drugset / Trial / NCT02959554
Study in Which Therapy is Either Switched to Nivolumab After 3 Months of Treatment or Therapy is Continued With a Tyrosine Kinase Inhibitor in Patients With Metastatic Renal Cell Carcinoma (RCC) and Disease Control
RandomizedParallel-groupOpen-labelTreatment
Summary
This study aims to assess the survival benefit from an early switch approach from sunitinib or pazopanib (10-12 weeks of 1st-line therapy) to nivolumab (anti-angiogenic to immunotherapy switch).
Timeline
- Start
- 2016-12
- Primary completion
- 2020-08
- Completion
- 2021-01
Publications
- Grunwald V, Ivanyi P, Zschabitz S, Wirth M, Staib P, Schostak M, Dargatz P, Muller L, Metz M, Bergmann L, Steiner T, Welslau M, Lorch A, Rafiyan R, Hellmis E, Darr C, Schutt P, Meiler J, Kretz T, Loidl W, Florcken A, Manz M, Hinke A, Hartmann A, Grullich C. Nivolumab Switch Maintenance Therapy After Tyrosine Kinase Inhibitor Induction in Metastatic Renal Cell Carcinoma: A Randomized Clinical Trial by the Interdisciplinary Working Group on Renal Tumors of the German Cancer Society (NIVOSWITCH; AIO-NZK-0116ass). Eur Urol. 2023 Dec;84(6):571-578. doi: 10.1016/j.eururo.2023.09.004. Epub 2023 Sep 26.
- Hofmann F, Hwang EC, Lam TB, Bex A, Yuan Y, Marconi LS, Ljungberg B. Targeted therapy for metastatic renal cell carcinoma. Cochrane Database Syst Rev. 2020 Oct 14;10(10):CD012796. doi: 10.1002/14651858.CD012796.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |
| Comparator | Pazopanib | Small molecule | 800 mg | Oral |
| Comparator | Sunitinib | Small molecule | 50 mg | Oral |