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NCT02603419 · ClinicalTrials.gov registry record · Phase 1
Avelumab In Patients With Previously Treated Advanced Stage Classical Hodgkin's Lymphoma (JAVELIN HODGKINS)
A Phase 1 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT02603419 is a Phase 1 study that was terminated before completion, run by Pfizer. The registered enrollment target is 34 participants.
The verdict
NCT02603419, a Phase 1 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
This is a Phase 1b, open-label, multi-center study comprising a lead-in phase and an expansion phase. The lead-in phase is a multiple-dose, randomized, parallel-arm, pharmacokinetic and pharmacodynamic study of avelumab as a single agent in adult patients with cHL. Patients enrolled in the lead-in phase of this study are required to have relapsed following a prior autologous or allogeneic HSCT, or to be ineligible for HSCT. Based on the preliminary TO, safety, and efficacy results from the lead-in phase, the expansion phase will evaluate the anti-tumor activity and safety of single-agent avelumab utilizing an intra-patient dose escalation paradigm based on two of the dosing regimens studied in the lead-in phase in 40 cHL patients in whom an allogeneic HSCT has failed.
Interventions
- DRUG Avelumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2016-03-10 |
| Est. Completion | 2019-04-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02603419
The ClinicalTrials.gov registry entry for NCT02603419 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Avelumab is the first listed.
NCT02603419 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02603419 about?
NCT02603419 is a clinical study titled "Avelumab In Patients With Previously Treated Advanced Stage Classical Hodgkin's Lymphoma (JAVELIN HODGKINS)". This is a Phase 1b, open-label, multi-center study comprising a lead-in phase and an expansion phase. The lead-in phase is a multiple-dose, randomized, parallel-arm, pharmacokinetic and pharmacodynamic study of avelumab as a single agent in adult patients with cHL. Patients enrolled in the lead-in p...
What is the current status of trial NCT02603419?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2016-03-10. Estimated completion is 2019-04-11.
What interventions are being tested in trial NCT02603419?
The interventions under investigation include: Avelumab (DRUG).
Who is sponsoring clinical trial NCT02603419?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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