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

• Status: Recruiting
• Trial end date: 2025-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seagen Inc.
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Carboplatin; Pembrolizumab; Pemetrexed

Criteria

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

• Cohort 2: Metastatic uveal melanoma

• Must not have received prior treatment for advanced or metastatic disease except for prior adjuvant/neoadjuvant immunotherapy

• No prior regional, liver-directed therapy

• Cohort 3: Metastatic PD-(L)1-naïve melanoma

• Uveal/ocular melanoma is excluded

• Must not have received prior treatment for advanced or metastatic disease except for prior adjuvant/neoadjuvant immunotherapy.

• Participants with 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

• 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