Clinical Trial: Study to Evaluate Efficacy and Safety of Sunitinib in Patients With Renal Cell Carcinoma Who Have Progressed to First-line Immunotherapy Treatment

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Phase II Study to Evaluate Efficacy and Safety of Sunitinib Therapy in Patients With Metastatic Renal Clear Cell Carcinoma Who Have Progressed to First-line Immunotherapy

Brief 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.


Detailed Summary:
Sponsor: Spanish Oncology Genito-Urinary Group

Current Primary Outcome: Objective response rate [ Time Frame: 12 months ]

Percentage of patients with documented response according RECIST 1.1 criteria (complete response + partial response)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression-free survival [ Time Frame: 12 months ]
    Time from start of treatment to disease progression or death.
  • Time to progression [ Time Frame: 12 months ]
    Time from start of treatment to disease progression or death due to the illness
  • Duration of the response [ Time Frame: 12 months ]
    Time from first response to disease progression or death.
  • Overall survival [ Time Frame: 18 months ]
    Time from start of treatment to death.
  • Clinical benefit [ Time Frame: 12 months ]
    Percentage of patients with documented response or disease stabilization according RECIST 1.1 criteria
  • Safety [ Time Frame: 12 months ]
    Percentage of patients with each of the adverse event per grade


Original Secondary Outcome: Same as current

Information By: Spanish Oncology Genito-Urinary Group

Dates:
Date Received: February 23, 2017
Date Started: April 30, 2017
Date Completion: May 31, 2020
Last Updated: February 28, 2017
Last Verified: February 2017