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

NCT04993677 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: SGNS40-002KEYNOTE-C86
• Study Type: interventional
• Target: 77
• Locations: 6 countries
• Sites: 29

Brief 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.

Conditions

Melanoma; Carcinoma, Non-Small- Cell Lung

Keywords

Relapsed melanoma; Refractory melanoma; Metastatic uveal melanoma; Metastatic PD-(L)1-naïve melanoma; Non-squamous NSCLC; NSCLC; Non-small cell lung cancer; Seattle Genetics

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (8)

• 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

• 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)

Study Arms (2)

Melanoma Arm

EXPERIMENTAL

SEA-CD40 + pembrolizumab

Drug: SEA-CD40; Drug: pembrolizumab (KEYTRUDA®)

NSCLC Arm

EXPERIMENTAL

SEA-CD40 + pembrolizumab + pemetrexed + carboplatin

Drug: SEA-CD40; Drug: pembrolizumab (KEYTRUDA®); Drug: pemetrexed; Drug: carboplatin

Interventions

SEA-CD40 DRUG

Given into the vein (IV; intravenously); schedule is cohort-specific

Melanoma Arm; NSCLC Arm

pembrolizumab (KEYTRUDA®) DRUG

Given by IV; schedule is cohort-specific.

Melanoma Arm; NSCLC Arm

pemetrexed DRUG

Given by IV on Day 1 of each 21-day cycle.

Also known as: Alimta

NSCLC Arm

carboplatin DRUG

Given by IV on Day 1 of Cycles 1-4. Each cycle will be 21 days long.

Also known as: Paraplatin

NSCLC Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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

Sponsors & Collaborators

• Seagen Inc.: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (29)

Highlands Oncology Group

Springdale, Arkansas, 72762, United States

Location

The Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

Location

California Pacific Medical Center Research Institute/Sutter Medical Centre

San Francisco, California, 94115, United States

Location

University of California at San Francisco

San Francisco, California, 94134, United States

Location

Florida Cancer Specialists - South Region

Fort Myers, Florida, 33901, United States

Location

Florida Cancer Specialists - North Region

St. Petersburg, Florida, 33705, United States

Location

University Cancer & Blood Center, LLC

Athens, Georgia, 30607, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Community Health Network

Indianapolis, Indiana, 46250, United States

Location

American Oncology Networks LLC

Baton Rouge, Louisiana, 70809, United States

Location

Allina Health Cancer Institute

Minneapolis, Minnesota, 55407, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Regions Cancer Care Center

Saint Paul, Minnesota, 55101, United States

Location

Morristown Medical Center/ Carol G. Simon Cancer Center

Morristown, New Jersey, 07960, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Gabrail Cancer Center Research, LLC

Canton, Ohio, 44718, United States

Location

Cleveland Clinic - Taussig Cancer Institute

Cleveland, Ohio, 44195, United States

Location

Kaiser Permanente Oregon

Portland, Oregon, 97227, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Tennessee Oncology-Nashville/Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

University of Texas Southwestern/Simmons Cancer Center

Dallas, Texas, 75390, United States

Location

MD Anderson Cancer Center / University of Texas

Houston, Texas, 77030-4095, United States

Location

Carbone Cancer Center / University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

CHU de Quebec-Universite Laval

Québec, G1R 2J6, Canada

Location

Hopital Foch

Suresnes, Other, 92150, France

Location

Universitatsklinikum Heidelberg

Heidelberg, Other, 69120, Germany

Location

START Madrid-CIOCC_Hospital HM Sanchinarro

Madrid, Other, 28050, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, Other, 46010, Spain

Location

Karolinska University Hospital

Stockholm, Other, 171 76, Sweden

Location

MeSH Terms

Conditions

Melanoma; Carcinoma, Non-Small-Cell Lung; Uveal Melanoma

Interventions

pembrolizumab; Pemetrexed; Carboplatin

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Uveal Neoplasms; Eye Neoplasms; Eye Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Jonathan Hayman, MD

  Seagen Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 6, 2021
• Study Start: October 6, 2021
• Primary Completion: January 3, 2024
• Study Completion: November 25, 2024
• Last Updated: May 11, 2025
• Results First Posted: January 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); DE (1); ES (2); FR (1); SE (1); US (23)