Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib Hydrochloride to Sorafenib in Subjects With Refractory Advanced Renal Cell Carcinoma
Brief Summary: This is a Phase 3, open-label, randomized, controlled, multi-national, multi-center, parallel-arm study comparing tivozanib to sorafenib in participants with refractory advanced renal cell carcinoma (RCC).

Participants will be randomized (1:1) to treatment with tivozanib or sorafenib.

Participants will be stratified by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk category (favorable; intermediate; poor) and prior therapy (two prior vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKI); a prior checkpoint inhibitor \[programmed cell death -1 protein (PD-1) or PD-1 ligand (PD1-L) inhibitor\] plus a prior VEGFR TKI; a prior VEGFR TKI plus any other systemic agent).

All participants will be evaluated for progression free survival, overall survival, objective response rate, and the duration of response as well as safety and tolerability.

Pharmacokinetic (PK) analyses are also included in study.


Options:
A: Arm Label: A; Type: EXPERIMENTAL; Interventions: Drug: Temsirolimus, Drug: Bevacizumab | Arm Label: B; Type: ACTIVE_COMPARATOR; Interventions: Drug: Sunitinib | Arm Label: C; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bevacizumab, Drug: Interferon alpha-2a | Intervention Type: DRUG; Name: Temsirolimus; Assigned to Arm(s): A | Intervention Type: DRUG; Name: Bevacizumab; Assigned to Arm(s): A, C | Intervention Type: DRUG; Name: Sunitinib; Assigned to Arm(s): B | Intervention Type: DRUG; Name: Interferon alpha-2a; Assigned to Arm(s): C
B: Arm Label: Sorafenib Tosylate; Type: EXPERIMENTAL; Interventions: Drug: Sorafenib Tosylate, Other: Laboratory Biomarker Analysis | Arm Label: Sorafenib Tosylate, Recombinant interferon alfa-2b; Type: EXPERIMENTAL; Interventions: Drug: Sorafenib Tosylate, Biological: Recombinant Interferon Alfa-2b, Other: Laboratory Biomarker Analysis | Intervention Type: DRUG; Name: Sorafenib Tosylate; Assigned to Arm(s): Sorafenib Tosylate, Sorafenib Tosylate, Recombinant interferon alfa-2b | Intervention Type: BIOLOGICAL; Name: Recombinant Interferon Alfa-2b; Assigned to Arm(s): Sorafenib Tosylate, Recombinant interferon alfa-2b | Intervention Type: OTHER; Name: Laboratory Biomarker Analysis; Assigned to Arm(s): Sorafenib Tosylate, Sorafenib Tosylate, Recombinant interferon alfa-2b
C: Arm Label: tivozanib (AV-951); Type: EXPERIMENTAL; Interventions: Drug: tivozanib (AV-951) | Arm Label: sorafenib; Type: ACTIVE_COMPARATOR; Interventions: Drug: Sorafenib | Intervention Type: DRUG; Name: tivozanib (AV-951); Assigned to Arm(s): tivozanib (AV-951) | Intervention Type: DRUG; Name: Sorafenib; Assigned to Arm(s): sorafenib
D: Arm Label: Tivozanib hydrochloride; Type: EXPERIMENTAL; Interventions: Drug: Tivozanib hydrochloride | Arm Label: Sorafenib; Type: ACTIVE_COMPARATOR; Interventions: Drug: Sorafenib | Intervention Type: DRUG; Name: Tivozanib hydrochloride; Assigned to Arm(s): Tivozanib hydrochloride | Intervention Type: DRUG; Name: Sorafenib; Assigned to Arm(s): Sorafenib

Answer: D