Giving Upfront Anti-p40 to Reduce toxicity from Dual Immune Checkpoint Inhibition in MESOthelioma

Conditions

Pleural mesothelioma

Brief summary

The primary endpoint of the study is the incidence of severe (grade ≥3) irAEs occurring within 24 weeks after initiation of dual ICB, graded according to CTCAE version 5.0

Detailed description

The incidence of grade ≥2 irAEs within 24 weeks after initiation of dual ICB therapy, graded according to CTCAE version 5.0., Time from initiation of dual ICB to first occurrence of grade ≥3 irAE., Objective response rate on chest CT scan assessed by mRECIST v1.1., Duration of response from initiation of dual ICB until progression or death whichever occurs first., Median progression free survival (PFS) from initiation of dual ICB until progression or death whichever occurs first, The incidence of severe (grade ≥3) irAEs from 24 and 48 weeks after initiation of dual ICB therapy, graded according to CTCAE version 5., T-cell population dynamics after initiation of dual ICB, Serum proteome level dynamics after initiation of dual ICB, cfDNA level dynamics after initiation of dual ICB and at time of irAE occurrence

Related papers

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Interventions

DRUGSTELARA 90 mg solution for injection in pre-filled pen

DRUGSTELARA 130 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is the incidence of severe (grade ≥3) irAEs occurring within 24 weeks after initiation of dual ICB, graded according to CTCAE version 5.0	—

Secondary

Measure	Time frame
The incidence of grade ≥2 irAEs within 24 weeks after initiation of dual ICB therapy, graded according to CTCAE version 5.0., Time from initiation of dual ICB to first occurrence of grade ≥3 irAE., Objective response rate on chest CT scan assessed by mRECIST v1.1., Duration of response from initiation of dual ICB until progression or death whichever occurs first., Median progression free survival (PFS) from initiation of dual ICB until progression or death whichever occurs first, The incidence of severe (grade ≥3) irAEs from 24 and 48 weeks after initiation of dual ICB therapy, graded according to CTCAE version 5., T-cell population dynamics after initiation of dual ICB, Serum proteome level dynamics after initiation of dual ICB, cfDNA level dynamics after initiation of dual ICB and at time of irAE occurrence	—

Measure

Time frame

The incidence of grade ≥2 irAEs within 24 weeks after initiation of dual ICB therapy, graded according to CTCAE version 5.0., Time from initiation of dual ICB to first occurrence of grade ≥3 irAE., Objective response rate on chest CT scan assessed by mRECIST v1.1., Duration of response from initiation of dual ICB until progression or death whichever occurs first., Median progression free survival (PFS) from initiation of dual ICB until progression or death whichever occurs first, The incidence of severe (grade ≥3) irAEs from 24 and 48 weeks after initiation of dual ICB therapy, graded according to CTCAE version 5., T-cell population dynamics after initiation of dual ICB, Serum proteome level dynamics after initiation of dual ICB, cfDNA level dynamics after initiation of dual ICB and at time of irAE occurrence

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Outcome results

None listed