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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