Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors
- Conditions
- Non-small Cell Lung CancerMelanomaSquamous Cell Carcinoma of the Head and Neck
- Interventions
- Registration Number
- NCT04609566
- Lead Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 141
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Combination Therapy brentuximab vedotin brentuximab vedotin + pembrolizumab Combination Therapy pembrolizumab brentuximab vedotin + pembrolizumab
- Primary Outcome Measures
Name Time Method Confirmed objective response rate (ORR) based on investigator assessment using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria Up to approximately 2 years 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.
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) based on investigator assessment using RECIST v1.1 criteria Up to approximately 3 years 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.
ORR per iRECIST by investigator assessment Up to approximately 2 years ORR per iRECIST is defined as the proportion of participants with confirmed CR or PR based on iRECIST guidelines
Duration of response (DOR) based on investigator assessment using RECIST v1.1 criteria Up to approximately 3 years 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.
iDOR per iRECIST by investigator assessment Up to approximately 3 years 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.
iPFS per iRECIST by investigator assessment Up to approximately 3 years 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.
Incidence of adverse events (AEs) Up to approximately 2 years National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Analyses of AEs will be summarized with descriptive statistics.
Trial Locations
- Locations (34)
California Cancer Associates for Research and Excellence Inc (cCARE)
🇺🇸San Marcos, California, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Toledo Clinic Cancer Center
🇺🇸Toledo, Ohio, United States
University of Ottawa / Ottawa General Hospital
🇨🇦Ottawa, Ontario, Canada
Arizona Oncology Associates, PC - HOPE
🇺🇸Tucson, Arizona, United States
cCARE - Northern
🇺🇸Fresno, California, United States
Affiliated Oncologists, LLC
🇺🇸Chicago Ridge, Illinois, United States
University of Kansas Cancer Center
🇺🇸Kansas City, Kansas, United States
Willamette Valley Cancer Institute and Research Center
🇺🇸Eugene, Oregon, United States
Texas Oncology - Austin Central
🇺🇸Austin, Texas, United States
Texas Oncology - Baylor Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Oncology Consultants, PA
🇺🇸Houston, Texas, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
Virginia Commonwealth University Medical Center
🇺🇸Richmond, Virginia, United States
McGill University Department of Oncology / McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Highlands Oncology Group
🇺🇸Springdale, Arkansas, United States
The Angeles Clinic and Research Institute
🇺🇸Los Angeles, California, United States
University of Colorado Hospital / University of Colorado
🇺🇸Aurora, Colorado, United States
Rocky Mountain Cancer Centers - Aurora
🇺🇸Denver, Colorado, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Oncology Hematology Care
🇺🇸Cincinnati, Ohio, United States
Texas Oncology - Fort Worth 12th Avenue
🇺🇸Fort Worth, Texas, United States
Inova Schar Cancer Institute
🇺🇸Fairfax, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia
🇺🇸Roanoke, Virginia, United States
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute
🇺🇸Los Angeles, California, United States
Memorial Healthcare System
🇺🇸Pembroke Pines, Florida, United States
Minnesota Oncology Hematology P.A.
🇺🇸Minneapolis, Minnesota, United States
New York Oncology Hematology, P.C.
🇺🇸Clifton Park, New York, United States
Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
🇺🇸Seattle, Washington, United States