Lung Cancer Clinical Trial
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.
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
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
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There are 29 Locations for this study
Springdale Arkansas, 72762, United States
Los Angeles California, 90025, United States
San Francisco California, 94115, United States
San Francisco California, 94134, United States
Fort Myers Florida, 33901, United States
Saint Petersburg Florida, 33705, United States
Athens Georgia, 30607, United States
Chicago Illinois, 60612, United States
Indianapolis Indiana, 46250, United States
Baton Rouge Louisiana, 70809, United States
Minneapolis Minnesota, 55047, United States
Minneapolis Minnesota, 55455, United States
Saint Paul Minnesota, 55101, United States
Morristown New Jersey, 07960, United States
Durham North Carolina, 27710, United States
Canton Ohio, 44718, United States
Cleveland Ohio, 44195, United States
Portland Oregon, 97227, United States
Philadelphia Pennsylvania, 19107, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Madison Wisconsin, 53792, United States
Quebec , G1R 2, Canada
Suresnes Other, 92150, France
Heidelberg Other, 69120, Germany
Madrid Other, 28050, Spain
Valencia Other, 46010, Spain
Stockholm Other, 171 7, Sweden
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