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

• Status: Completed
• Trial end date: 2020-06-04
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study of MCS110 with PDR001 was 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Sargramostim; Spartalizumab

Criteria

Main 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.