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The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
Active enrolling
United States, Canada
EXPERIMENTAL: Combination Therapy
brentuximab vedotin + pembrolizumab
DRUG: brentuximab vedotin
1.8 mg/kg given into the vein (IV; intravenously) every 3 weeksDRUG: pembrolizumab
200 mg given intravenously every 3 weeksConfirmed objective response rate (ORR) based on investigator assessment using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria
Confirmed ORR per RECIST v1.1 is defined as the proportion of participants whose best overall response is a confirmed complete response (CR) or partial response (PR) per RECIST v1.1.
Up to approximately 2 years
Duration of response (DOR) based on investigator assessment using RECIST v1.1 criteria
DOR per RECIST v1.1 is defined as the time from start of the first documentation of confirmed objective tumor response (CR or PR) per RECIST v1.1 to the first documentation of PD (per RECIST v1.1) or to death due to any cause, whichever comes first.
Up to approximately 3 years
Progression-free survival (PFS) based on investigator assessment using RECIST v1.1 criteria
PFS is defined as the time from start of study treatment to first documentation of objective tumor progression (PD per RECIST v1.1), or to death due to any cause, whichever comes first.
Up to approximately 3 years
ORR per iRECIST by investigator assessment
ORR per iRECIST is defined as the proportion of participants with confirmed CR or PR based on iRECIST guidelines
Up to approximately 2 years
iDOR per iRECIST by investigator assessment
DOR per iRECIST is defined as the time from first documentation of confirmed objective response (CR or PR) based on iRECIST guidelines by investigator assessment to the first documentation of confirmed objective tumor progression per iRECIST by investigator assessment, or to death due to any cause, whichever comes first.
Up to approximately 3 years
iPFS per iRECIST by investigator assessment
iPFS is defined as the time from start of study treatment to the first documentation of confirmed objective tumor progression per iRECIST by investigator assessment, treatment discontinuation following the unconfirmed progression or death due to any cause, whichever comes first.
Up to approximately 3 years
Incidence of adverse events (AEs)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Analyses of AEs will be summarized with descriptive statistics.
Up to approximately 2 years
140
Sponsor: Seagen Inc.
Collaborator: Merck Sharp & Dohme LLC
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number: