Safety Study of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors

Brief summary (registry, in English)

Part A+B+A1:to assess safety,tolerability,DLTs,MTD of BMS986016 alone &in combo with nivo (advanced solid tumors); to gather preliminary efficacy information of BMS986016 alone Part C:to further establish safety & tolerability of BMS986016 + nivo administered sequentially; to investigate the preliminary efficacy of BMS986016 in combo with nivo as measured by ORR, DCR,DOR (multiple tumor types) Part D: to assess safety & tolerability of more convenient dosing regimen;Part D1-Q2W: to demonstrate preliminary clinical evidence of the treatment effect,measured by ORR,as determined by BICR using RECIST v1.1 (advanced melanoma);Part D1-Q4W: to confirm with Q4W dosing of BMS986016 160 mg in combo with nivo480 mg,the safety&efficacy of the Q2W dosing of BMS986016 80 mg in combo with nivo 240mg (advanced melanoma) Part E: to demonstrate that 480 mg BMS986016 +480 mg nivo Q4W provides significantly greater clin benefit (increased ORR) vs 160mg BMS 986016+480 mg nivoQ4W dose (melanoma)

What you commit to

• Study type: Interventional · Phase 1/2
• Participants enrolled: 1003
• 19 sites in 9 countries
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (19)

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