Phase Ib/II Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies

Inclusion Criteria

• Signed informed consent prior to any procedures
• Phase Ib part: Adult 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.
• Phase II part: Adult patients with advanced solid tumors who have received standard therapy (no more than 3 prior lines of treatment) or are intolerant of standard therapy, 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 anti-PD-1/PD-L1 treatment. Main

Exclusion Criteria

• Patients with the following:
• Symptomatic central nervous system (CNS) metastases or those requiring local CNS-directed therapy.
• Abnormal liver, renal, or blood lab values.
• Impaired cardiac function or clinically significant cardiac disease.
• Active autoimmune disease or documented autoimmune disease within 3 years of screening.
• Active infection requiring antibiotic therapy.
• Known HIV, active hepatitis B or C virus.
• Concurrent malignant disease.
• Patients who received systemic anticancer therapy, major surgery, or radiotherapy within 2 weeks of study treatment, or live vaccines within 4 weeks of study treatment.
• Patients requiring chronic treatment with systemic steroid therapy or any immunosuppressive therapy.
• Patients who used hematopoietic colony-stimulating growth factors within 2 weeks of study treatment.