Sunitinib Followed by Avelumab or the Reverse for Metastatic Renal Cell Carcinoma

Kidney Cancer Clinical Trial

Official title: Randomized Phase II Trial Comparing Sequential First-line Sunitinib and Second-line Avelumab vs First-line Avelumab and Second-line Sunitinib for Metastatic Renal Cell Carcinoma: SUAVE Trial. Hoosier Cancer Research Network GU15-223

Status Withdrawn

Clinical Trial Summary

This is an open label, randomized phase II trial. Eligible subjects will be randomized in a 1:1 ratio and stratified for known prognostics variables to one of two first-line medication treatment arms. Once disease progression has been documented, and following a required inter-line washout period, subjects will receive either second-line medication treatment or discontinue treatment, per discretion of treating investigator.

Clinical Trial Description

OUTLINE: This is a multi-center trial. Eligible subjects will be randomized and stratified to one of two arms:

FIRST-LINE INVESTIGATIONAL TREATMENT ARM A:

• Avelumab 10mg/kg intravenously (IV) on Day 1 (D1) and Day 15 (D15) of every 28 day cycle until documented disease progression per Immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) 1.1

SECOND-LINE INVESTIGATIONAL TREATMENT ARM A:

• Following completion of an inter-line washout period of a minimum of 2 weeks up to a maximum of 60 days (or at the discretion of treating investigator) subjects will receive:

• Sunitinib 50 mg by mouth (po) once daily from D1 to D14 of every 21 day cycle until documented disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 OR

• Discontinue treatment

FIRST-LINE INVESTIGATIONAL TREATMENT ARM B:

• Sunitinib 50 mg po once daily from D1 to D14 of every 21 day cycle until documented disease progression per RECIST 1.1

SECOND-LINE INVESTIGATIONAL TREATMENT ARM B:

• Following completion of an inter-line washout period of a minimum of 2 weeks up to a maximum of 60 days (or at the discretion of treating investigator) subjects will receive:

• Avelumab 10mg/kg IV on D1 and D15 every 28 day cycle until documented disease progression per irRECIST 1.1 OR

• Discontinue treatment

NOTE:

Subjects who do not experience disease progression at end of first-line treatment and are removed from first-line treatment due to toxicities or personal decision, may also either receive second-line therapy or be monitored during the inter-line period until progression (which may be longer than 60 days) per discretion of treating investigator.

Radiological disease evaluation assessments will be completed every 12 weeks.

To demonstrate adequate organ function, all screening labs must be obtained within 14 days prior to registration:

Hematological:

• Absolute Neutrophil Count (ANC) ≥ 1.5 K/mm3

• Hemoglobin (Hgb) ≥ 9 g/dL

• Platelets ≥ 100 K/ mm3

Renal:

• Calculated creatinine clearance by Cockcroft-Gault formula ≥ 40 ml/min

Hepatic:

• Bilirubin ≤ 1.5 × upper limit of normal (ULN)

• Aspartate aminotransferase (AST) ≤ 2.5 × ULN

• Alanine aminotransferase (ALT) ≤ 2.5 × ULN

Miscellaneous:

• Urine/serum pregnancy test - Negative ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Clear-cell Kidney Carcinoma
• Clear-cell Renal Cell Carcinoma
• Kidney Cancer
• Kidney Neoplasms
• RCC

• NCT number: NCT03035630
• Study type: Interventional
• Source: Hoosier Cancer Research Network
• Status: Withdrawn
• Phase: Phase 2
• Start date: May 23, 2017
• Completion date: December 2020