NCT04993677|CompletedPhase 2ResultsFDA Drug
A Study of SEA-CD40 Given With Other Drugs in Cancers
An Open-label, Phase 2 Basket Study of SEA-CD40 Combination Therapies in Advanced Malignancies
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Sponsor study identifier
Secondary identifiers
OTHER · Merck Sharp & Dohme Corp
interventional
77
6 countries
29
Study Start
October 6, 2021
Actual (reported)Primary Completion
January 3, 2024
Actual (reported)Study Completion
November 25, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 25, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 30, 2021
Actual (reported)August 6, 2021
Actual (reported)October 6, 2021
Actual (reported)January 3, 2024
Actual (reported)November 25, 2024
Actual (reported)January 22, 2025
Actual (reported)Confirmed Objective Response Rate (cORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Per Investigator Assessment
cORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target, non-target lesions, all lymph nodes must be non-pathological in size (\<10 millimeter \[mm\] short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters persistence of one or more non-target lesions.
From start of study treatment until CR or PR (maximum up to 15.2 months)
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE
From first dose of the study treatment (Day 1) up to approximately 18.5 months
SEA-CD40 + pembrolizumab
SEA-CD40 + pembrolizumab + pemetrexed + carboplatin
Given into the vein (IV; intravenously); schedule is cohort-specific
Highlands Oncology Group
Springdale, Arkansas, 72762, United States
The Angeles Clinic and Research Institute
Los Angeles, California, 90025, United States
California Pacific Medical Center Research Institute/Sutter Medical Centre
San Francisco, California, 94115, United States
University of California at San Francisco
San Francisco, California, 94134, United States
Florida Cancer Specialists - South Region
Fort Myers, Florida, 33901, United States
Florida Cancer Specialists - North Region
St. Petersburg, Florida, 33705, United States
University Cancer & Blood Center, LLC
Jonathan Hayman, MD
Seagen Inc.
77 participants (actual enrollment reported by the registry).
First Submitted
July 30, 2021
First Posted
August 6, 2021
Study Start
October 6, 2021
Actual (reported)Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE
Baseline up to approximately 15.8 months
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE
Baseline up to approximately 15.8 months
Number of Participants With Treatment Interruptions, Dose Reductions, Treatment Discontinuations Due to Adverse Events
From first dose of the study treatment (Day 1) up to approximately 18.5 months
Disease Control Rate (DCR) Per Investigator Assessment
From the first dose of study treatment until the first documented CR, PR or SD or new anticancer therapies or death, whichever occurred first (maximum up to 15.2 months)
Given by IV on Day 1 of Cycles 1-4. Each cycle will be 21 days long.
Contact the study team to confirm eligibility.
Athens, Georgia, 30607, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Community Health Network
Indianapolis, Indiana, 46250, United States
American Oncology Networks LLC
Baton Rouge, Louisiana, 70809, United States
Allina Health Cancer Institute
Minneapolis, Minnesota, 55407, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Regions Cancer Care Center
Saint Paul, Minnesota, 55101, United States
Morristown Medical Center/ Carol G. Simon Cancer Center
Morristown, New Jersey, 07960, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Gabrail Cancer Center Research, LLC
Canton, Ohio, 44718, United States
Cleveland Clinic - Taussig Cancer Institute
Cleveland, Ohio, 44195, United States
Kaiser Permanente Oregon
Portland, Oregon, 97227, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Tennessee Oncology-Nashville/Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
University of Texas Southwestern/Simmons Cancer Center
Dallas, Texas, 75390, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, 77030-4095, United States
Carbone Cancer Center / University of Wisconsin
Madison, Wisconsin, 53792, United States
CHU de Quebec-Universite Laval
Québec, G1R 2J6, Canada
Hopital Foch
Suresnes, Other, 92150, France
Universitatsklinikum Heidelberg
Heidelberg, Other, 69120, Germany
START Madrid-CIOCC_Hospital HM Sanchinarro
Madrid, Other, 28050, Spain
Hospital Clinico Universitario de Valencia
Valencia, Other, 46010, Spain
Karolinska University Hospital
Stockholm, Other, 171 76, Sweden
Primary Completion
January 3, 2024
Actual (reported)Study Completion
November 25, 2024
Actual (reported)Last Updated
May 11, 2025
Results First Posted
January 22, 2025
Record last verified: 2025-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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