CompletedPhase 2NCT04609566
Official study title

Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors

Study 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. A side effect is anything the treatment does besides treat cancer. This is a multi-cohort study.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedbrentuximab vedotin and pembrolizumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 6, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?90 U.S. locations

Locations may change over time.

Who runs it?Seagen, a wholly owned subsidiary of Pfizer

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Seagen, a wholly owned subsidiary of Pfizer
Interventions being studied
Drug: brentuximab vedotin; Drug: pembrolizumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Arizona Oncology Associates, PC - HOPETucson, Arizona
  • Arizona Oncology Associates, PC - HOPETucson, Arizona
  • Arizona Oncology Associates, PC - HOPETucson, Arizona
  • Highlands Oncology Group, PAFayetteville, Arkansas
  • Highlands Oncology Group, PARogers, Arkansas
  • Highlands Oncology Group, PASpringdale, Arkansas
  • California Cancer Associates for Research and Excellence, Inc (cCARE)Encinitas, California
  • California Cancer Associates for Research and Excellence, Inc. cCAREFresno, California
  • The Angeles Clinic And Research Institute, A Cedars-Sinai AffiliateLos Angeles, California
  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute (SOCCI)Los Angeles, California
  • California Cancer Associates for Research and Excellence Inc (cCARE)San Marcos, California
  • The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate (Emergency Back-Up Only)Santa Monica, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 6, 2026. Always confirm current availability with the study team.

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