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Study to Evaluate Efficacy and Safety of Sunitinib in Renal Cell Carcinoma Progressed to 1L Immunotherapy Treatment.

NCT03066427 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2020-11-13

No results posted yet for this study

Summary

The therapeutic scenario of metastatic renal cancer is undergoing a new revolution with the appearance of a novel therapeutic strategy after the antiangiogenic treatments, that is the immunotherapy, in addition to the approval of new active drugs in the following lines of treatment.

There are currently two phase III trials in the first line of treatment in metastatic renal cancer that include different combinations of treatment based on immunotherapy. If results of these studies were positive, the therapeutic algorithm would be modified so that the remaining drugs would have to be repositioned within the therapeutic decision scheme.

Sunitinib has previously demonstrated its benefit in patients who had failed to prior treatment with cytokines, so it is likely to continue to be effective in patients who have become resistant to treatment with new drugs based on immune checkpoint blockade.

This phase II study is developed to evaluate the activity of sunitinib after treatment with immunotherapy-based regimens that are currently being developed within phase III clinical trials.

Conditions

  • Clear Cell Renal Carcinoma

Interventions

DRUG

Sunitinib

Sunitinib 50 mg/d

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Apices Soluciones S.L.

    collaborator INDUSTRY

  • Spanish Oncology Genito-Urinary Group

    lead OTHER

Principal Investigators

  • Enrique Grande, MD · MD Anderson Cancer Center Madrid

  • Cristina Suárez, MD · Hospital Vall d'Hebron

  • Xavier García del Muro, MD · Hestia Duran i Reynals

  • Oscar Reig, MD · Hospital Clínic i Provincial de Barcelona

  • María J Méndez, MD · Complejo Hospitalario Regional Reina Sofia

  • Daniel Castellano, MD · Hospital Universitario 12 de Octubre

  • Teresa Alonso, MD · Hospital Universitario Ramon y Cajal

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-10
Primary Completion
2020-09-22
Completion
2020-09-22

Countries

  • Spain

Study Locations

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Entities

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 NCT03066427 on ClinicalTrials.gov