A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301)

Conditions

Advanced (unresectable or metastatic) melanoma

Brief summary

PFS as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Detailed description

Overall survival, Objective response rate (ORR) as assessed by BICR according to RECIST 1.1, Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and changes from baseline in laboratory parameters, vital signs, and electrocardiograms (ECGs), Dose interruptions and reductions, and dose discontinuation, Brenetafusp PK parameters, Incidence of anti-brenetafusp antibodies, including neutralizing antibodies, Cluster of differentiation, CD3 and CD163 positive immune cells within the tumor, Change from baseline over time and between treatments for Global Health Status, Social Functioning, Cognitive Functioning, Emotional Functioning, Role Functioning and Physical Functioning

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGNIVOLUMAB

DRUGBrenetafusp

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1	—

Secondary

Measure	Time frame
Overall survival, Objective response rate (ORR) as assessed by BICR according to RECIST 1.1, Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and changes from baseline in laboratory parameters, vital signs, and electrocardiograms (ECGs), Dose interruptions and reductions, and dose discontinuation, Brenetafusp PK parameters, Incidence of anti-brenetafusp antibodies, including neutralizing antibodies, Cluster of differentiation, CD3 and CD163 positive immune cells within the tumor, Change from baseline over time and between treatments for Global Health Status, Social Functioning, Cognitive Functioning, Emotional Functioning, Role Functioning and Physical Functioning	—

Measure

Time frame

Overall survival, Objective response rate (ORR) as assessed by BICR according to RECIST 1.1, Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and changes from baseline in laboratory parameters, vital signs, and electrocardiograms (ECGs), Dose interruptions and reductions, and dose discontinuation, Brenetafusp PK parameters, Incidence of anti-brenetafusp antibodies, including neutralizing antibodies, Cluster of differentiation, CD3 and CD163 positive immune cells within the tumor, Change from baseline over time and between treatments for Global Health Status, Social Functioning, Cognitive Functioning, Emotional Functioning, Role Functioning and Physical Functioning

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Countries

Austria, Belgium, Bulgaria, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Lithuania, Norway, Poland, Portugal, Romania, Spain, Sweden

Outcome results

None listed