Primary Outcome Measures
Best Overall Response rate [Time Frame: Start of cycle 3, start of cycle 5, and then the start of every subsequent cycle for the remainder of treatment. One cycle is 4 weeks. (approximately 3 years)] [Designated as safety issue: ]
Secondary Outcome Measures
Number of Participants With Treatment Related Adverse Events [Time Frame: From the start of treatment until 30 days after the last dose of study drug is received (approximately 5 years)] [Designated as safety issue: ]
Overall Survival [Time Frame: From the start of treatment until the time of death or loss to follow-up (approximately 7 years)] [Designated as safety issue: ]
Disease Control Rate [Time Frame: Screening, start of cycle 3, start of cycle 5, and then the start of every subsequent 4-week cycle for the remainder of treatment (approximately 3 years)] [Designated as safety issue: ]
Progression Free Survival [Time Frame: From the start of treatment until the time of death or loss to follow-up, whichever occurs first (approximately 7 years)] [Designated as safety issue: ]
Duration of Response [Time Frame: From first documentation of response to treatment until the time of disease progression (approximately 2 years)] [Designated as safety issue: ]
Time to Disease Progression [Time Frame: From the start of treatment until the time of disease progression (approximately 7 years)] [Designated as safety issue: ]