A Study of SEA-CD40 Given With Other Drugs in Cancers
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.
Checked against the public recordLast updated May 11, 2025 · Source: ClinicalTrials.gov
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion 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 Exclusion 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.
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.