A Randomized, Phase 2/3, Open-Label Study to Investigate the Efficacy and Safety of RP2 in Combination with Nivolumab versus Ipilimumab in Combination with Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients with Metastatic Uveal Melanoma

Conditions

metastatic uveal melanoma

Brief summary

OS, defined as the time from randomization to death from any cause, PFS, defined as the time from randomization to first evidence of disease progression (which is subsequently confirmed) as assessed by BICR per RECIST 1.1 or death from any cause

Detailed description

ORR, defined as the proportion of patients with a confirmed best overall response of CR or PR, as assessed by BICR per RECIST 1.1, DOR, defined as the time from onset of response to disease progression (which is subsequently confirmed) or death in patients who achieve either a CR or PR, as assessed by BICR per RECIST 1.1, DCR, defined as the proportion of patients with a confirmed best overall response of CR, PR, or Stable Disease (SD), as assessed by BICR per RECIST 1.1, CBR, defined as the percentage of patients who achieve a best confirmed response of CR, PR, or SD for at least 24 weeks, as assessed by BICR per RECIST 1.1, DOCB, defined as the time from randomization to disease progression or death due to any cause (whichever occurs first) in patients who achieve a best confirmed response of CR, PR, or SD for at least 24 weeks, as assessed by BICR per RECIST 1.1, Incidence of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs) in each study arm, Incidence of imAEs in each study arm

Related papers

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Interventions

DRUGYERVOY 5 mg/ml concentrate for solution for infusion

DRUGRP2

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
OS, defined as the time from randomization to death from any cause, PFS, defined as the time from randomization to first evidence of disease progression (which is subsequently confirmed) as assessed by BICR per RECIST 1.1 or death from any cause	—

Secondary

Measure	Time frame
ORR, defined as the proportion of patients with a confirmed best overall response of CR or PR, as assessed by BICR per RECIST 1.1, DOR, defined as the time from onset of response to disease progression (which is subsequently confirmed) or death in patients who achieve either a CR or PR, as assessed by BICR per RECIST 1.1, DCR, defined as the proportion of patients with a confirmed best overall response of CR, PR, or Stable Disease (SD), as assessed by BICR per RECIST 1.1, CBR, defined as the percentage of patients who achieve a best confirmed response of CR, PR, or SD for at least 24 weeks, as assessed by BICR per RECIST 1.1, DOCB, defined as the time from randomization to disease progression or death due to any cause (whichever occurs first) in patients who achieve a best confirmed response of CR, PR, or SD for at least 24 weeks, as assessed by BICR per RECIST 1.1, Incidence of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs) in each study arm, Inciden	—

Measure

Time frame

ORR, defined as the proportion of patients with a confirmed best overall response of CR or PR, as assessed by BICR per RECIST 1.1, DOR, defined as the time from onset of response to disease progression (which is subsequently confirmed) or death in patients who achieve either a CR or PR, as assessed by BICR per RECIST 1.1, DCR, defined as the proportion of patients with a confirmed best overall response of CR, PR, or Stable Disease (SD), as assessed by BICR per RECIST 1.1, CBR, defined as the percentage of patients who achieve a best confirmed response of CR, PR, or SD for at least 24 weeks, as assessed by BICR per RECIST 1.1, DOCB, defined as the time from randomization to disease progression or death due to any cause (whichever occurs first) in patients who achieve a best confirmed response of CR, PR, or SD for at least 24 weeks, as assessed by BICR per RECIST 1.1, Incidence of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs) in each study arm, Inciden

—

Countries

France, Germany, Italy, Poland, Spain

Outcome results

None listed