Moderately differentiated/undifferentiated locally advanced recurrent or metastatic nasopharyngeal carcinoma
Conditions
Interventions
Product Code: PDR001
Pharmaceutical Form: Lyophilisate for solution for infusion
Current Sponsor code: PDR001
Other descriptive name: PDR001
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically documented non-keratinizing locally advanced recurrent or metastatic NPC. 2. Must be resistant to platinum-based chemotherapy (defined as progression on or after platinum-based chemotherapy given in the recurrent/metastatic setting). 3. May have received at least 1 prior therapy for recurrent or metastatic disease, up to 2 prior systemic therapies. 4. An archival tumor specimen or newly obtained tumor sample may be submitted at screening/baseline (a fresh tumor sample is preferred), unless agreed differently between Novartis and the Investigator. 5. At least 1 measurable lesion (as per RECIST v1.1) progressing or new since last anti-tumor therapy. 6. Prior treated brain or meningeal metastases must be without MRI evidence of progression for at least 8 weeks and off systemic steroids for at least 2 weeks prior to screening/baseline. 7. Patient must be willing to undergo testing for human immunodeficiency virus (HIV) if not tested within the past 6 months. If HIV+ positive, patient will be eligible if: his/ her CD4+ count = 300/µL; his/her viral load is undetectable; he/she is currently receiving highly active antiretroviral therapy (HAART). Other protocol-defined inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 74
Exclusion criteria
Exclusion criteria: 1. History of severe hypersensitivity reactions to other mAbs 2. Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved asthma/atopy that is treated with broncho-dilators. 3. Active HBV or HCV infections requiring therapy. 4. Prior PD-1- or PD-L1-directed therapy or any therapeutic cancer vaccine. 5. Patients receiving systemic treatment with any immunosuppressive medication. 6. Use of any vaccines against infectious diseases (e.g. varicella, pneumococcus) within 4 weeks of initiation of study treatment. Other protocol-defined exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of PDR001 versus investigator’s choice of chemotherapy in patients with moderately differentiated / undifferentiated locally advanced recurrent or metastatic NPC who progressed on or after first-line therapy;Secondary Objective: 1- To evaluate the anti-tumor activity of PDR001 versus investigator ‘choice of chemotherapy in patients with moderately differentiated/undifferentiated locally advanced recurrent or metastatic NPC who progressed on or after first-line therapy 2- To characterize the safety and tolerability of PDR001 3- To characterize the pharmacokinetic profile of PDR001 (patients in PDR001 arm) 4- To assess emergence of anti-PDR001 antibodies following one or more intravenous (i.v.) infusions of PDR001(patients in PDR001 arm) 5- To assess the pharmacodynamic effect of PDR001 in peripheral blood (patients in PDR001 arm);Primary end point(s): Progression free survival (PFS) as per RECIST v1.1 using central assessment;Timepoint(s) of evaluation of this end point: PFS will be assessed after 70 events (progressive diseases or death due to any cause) are observed from the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- Overall survival (OS), overall response rate (ORR), duration of response (DOR), time to progression (TTP) and immune related progression free survival (irPFS) as per irRC using central assessment 2- Safety: Incidence and severity of adverse events (AEs),immunorelated AEs (irAEs) and serious adverse events (SAEs), including changes in laboratory parameters, vital signs and electrocardiograms (ECGs) 3- Serum PK parameters (e.g. AUC, Cmax, Tmax, half-life); Serum concentration vs. time profiles 4- Presence and/or concentration of anti-PDR001 antibodies 5- Assess peripheral, soluble ligands and cytokine levels (including but not limited to IFN-?, TNF-a, IL-6);Timepoint(s) of evaluation of this end point: 1- During treatment: 8 weeks after Cycle 1 Day 1, and then every 8 weeks until week 40. Then every 12 until progression or patient withdrawal Follow up for progression: every 8 weeks until week 40, then every 12 weeks until progression or lost to follow-up 2- Assessed continously throughout study for all patients. ECGs during screening on Cycle 1 and 3 on Day 1 and at end of treatment 3- Cycle 1 and Cycle 3 on Day 1, 2, 8 and 15. Cycle 2 on Day 1, 8 and 15. Cycle 4, 5 and 6 on Day 1 and end of treatment 4- Cycle 1 to Cycle 6 on Day 1 and end of treatement 5- At Cycle 1 and Cycle 2 on Day 1, 8 and 15 (pre-dose) and end of treatment | — |
Countries
Canada, China, France, Hong Kong, Singapore, Taiwan, Thailand, United States
Contacts
Public ContactInformation&CommunicationMédicales
Novartis Pharma S.A.S
Outcome results
None listed