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NCT02605967 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of PDR001 in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 122
- Enrollment target
NCT02605967: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT02605967 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 122 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02605967, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 122 participants
- Enrollment target
Study Summary
The purpose of this randomized controlled Phase II study is to assess the efficacy of PDR001 versus investigator's choice of chemotherapy in patients with advanced nasopharyngeal carcinoma (NPC). By blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2, PDR001 leads to the activation of a T-cell mediated antitumor immune response.
Primary Outcome
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
Interventions
- DRUG Spartalizumab
- DRUG Investigator choice of chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2016-04-20 |
| Est. Completion | 2021-02-19 |
| Phase | Phase 2 |
What the finished NCT02605967 record still lists
NCT02605967 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Spartalizumab is the first listed.
NCT02605967 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02605967 about?
NCT02605967 is a clinical study titled "Safety and Efficacy Study of PDR001 in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma". The purpose of this randomized controlled Phase II study is to assess the efficacy of PDR001 versus investigator's choice of chemotherapy in patients with advanced nasopharyngeal carcinoma (NPC). By blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2, PDR001 leads to the activatio...
What is the current status of trial NCT02605967?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 122 participants. The study started on 2016-04-20. Estimated completion is 2021-02-19.
What interventions are being tested in trial NCT02605967?
The interventions under investigation include: Spartalizumab (DRUG), Investigator choice of chemotherapy (DRUG).
Who is sponsoring clinical trial NCT02605967?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02605967's enrollment target sits among peer trials
122 565th of 2000 higher than 1,434 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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