CompletedPhase 2NCT04993677
Official study title

A Study of SEA-CD40 Given With Other Drugs in Cancers

Study summary

This trial is being done to see if an experimental drug (SEA-CD40) works when it's given with other cancer drugs to treat some types of cancer. It will also study side effects from the drug. There are 2 parts in this trial. In one part, participants have melanoma that has come back after treatment or can't be removed by surgery. Participants in this part will get SEA-CD40 and pembrolizumab. In the other part, participants have non-small cell lung cancer (NSCLC) that has spread through their body. These participants will get SEA-CD40, pembrolizumab, carboplatin, and pemetrexed.

Ask AI to explain this study
Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedSEA-CD40 and pembrolizumab (KEYTRUDA®)

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 11, 2025 · 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?29 U.S. locations

Locations may change over time.

Who runs it?Seagen Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Seagen Inc.
Interventions being studied
Drug: SEA-CD40; Drug: pembrolizumab (KEYTRUDA®); Drug: pemetrexed; Drug: carboplatin
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
  • Histologically or cytologically confirmed unresectable malignancy defined as one of the following:
  • Cohort 1: Relapsed and/or refractory metastatic melanoma
  • Uveal/ocular melanoma is excluded
  • Must have progressed on treatment with an anti-PD-(L)1 mAb. PD-(L)1 treatment progression is defined as meeting all of the following criteria:
  • Has received at least 2 doses of an approved anti-PD-(L)1 mAb
  • Has demonstrated disease progression after PD-(L)1 as defined by RECIST v1.1.
  • Progressive disease has been documented within 12 weeks from the last dose of anti- PD-(L)1 mAb
  • Last dose of anti-PD-(L)1 must have been within 90 days prior to enrollment
  • Participants with a targetable BRAF mutation must have been treated with, been intolerant of, or declined treatment with BRAF/MEK targeted therapy prior to study entry
  • Cohort 2: Metastatic uveal melanoma
  • Must not have received prior treatment for advanced or metastatic disease except for prior adjuvant/neoadjuvant immunotherapy
  • No prior liver-directed therapy
  • Cohort 3: Metastatic PD-(L)1-naive melanoma
  • Uveal/ocular melanoma is excluded
  • Must not have received prior treatment for advanced or metastatic disease except for prior adjuvant/neoadjuvant immunotherapy.
  • For participants with a targetable BRAF mutation, prior BRAF/MEK targeted therapy is allowed if completed 4 weeks prior to first dose of study treatment.
  • Cohorts 4 and 5: Non-squamous NSCLC
  • Participants must have stage IV disease per AJCC 8th edition
  • No known driver mutations/alterations mutation for which targeted therapy is available
  • Must have non-squamous histology.
  • No prior therapy for metastatic disease
  • No prior treatment with anti-PD-(L)1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms
  • Able to provide archival tumor tissue from locations not radiated prior to biopsy. If archival tumor sample is not available a fresh baseline biopsy is required.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  • Measurable disease per RECIST v1.1 at baseline
Reasons someone may not be able to joinExclusion criteria
  • History of another malignancy within 3 years of first dose of study drug
  • Active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Previous exposure to CD40-targeted therapy
  • Currently on chronic systemic steroids in excess of physiologic replacement
  • Has had an allogeneic tissue/solid organ transplant.
  • History of autoimmune disease that has required systemic treatment in the past 2 years

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

  • Highlands Oncology GroupSpringdale, Arkansas
  • The Angeles Clinic and Research InstituteLos Angeles, California
  • California Pacific Medical Center Research Institute/Sutter Medical CentreSan Francisco, California
  • University of California at San FranciscoSan Francisco, California
  • Florida Cancer Specialists - South RegionFort Myers, Florida
  • Florida Cancer Specialists - North RegionSt. Petersburg, Florida
  • University Cancer & Blood Center, LLCAthens, Georgia
  • Rush University Medical CenterChicago, Illinois
  • Community Health NetworkIndianapolis, Indiana
  • American Oncology Networks LLCBaton Rouge, Louisiana
  • Allina Health Cancer InstituteMinneapolis, Minnesota
  • University of MinnesotaMinneapolis, Minnesota

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 11, 2025. Always confirm current availability with the study team.

View original record ↗