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

Completed · Phase 2

Conditions studied: Melanoma, Carcinoma, Non-Small- Cell Lung

In brief

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.

Key facts

Study ID

NCT04993677

Run by

Seagen Inc.

People needed

77

Starts

2021-10-06

Expected to finish

2024-11-25

Last updated by the study team

2025-05-11

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Highlands Oncology Group — Springdale, Arkansas, United States
• The Angeles Clinic and Research Institute — Los Angeles, California, United States
• California Pacific Medical Center Research Institute/Sutter Medical Centre — San Francisco, California, United States
• University of California at San Francisco — San Francisco, California, United States
• Florida Cancer Specialists - South Region — Fort Myers, Florida, United States
• Florida Cancer Specialists - North Region — St. Petersburg, Florida, United States
• University Cancer & Blood Center, LLC — Athens, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Community Health Network — Indianapolis, Indiana, United States
• American Oncology Networks LLC — Baton Rouge, Louisiana, United States
• Allina Health Cancer Institute — Minneapolis, Minnesota, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Regions Cancer Care Center — Saint Paul, Minnesota, United States
• Morristown Medical Center/ Carol G. Simon Cancer Center — Morristown, New Jersey, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Gabrail Cancer Center Research, LLC — Canton, Ohio, United States
• Cleveland Clinic - Taussig Cancer Institute — Cleveland, Ohio, United States
• Kaiser Permanente Oregon — Portland, Oregon, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Tennessee Oncology-Nashville/Sarah Cannon Research Institute — Nashville, Tennessee, United States
• University of Texas Southwestern/Simmons Cancer Center — Dallas, Texas, United States
• MD Anderson Cancer Center / University of Texas — Houston, Texas, United States
• Carbone Cancer Center / University of Wisconsin — Madison, Wisconsin, United States
• CHU de Quebec-Universite Laval — Québec, Canada
• Hopital Foch — Suresnes, Other, France

Full record on ClinicalTrials.gov

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