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

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 Overview

• Status: Completed
• Conditions: Melanoma; Squamous Cell Carcinoma of the Head and Neck; Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: brentuximab vedotin; Drug: pembrolizumab

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85711
      • Arizona Oncology Associates, PC - HOPE
    • Tucson, Arizona, United States, 85704
      • Arizona Oncology Associates, PC - HOPE
    • Tucson, Arizona, United States, 85745
      • Arizona Oncology Associates, PC - HOPE
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Highlands Oncology Group, PA
    • Rogers, Arkansas, United States, 72758
      • Highlands Oncology Group, PA
    • Springdale, Arkansas, United States, 72762
      • Highlands Oncology Group, PA
  • California
    • Encinitas, California, United States, 92024
      • California Cancer Associates for Research and Excellence, Inc (cCARE)
    • Fresno, California, United States, 93720
      • California Cancer Associates for Research and Excellence, Inc. cCARE
    • Los Angeles, California, United States, 90025
      • The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute (SOCCI)
    • San Marcos, California, United States, 92069
      • California Cancer Associates for Research and Excellence Inc (cCARE)
    • Santa Monica, California, United States, 90404
      • The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate (Emergency Back-Up Only)
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
    • Aurora, Colorado, United States, 80012
      • Rocky Mountain Cancer Centers, LLP
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital-Anschutz Cancer Pavilion (ACP)
    • Aurora, Colorado, United States, 80045
      • Clinical and Translational Research Center (CTRC)
    • Boulder, Colorado, United States, 80303
      • Rocky Mountain Cancer Centers, LLP
    • Colorado Springs, Colorado, United States, 80907
      • Rocky Mountain Cancer Centers, LLP
    • Denver, Colorado, United States, 80218
      • Rocky Mountain Cancer Centers, LLP
    • Denver, Colorado, United States, 80220
      • Rocky Mountain Cancer Centers, LLP
    • Lakewood, Colorado, United States, 80228
      • Rocky Mountain Cancer Centers, LLP
    • Littleton, Colorado, United States, 80120
      • Rocky Mountain Cancer Centers, LLP
    • Lone Tree, Colorado, United States, 80124
      • Rocky Mountain Cancer Centers, LLP
    • Longmont, Colorado, United States, 80504
      • Rocky Mountain Cancer Centers, LLP
    • Pueblo, Colorado, United States, 81003
      • Rocky Mountain Cancer Centers, LLP
    • Thornton, Colorado, United States, 80260
      • Rocky Mountain Cancer Centers, LLP
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Chicago, Illinois, United States, 60611
      • Northwestern Medical Group
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
    • Westwood, Kansas, United States, 66205
      • The University of Kansas Cancer Center
    • Westwood, Kansas, United States, 66205
      • The University of Kansas Cancer Center, Investigational Drug Services
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Hospital
    • Louisville, Kentucky, United States, 40202
      • Norton Cancer Institute Downtown
    • Louisville, Kentucky, United States, 40217
      • Norton Cancer Institute, Audubon Hospital Campus
    • Louisville, Kentucky, United States, 40241
      • Norton Brownsboro Hospital
    • Louisville, Kentucky, United States, 40241
      • Norton Cancer Institute, Brownsboro Hospital Campus
    • Louisville, Kentucky, United States, 40217
      • Norton Audubon Hospital
  • Minnesota
    • Burnsville, Minnesota, United States, 55337
      • Minnesota Oncology Hematology PA
    • Coon Rapids, Minnesota, United States, 55433
      • Minnesota Oncology Hematology PA
    • Edina, Minnesota, United States, 55435
      • Minnesota Oncology Hematology PA
    • Fridley, Minnesota, United States, 55432
      • Minnesota Oncology Hematology PA
    • Maple Grove, Minnesota, United States, 55369
      • Minnesota Oncology Hematology PA
    • Maplewood, Minnesota, United States, 55109
      • Minnesota Oncology Hematology PA
    • Minneapolis, Minnesota, United States, 55404
      • Minnesota Oncology Hematology PA
    • Plymouth, Minnesota, United States, 55441
      • Minnesota Oncology Hematology PA
    • Saint Paul, Minnesota, United States, 55102
      • Minnesota Oncology Hematology PA
    • Woodbury, Minnesota, United States, 55125
      • Minnesota Oncology Hematology PA
  • Nebraska
    • Bellevue, Nebraska, United States, 68123
      • Nebraska Medicine - Bellevue Medical Center
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
    • Omaha, Nebraska, United States, 68105
      • Nebraska Medicine
    • Omaha, Nebraska, United States, 68118
      • Nebraska Medicine - Village Pointe
  • New York
    • Albany, New York, United States, 12206
      • New York Oncology Hematology, P.C.
    • Albany, New York, United States, 12208
      • New York Oncology Hematology, P.C.
    • Clifton Park, New York, United States, 12065
      • New York Oncology Hematology, P.C.
  • Ohio
    • Cincinnati, Ohio, United States, 45211
      • Oncology_Hematology Care Clinical Trials,LLC
    • Cincinnati, Ohio, United States, 45236
      • Oncology_Hematology Care Clinical Trials,LLC
    • Cincinnati, Ohio, United States, 45242
      • Oncology_Hematology Care Clinical Trials,LLC
    • Cincinnati, Ohio, United States, 45245
      • Oncology_Hematology Care Clinical Trials,LLC
    • Fairfield, Ohio, United States, 45014
      • Oncology_Hematology Care Clinical Trials,LLC
    • Toledo, Ohio, United States, 43623
      • Toledo Clinic Cancer Center
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Oncology Associates of Oregon, P.C.
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Oncology - Central South
    • Austin, Texas, United States, 78731
      • Texas Oncology - Central South (Balcones Dr)
    • Austin, Texas, United States, 78745
      • Texas Oncology - Central South (James Casey)
    • Dallas, Texas, United States, 75246
      • Texas Oncology-DFW
    • Fort Worth, Texas, United States, 76104
      • Texas Oncology - Fort Worth Cancer Center
    • Fort Worth, Texas, United States, 76104
      • Texas Oncology-DFW
    • Houston, Texas, United States, 77024
      • Oncology Consultants, PA
    • Irving, Texas, United States, 75063
      • US Oncology Investigational Products Center (IPC)
    • Irving, Texas, United States, 75063
      • US Oncology Investigational Product Center (IPC)
  • Virginia
    • Blacksburg, Virginia, United States, 24060
      • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
    • Chesapeake, Virginia, United States, 23320
      • Virginia Oncology Associates
    • Fairfax, Virginia, United States, 22031
      • Inova Schar Cancer Institute
    • Fairfax, Virginia, United States, 22031
      • Inova Schar Cancer Institue Infusion Pharmacy
    • Hampton, Virginia, United States, 23666
      • Virginia Oncology Associates
    • Low Moor, Virginia, United States, 24457
      • Oncology & Hematology Associates of Southwest Virginia Inc.
    • Newport News, Virginia, United States, 23606
      • Virginia Oncology Associates
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University Massey Cancer Center
    • Richmond, Virginia, United States, 23235
      • VCU Health Stony Point
    • Richmond, Virginia, United States, 23298
      • Massey Cancer Center Clinical & Translational Research Lab
    • Richmond, Virginia, United States, 23298
      • Tissue and Data Acquisition and Analysis Core (TDAAC)
    • Richmond, Virginia, United States, 23298
      • VCU Health- Adult Outpatient Pavilion (AOP) Investigational Drug Services
    • Roanoke, Virginia, United States, 24014
      • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
    • Salem, Virginia, United States, 24153
      • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
    • South Hill, Virginia, United States, 23970
      • VCU Health Community Memorial Hospital
    • Tappahannock, Virginia, United States, 22560
      • VCU Health Tappahannock Hospital
    • Virginia Beach, Virginia, United States, 23456
      • Virginia Oncology Associates
    • Williamsburg, Virginia, United States, 23188
      • Virginia Oncology Associates
    • Wytheville, Virginia, United States, 24382
      • Oncology & Hematology Associates of Southwest Virginia, Inc.
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination Therapy; brentuximab vedotin + pembrolizumab	Drug: brentuximab vedotin; 1.8 mg/kg given into the vein (IV; intravenously) every 3 weeks; Other Names: ADCETRIS; Drug: pembrolizumab; 200 mg given intravenously every 3 weeks; Other Names: KEYTRUDA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Seagen, a wholly owned subsidiary of Pfizer
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2021
• Primary Completion (Actual): February 3, 2026
• Study Completion (Actual): February 3, 2026

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: October 23, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Seattle Genetics
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lung Diseases; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Skin Diseases; Carcinoma; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Carcinoma, Squamous Cell; Skin and Connective Tissue Diseases; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Non-Small-Cell Lung; Melanoma; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Brentuximab Vedotin; pembrolizumab
• Other Study ID Numbers: SGN35-033; C5691005 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No