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Drug combo shows promise for Tough-to-Treat cancers

NCT ID NCT04609566

Disease control Sponsor: Seagen, a wholly owned subsidiary of Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This study tested whether combining two drugs, brentuximab vedotin and pembrolizumab, can shrink tumors in people with advanced melanoma, lung cancer, or head and neck cancer that has spread. About 161 adults took part. The main goal was to see how many patients had their tumors shrink or disappear, and to track side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

161 people

The number who actually took part.

Started

Jan 2021

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma melanoma metastatic melanoma non-small cell lung carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Melanoma Non-small cell lung cancer Squamous cell carcinoma of the head and neck

Contacts and locations

Locations

  • 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

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

    San Marcos, California, 92069, 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

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

    Los Angeles, California, 90048, United States

  • Clinical and Translational Research Center (CTRC)

    Aurora, Colorado, 80045, United States

  • Fred Hutchinson Cancer Care Center

    Seattle, Washington, 98109, 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

  • Inova Schar Cancer Institue Infusion Pharmacy

    Fairfax, Virginia, 22031, United States

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031, United States

  • Massey Cancer Center Clinical & Translational Research Lab

    Richmond, Virginia, 23298, 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

    Omaha, Nebraska, 68105, United States

  • Nebraska Medicine - Bellevue Medical Center

    Bellevue, Nebraska, 68123, United States

  • Nebraska Medicine - Village Pointe

    Omaha, Nebraska, 68118, 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

  • Northwestern Medical Group

    Chicago, Illinois, 60611, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Norton Audubon Hospital

    Louisville, Kentucky, 40217, United States

  • Norton Brownsboro Hospital

    Louisville, Kentucky, 40241, United States

  • Norton Cancer Institute Downtown

    Louisville, Kentucky, 40202, United States

  • Norton Cancer Institute, Audubon Hospital Campus

    Louisville, Kentucky, 40217, United States

  • Norton Cancer Institute, Brownsboro Hospital Campus

    Louisville, Kentucky, 40241, United States

  • Norton Hospital

    Louisville, Kentucky, 40202, United States

  • Oncology & Hematology Associates of Southwest Virginia Inc.

    Low Moor, Virginia, 24457, United States

  • Oncology & Hematology Associates of Southwest Virginia, INC.

    Wytheville, Virginia, 24382, United States

  • Oncology Associates of Oregon, P.C.

    Eugene, Oregon, 97401, United States

  • Oncology Consultants, PA

    Houston, Texas, 77024, United States

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

    Blacksburg, Virginia, 24060, 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

  • 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

  • Rocky Mountain Cancer Centers, LLP

    Aurora, Colorado, 80012, 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

  • Texas Oncology

    Dallas, Texas, 75246, 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 - Fort Worth Cancer Center

    Fort Worth, Texas, 76104, United States

  • Texas Oncology-DFW

    Dallas, Texas, 75246, United States

  • Texas Oncology-DFW

    Fort Worth, Texas, 76104, United States

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

    Los Angeles, California, 90025, United States

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

    Santa Monica, California, 90404, United States

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205, United States

  • Tissue and Data Acquisition and Analysis Core (TDAAC)

    Richmond, Virginia, 23298, United States

  • Toledo Clinic Cancer Center

    Toledo, Ohio, 43623, United States

  • University Of Nebraska Medical Center

    Omaha, Nebraska, 68198, 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

  • VCU Health Community Memorial Hospital

    South Hill, Virginia, 23970, United States

  • VCU Health Stony Point

    Richmond, Virginia, 23235, United States

  • VCU Health Tappahannock Hospital

    Tappahannock, Virginia, 22560, United States

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

    Richmond, Virginia, 23298, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia, 23219, United States

  • Virginia Oncology Associates

    Chesapeake, Virginia, 23320, United States

  • Virginia Oncology Associates

    Hampton, Virginia, 23666, United States

  • Virginia Oncology Associates

    Newport News, Virginia, 23606, United States

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502, United States

  • Virginia Oncology Associates

    Virginia Beach, Virginia, 23456, United States

  • Virginia Oncology Associates

    Williamsburg, Virginia, 23188, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.