Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors

Completed · Phase 2

Conditions studied: Melanoma, Non-small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck

In brief

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.

Key facts

Study ID: NCT04609566
Run by: Seagen, a wholly owned subsidiary of Pfizer
People needed: 161
Starts: 2021-01-26
Expected to finish: 2026-02-03
Last updated by the study team: 2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Arizona Oncology Associates, PC - HOPE — Tucson, Arizona, United States
Arizona Oncology Associates, PC - HOPE — Tucson, Arizona, United States
Highlands Oncology Group, PA — Fayetteville, Arkansas, United States
Highlands Oncology Group, PA — Rogers, Arkansas, United States
Highlands Oncology Group, PA — Springdale, Arkansas, United States
California Cancer Associates for Research and Excellence, Inc (cCARE) — Encinitas, California, United States
California Cancer Associates for Research and Excellence, Inc. cCARE — Fresno, California, United States
The Angeles Clinic And Research Institute, A Cedars-Sinai Affiliate — Los Angeles, California, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute (SOCCI) — Los Angeles, California, United States
California Cancer Associates for Research and Excellence Inc (cCARE) — San Marcos, California, United States
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate (Emergency Back-Up Only) — Santa Monica, California, United States
Rocky Mountain Cancer Centers, LLP — Aurora, Colorado, United States
Clinical and Translational Research Center (CTRC) — Aurora, Colorado, United States
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) — Aurora, Colorado, United States
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) — Aurora, Colorado, United States
University of Colorado Hospital-Anschutz Cancer Pavilion (ACP) — Aurora, Colorado, United States
Rocky Mountain Cancer Centers, LLP — Boulder, Colorado, United States
Rocky Mountain Cancer Centers, LLP — Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers, LLP — Denver, Colorado, United States
Rocky Mountain Cancer Centers, LLP — Denver, Colorado, United States
Rocky Mountain Cancer Centers, LLP — Lakewood, Colorado, United States
Rocky Mountain Cancer Centers, LLP — Littleton, Colorado, United States
Rocky Mountain Cancer Centers, LLP — Lone Tree, Colorado, United States
Rocky Mountain Cancer Centers, LLP — Longmont, Colorado, United States
Arizona Oncology Associates, PC - HOPE — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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