Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02605967 | Safety and Efficacy Study of PDR001 in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma | PHASE2 | COMPLETED | 122 | — | — | Apr 20, 2016 | Feb 19, 2021 | Feb 10, 2022 | 18 | United States, China +5 |
PFS is the time from the date of randomization to the date of event defined as the first documented confirmed progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Tumor response was based on central review of tumor scan and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Progressive disease is at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. Number of participants in each category (progression, death, censored) is reported in this record.
PFS is the time from the date of randomization to the date of event defined as the first documented confirmed progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Tumor response was based on central review of tumor scan and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Progressive disease is at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline.
| Arm | Type | Description |
|---|---|---|
| Spartalizumab 400 mg Q4W | EXPERIMENTAL | anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab |
| Chemotherapy | ACTIVE_COMPARATOR | commonly used chemotherapy as per investigator's choice |
| Name | Type | Description |
|---|---|---|
| Spartalizumab | DRUG | Spartalizumab was administered via intravenous infusion at a dose of 400 mg every 4 weeks (Q4W). Spartalizumab is a humanized anti-PD-1 IgG4 antibody which blocks the binding of PD1 to its ligands PD-L1 and PD-L2. |
| Investigator choice of chemotherapy | DRUG | Commonly used chemotherapy as per investigator's choice. The dose and route of administration was the one described in each drug's label. |
Inclusion Criteria: * Histologically documented non-keratinizing locally advanced recurrent or metastatic NPC. * Must be resistant to platinum-based chemotherapy (defined as progression on or after platinum-based chemotherapy given in the recurrent/metastatic setting). * May have received at least ...