Registrationsdatum der Studie
Einschluss der ersten teilnehmenden Person
Authorised-recruitment may be ongoing or finished
Wissenschaftlicher Titel (Datenquelle: WHO)
An Open Label, Randomized, Two Arm Phase III Study of Nivolumab in Combination with Ipilimumab versus Extreme Study Regimen (cetuximab + cisplatin/carboplatin + fluorouracil) as First Line Therapy in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) - (CheckMate 651: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 651)
Studientyp (Datenquelle: WHO)
Interventional clinical trial of medicinal product
Design der Studie (Datenquelle: WHO)
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
If controlled, specify comparator, Other Medicinial Product: yes
Number of treatment arms in the trial: 2
Phase (Datenquelle: WHO)
Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no
Primäre Endpunkte (Datenquelle: WHO)
Timepoint(s) of evaluation of this end point: PFS will be mature after at least 430 PFS events have been observed in the PD-L1+ population.
OS comparison will require up to 433 deaths.
The analysis of PFS is projected to occur 32 months after first patient first visit. There will be no interim analyses of PFS.
The first interim analysis of OS will be conducted at the time of PFS analysis. (We expect to have approximately
70% of OS events at this time.) The second interim analysis of OS and the final OS analysis are projected for 38 and 46 months from first patient first visit;Main Objective: -To compare the progression-free survival (PFS) of nivolumab combined with ipilimumab to that of the EXTREME regimen, in subjects with PD-L1 expressing tumors
-To compare the overall survival (OS) of nivolumab combined with ipilimumab to that of the EXTREME regimen, in subjects with PD-L1 expressing tumors.;Primary end point(s): PFS and OS in subjects with PD-L1 expressing tumors are primary endpoints for this study.
Sekundäre Endpunkte (Datenquelle: WHO)
Secondary end point(s): - Objective response rate (ORR)
- Duration of response (DOR)
- PFS and OS in all randomized subjects
Kontakt für Auskünfte (Datenquelle: WHO)
Bristol-Myers Squibb International Corporation