advanced malignancies MedDRA version: 21.0 Level: LLT Classification code 10048683 Term: Advanced cancer System Organ Class: 100000004864
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years. •Phase Ib part: Patients with advanced melanoma, endometrial carcinoma, pancreatic or triple negative breast cancer, with measurable or non-measurable disease as determined by RECIST version 1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists. •Phase II part: Patients with advanced solid tumors with at least one measurable lesion as determined by RECIST version 1.1, who have received standard therapy or are intolerant of standard therapy, who have progressed following their last prior therapy, and fit into one of the following groups: - Group 1: TNBC who did not receive prior anti-PD-1/PD-L1 treatment - Group 2 : Pancreatic adenocarcinoma who did not receive prior anti-PD-1/PD-L1 treatment - Group 3 : Endometrial carcinoma who did not receive prior anti-PD-1/PD-L1 treatment - Group 4: Melanoma who progressed on prior PD-1- and PD-L1-directed therapies. • ECOG Performance Status = 2. • Patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution’s guidelines. Patient must be willing to undergo a new tumor biopsy at screening, and during therapy on this study. Exceptions for patients with sites of disease not amenable to biopsy may be considered after discussion with the sponsor. Other inclusion criteria as per protocol 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 105 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: • Presence of symptomatic CNS metastases, or CNS metastases thatrequire local CNS-directed therapy • History of severe hypersensitivity reactions to other mAbs • Impaired cardiac function or clinically significant cardiac disease • Active autoimmune disease or a documented history of autoimmune disease within three years before screening • Active infection requiring systemic antibiotic therapy • Known history of HIV infection • Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, or requiring antiviral treatment Other exclusion criteria as per protocol may apply.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase Ib part: 1. ORR, progression free survival (PFS), CBR,duration of response (DOR) and disease control rate (DCR) per RECIST v1.1 and per immune related Response Criteria (irRC) Phase II part: 2. Frequency, severity and seriousness of AEs, laboratory abnormalities and other safety parameters. 3. ORR per irRC, PFS, DOR, DCR, CBR per RECIST v1.1 and per irRC (Group 1, 3 and 4) 4. ORR per irRC, PFS, DOR, DCR, ORR per RECIST v1.1 and per irRC (Group 2) Phase Ib and Phase II parts: 4. Serum concentration of MCS110 and PDR001 and PK parameters 5. Presence and/or concentration of anti-PDR001 or anti-MCS110 antibodies 6. Overall survival (OS);Timepoint(s) of evaluation of this end point: at protocol-defined timepoints (PK, PD and preliminary anti-tumor activity endpoint). | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase Ib part: To characterize the safety and tolerability of MCS110 given in combination with PDR001 and to identify a recommended dose combination for Phase II. Phase II part: To estimate the anti-tumor activity of the combination of MCS110 with PDR001 ;Secondary Objective: Phase Ib part: 1. To estimate the preliminary anti-tumor activity of the combination of MCS110 with PDR001 Phase II part: 2. To further characterize the safety and tolerability of MCS110 given in combination with PDR001 3. To evaluate the preliminary anti-tumor activity of the combination of MCS110 with PDR001 by additional efficacy measures Phase Ib and Phase II parts: 4. To characterize the pharmacokinetics of MCS110 and PDR001 in combination 5. To assess immunogenicity of MCS110 and PDR001 6. To describe survival with MCS110 and PDR001 in combination ;Primary end point(s): Phase 1b part: Frequency, severity and seriousness of AEs, laboratory abnormalities and other safety parameters. Dose interruptions, reductions, and dose intensity. Incidence rate of DLTs Phase II part: Overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) (groups 1, 3 and 4). Clinical benefit rate (CBR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1), which is defined as confirmed objective response or SD>4 months. (Group 2);Timepoint(s) of evaluation of this end point: Phase 1b part: hroughout study conduct Incidence rate of DLTs: during the first two cycles of study treatment. Phase II part: at protocol-defined timepoints | — |
Countries
Belgium, Finland, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Spain, Switzerland, United States
Contacts
Public ContactMedical Information Service
Novartis Finland Oy
Outcome results
None listed