SEA-CD40 Combination Therapy for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the effectiveness of a new drug, SEA-CD40, when combined with other cancer treatments for certain types of cancer. It specifically targets individuals with melanoma that has returned or cannot be surgically removed, and those with non-small cell lung cancer (NSCLC) that has spread. Participants with NSCLC will receive SEA-CD40 along with three other drugs: pembrolizumab (an immunotherapy drug), carboplatin (a chemotherapy drug), and pemetrexed (a chemotherapy drug). Those with melanoma will receive SEA-CD40 and pembrolizumab. This trial may suit individuals with advanced melanoma or NSCLC who have not previously received certain therapies. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, it does mention that you cannot be on chronic systemic steroids in excess of physiologic replacement. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the treatment SEA-CD40, when combined with pembrolizumab and chemotherapy drugs like carboplatin and pemetrexed, yields promising results for safety and effectiveness. Early studies suggest this combination can enhance the immune system's ability to fight cancer.
Most patients have tolerated the SEA-CD40 and pembrolizumab treatment well. However, some experienced serious side effects, such as immune system issues and infections. A few patients discontinued treatment due to lung problems or severe infection reactions.
The combination of pembrolizumab with pemetrexed and carboplatin has a strong history of safety in treating advanced lung cancer. Many studies have demonstrated this combo to be effective and generally well-tolerated by patients over time.
Overall, while SEA-CD40 remains under study, its safety with other drugs appears promising based on research and past studies. However, awareness of the potential for serious side effects is important.12345Why are researchers excited about this trial's treatments?
Most treatments for non-small cell lung cancer (NSCLC) involve chemotherapy and immunotherapy, like carboplatin, pemetrexed, and pembrolizumab. However, SEA-CD40 is unique because it targets the CD40 protein on immune cells, potentially boosting the body's immune response against cancer. Researchers are excited about SEA-CD40 because it could enhance the effectiveness of existing treatments by making the immune system more aggressive in attacking cancer cells. This novel mechanism of action sets it apart and offers hope for improved outcomes in NSCLC patients.
What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer and melanoma?
Research shows that the SEA-CD40 drug appears promising when combined with other cancer treatments. Early studies have found that SEA-CD40 can help the immune system fight cancer cells more effectively. In this trial, participants in the NSCLC Arm will receive a combination of SEA-CD40, pembrolizumab, carboplatin, and pemetrexed. This combination has demonstrated positive effects against advanced non-small cell lung cancer (NSCLC), working together to stop cancer cells from growing and spreading. Meanwhile, participants in the Melanoma Arm will receive SEA-CD40 combined with pembrolizumab, which has shown promise in treating melanoma. Although more research is needed, the initial results offer hope for people with these challenging conditions.12456
Who Is on the Research Team?
Jonathan Hayman, MD
Principal Investigator
Seagen Inc.
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive SEA-CD40 in combination with other cancer drugs (pembrolizumab, carboplatin, pemetrexed) for NSCLC or SEA-CD40 with pembrolizumab for melanoma
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Pembrolizumab
- Pemetrexed
- SEA-CD40
Carboplatin is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Seagen Inc.
Lead Sponsor
Dr. Roger Dansey
Seagen Inc.
Chief Medical Officer since 2018
MD from University of Witwatersrand
David R. Epstein
Seagen Inc.
Chief Executive Officer since 2022
BSc in Pharmacy from Rutgers University, MBA from Columbia University
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University