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

NCT03035630 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-02-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Avelumab

Avelumab 10mg/kg IV over 60 minutes on D1 and D15 of every 28 day cycle

DRUG

Sunitinib

Sunitinib 50 mg once daily from D1 to D14 of every 21 day cycle

Sponsors & Collaborators

  • Hoosier Cancer Research Network

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • Guru Sonpavde

    lead OTHER

Principal Investigators

  • Guru Sonpavde, M.D. · Hoosier Cancer Research Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-23
Primary Completion
2018-12-31
Completion
2020-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03035630 on ClinicalTrials.gov