SEA-CD40 Combination Therapy for Non-Small Cell Lung Cancer

Recruiting at 33 trial locations

Overseen BySeagen Trial Information Support

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Seagen Inc.

Must be taking: Anti-PD-(L)1 mAb

Must not be taking: Chronic systemic steroids

Disqualifiers: CNS metastases, Autoimmune disease, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called SEA-CD40 to see if it can help treat certain types of cancer when used with other medications. It targets patients with hard-to-treat melanoma and advanced lung cancer. The drug works by boosting the immune system and working with other drugs to attack cancer cells. This new treatment option has the potential to generate anticancer immunity through various mechanisms.

Research Team

Jonathan Hayman, MD

Principal Investigator

Seagen Inc.

Eligibility Criteria

This trial is for adults with certain types of cancer, like melanoma that's returned or can't be surgically removed, and NSCLC that has spread. They must not have had CD40-targeted therapy before, no other cancers in the last 3 years, no autoimmune diseases treated in the past 2 years, and they shouldn't be on high doses of steroids or have active brain metastases.

Inclusion Criteria

My cancer is confirmed by lab tests and cannot be removed by surgery.

Participants must meet specific criteria for each cohort as outlined in the text

Exclusion Criteria

My cancer has spread to my brain or the protective layers of my brain.

I have had another type of cancer in the last 3 years.

I have been treated with CD40-targeted therapy before.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SEA-CD40 in combination with other cancer drugs (pembrolizumab, carboplatin, pemetrexed) for NSCLC or SEA-CD40 with pembrolizumab for melanoma

Up to 18.5 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

Carboplatin
Pembrolizumab
Pemetrexed
SEA-CD40

Trial Overview The study tests an experimental drug called SEA-CD40 combined with pembrolizumab for melanoma patients; and SEA-CD40 with pembrolizumab, carboplatin, and pemetrexed for those with advanced NSCLC. It aims to see if these combinations are effective against these cancers.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: NSCLC ArmExperimental Treatment4 Interventions

SEA-CD40 + pembrolizumab + pemetrexed + carboplatin

Group II: Melanoma ArmExperimental Treatment2 Interventions

SEA-CD40 + pembrolizumab

Carboplatin is already approved in United States, European Union, Canada for the following indications: