Skip to main content

Advertisement

Table 3 Clinical studies that supported approval of the combination

From: Combination of CTLA-4 and PD-1 blockers for treatment of cancer

Patients Trial, ID Follow-up Outcomes Reference
Advanced melanoma Phase 1
NCT01024231
≥24 weeks ORR, 53%
Grade 3-4 AEs, 53%
Wolchok et al 2013
Previously untreated advanced melanoma Phase 1
NCT01927419
≥11 months In patients with BRAF-WT tumors
ORR 61%
Median PFS, not reached
HR for disease progression or death, 0.40
Grade 3-4 AEs, 54%
Postow et al 2015
Previously untreated advanced melanoma Phase 3
NCT01844505
> 12 months Median PFS, 11.5 months
HR for death or disease progression, 0.42
Investigator assessed ORR, 57%
Grade 3-4 AEs, 55%
Larkin et al 2015
Previously untreated advanced melanoma Phase 3
NCT01844505
≥ 36 months Median OS, not reached
3-year OS rate, 58%
HR for death, 0.55
Grade 3-4 AEs, 59%
Wolchok et al 2017
Previously untreated advanced melanoma Phase 3
NCT01844505
≥ 48 months Median OS, not reached
4-year OS rate, 54%
ORR, 58%
HR for death, 0.54
HR for progression-free survival, 0.42
Grade 3-4 AEs, 59%
Hodi et al 2018
Advanced melanoma patients with at least one brain metastasis Phase 2
NCT02320058
≥ 6 months Rate of intracranial clinical benefit, 57%; Rate of extracranial clinical benefit, 56%
9-month PFS (global) rate, 57%; 9-month OS rate, 83
12-month OS rate, 82%
Grade 3-4 AEs, 55%
Tawbi et al 2018
Advanced melanoma Phase 2
NCT01783938
≥ 15 months ORR, 56%
Median OS, not reached
1-year OS rate, 76%
Grade 3-5 AEs, 50%
Weber et al 2018
Previously untreated advanced clear cell renal cell carcinoma Phase 3
NCT02231749
> 17 months ORR, 42%
Median OS, not reached
HR for death, 0.63
Median PFS, 11.6 months
HR for disease progression, 0.82
Motzer et al 2018
Previously treated, MMR/MSI-H positive advanced colorectal cancer Phase 2
NCT02060188
> 9 months ORR, 55%
Median PFS, not reached
12-month PFS rate, 71%
Median OS, not reached
12-month OS rate, 85%
Grade 3-4 AEs, 32%
Overman et al 2018