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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Sunitinib 50 mg/d
ICO Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain
Complejo Hospitalario Regional Reina Sofía
Córdoba, Spain
Hospital Ramón Y Cajal
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Centro Integral Oncologico Clara Campal
Madrid, Spain
MD Anderson Cancer Center Madrid
Madrid, Spain
Hospital Central de Asturias
Oviedo, Spain
Objective response rate
Percentage of patients with documented response according RECIST 1.1 criteria (complete response + partial response)
Time frame: 12 months
Progression-free survival
Time from start of treatment to disease progression or death.
Time frame: 12 months
Time to progression
Time from start of treatment to disease progression or death due to the illness
Time frame: 12 months
Duration of the response
Time from first response to disease progression or death.
Time frame: 12 months
Overall survival
Time from start of treatment to death.
Time frame: 18 months
Clinical benefit
Percentage of patients with documented response or disease stabilization according RECIST 1.1 criteria
Time frame: 12 months
Number of individual events (hematologic events and not hematologic events)
Percentage of patients with each of the adverse event per grade
Time frame: 12 months
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