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The purpose of this study is to characterize the safety, tolerability, Pharmacokinetics (PK), and antitumor activity of PDR001 administered intravenous (i.v.) as a single agent to Japanese patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDR001 | Experimental | PDR001 will be administered i.v. every two weeks until a patient experiences unacceptable toxicity, progressive disease as per irRC and/or treatment is discontinued at the discretion of the investigator or the patient. The treatment period will begin on Cycle 1 Day 1. For the purpose of scheduling and evaluations, a treatment cycle will consist of 28 days. During the study, cohorts of patients will be treated with PDR001 until the maximum tolerated dose (MTD) is reached or a lower recommended dose (RD) is established. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDR001 | Drug | PDR001 is a high-affinity, ligand-blocking, humanized anti-PD-1 IgG4 antibody that blocks the binding of PD-L1 and PD-L2 to PD-1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose limiting toxicities (DLTs) | cycle = 28 days | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter: AUC | To characterize the PK profile of PDR001; cycle = 28 days | Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1) |
| Serum concentration vs. time profiles | Serum concentration of PDR001 at the scheduled timepoints up to 336 hours after administration |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Nagoya | Aichi-ken | 466-8560 | Japan | ||
| Novartis Investigative Site |
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| ID | Term |
|---|---|
| C000711728 | spartalizumab |
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| C1D1, C3D1 |
| Presence and/or concentration of anti-PDR001 antibodies | To assess the emergence of anti-PDR001 antibodies following one or more intravenous infusions of PDR001. | Day 1 on from C1 to C6 |
| Objective response rate (ORR) | cycle = 28 days | up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks) |
| Duration of response rate (DOR) | cycle = 28 days | up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks) |
| Disease control rate (DCR) | cycle = 28 days | up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks) |
| PK parameter: Cmax | To characterize the PK profile of PDR001; cycle = 28 days | Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1) |
| PK parameter: Tmax | To characterize the PK profile of PDR001; cycle = 28 days | Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1) |
| PK parameter: half-life | To characterize the PK profile of PDR001; cycle = 28 days | Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1) |
| Kashiwa |
| Chiba |
| 277-8577 |
| Japan |
| Novartis Investigative Site | Kobe | Hyōgo | 650-0017 | Japan |