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NCT04609566

Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-26

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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Seattle Genetics

Study Design

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Allocation Method

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Combination Therapy

brentuximab vedotin + pembrolizumab

Group Type EXPERIMENTAL

brentuximab vedotin

Intervention Type DRUG

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

pembrolizumab

Intervention Type DRUG

200 mg given intravenously every 3 weeks

Interventions

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brentuximab vedotin

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

Intervention Type DRUG

pembrolizumab

200 mg given intravenously every 3 weeks

Intervention Type DRUG

Other Intervention Names

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ADCETRIS KEYTRUDA®

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Arizona Oncology Associates, PC - HOPE

Tucson, Arizona, United States

Site Status

Arizona Oncology Associates, PC - HOPE

Tucson, Arizona, United States

Site Status

Arizona Oncology Associates, PC - HOPE

Tucson, Arizona, United States

Site Status

Highlands Oncology Group, PA

Fayetteville, Arkansas, United States

Site Status

Highlands Oncology Group, PA

Rogers, Arkansas, United States

Site Status

Highlands Oncology Group, PA

Springdale, Arkansas, United States

Site Status

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

Encinitas, California, United States

Site Status

California Cancer Associates for Research and Excellence, Inc. cCARE

Fresno, California, United States

Site Status

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

Los Angeles, California, United States

Site Status

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

Los Angeles, California, United States

Site Status

California Cancer Associates for Research and Excellence Inc (cCARE)

San Marcos, California, United States

Site Status

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

Santa Monica, California, United States

Site Status

Rocky Mountain Cancer Centers, LLP

Aurora, Colorado, United States

Site Status

Clinical and Translational Research Center (CTRC)

Aurora, Colorado, United States

Site Status

University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)

Aurora, Colorado, United States

Site Status

University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)

Aurora, Colorado, United States

Site Status

University of Colorado Hospital-Anschutz Cancer Pavilion (ACP)

Aurora, Colorado, United States

Site Status

Rocky Mountain Cancer Centers, LLP

Boulder, Colorado, United States

Site Status

Rocky Mountain Cancer Centers, LLP

Colorado Springs, Colorado, United States

Site Status

Rocky Mountain Cancer Centers, LLP

Denver, Colorado, United States

Site Status

Rocky Mountain Cancer Centers, LLP

Denver, Colorado, United States

Site Status

Rocky Mountain Cancer Centers, LLP

Lakewood, Colorado, United States

Site Status

Rocky Mountain Cancer Centers, LLP

Littleton, Colorado, United States

Site Status

Rocky Mountain Cancer Centers, LLP

Lone Tree, Colorado, United States

Site Status

Rocky Mountain Cancer Centers, LLP

Longmont, Colorado, United States

Site Status

Rocky Mountain Cancer Centers, LLP

Pueblo, Colorado, United States

Site Status

Rocky Mountain Cancer Centers, LLP

Thornton, Colorado, United States

Site Status

Northwestern Medical Group

Chicago, Illinois, United States

Site Status

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

The University of Kansas Cancer Center, Investigational Drug Services

Westwood, Kansas, United States

Site Status