (PK) Parameters: AUCtauSecondary· day 21 (end cycle 1); day 84 (end cycle 4)
AUC tau derived from day 0 to 21 (cycle 1) from day 0 to 21 (cycle 4) Cycle duration is 21 days
day 21
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
1430
± 23.5
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
2960
± 22.7
day 84
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
1840
± 34.9
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
3240
± 30.0
Free MCS110 : Derived Pharmacokinetics (PK) Parameters: CmaxSecondary· day 21 (end cycle 1); day 84 (end cycle 4)
day 21
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
186
± 28.5
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
281
± 21.2
day 84
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
240
± 14.8
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
319
± 27.8
Cmax Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)Secondary· day 21, day 84
day 21 (end cycle 1); day 84 (end cycle 4)
Cmax Carboplatin Day 21
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
12400
± 37.3
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
12500
± 33.2
Carboplatin+Gemcitabine
11200
± 70.9
Cmax Carboplatin Day 84
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
9550
± 33.0
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
10000
± 28.9
Carboplatin+Gemcitabine
11600
± 55.0
Cmax Gemcitabine Day 21
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
2750
± 194.5
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
5480
± 95.1
Carboplatin+Gemcitabine
2370
± 484.9
Cmax Gemcitabine Day 84
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
2470
± 227.3
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
3400
± 173.9
Carboplatin+Gemcitabine
8630
± 101.2
Cmax dFdU Day 21
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
39100
± 21.6
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
33900
± 19.5
Carboplatin+Gemcitabine
37700
± 28.2
Cmax dFdU Day 84
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
36600
± 88.6
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
30300
± 11.8
Carboplatin+Gemcitabine
32300
± 12.4
AUClast Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)Secondary· day 21, day 84
day 21 (end cycle 1); day 84 (end cycle 4)
AUC Carboplatin Day 21
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
24500
± 31.1
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
21400
± 27.3
Carboplatin+Gemcitabine
21800
± 56.0
AUC Carboplatin Day 84
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
18300
± 21.8
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
17500
± 25.0
Carboplatin+Gemcitabine
20500
± 34.6
AUC Gemcitabine Day 21
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
2390
± 157.3
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
4270
± 79.3
Carboplatin+Gemcitabine
2620
± 225.5
AUC Gemcitabine Day 84
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
2410
± 115.2
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
2770
± 118.8
Carboplatin+Gemcitabine
6320
± 76.2
AUC dFdU Day 21
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
230000
± 34.7
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
181000
± 37.7
Carboplatin+Gemcitabine
231000
± 25.2
AUC dFdU Day 84
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
229000
± 31.9
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
147000
± 28.7
Carboplatin+Gemcitabine
211000
± 24.7
Total Colony Stimulation Factor -1 (CSF-I) Circulating LevelsSecondary· baseline, day 1, 4, 15, 22, 43, 64, 85, 106, 127, 148
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.
Day 1
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
110
± 19.8
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
115
± 34.8
Day 4
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
4930
± 2280
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
4350
± 1620
Day 15
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
21600
± 8290
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
19500
± 6130
Day 22 (cycle 2 day 1)
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
32000
± 9190
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
34400
± 14900
Day 43 (cycle 3 day 1)
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
57900
± 14100
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
70000
± 27400
Day 64 (cycle 4 day 1)
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
73600
± 16200
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
78000
± 41200
Day 85 (cycle 5 day 1)
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
79300
± 27000
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
107000
± 51400
Day 106 (cycle 6 day 1)
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
97500
± 15600
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
103000
± 50700
Serum C-terminal Telopeptide of Type I Collagen (CTX-I)Secondary· baseline, day 2, 4, 15, 22, 43, 64, 85, 106, 127, 148
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.
Day 2
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
79.4
± 22.8
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
85.0
± 44.0
Day 4
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
72.5
± 25.4
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
80.2
± 39.6
Day 15
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
65.6
± 44.3
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
69.4
± 27.4
Day 22 (cycle 2 day 1)
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
67.9
± 43.6
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
52.9
± 26.5
Day 43 (cycle 3 day 1)
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
64.3
± 58.7
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
39.3
± 23.8
Day 64 (cycle 4 day 1)
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
69.7
± 62.2
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
29.5
± 23.7
Day 85 (cycle 5 day 1)
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
102
± 124
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
40.6
± 34.8
Day 106 (cycle 6 day 1)
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
41.2
± 13.2
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
50.2
± 45.3
Tumor Response Per RECIST v1.1 (by Local Investigator Assessment)Secondary· 4 years
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.
PR
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
8
Carboplatin+Gemcitabine
6
Non-CR/ Non-progressive disease
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
1
Carboplatin+Gemcitabine
0
SD
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
19
Carboplatin+Gemcitabine
7
progressive disease
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
4
Carboplatin+Gemcitabine
1
unknown
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
2
Carboplatin+Gemcitabine
2
clinical benefit rate
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
10
Carboplatin+Gemcitabine
7
ORR
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
8
Carboplatin+Gemcitabine
6
Tumor Response Per RECIST v1.1 (by Local Investigator Assessment) Duration of ResponseSecondary· 4 years
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.
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
9.6
3.6 – 42.5
Carboplatin+Gemcitabine
5
2.7 – 13.3
Number of Patients With at Least One MCS110 Dose Reduction, and Number of Patients With at Least One MCS110 Dose InterruptionSecondary· 4 years
patients treated with MCS110 only
MCS110 dose reduction
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
3
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
5
MCS110 dose interruption
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
6
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
9
MCS110 Dose IntensitySecondary· 4 years
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%
<50%
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
1
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
4
50-<75%
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
8
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
3
75-<90%
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
7
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
5
90-<110%
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
3
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
3
Tumor Associated Macrophage (TAM) and Tumor Infiltrating Lymphocyte (TIL) Content in Pre- and Post-dose Tumor Biopsies.Secondary· Baseline, Day 29-43
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
CD163
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
42.1
± 62.1
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
43.5
± 239.5
CD8
Group
Value
95% CI
MCS110+Carboplatin+Gemcitabine
102
± 747.3
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
99.0
± 92.2
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
MCS110 + Carbo/Gem
Serious: 10/19 (53%)
Deaths: 1/19
MCS110 With C1D8@Dose + Carbo/Gem
Serious: 7/15 (47%)
Deaths: 1/15
All MCS110 + @Carbo/Gem Patients
Serious: 17/34 (50%)
Deaths: 2/34
Carbo/Gem
Serious: 1/15 (7%)
Deaths: 1/15
All@Patients
Serious: 18/49 (37%)
Deaths: 3/49
Serious adverse events (33 terms)
Reaction
System
MCS110 + Carbo/Gem
MCS110 With C1D8@Dose + Ca…
All MCS110 + @Carbo/Gem Pa…
Carbo/Gem
All@Patients
Thrombocytopenia
Blood and lymphatic system disorders
—
—
—
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
—
—
Renal failure
Renal and urinary disorders
—
—
—
—
—
Anaemia
Blood and lymphatic system disorders
—
—
—
—
—
Atypical haemolytic uraemic syndrome
Blood and lymphatic system disorders
—
—
—
—
—
Myocardial ischaemia
Cardiac disorders
—
—
—
—
—
Nausea
Gastrointestinal disorders
—
—
—
—
—
Obstructive pancreatitis
Gastrointestinal disorders
—
—
—
—
—
Fatigue
General disorders
—
—
—
—
—
Generalised oedema
General disorders
—
—
—
—
—
Pyrexia
General disorders
—
—
—
—
—
Device related infection
Infections and infestations
—
—
—
—
—
Erysipelas
Infections and infestations
—
—
—
—
—
Genital infection
Infections and infestations
—
—
—
—
—
Infection
Infections and infestations
—
—
—
—
—
Lower respiratory tract infection
Infections and infestations
—
—
—
—
—
Mastitis
Infections and infestations
—
—
—
—
—
Sepsis
Infections and infestations
—
—
—
—
—
Upper respiratory tract infection
Infections and infestations
—
—
—
—
—
Ankle fracture
Injury, poisoning and procedural complications
—
—
—
—
—
Blood creatine phosphokinase increased
Investigations
—
—
—
—
—
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
—
—
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
—
—
Anxiety
Psychiatric disorders
—
—
—
—
—
Other adverse events (218 terms — click to expand)
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· Phase 1
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· Phase 1
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· Phase 1, PHASE2
· completed
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· Phase 1, PHASE2
· completed
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· Phase 2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 21 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02435680.