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NCT04609566

PHASE2

Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors

Sponsor: Seagen, a wholly owned subsidiary of Pfizer

View on ClinicalTrials.gov

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.

Official title: A Phase 2 Study of Brentuximab Vedotin in Combination With Pembrolizumab in Participants With Metastatic Solid Malignancies

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

161

Start Date

2021-01-26

Completion Date

2026-02-03

Last Updated

2026-07-06

Healthy Volunteers

Conditions

Melanoma Non-small Cell Lung Cancer Squamous Cell Carcinoma of the Head and Neck

Interventions

DRUG

brentuximab vedotin

1.8 mg/kg given into the vein (IV; intravenously) every 3 weeks

DRUG

pembrolizumab

200 mg given intravenously every 3 weeks

Inclusion Criteria * 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 Exclusion Criteria * 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.

Locations (90)

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

California Cancer Associates for Research and Excellence Inc (cCARE)

San Marcos, California, United States

The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate (Emergency Back-Up Only)

Santa Monica, California, United States

Rocky Mountain Cancer Centers, LLP

Aurora, Colorado, United States

Clinical and Translational Research Center (CTRC)

Aurora, Colorado, United States

University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)

Aurora, Colorado, United States

University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)

Aurora, Colorado, United States

University of Colorado Hospital-Anschutz Cancer Pavilion (ACP)

Aurora, Colorado, United States

Rocky Mountain Cancer Centers, LLP

Boulder, Colorado, United States

Rocky Mountain Cancer Centers, LLP

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers, LLP

Denver, Colorado, United States

Rocky Mountain Cancer Centers, LLP

Denver, Colorado, United States

Rocky Mountain Cancer Centers, LLP

Lakewood, Colorado, United States

Rocky Mountain Cancer Centers, LLP

Littleton, Colorado, United States

Rocky Mountain Cancer Centers, LLP

Lone Tree, Colorado, United States

Rocky Mountain Cancer Centers, LLP

Longmont, Colorado, United States

Rocky Mountain Cancer Centers, LLP

Pueblo, Colorado, United States

Rocky Mountain Cancer Centers, LLP

Thornton, Colorado, United States

Northwestern Medical Group

Chicago, Illinois, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

The University of Kansas Cancer Center

Westwood, Kansas, United States

Norton Cancer Institute Downtown

Louisville, Kentucky, United States

Norton Hospital

Louisville, Kentucky, United States

Norton Audubon Hospital

Louisville, Kentucky, United States

Norton Cancer Institute, Audubon Hospital Campus

Louisville, Kentucky, United States

Norton Brownsboro Hospital

Louisville, Kentucky, United States

Norton Cancer Institute, Brownsboro Hospital Campus

Louisville, Kentucky, United States

Minnesota Oncology Hematology PA

Burnsville, Minnesota, United States

Minnesota Oncology Hematology PA

Coon Rapids, Minnesota, United States

Minnesota Oncology Hematology PA

Edina, Minnesota, United States

Minnesota Oncology Hematology PA

Fridley, Minnesota, United States

Minnesota Oncology Hematology PA

Maple Grove, Minnesota, United States

Minnesota Oncology Hematology PA

Maplewood, Minnesota, United States

Minnesota Oncology Hematology PA

Minneapolis, Minnesota, United States

Minnesota Oncology Hematology PA

Plymouth, Minnesota, United States

Minnesota Oncology Hematology PA

Saint Paul, Minnesota, United States

Minnesota Oncology Hematology PA

Woodbury, Minnesota, United States

Nebraska Medicine - Bellevue Medical Center

Bellevue, Nebraska, United States

Nebraska Medicine

Omaha, Nebraska, United States

Nebraska Medicine - Village Pointe

Omaha, Nebraska, United States

University Of Nebraska Medical Center

Omaha, Nebraska, United States

New York Oncology Hematology, P.C.

Albany, New York, United States

New York Oncology Hematology, P.C.

Albany, New York, United States

New York Oncology Hematology, P.C.

Clifton Park, New York, United States

Oncology_Hematology Care Clinical Trials,LLC

Cincinnati, Ohio, United States

Oncology_Hematology Care Clinical Trials,LLC

Cincinnati, Ohio, United States

Oncology_Hematology Care Clinical Trials,LLC

Cincinnati, Ohio, United States

Oncology_Hematology Care Clinical Trials,LLC

Cincinnati, Ohio, United States

Oncology_Hematology Care Clinical Trials,LLC

Fairfield, Ohio, United States

Toledo Clinic Cancer Center

Toledo, Ohio, United States

Oncology Associates of Oregon, P.C.

Eugene, Oregon, United States

Texas Oncology - Central South

Austin, Texas, United States

Texas Oncology - Central South (Balcones Dr)

Austin, Texas, United States

Texas Oncology - Central South (James Casey)

Austin, Texas, United States

Texas Oncology-DFW

Dallas, Texas, United States

Texas Oncology

Dallas, Texas, United States

Texas Oncology - Fort Worth Cancer Center

Fort Worth, Texas, United States

Texas Oncology-DFW

Fort Worth, Texas, United States

Oncology Consultants, PA

Houston, Texas, United States

Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Blacksburg, Virginia, United States

Virginia Oncology Associates

Chesapeake, Virginia, United States

Inova Schar Cancer Institue Infusion Pharmacy

Fairfax, Virginia, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Virginia Oncology Associates

Hampton, Virginia, United States

Oncology & Hematology Associates of Southwest Virginia Inc.

Low Moor, Virginia, United States

Virginia Oncology Associates

Newport News, Virginia, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, United States

VCU Health Stony Point

Richmond, Virginia, United States

Massey Cancer Center Clinical & Translational Research Lab

Richmond, Virginia, United States

Tissue and Data Acquisition and Analysis Core (TDAAC)

Richmond, Virginia, United States

VCU Health- Adult Outpatient Pavilion (AOP) Investigational Drug Services

Richmond, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Roanoke, Virginia, United States

Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Salem, Virginia, United States

VCU Health Community Memorial Hospital

South Hill, Virginia, United States

VCU Health Tappahannock Hospital

Tappahannock, Virginia, United States

Virginia Oncology Associates

Virginia Beach, Virginia, United States

Virginia Oncology Associates

Williamsburg, Virginia, United States

Oncology & Hematology Associates of Southwest Virginia, INC.

Wytheville, Virginia, United States

Fred Hutchinson Cancer Care Center

Seattle, Washington, United States

Clinical Research Directory

Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (90)