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MelanomaPhase 2NCT04609566

Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors

A Phase 2 study testing brentuximab vedotin and pembrolizumab in people with Melanoma and Non-small Cell Lung Cancer, run by Seagen, a wholly owned subsidiary of Pfizer at 90 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
brentuximab vedotin and pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
161 participants
Where
90 sitesUnited States
Study dates
26 Jan 2021to 3 Feb 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 15Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

90 sites in 1 country.

90 sites in 1 country

United States90 sites

  • New York Oncology Hematology, P.C.

    Albany, New York, 12206

  • New York Oncology Hematology, P.C.

    Albany, New York, 12208

  • Rocky Mountain Cancer Centers, LLP

    Aurora, Colorado, 80012

  • Clinical and Translational Research Center (CTRC)

    Aurora, Colorado, 80045

  • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)

    Aurora, Colorado, 80045

  • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)

    Aurora, Colorado, 80045

  • University of Colorado Hospital-Anschutz Cancer Pavilion (ACP)

    Aurora, Colorado, 80045

  • Texas Oncology - Central South

    Austin, Texas, 78705

  • Texas Oncology - Central South (Balcones Dr)

    Austin, Texas, 78731

  • Texas Oncology - Central South (James Casey)

    Austin, Texas, 78745

  • Nebraska Medicine - Bellevue Medical Center

    Bellevue, Nebraska, 68123

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

    Blacksburg, Virginia, 24060

  • Rocky Mountain Cancer Centers, LLP

    Boulder, Colorado, 80303

  • Minnesota Oncology Hematology PA

    Burnsville, Minnesota, 55337

  • Virginia Oncology Associates

    Chesapeake, Virginia, 23320

  • Northwestern Medical Group

    Chicago, Illinois, 60611

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Oncology_Hematology Care Clinical Trials,LLC

    Cincinnati, Ohio, 45211

  • Oncology_Hematology Care Clinical Trials,LLC

    Cincinnati, Ohio, 45236

  • Oncology_Hematology Care Clinical Trials,LLC

    Cincinnati, Ohio, 45242

  • Oncology_Hematology Care Clinical Trials,LLC

    Cincinnati, Ohio, 45245

  • New York Oncology Hematology, P.C.

    Clifton Park, New York, 12065

  • Rocky Mountain Cancer Centers, LLP

    Colorado Springs, Colorado, 80907

  • Minnesota Oncology Hematology PA

    Coon Rapids, Minnesota, 55433

  • Texas Oncology-DFW

    Dallas, Texas, 75246

  • Texas Oncology

    Dallas, Texas, 75246

  • Rocky Mountain Cancer Centers, LLP

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers, LLP

    Denver, Colorado, 80220

  • Minnesota Oncology Hematology PA

    Edina, Minnesota, 55435

  • California Cancer Associates for Research and Excellence, Inc (cCARE)

    Encinitas, California, 92024

  • Oncology Associates of Oregon, P.C.

    Eugene, Oregon, 97401

  • Inova Schar Cancer Institue Infusion Pharmacy

    Fairfax, Virginia, 22031

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Oncology_Hematology Care Clinical Trials,LLC

    Fairfield, Ohio, 45014

  • Highlands Oncology Group, PA

    Fayetteville, Arkansas, 72703

  • Texas Oncology - Fort Worth Cancer Center

    Fort Worth, Texas, 76104

  • Texas Oncology-DFW

    Fort Worth, Texas, 76104

  • California Cancer Associates for Research and Excellence, Inc. cCARE

    Fresno, California, 93720

  • Minnesota Oncology Hematology PA

    Fridley, Minnesota, 55432

  • Virginia Oncology Associates

    Hampton, Virginia, 23666

  • Oncology Consultants, PA

    Houston, Texas, 77024

  • Rocky Mountain Cancer Centers, LLP

    Lakewood, Colorado, 80228

  • Rocky Mountain Cancer Centers, LLP

    Littleton, Colorado, 80120

  • Rocky Mountain Cancer Centers, LLP

    Lone Tree, Colorado, 80124

  • Rocky Mountain Cancer Centers, LLP

    Longmont, Colorado, 80504

  • The Angeles Clinic And Research Institute, A Cedars-Sinai Affiliate

    Los Angeles, California, 90025

  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute (SOCCI)

    Los Angeles, California, 90048

  • Norton Cancer Institute Downtown

    Louisville, Kentucky, 40202

  • Norton Hospital

    Louisville, Kentucky, 40202

  • Norton Audubon Hospital

    Louisville, Kentucky, 40217

  • Norton Cancer Institute, Audubon Hospital Campus

    Louisville, Kentucky, 40217

  • Norton Brownsboro Hospital

    Louisville, Kentucky, 40241

  • Norton Cancer Institute, Brownsboro Hospital Campus

    Louisville, Kentucky, 40241

  • Oncology & Hematology Associates of Southwest Virginia Inc.

    Low Moor, Virginia, 24457

  • Minnesota Oncology Hematology PA

    Maple Grove, Minnesota, 55369

  • Minnesota Oncology Hematology PA

    Maplewood, Minnesota, 55109

  • Minnesota Oncology Hematology PA

    Minneapolis, Minnesota, 55404

  • Virginia Oncology Associates

    Newport News, Virginia, 23606

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Nebraska Medicine

    Omaha, Nebraska, 68105

  • Nebraska Medicine - Village Pointe

    Omaha, Nebraska, 68118

  • University Of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Minnesota Oncology Hematology PA

    Plymouth, Minnesota, 55441

  • Rocky Mountain Cancer Centers, LLP

    Pueblo, Colorado, 81003

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia, 23219

  • VCU Health Stony Point

    Richmond, Virginia, 23235

  • Massey Cancer Center Clinical & Translational Research Lab

    Richmond, Virginia, 23298

  • Tissue and Data Acquisition and Analysis Core (TDAAC)

    Richmond, Virginia, 23298

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

    Richmond, Virginia, 23298

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

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

    Roanoke, Virginia, 24014

  • Highlands Oncology Group, PA

    Rogers, Arkansas, 72758

  • Minnesota Oncology Hematology PA

    Saint Paul, Minnesota, 55102

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

    Salem, Virginia, 24153

  • California Cancer Associates for Research and Excellence Inc (cCARE)

    San Marcos, California, 92069

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

    Santa Monica, California, 90404

  • Fred Hutchinson Cancer Care Center

    Seattle, Washington, 98109

  • VCU Health Community Memorial Hospital

    South Hill, Virginia, 23970

  • Highlands Oncology Group, PA

    Springdale, Arkansas, 72762

  • VCU Health Tappahannock Hospital

    Tappahannock, Virginia, 22560

  • Rocky Mountain Cancer Centers, LLP

    Thornton, Colorado, 80260

  • Toledo Clinic Cancer Center

    Toledo, Ohio, 43623

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona, 85704

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona, 85711

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona, 85745

  • Virginia Oncology Associates

    Virginia Beach, Virginia, 23456

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205

  • Virginia Oncology Associates

    Williamsburg, Virginia, 23188

  • Minnesota Oncology Hematology PA

    Woodbury, Minnesota, 55125

  • Oncology & Hematology Associates of Southwest Virginia, INC.

    Wytheville, Virginia, 24382

Other trials in United States

About this study

Official title: 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.

Being tested
brentuximab vedotin, pembrolizumab
Keywords
Seattle Genetics
Medical subject headings
Melanoma, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • brentuximab vedotinDrug

    Also called ADCETRIS

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

  • pembrolizumabDrug

    Also called KEYTRUDA®

    200 mg given intravenously every 3 weeks

Study groups in NCT04609566
Study groupRoleWhat they receive
Combination TherapyExperimentalbrentuximab vedotin + pembrolizumab
Receives: Drug: brentuximab vedotin; Drug: pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to approximately 2 years

Secondary outcomes (6)

  1. 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.

    Measured: Up to approximately 3 years

  2. 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.

    Measured: Up to approximately 3 years

  3. 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

    Measured: Up to approximately 2 years

  4. 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.

    Measured: Up to approximately 3 years

  5. 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.

    Measured: Up to approximately 3 years

  6. 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.

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2020
  2. Study start26 Jan 2021
  3. Primary completion3 Feb 2026
  4. Study completion3 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04609566
Sponsor's protocol ID
SGN35-033
Other IDs
C5691005
Status last verified
Jul 2026
First submitted
23 Oct 2020
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing brentuximab vedotin and pembrolizumab in people with Melanoma and Non-small Cell Lung Cancer, run by Seagen, a wholly owned subsidiary of Pfizer at 90 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04609566.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.

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