Clinical Trial: NCT02684006
A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Pfizer |
| Information Provided By: | Pfizer |
| Last Update Posted: | 2025-07-30 |
Study Overview
Brief 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
Official Title
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
Conditions
Renal Cell Cancer
Intervention / Treatment
- Drug: Avelumab (MSB0010718C)
- Drug: Axitinib (AG-013736)
- Drug: Sunitinib
Other Study ID Numbers
- B9991003
- 2015-002429-20
- JAVELIN RENAL 101
- 2015
Start Date (Actual)
2016-03-23
Primary Completion Date (Actual)
2023-08-31
Study Completion Date (Actual)
2024-06-26
Enrollment (Actual)
886
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Pfizer |
| Information Provided By: | Pfizer |
| Last Update Posted: | 2025-07-30 |
Study Overview
Brief 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
Official Title
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
Conditions
Renal Cell Cancer
Intervention / Treatment
- Drug: Avelumab (MSB0010718C)
- Drug: Axitinib (AG-013736)
- Drug: Sunitinib
Other Study ID Numbers
- B9991003
- 2015-002429-20
- JAVELIN RENAL 101
- 2015
Start Date (Actual)
2016-03-23
Primary Completion Date (Actual)
2023-08-31
Study Completion Date (Actual)
2024-06-26
Enrollment (Actual)
886
Study Type
Interventional
Phase
Phase 3