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NCT01772004 · ClinicalTrials.gov registry record · Phase 1
Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor)
A Phase 1 study, sponsored by EMD Serono Research & Development Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 1,756
- Enrollment target
NCT01772004: Completed Phase 1 study, sponsored by EMD Serono Research & Development Institute.
NCT01772004 is a Phase 1 study that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 1,756 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (2827% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01772004, a Phase 1 study, has completed, sponsored by EMD Serono Research & Development Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1,756 participants
- Enrollment target
Study Summary
This is a Phase 1, open-label, dose-escalation trial of avelumab \[antibody targeting programmed death ligand 1 (anti PD-L1)\] with consecutive parallel group expansion in participants with selected tumor indications. New recruitment is open for all active cohorts. Active cohorts: Escalation revised dosing regimen cohort. Closed cohorts: Non-small cell lung cancer (NSCLC, first line), NSCLC (post-platinum), metastatic breast cancer (MBC), colorectal cancer (CRC), urothelial carcinoma (secondary), mesothelioma, gastric/GEJ cancer (first line switch maintenance and second line), and ovarian cancer (secondary and platinum refractory + liposomal doxorubicin), renal cell carcinoma (second line) melanoma and head, neck squamous cell carcinoma (HNSCC), castrate-resistant prostate cancer (CRPC), adrenocortical carcinoma (ACC) urothelial carcinoma (efficacy), gastric/gastroesophageal junction (GEJ) cancer (third line), renal cell carcinoma (RCC, first line) and escalation phase .
Primary Outcome
DLT: defined using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0, as any one of following: any Grade (Gr) \>=3toxicity that is possibly/probably/ definitely related to avelumab, except for any of following: Gr 3 infusion-related reaction resolving within 6 hours and controlled with medical management, Transient Gr 3 flu-like symptoms/fever, which is controlled with medical management, Transient Gr 3 fatigue, local reactions, headache, nausea, emesis that resol
Interventions
- DRUG Avelumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,756 participants |
| Start Date | 2013-01-31 |
| Est. Completion | 2019-12-16 |
| Phase | Phase 1 |
What the finished NCT01772004 record still lists
NCT01772004 is an interventional study that assigns participants to a tested intervention. Its 1,756 participants enrollment target places it among the larger protocols in the corpus, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (2827% higher).
The record links to 0 conditions, and to 1 intervention - of which Avelumab is the first listed.
NCT01772004 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01772004 about?
NCT01772004 is a clinical study titled "Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor)". This is a Phase 1, open-label, dose-escalation trial of avelumab \[antibody targeting programmed death ligand 1 (anti PD-L1)\] with consecutive parallel group expansion in participants with selected tumor indications. New recruitment is open for all active cohorts. Active cohorts: Escalation revise...
What is the current status of trial NCT01772004?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1,756 participants. The study started on 2013-01-31. Estimated completion is 2019-12-16.
What interventions are being tested in trial NCT01772004?
The interventions under investigation include: Avelumab (DRUG).
Who is sponsoring clinical trial NCT01772004?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01772004's enrollment target sits among peer trials
1,756 3rd of 2000 higher than 1,998 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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