This trial will find out whether brentuximab vedotin and pembrolizumab work together to treat different types of cancer. There will be several different types of cancer studied in the trial. The cancer must have spread to other parts of the body (metastatic). The study will also find out what side effects occur. A side effect is anything the treatment does besides treat cancer. This is a multi-cohort study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
161
1.8 mg/kg given into the vein (IV; intravenously) every 3 weeks
200 mg given intravenously every 3 weeks
Confirmed 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Up to approximately 3 years
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Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States
Highlands Oncology Group, PA
Fayetteville, Arkansas, United States
Highlands Oncology Group, PA
Rogers, Arkansas, United States
Highlands Oncology Group, PA
Springdale, Arkansas, United States
California Cancer Associates for Research and Excellence, Inc (cCARE)
Encinitas, California, United States
California Cancer Associates for Research and Excellence, Inc. cCARE
Fresno, California, United States
The Angeles Clinic And Research Institute, A Cedars-Sinai Affiliate
Los Angeles, California, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute (SOCCI)
Los Angeles, California, United States
...and 78 more locations
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.
Time frame: 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.
Time frame: Up to approximately 2 years