Nivolumab immune checkpoint inhibition

Opdivo - BMS-936558 - ONO-4538 - MDX-1106

Gastric or gastro-oesophageal junction cancer (advanced)

All type of patients:  1 trials  - ATTRACTION-2

nivolumab vs placebo

No demonstrated result

suggested death (overall survival) by 37% (not demonstrated)

Head and neck cancer

All type of patients:  2 trials  - Checkmate-141 - Checkmate-651

nivolumab vs standard treatment

death (overall survival) by 30% (fully demonstrated)

nivolumab + ipilumab vs standard treatment

No demonstrated result

Lung cancer (metastatic)

All type of patients:  9 trials  - CheckMate 057 - CheckMate 153 - CheckMate 026 - CheckMate 017 - Checkmate 032 - CheckMate 078 - CheckMate 227 (High Tumor Mutational Burden) - CheckMate 227 (nivolumab alone) - CheckMate 227 (nivolumab + CT)

nivolumab vs docetaxel

No demonstrated result

suggested objective response (ORR) by 128% (not demonstrated)

suggested Grade 3–5 drug-related AEs by 83% (not demonstrated)

suggested death (overall survival) by 32% (not demonstrated)

suggested progression or death (progression free survival PFS) by 18% (not demonstrated)

nivolumab vs platinum-based CT

No demonstrated result

nivolumab + CT vs platinum-based CT

No demonstrated result

suggested progression or death (progression free survival PFS) by 26% (not demonstrated)

nivolumab + ipilimumab vs nivolumab

No demonstrated result

nivolumab + ipilimumab vs platinum-based CT

No demonstrated result

suggested progression or death (progression free survival PFS) by 42% (not demonstrated)

nivolumab for 1 year vs nivolumab

No demonstrated result

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First line:  4 trials  - CheckMate 026 - CheckMate 227 (High Tumor Mutational Burden) - CheckMate 227 (nivolumab alone) - CheckMate 227 (nivolumab + CT)

nivolumab vs platinum-based CT

No demonstrated result

nivolumab + CT vs platinum-based CT

No demonstrated result

suggested progression or death (progression free survival PFS) by 26% (not demonstrated)

nivolumab + ipilimumab vs platinum-based CT

No demonstrated result

suggested progression or death (progression free survival PFS) by 42% (not demonstrated)

Second line :  8 trials  - CheckMate 057 - CheckMate 153 - CheckMate 017 - Checkmate 032 - CheckMate 078 - CheckMate 451 - CheckMate 331 - CheckMate 722

nivolumab vs CT

No demonstrated result

nivolumab vs docetaxel

No demonstrated result

suggested objective response (ORR) by 128% (not demonstrated)

suggested Grade 3–5 drug-related AEs by 83% (not demonstrated)

suggested death (overall survival) by 32% (not demonstrated)

suggested progression or death (progression free survival PFS) by 18% (not demonstrated)

nivolumab vs placebo

No demonstrated result

nivolumab + ipilimumab vs nivolumab

No demonstrated result

nivolumab + ipilimumab vs platinum-based CT

No demonstrated result

nivolumab for 1 year vs nivolumab

No demonstrated result

Melanoma

Adjuvant 1 - NOVARTIS:  1 trials  - CheckMate 238

nivolumab vs ipilimumab

recurrence free survival by 35% (fully demonstrated)

suggested Grade 3–5 drug-related AEs by 69% (not demonstrated)

suggested progression or death (progression free survival PFS) by 35% (not demonstrated)

suggested Adverse events leading to treatment discontinuation by 77% (not demonstrated)

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Adjuvant setting:  1 trials  - CheckMate 238

nivolumab vs ipilimumab

recurrence free survival by 35% (fully demonstrated)

suggested Grade 3–5 drug-related AEs by 69% (not demonstrated)

suggested progression or death (progression free survival PFS) by 35% (not demonstrated)

suggested Adverse events leading to treatment discontinuation by 77% (not demonstrated)

Adjuvant stage III only - NOVARTIS :  1 trials  - CheckMate 238 subgroup IIIB-C

nivolumab vs ipilimumab

No demonstrated result

suggested recurrence free survival by 35% (not demonstrated)

suggested distant metastasis free survival by 27% (not demonstrated)

suggested progression or death (progression free survival PFS) by 35% (not demonstrated)

All type of patients:  7 trials  - CheckMate 067 (nivo + ipi vs ipi) - CheckMate 066 (Robert) - CheckMate 037 (Weber) - CheckMate 238 - Postow - CheckMate 067 (nivo vs ipi) - CheckMate 067 (nivo + ipi vs nivo)

nivolumab vs chemotherapy

No demonstrated result

suggested objective response (ORR) by 272% (not demonstrated)

suggested Grade 3–5 drug-related AEs by 71% (not demonstrated)

nivolumab vs dacarbazine

death (overall survival) by 58% (fully demonstrated)

vitiligo any grade by 2089% (harmful effect)

suggested progression or death (progression free survival PFS) by 57% (not demonstrated)

nivolumab vs ipilimumab

recurrence free survival by 35% (fully demonstrated)

progression or death (progression free survival PFS) by 39% (fully demonstrated)

suggested Grade 3–5 drug-related AEs by 59% (not demonstrated)

suggested Adverse events leading to treatment discontinuation by 70% (not demonstrated)

nivolumab + ipilimumab vs ipilimumab

progression or death (progression free survival PFS) by 58% (fully demonstrated)

Adverse events leading to treatment discontinuation by 146% (harmful effect)

suggested Grade 3–5 drug-related AEs by 101% (not demonstrated)

nivolumab + ipilimumab vs nivolumab

No demonstrated result

First line :  4 trials  - CheckMate 067 (nivo + ipi vs ipi) - CheckMate 066 (Robert) - CheckMate 067 (nivo vs ipi) - CheckMate 067 (nivo + ipi vs nivo)

nivolumab vs dacarbazine

death (overall survival) by 58% (fully demonstrated)

vitiligo any grade by 2089% (harmful effect)

suggested progression or death (progression free survival PFS) by 57% (not demonstrated)

nivolumab vs ipilimumab

progression or death (progression free survival PFS) by 43% (fully demonstrated)

suggested Grade 3–5 drug-related AEs by 40% (not demonstrated)

suggested Adverse events leading to treatment discontinuation by 48% (not demonstrated)

nivolumab + ipilimumab vs ipilimumab

progression or death (progression free survival PFS) by 58% (fully demonstrated)

Adverse events leading to treatment discontinuation by 146% (harmful effect)

suggested Grade 3–5 drug-related AEs by 101% (not demonstrated)

nivolumab + ipilimumab vs nivolumab

No demonstrated result

Second line (or later):  1 trials  - CheckMate 037 (Weber)

nivolumab vs chemotherapy

No demonstrated result

suggested objective response (ORR) by 272% (not demonstrated)

suggested Grade 3–5 drug-related AEs by 71% (not demonstrated)

Multiple myeloma

All type of patients:  1 trials  - CheckMate 602

Nivolumab, Elotuzumab, Pomalidomide, dexaM vs

No demonstrated result

Renal-cell carcinoma (advanced)

All type of patients:  2 trials  - Chekmate 025 (Motzer) - CheckMate-214

nivolumab vs everolimus

No demonstrated result

suggested death (overall survival) by 27% (not demonstrated)

nivolumab + ipilimumab vs sunitinib

death (overall survival) by 32% (fully demonstrated)

Urothelial carcinoma (advanced)

All type of patients:  4 trials  - CheckMate 274 - Checkmate 275 - CHECKMATE 901A - CHECKMATE 274A

nivolumab vs nil

No demonstrated result

nivolumab vs placebo

No demonstrated result

nivolumab + CT vs chemotherapy

No demonstrated result