Phase Ib / II Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies
The purpose of this study of MCS110 with PDR001 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of the combination of MCS110 with PDR001 in adult patients with solid tumors.
- Signed informed consent prior to any procedures
- Patients with advanced melanoma, endometrial carcinoma, pancreatic or TNBC, with measurable or non-measurable disease who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists.
- Patient having out of range laboratory values defined as:
- Creatinine clearance < 40 mL/min
- Total bilirubin > 1.5 x ULN
- Absolute neutrophil count < 1.0 x 109/L
- Hemoglobin (Hgb) < 9 g/dL
- Impaired cardiac function or clinically significant cardiac disease
- Active autoimmune disease
- Malignant disease, other than that being treated in this study.
- Presence of ≥ CTCAE Grade 2 toxicity due to prior cancer therapy.
- Pregnant or lactating women
Locations & Contacts
Name Not Available
Trial Objectives and Outline
Combined treatment with MCS110 and PDR001 is expected to result in TAM depletion, enhanced T-cell activation and synergistic antitumor activity in the clinical setting.
Trial Phase & Type
Novartis Pharmaceuticals Corporation
Secondary IDs NCI-2016-01142, 2016-000210-29
Clinicaltrials.gov ID NCT02807844