Hospital Clinico Universitario de Valencia | Nephrology Department
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About
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.
Enrollment
Sex
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Volunteers
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:
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
Cohort 3: Metastatic PD-(L)1-naive melanoma
Cohorts 4 and 5: Non-squamous NSCLC
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
Primary purpose
Allocation
Interventional model
Masking
77 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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