Table 4.

Best overall response among patients retreated with their original randomized regimen (total retreatment population; N = 40)

Patients
Best overall responseaIpi + gp100 (n = 29)Ipi + placebo (n = 9)gp100 + placebo (n = 2)
At treatmentAfter retreatmentn (%)n (%)n (%)
PRCR0 (0)1 (11.1)0 (0)
PR3b (10.3)0 (0)0 (0)
SD3 (10.3)1 (11.1)0 (0)
PD2 (6.9)1b (11.1)1 (100.0)
SDCR0 (0)0 (0)0 (0)
PR1 (3.4)2 (22.2)0 (0)
SD8 (27.6)2 (22.2)0 (0)
PD6 (20.7)2 (22.2)1b (100.0)
PDcSD1 (3.4)0 (0)0 (0)
PD4 (13.8)0 (0)0 (0)
UnknowncSD1 (3.4)0 (0)0 (0)

Abbreviation: Ipi, ipilimumab 3 mg/kg intravenously every 3 weeks for up to 4 doses.

  • aMeasured by modified World Health Organization criteria.

  • bIncludes 1 patient in each arm with protocol violation.

  • cPatients (n = 6) did not meet the protocol-defined eligibility criteria for retreatment.