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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 is a Phase 1 study that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 1,756 participants.
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 .
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01772004
The ClinicalTrials.gov registry entry for NCT01772004 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 1,756 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono Research & Development Institute, which has 81 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Avelumab is the first listed.
NCT01772004 reports 0 study locations.
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.
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