Randomized Phase-II Study of Nivolumab Plus Ipilimumab vs. Standard of Care in Untreated and Advanced Non-clear Cell RCC (SUNIFORECAST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03075423|
Recruitment Status : Recruiting
First Posted : March 9, 2017
Last Update Posted : March 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Renal Cell Carcinoma||Drug: Ipilimumab plus nivolumab Drug: Sunitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||306 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Randomized, Open-Label Study of Nivolumab Combined With Ipilimumab Versus Standard of Care in Subjects With Previously Untreated and Advanced (Unresectable or Metastatic) Non-clear Cell Renal Cell Carcinoma (nccRCC)|
|Actual Study Start Date :||November 1, 2017|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Ipilimumab plus nivolumab
Ipilimumab 1mg/kg plus nivolumab 3mg/kg, both, will be administered i.v. every 3 weeks for 4 times as an induction therapy followed by a maintenance therapy with a flat dose of 240 mg nivolumab biweekly until progression.
Drug: Ipilimumab plus nivolumab
Ipilimumab every 3 weeks for 4 times Nivolumab every 3 weeks for 4 times followed by maintenance therapy with nivolumab every 2nd week
Other Name: Yervoy plus Opdivo
Active Comparator: Sunitinib
Sunitinib will be administered at a starting dose of 50 mg/die p.o. for 4 weeks on and 2 weeks off per cycle until progression.
Sunitinib is administered orally 50 mg tablets for 4 weeks on and 2 weeks off
Other Name: Sutent
- Overall survival rate at 12 months (OS12) (landmark) [ Time Frame: 12 months ]The overall survival rate at 12 months will be compared in both arms. OS is calculated from date of randomization to death.
- OS rate at 6 and 18 months in overall population and histological and prognostic subgroups [ Time Frame: 6 and 18 months ]The overall survival rate at 6 and 18 months will be compared in both arms. OS is calculated from date of randomization to death.
- Overall survival (OS) [ Time Frame: 5 years ]The overall survival will be compared in both arms by Kaplan-Meyer plots. OS is calculated from date of randomization to death.
- Progression-free survival (PFS) [ Time Frame: 5 years ]PFs will be compared in both arms. PFS is calculated from date of randomization to progression.
- Objective response rate (ORR) [ Time Frame: 4 years ]ORR will be compared in both both arms. ORR will be assessed by regular tumor imaging as CT or magnetic resonance tomography (MRT).
- Incidence of treatment related adverse events [ Time Frame: 5 years ]Adverse events (AEs) and serious adverse event (SAEs) will be recorded in both arms and the frequency will be compared.
- Quality of Life (QoL) as assessed by patient outcome measurement (FKSI-DRS) questionnaire [ Time Frame: 5 years ]Quality of life will be assessed during therapy using the FKSI-DRS questionnaire and evaluated over time and in comparison of both arms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075423
|Contact: Lothar Bergmann, MD||+49 69 63015121||L.Bergmann@em.uni-frankfurt.de|
|Contact: Nicola Goekbuget, MD||+49 69 firstname.lastname@example.org|
|Medizinische Hochschule Hannover||Recruiting|
|Hannover, Niedersachsen, Germany, 30625|
|Charité Universitätsmedizin Berlin||Recruiting|
|University Hospital Erlangen||Recruiting|
|Erlangen, Germany, 91054|
|Contact: Stefan Krause, Prof.|
|Goethe University Frankfurt||Recruiting|
|Frankfurt am Main, Germany, D-60590|
|Contact: Lothar Prof. Dr. med. Bergmann, MD +40 69 63015121 email@example.com|
|Contact: Nicola Goekbuget, MD|
|Universitätsklinkum Gießen und Marburg||Recruiting|
|Klinikum Rechts der Isar der TU München||Recruiting|
|University of Muenster||Recruiting|
|Münster, Germany, 48149|
|Medizinische Universitätsklinik Ulm||Recruiting|
|Ulm, Germany, 89070|
|Principal Investigator:||Lothar Bergmann, MD||Goethe University (Hospital) Frankfurt|