Phase I/II Study of PDR001 in Patients With Advanced Malignancies
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|ClinicalTrials.gov Identifier: NCT02404441|
Recruitment Status : Active, not recruiting
First Posted : March 31, 2015
Last Update Posted : April 21, 2020
The purpose of this "first-in-human" study of PDR001 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of PDR001 administered i.v. as a single agent to adult patients with solid tumors.
By blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, PDR001 inhibits the PD-1 immune checkpoint, resulting in activation of an antitumor immune response by activating effector T-cells and inhibiting regulatory T-cells.
This study has been designed as a phase I/II, multi-center, open-label study starting with a phase I dose escalation part followed by a phase II part.
PDR001 will be administered every 2 weeks until patient experiences unacceptable toxicity, progressive disease per immune related Response Criteria (irRC) and/or treatment is discontinued at the discretion of the investigator or the patient.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma NSCLC Triple Negative Breast Cancer Anaplastic Thyroid Cancer Other Solid Tumors||Biological: PDR001||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||319 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label Multicenter Phase I/II Study of the Safety and Efficacy of PDR001 Administered to Patients With Advanced Malignancies|
|Actual Study Start Date :||April 27, 2015|
|Estimated Primary Completion Date :||July 1, 2020|
|Estimated Study Completion Date :||July 3, 2020|
patients with solid tumors
Phase I Dose escalation cohorts
Selected tumor types
Phase II expansion: Selected tumor types: melanoma, NSCLC, triple negative breast cancer, anaplastic thyroid cancer
- Part l: The exposure (AUC(0-336h)) after first dose of treatment [ Time Frame: 8 months ]To estimate the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD) for PDR001
- Part l: Incidence of dose limiting toxicities (DLTs) [ Time Frame: 8 months ]To estimate the RP2D and/or the MTD for PDR001
- Part ll: Overall response Rate (ORR) [ Time Frame: 61 months ]As per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 - to estimte the anti-tumor activity of PDR001. Each cycle = 28 days
- Presence and/or concentration of anti-PDR001 [ Time Frame: 42 months ]To assess emergence of anti-PDR001 antibodies following one or more intravenous (i.v.) infusions of PDR001. Each cycle = 28 days; End of treatment = expected to be in average 1 year after the start of study treatment
- Overall Response Rate (ORR) - Phase l only [ Time Frame: 27 months ]Preliminary antitumor activity of PDR001
- Progression Free Survival (PFS) - Phase l/ll [ Time Frame: 61 months ]Preliminary antitumor activity of PDR001
- Duration of Response (DOR) - Phase l/ll [ Time Frame: 61 months ]Preliminary antitumor activity of PDR001
- Disease Control Rate (DCR) - Phase l/ll [ Time Frame: 61 months ]Preliminary antitumor activity of PDR001
- Overall Response Rate (ORR) per immune related Response Criteria - Phase ll only [ Time Frame: 61 months ]Preliminary antitumor activity of PDR001
- Serum pharmacokinetic (PK) parameter AUCs [ Time Frame: 37 months ]Characterize the pharmacokinetic (PK) profile of PDR001
- Serum Pharmacokinetic (PK) parameter Cmax [ Time Frame: 37 months ]Characterize the pharmacokinetic (PK) profile of PDR001
- Serum Pharmacokinetic (PK) parameter Tmax [ Time Frame: 37 months ]Characterize the pharmacokinetic (PK) profile of PDR001
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02404441
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|