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Name clinical trial
Phase | Number of patients | Treatment plan | Primary endpoint | Median OS
(95% CI) | Median progression-free survival PFS
(95% CI) | Overall survival rates
OS |
|
CA184-002
Phase III [4] | 676 | G1:IPI 3 mg/kg + gp100
G2: IPI
G3: gp100
Dose: Every 3 weeks for four cycles
Mode: IV | OS | IPI + gp100: 10.0 mos. (8.5-11.5)
IPI: 10.1 mos. (8.0-13.8)
gp100: 6.4 mos. (5.5-8.7) | IPI + gp100: 2.76 mos. (2.73-2.79)
IPI: 2.86 mos. (2.76-3.02)
gp100, 2.76 mos. (2.73-2.83) | IPI + gp100, IPI, gp100:
1 yr.: 43.6% vs 45.6% vs 25.3%
2 yrs.: 21.6%, 23.5%, 13.7% |
|
CA184-024
Phase III [5, 6] | 502 | G1: IPI 10 mg/kg + dacarbazine 850mg/m2
G2: dacarbazine + placebo
Dose: weeks 1, 4, 7, and 10, followed by dacarbazine monotherapy every 3 weeks until week 22.
Mode: IV | OS | IPI + dacarbazine: 11.2 mos. (9.4-13.6)
Dacarbazine + placebo: 9.1 mos. (7.8-10.5) | Median values for PFS were similar in the two groups at week 12 | IPI + dacarbazine, dacarbazine:
1 yr.: 47.3% vs. 36.3%
2 yrs.: 28.5% vs. 17.9%
3 yrs.: 20.8% vs. 12.2%
5 yrs.: 18.2% vs. 8.8% |
|
| Expanded access program EURO-VOYAGE [7] | 1034 | IPI 3 mg/kg | OS | 6.8 mos. (6.1-7.4) | Median PFS 2.6 mos. (2.6-2.7) | 3 yrs.: 10.9 %
4 yrs.: 8% |
|
CA184-367
III [8] | 727 | G1: IPI 3 mg/kg
G2: IPI 10 mg/kg | OS | IPI 3 mg/kg: 11.5 mos. (9.9-13.3)
IPI 10 mg/kg: 15.7 mos. (6-17.8) | IPI 3mg/kg: 2.8 mos. (2.8-2.8);
IPI 10 mg/kg, 2.8 mos. (2.8-3.0) | IPI 3 mg/kg, IPI 10 mg/kg:
1 yr.: 47.6% vs. 54.3%
2 yrs.: 31.0% vs. 38.5%
3 yrs.: 23.2% vs. 31.2% |
|
| Pooled analysis from Phase II and Phase III [9] | 1861 | The majority of patients had received IPI 3 mg/kg or 10 mg/kg | OS | 11.4 mos. (10.7-12.1) | | 3 yrs.: 22% for all patients, 26% for treatment-naïve patients and 20% for previously treated patients |
|
KEYNOTE-001
Phase Ib [10–49] | 655 | PEMBRO 2 mg/kg every 3 weeks, PEMBRO 10 mg/kg every 3 weeks or PEMBRO 10 mg/kg every 2 weeks until disease progression or intolerable toxicity | CR | 23.8 mos. (20.2-30.4) | 8.3 mos. (5.8-11.1) in all treated patients
16.9 mos. (9.3-35.5) in treatment naïve patients | 3 yrs.: 42% in all treated patients; 51% in treatment-naïve patients
4 yrs.: 37% in all treated patients; 48% in treatment-naïve patients
5 yrs.: 34 % in all patients, 41% in treatment naive |
|
KEYNOTE-006
Phase III [13] | 834 | PEMBRO 10mg/kg every 2 weeks
PEMBRO 10 mg/kg every 3 weeks
IPI 3 mg/kg every 3 weeks for four cycles | PFS and OS | Median OS was not reached in the resp. PEMBRO arms
IPI: 16.0 mos. | PEMBRO every 2 weeks, 5.5 mos. (3.4-6.9); PEMBRO every 3 weeks 4.1 mos. (2.9-6.9); IPI 2.8 mos. (2.8-2.9) | PEMBRO every 2 weeks, PEMBRO every 3 weeks, IPI:
1 yr.: 74.1% vs 68.4% vs 58.2%
2 yrs.: 55% vs. 55% vs. 43% |
|
Checkmate-067
Phase III [14] | 945 | NIVO 3 mg/kg or NIVO 1mg/kg + IPI 3 mg/kg every 3 weeks for 4 doses followed by NIVO 3 mg/kg every 2 weeks or IPI 3 mg/kg every 3 weeks for 4 doses | PFS | NIVO, 37.6 mos. (29.1 to not reached); NIVO + IPI not reached; IPI 19.9 mos. (16.9-24.6) | NIVO, 6.9 mos. (5.1-9.7); NIVO+IPI, 11.5 mos. (8.7-19.3); IPI, 2.9 mos. (2.8-3.2) | NIVO, NIVO+IPI, IPI:
3 yrs.: 52% vs. 58% vs. 34%
4 yrs.: 46% vs 53% vs 30% |
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