Spots Global Cancer Trial Database for Study to Evaluate Efficacy and Safety of Sunitinib in Renal Cell Carcinoma Progressed to 1L Immunotherapy Treatment.
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Trial Identification
Brief Title: Study to Evaluate Efficacy and Safety of Sunitinib in Renal Cell Carcinoma Progressed to 1L Immunotherapy Treatment.
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 Treatment (INMUNOSUN Study)
Study ID: NCT03066427
Conditions
Interventions
Study Description
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 Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Enrique Grande, MD
Affiliation: MD Anderson Cancer Center Madrid
Role: STUDY_CHAIR
Name: Cristina Suárez, MD
Affiliation: Hospital Vall d'Hebron
Role: PRINCIPAL_INVESTIGATOR
Name: Xavier García del Muro, MD
Affiliation: Hestia Duran i Reynals
Role: PRINCIPAL_INVESTIGATOR
Name: Oscar Reig, MD
Affiliation: Hospital Clínic i Provincial de Barcelona
Role: PRINCIPAL_INVESTIGATOR
Name: María J Méndez, MD
Affiliation: Complejo Hospitalario Regional Reina Sofia
Role: PRINCIPAL_INVESTIGATOR
Name: Daniel Castellano, MD
Affiliation: Hospital Universitario 12 de Octubre
Role: PRINCIPAL_INVESTIGATOR
Name: Teresa Alonso, MD
Affiliation: Hospital Universitario Ramon y Cajal
Role: PRINCIPAL_INVESTIGATOR
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