Table 1

Monotherapy and combination studies of nivolumab in NSCLC and melanoma included in DOR analyses

Study #/populationStudy objectiveStudy design and treatment regimenORR per RECISTMedian OS, months HR (CI)
NSCLC
 CheckMate 012/chemo-naive recurrent stage IIIb or stage IV NSCLC34To assess safety and tolerabilityPhase I, randomized (1:1:1), open-label, multiple-cohort study of NIVO as monotherapy or in combination with IPI
NIVO (3 mg/kg Q2W) +IPI (1 mg/kg Q12W) cohort 1 (n=38)
NIVO (3 mg/kg Q2W) +IPI (1 mg/kg Q6W) cohort 2 (n=39)
47% (cohort 1)
38% (cohort 2)
Not available
 CheckMate 017/previously treated advanced or metastatic SQ NSCLC after one prior platinum doublet-based chemo regimen39To compare OS of NIVO with docetaxelPhase III, randomized (1:1), open-label study of NIVO (n=135) vs docetaxel (n=137)
NIVO: 3 mg/kg IV Q2W
Docetaxel: 75 mg/m2 Q3W
20% vs 9%9.2 v 6.0 HR=0.59 (95% CI 0.44 to 0.79)
 CheckMate 026/chemo-naive stage IV or recurrent PD-L1-expressing NSCLC32To compare PFS (BICR) of NIVO with IC chemo in patients with ≥5% PD-L1+ tumor expressionPhase III, open-label, randomized study of NIVO (n=271) vs IC chemo (n=270)
NIVO: 3 mg/kg IV Q2W
IC chemo: gemcitabine with cisplatin or carboplatin; paclitaxel with carboplatin; pemetrexed with cisplatin or carboplatin Q3W
26% vs 33%14.4 vs 13.2
HR=1.02 (95% CI 0.80 to 1.30)
 CheckMate 057/previously treated advanced or metastatic NSQ NSCLC after one prior platinum doublet-based chemo regimen4To compare OS of NIVO with docetaxelPhase III, randomized (1:1), open-label study of NIVO (n=292) vs docetaxel (n=290)
NIVO: 3 mg/kg IV Q2W
Docetaxel: 75 mg/m2 Q3W
19% vs 12%12.2 vs 9.4
HR=0.73 (96% CI 0.59 to 0.89)
 CheckMate 063/advanced, refractory SQ NSCLC after platinum doublet-based chemo and at least one additional systemic therapy33To assess ORR (BICR) of NIVOSingle-arm, phase II study of NIVO monotherapy (n=117)
NIVO: 3 mg/kg IV Q2W
15%8.2
Melanoma
 CheckMate 037/advanced melanoma s/p anti-CTLA-4 therapy, and if BRAF V600 mutation +s/p BRAF inhibitor37To estimate ORR in the NIVO group and compare OS of NIVO with ICPhase III, randomized (2:1), open-label study of NIVO (n=272) vs IC chemo (n=133)
NIVO: 3 mg/kg IV Q2W
IC: dacarbazine 1000 mg/m2 IV Q3W or carboplatin (AUC 6) IV and paclitaxel 175 mg/m2 Q3W
26.5% vs 9.0%15.74 vs 14.39 HR=0.95
(95.54% CI 0.73 to 1.24)
 CheckMate 066/previously untreated, BRAF WT unresectable or metastatic melanoma36To compare the OS of NIVO with dacarbazinePhase III, randomized (1:1), double-blind study of NIVO (n=210) vs dacarbazine (n=208)
NIVO: 3 mg/kg IV Q2W
Dacarbazine: 1000 mg/m2 Q3W
40.0% vs 13.9%NR vs 10.8
HR=0.42 (99.79% CI 0.25 to 0.73)
 CheckMate 067/previously untreated, unresectable, or metastatic melanoma35To compare PFS and OS of NIVO monotherapy with IPI monotherapy, NIVO+IPI to IPI monotherapyPhase III, randomized (1:1:1), double-blind study of NIVO (n=316) or NIVO+IPI (n=314) vs IPI (n=315)
NIVO: 3 mg/kg IV Q2W
NIVO+IPI: NIVO 1 mg/kg+IPI 3 mg/kg Q3W for four doses then NIVO 3 mg/kg Q2W
IPI: 3 mg/kg Q3W for four doses
PD-L1 positive vs negative
57.5% vs 41.3% (NIVO)
72.1% vs 54.8% (NIVO+IPI)
21.3% vs 17.8% (IPI)
NR vs 19.98
(NIVO mono vs IPI mono) –
HR=0.63 (98% CI 0.48 to 0.81)
 CheckMate 069/previously untreated, unresectable, or metastatic melanoma32To compare ORR, as determined by investigators, of NIVO+IPI with IPI monotherapyPhase II, randomized (2:1), double-blind study of NIVO+IPI (n=95) vs IPI (n=47)
NIVO+IPI: NIVO 1 mg/kg+IPI 3 mg/kg Q3W for four doses; then NIVO 3 mg/kg Q2W
IPI: 3 mg/kg Q3W for four doses
61.1% vs 10.8% among BRAF WT patientsNR vs NR
HR=0.73
(95% CI 0.39 to 1.36)
SCCHN
 CheckMate 141/recurrent or metastatic platinum-refractory SCCHN41To compare OS of NIVO monotherapy with ICPhase III, randomized (2:1), open-label study of NIVO (n=240) vs IC (n=121)
NIVO: 3 mg/kg IV Q2W
IC: cetuximab, methotrexate, or docetaxel
13.3% vs 5.8%7.5 vs 5.1
HR=0.70
(97.73% CI 0.51 to 0.96)
RCC
 CheckMate 025/advanced or metastatic clear-cell RCC previously treated with 1–2 regimens of antiangiogenic therapy40To compare OS of NIVO monotherapy with everolimusPhase III, randomized (1:1), open-label study of NIVO (n=410) vs everolimus (n=411)
NIVO: 3 mg/kg IV Q2W
Everolimus: 10 mg PO daily
25% vs 5%25.0 vs 19.6
HR=0.73 (98.5% CI 0.57 to 0.93)
 CheckMate 214/previously untreated, advanced, or metastatic RCC42To compare OS, PFS, and ORR of NIVO+IPI with sunitinibPhase III, randomized (1:1) study of NIVO+IPI (n=550) vs sunitinib (n=546)
NIVO+IPI: NIVO 3 mg/kg+IPI 1 mg/kg IV Q3W for four doses; then NIVO 3 mg/kg Q2W
Sunitinib: 50 mg PO daily for 4 weeks, then 2 weeks off
39% vs 32%NR vs 32.9
HR=0.68 (99.8% CI 0.49 to 0.95)
  • AUC, area under the curve; BICR, blinded independent central review; chemo, chemotherapy; CTLA-4, cytotoxic T lymphocyte antigen-4; DOR, duration of response; IC, investigator’s choice; IPI, ipilimumab; IV, intravenous; MONO, monotherapy; NIVO, nivolumab; NR, not reached; NSCLC, non-small-cell lung cancer; NSQ, non-squamous; ORR, objective response rate; OS, overall survival; PD-L1, programmed death ligand 1; PFS, progression-free survival; PO, take by mouth; QXW, every X weeks; RCC, renal cell carcinoma; RECIST, Response Evaluation Criteria in Solid Tumors; SCCHN, squamous cell carcinoma of the head and neck; s/p, status post; SQ, squamous; WT, wild type.