Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors
A Phase 2 Study of Brentuximab Vedotin in Combination With Pembrolizumab in Participants With Metastatic Solid Malignancies
2 other identifiers
interventional
161
1 country
93
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2021
Longer than P75 for phase_2
93 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2020
CompletedFirst Posted
Study publicly available on registry
October 30, 2020
CompletedStudy Start
First participant enrolled
January 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 3, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 3, 2026
CompletedMarch 16, 2026
March 1, 2026
5 years
October 23, 2020
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Up to approximately 2 years
Secondary Outcomes (6)
Duration of response (DOR) based on investigator assessment using RECIST v1.1 criteria
Up to approximately 3 years
Progression-free survival (PFS) based on investigator assessment using RECIST v1.1 criteria
Up to approximately 3 years
ORR per iRECIST by investigator assessment
Up to approximately 2 years
iDOR per iRECIST by investigator assessment
Up to approximately 3 years
iPFS per iRECIST by investigator assessment
Up to approximately 3 years
- +1 more secondary outcomes
Study Arms (1)
Combination Therapy
EXPERIMENTALbrentuximab vedotin + pembrolizumab
Interventions
1.8 mg/kg given into the vein (IV; intravenously) every 3 weeks
200 mg given intravenously every 3 weeks
Eligibility Criteria
You may qualify if:
- Participants must have
- Metastatic squamous or nonsquamous non-small cell lung cancer (NSCLC) (without known targetable EGFR, ALK, ROS1, or BRAF mutations) who either
- a) have not yet received frontline therapy for metastatic disease and without prior exposure to anti PD-1/PD-L1 or
- b) are relapsed/refractory with progression on anti PD-1/PD therapy.
- Relapsed/refractory metastatic cutaneous melanoma (regardless of mutation status) with progression on a PD-1 inhibitor
- Metastatic head and neck squamous cell carcinoma (HNSCC) who have not yet received frontline therapy for metastatic disease and without prior exposure to a PD-1/PD-L1 inhibitor.
- Cohorts 1-4 only: Melanoma participants must be currently on PD-1 checkpoint inhibitor (CPI) therapy (e.g. nivolumab or pembrolizumab) or had their last dose of PD-1 CPI containing therapy as the last previous line of therapy within 90 days prior to enrollment; PD-1 CPI therapy must be the immediate prior line of treatment.
- Cohorts 1-4 only: Participants must have progressed on treatment with an anti-PD-1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other CPIs or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria.
- Have received at least 2 doses of an approved PD-1 inhibitor.
- Have demonstrated disease progression (PD) after a PD-1 inhibitor as defined by RECIST v1.1.
- Progressive disease has been documented within 90 days from the last dose of PD-1 inhibitor.
- Participants with melanoma will need iRECIST confirmation of progression with a second assessment at least four weeks after the initial date of progressive disease
- NSCLC participants on PD-1 inhibitor containing therapy for less than 90 days will need iRECIST confirmation of progression at least 4 weeks after the initial date of progressive disease
- Tumor tissue sample obtained within 3 months prior to enrollment is required, and no systemic anticancer therapy given after the sample was obtained.
- An Eastern Cooperative Oncology Group (ECOG) Performance Status score of equal or less than 1
You may not qualify if:
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Prior immunosuppressive chemotherapy, any immunotherapy other than a PD-1 inhibitor within 4 weeks of first study drug dose.
- History of another malignancy within 3 years before the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (93)
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, 85704, United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, 85711, United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, 85745, United States
Highlands Oncology Group, PA
Fayetteville, Arkansas, 72703, United States
Highlands Oncology Group, PA
Rogers, Arkansas, 72758, United States
Highlands Oncology Group, PA
Springdale, Arkansas, 72762, United States
California Cancer Associates for Research and Excellence, Inc (cCARE)
Encinitas, California, 92024, United States
California Cancer Associates for Research and Excellence, Inc. cCARE
Fresno, California, 93720, United States
The Angeles Clinic And Research Institute, A Cedars-Sinai Affiliate
Los Angeles, California, 90025, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute (SOCCI)
Los Angeles, California, 90048, United States
California Cancer Associates for Research and Excellence Inc (cCARE)
San Marcos, California, 92069, United States
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate (Emergency Back-Up Only)
Santa Monica, California, 90404, United States
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, 80012, United States
Clinical and Translational Research Center (CTRC)
Aurora, Colorado, 80045, United States
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
Aurora, Colorado, 80045, United States
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
Aurora, Colorado, 80045, United States
University of Colorado Hospital-Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, 80045, United States
Rocky Mountain Cancer Centers, LLP
Boulder, Colorado, 80303, United States
Rocky Mountain Cancer Centers, LLP
Colorado Springs, Colorado, 80907, United States
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, 80220, United States
Rocky Mountain Cancer Centers, LLP
Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers, LLP
Littleton, Colorado, 80120, United States
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, 80124, United States
Rocky Mountain Cancer Centers, LLP
Longmont, Colorado, 80504, United States
Rocky Mountain Cancer Centers, LLP
Pueblo, Colorado, 81003, United States
Rocky Mountain Cancer Centers, LLP
Thornton, Colorado, 80260, United States
Northwestern Medical Group
Chicago, Illinois, 60611, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
The University of Kansas Cancer Center, Investigational Drug Services
Westwood, Kansas, 66205, United States
The University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
Norton Cancer Institute Downtown
Louisville, Kentucky, 40202, United States
Norton Hospital
Louisville, Kentucky, 40202, United States
Norton Audubon Hospital
Louisville, Kentucky, 40217, United States
Norton Cancer Institute, Audubon Hospital Campus
Louisville, Kentucky, 40217, United States
Norton Brownsboro Hospital
Louisville, Kentucky, 40241, United States
Norton Cancer Institute, Brownsboro Hospital Campus
Louisville, Kentucky, 40241, United States
Minnesota Oncology Hematology PA
Burnsville, Minnesota, 55337, United States
Minnesota Oncology Hematology PA
Coon Rapids, Minnesota, 55433, United States
Minnesota Oncology Hematology PA
Edina, Minnesota, 55435, United States
Minnesota Oncology Hematology PA
Fridley, Minnesota, 55432, United States
Minnesota Oncology Hematology PA
Maple Grove, Minnesota, 55369, United States
Minnesota Oncology Hematology PA
Maplewood, Minnesota, 55109, United States
Minnesota Oncology Hematology PA
Minneapolis, Minnesota, 55404, United States
Minnesota Oncology Hematology PA
Plymouth, Minnesota, 55441, United States
Minnesota Oncology Hematology PA
Saint Paul, Minnesota, 55102, United States
Minnesota Oncology Hematology PA
Woodbury, Minnesota, 55125, United States
Nebraska Medicine - Bellevue Medical Center
Bellevue, Nebraska, 68123, United States
Nebraska Medicine
Omaha, Nebraska, 68105, United States
Nebraska Medicine - Village Pointe
Omaha, Nebraska, 68118, United States
University Of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
New York Oncology Hematology, P.C.
Albany, New York, 12206, United States
New York Oncology Hematology, P.C.
Albany, New York, 12208, United States
New York Oncology Hematology, P.C.
Clifton Park, New York, 12065, United States
Oncology_Hematology Care Clinical Trials,LLC
Cincinnati, Ohio, 45211, United States
Oncology_Hematology Care Clinical Trials,LLC
Cincinnati, Ohio, 45236, United States
Oncology_Hematology Care Clinical Trials,LLC
Cincinnati, Ohio, 45242, United States
Oncology_Hematology Care Clinical Trials,LLC
Cincinnati, Ohio, 45245, United States
Oncology_Hematology Care Clinical Trials,LLC
Fairfield, Ohio, 45014, United States
Toledo Clinic Cancer Center
Toledo, Ohio, 43623, United States
Oncology Associates of Oregon, P.C.
Eugene, Oregon, 97401, United States
Texas Oncology - Central South
Austin, Texas, 78705, United States
Texas Oncology - Central South (Balcones Dr)
Austin, Texas, 78731, United States
Texas Oncology - Central South (James Casey)
Austin, Texas, 78745, United States
Texas Oncology-DFW
Dallas, Texas, 75246, United States
Texas Oncology - Fort Worth Cancer Center
Fort Worth, Texas, 76104, United States
Texas Oncology-DFW
Fort Worth, Texas, 76104, United States
Oncology Consultants, PA
Houston, Texas, 77024, United States
US Oncology Investigational Product Center (IPC)
Irving, Texas, 75063, United States
US Oncology Investigational Products Center (IPC)
Irving, Texas, 75063, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Blacksburg, Virginia, 24060, United States
Virginia Oncology Associates
Chesapeake, Virginia, 23320, United States
Inova Schar Cancer Institue Infusion Pharmacy
Fairfax, Virginia, 22031, United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Hampton, Virginia, 23666, United States
Oncology & Hematology Associates of Southwest Virginia Inc.
Low Moor, Virginia, 24457, United States
Virginia Oncology Associates
Newport News, Virginia, 23606, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23219, United States
VCU Health Stony Point
Richmond, Virginia, 23235, United States
Massey Cancer Center Clinical & Translational Research Lab
Richmond, Virginia, 23298, United States
Tissue and Data Acquisition and Analysis Core (TDAAC)
Richmond, Virginia, 23298, United States
VCU Health- Adult Outpatient Pavilion (AOP) Investigational Drug Services
Richmond, Virginia, 23298, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Roanoke, Virginia, 24014, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Salem, Virginia, 24153, United States
VCU Health Community Memorial Hospital
South Hill, Virginia, 23970, United States
VCU Health Tappahannock Hospital
Tappahannock, Virginia, 22560, United States
Virginia Oncology Associates
Virginia Beach, Virginia, 23456, United States
Virginia Oncology Associates
Williamsburg, Virginia, 23188, United States
Oncology & Hematology Associates of Southwest Virginia, INC.
Wytheville, Virginia, 24382, United States
Fred Hutchinson Cancer Care Center
Seattle, Washington, 98109, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2020
First Posted
October 30, 2020
Study Start
January 26, 2021
Primary Completion
February 3, 2026
Study Completion
February 3, 2026
Last Updated
March 16, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.