Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors

March 1, 2024 updated by: Seagen Inc.

A Phase 2 Study of Brentuximab Vedotin in Combination With Pembrolizumab in Subjects 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • University of Ottawa / Ottawa General Hospital
        • Principal Investigator:
          • Arif Awan
    • Quebec
      • Montreal, Quebec, Canada, H3T1E2
        • Recruiting
        • Jewish General Hospital
        • Principal Investigator:
          • Wilson H. Miller
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Recruiting
        • Arizona Oncology Associates, PC - HOPE
        • Contact:
        • Principal Investigator:
          • Richard K Rosenberg
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Recruiting
        • Highlands Oncology Group
        • Contact:
        • Principal Investigator:
          • J. Thaddeus Beck
    • California
      • Fresno, California, United States, 93720
        • Completed
        • cCARE - Northern
      • Los Angeles, California, United States, 90025
        • Recruiting
        • The Angeles Clinic and Research Institute
        • Principal Investigator:
          • Inderjit Mehmi
        • Contact:
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute
        • Principal Investigator:
          • Inderjit Mehmi
      • San Marcos, California, United States, 92069
        • Recruiting
        • California Cancer Associates for Research and Excellence Inc (cCARE)
        • Principal Investigator:
          • Edward F McClay
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Hospital / University of Colorado
        • Contact:
        • Principal Investigator:
          • Theresa M Medina, MD
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Rocky Mountain Cancer Centers - Aurora
        • Principal Investigator:
          • Robert Jotte
    • Florida
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Memorial Healthcare System
        • Principal Investigator:
          • Atif M Hussein
      • Pembroke Pines, Florida, United States, 33028
        • Recruiting
        • Memorial Healthcare System
        • Principal Investigator:
          • Atif M Hussein
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Sunandana Chandra
      • Chicago Ridge, Illinois, United States, 60415
        • Recruiting
        • Affiliated Oncologists, LLC
        • Principal Investigator:
          • Rami Haddad
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospitals and Clinics
        • Principal Investigator:
          • Yousef Zakharia
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Cancer Center
        • Principal Investigator:
          • Gary C Doolittle, MD
    • Kentucky
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Completed
        • Henry Ford Health System
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Recruiting
        • Minnesota Oncology Hematology P.A.
        • Principal Investigator:
          • Sandeep Jain
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Completed
        • Comprehensive Cancer Centers of Nevada
    • New York
      • Clifton Park, New York, United States, 12065
        • Recruiting
        • New York Oncology Hematology, P.C.
        • Contact:
        • Principal Investigator:
          • Stephen Wrzesinski
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • Oncology Hematology Care
        • Contact:
        • Principal Investigator:
          • Patrick J Ward
      • Toledo, Ohio, United States, 43623
        • Recruiting
        • Toledo Clinic Cancer Center
        • Principal Investigator:
          • Rex Mowat
        • Contact:
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Willamette Valley Cancer Institute and Research Center
        • Principal Investigator:
          • Christopher A Yasenchak
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • Texas Oncology - Austin Central
        • Principal Investigator:
          • Jeffrey Yorio
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Texas Oncology - Baylor Sammons Cancer Center
        • Principal Investigator:
          • Charles Cowey
        • Contact:
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Texas Oncology - Fort Worth 12th Avenue
        • Contact:
        • Principal Investigator:
          • Rachel L Theriault
      • Houston, Texas, United States, 77030
        • Recruiting
        • Oncology Consultants, PA
        • Principal Investigator:
          • Julio Peguero
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Inova Schar Cancer Institute
        • Contact:
        • Principal Investigator:
          • Sekwon Jang
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Virginia Oncology Associates
        • Contact:
        • Principal Investigator:
          • Graham T Watson, MD
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University Medical Center
        • Principal Investigator:
          • Erin Alesi
        • Contact:
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Oncology and Hematology Associates of Southwest Virginia
        • Contact:
        • Principal Investigator:
          • Amanda L. Gillespie-Twardy
    • Washington
      • Seattle, Washington, United States, 98109-1023
        • Recruiting
        • Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
        • Principal Investigator:
          • Sylvia M Lee
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
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
Time Frame: 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.
Up to approximately 3 years
Progression-free survival (PFS) based on investigator assessment using RECIST v1.1 criteria
Time Frame: 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.
Up to approximately 3 years
ORR per iRECIST by investigator assessment
Time Frame: Up to approximately 2 years
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
Time Frame: 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.
Up to approximately 3 years
iPFS per iRECIST by investigator assessment
Time Frame: 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.
Up to approximately 3 years
Incidence of adverse events (AEs)
Time Frame: 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.
Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Scott Knowles, MD, PhD, Seagen Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2021

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

September 30, 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 5, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGN35-033
  • KEYNOTE-B81 (Other Identifier: Merck Sharp & Dohme LLC)
  • MK-3475-B81 (Other Identifier: Merck Sharp & Dohme LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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