A study evaluating if the addition of MCS110 increases the efficacy of chemotherapy in women with disseminated breast cancer that is not dependent on hormones

A randomized phase II study of MCS110 combined with carboplatin and gemcitabine in advanced Triple Negative Breast Cancer (TNBC)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000179-29-CZ

Enrollment

Registered

2015-03-25

Start date

2015-04-14

Completion date

Unknown

Last updated

2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Triple Negative Breast Cancer MedDRA version: 20.0 Level: LLT Classification code 10072737 Term: Advanced breast cancer System Organ Class: 100000020819

Interventions

Product Name: MCS110 Product Code: MCS110 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: not yet defined Current Sponsor code: MCS110 Other descriptive name: MCS110 Co

Eligibility

Sex/Gender

All

Inclusion 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-) BC 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 - 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) or - Bone lesions: non-measurable lytic or mixed (lytic + blastic) in the absence of measurable disease as defined above. Patients with only non-measurable lesions (e.g. pleural effusion, ascites) and no lytic or mixed bone lesions are not eligible. Other inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 23

Exclusion 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 dose of study drug. - 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 pre-dose: - Absolute Neutrophil Count (ANC) 1.5 x ULN - Serum total bilirubin > 1.5 x ULN - AST/SGOT and ALT/SGPT > 3.0 x ULN Other exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the anti-tumor activity of MCS110 combined with carboplatin/gemcitabine (carbo/gem) compared to carbo/gem alone.;Primary end point(s): PFS as per RECIST v1.1 (by local investigator assessment);Timepoint(s) of evaluation of this end point: Tumor evaluation at sreening and then every six weeeks until the end of cycle 8. Thereafter every 9 weeks (after cycle 8).;Secondary Objective: 1. Characterize the safety and tolerability of MCS110 given in combination with carbo/gem. 2. Characterize PK of MCS110 when combined with carbo/gem. 3. Characterize PK of carbo and gem in the presence and absence of MCS110. 4. Characterize PD effect of MCS110 when combined with carbo/gem 5. To assess the anti-tumor activity of MCS110 given in combination with carbo/gem as measured by additional efficacy measures.	—

Measure

Time frame

Main Objective: To assess the anti-tumor activity of MCS110 combined with carboplatin/gemcitabine (carbo/gem) compared to carbo/gem alone.;Primary end point(s): PFS as per RECIST v1.1 (by local investigator assessment);Timepoint(s) of evaluation of this end point: Tumor evaluation at sreening and then every six weeeks until the end of cycle 8. Thereafter every 9 weeks (after cycle 8).;Secondary Objective: 1. Characterize the safety and tolerability of MCS110 given in combination with carbo/gem. 2. Characterize PK of MCS110 when combined with carbo/gem. 3. Characterize PK of carbo and gem in the presence and absence of MCS110. 4. Characterize PD effect of MCS110 when combined with carbo/gem 5. To assess the anti-tumor activity of MCS110 given in combination with carbo/gem as measured by additional efficacy measures.

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Secondary

Measure	Time frame
Secondary end point(s): 1. Safety: adverse event (AEs), serious adverse events (SAEs) Tolerability: Dose interruptions, reductions and dose intensity 2. Serum concentration of free MCS110 and derived PK parameters 3. Plasma concentration of carboplatin, gemcitabine and dFdU (the primary metabolite of gem), and derived PK parameters 4. Total CSF-I circulating levels, serum CTX-I and circulating monocytes in blood. TAM and TIL content in pre- and post-dose tumor biopsies 5. Tumor response per RECIST v1.1 (by local investigator assessment): Overall Response Rate (ORR), Duration of Response (DOR), Clinical Benefit Rate (Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) = 6 months) and Overall Survival (OS).;Timepoint(s) of evaluation of this end point: 1. Continuously 2. Please refer to protocol section 7 3. Please refer to protocol section 7 4. Please refer to protocol section 7 5. ORR:Tumor evaluation at screening and then every six weeks until the end of cycle 8. Thereafter every 9 weeks (after cycle 8). DOR: Tumor evaluation at screening and then every six weeks until the end of cycle 8. Thereafter every 9 weeks (after cycle 8). Clinical benefit rate: Tumor evaluation at screening and then every six weeks until the end of cycle 8. Thereafter every 9 weeks (after cycle 8). Overall survival: 4, 6, 9, 12 and 18 months	—

Measure

Time frame

Secondary end point(s): 1. Safety: adverse event (AEs), serious adverse events (SAEs) Tolerability: Dose interruptions, reductions and dose intensity 2. Serum concentration of free MCS110 and derived PK parameters 3. Plasma concentration of carboplatin, gemcitabine and dFdU (the primary metabolite of gem), and derived PK parameters 4. Total CSF-I circulating levels, serum CTX-I and circulating monocytes in blood. TAM and TIL content in pre- and post-dose tumor biopsies 5. Tumor response per RECIST v1.1 (by local investigator assessment): Overall Response Rate (ORR), Duration of Response (DOR), Clinical Benefit Rate (Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) = 6 months) and Overall Survival (OS).;Timepoint(s) of evaluation of this end point: 1. Continuously 2. Please refer to protocol section 7 3. Please refer to protocol section 7 4. Please refer to protocol section 7 5. ORR:Tumor evaluation at screening and then every six weeks until the end of cycle 8. Thereafter every 9 weeks (after cycle 8). DOR: Tumor evaluation at screening and then every six weeks until the end of cycle 8. Thereafter every 9 weeks (after cycle 8). Clinical benefit rate: Tumor evaluation at screening and then every six weeks until the end of cycle 8. Thereafter every 9 weeks (after cycle 8). Overall survival: 4, 6, 9, 12 and 18 months

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Countries

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

Contacts

Public ContactInformacní služba - klin. hodnocení

Novartis s.r.o.

dotazy.klinickehodnoceni@novartis.com+420225775204

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026