Trials / Completed
CompletedNCT02684006
A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)
A PHASE 3, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AXITINIB (INLYTA(REGISTERED)) VERSUS SUNITINIB (SUTENT(REGISTERED)) MONOTHERAPY IN THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 886 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Avelumab (MSB0010718C) | IV treatment Avelumab administered at 10 mg/kg IV every two weeks |
| DRUG | Axitinib (AG-013736) | Oral treatment Axitinib given 5 mg PO BID |
| DRUG | Sunitinib | Oral treatment Sunitinib given at 50 mg PO QD on schedule 4/2 |
Timeline
- Start date
- 2016-03-23
- Primary completion
- 2023-08-31
- Completion
- 2024-06-26
- First posted
- 2016-02-17
- Last updated
- 2025-07-30
- Results posted
- 2024-10-29
Locations
270 sites across 21 countries: United States, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Romania, Russia, South Korea, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT02684006. Inclusion in this directory is not an endorsement.