Combination Immunotherapy for Small Cell Lung Cancer
Trial Summary
What is the purpose of this trial?
This is a pilot study of patients who previously received platinum chemotherapy with recurrent SCLC to evaluate the change in the ratio of intratumoral Teff/Treg cells and clinical benefit of treatment with nivolumab and ipilimumab.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as systemic immunosuppressive drugs and high-dose steroids, at least 2 weeks before starting the study. However, inhaled or topical steroids and standard-dose NSAIDs are allowed. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drugs Ipilimumab and Nivolumab for small cell lung cancer?
Research shows that immune checkpoint inhibitors, like Ipilimumab and Nivolumab, have shown promise in treating small cell lung cancer (SCLC) by improving survival when combined with chemotherapy. Although specific data for these drugs in SCLC is still being studied, similar treatments have shown benefits in other cancers, suggesting potential effectiveness.12345
Is the combination of Ipilimumab and Nivolumab generally safe for humans?
The combination of Ipilimumab and Nivolumab has been associated with increased risk of immune-related side effects, which are reactions where the immune system attacks normal cells in the body. These side effects have been observed in treatments for conditions like melanoma and non-small cell lung cancer, and more studies are needed to fully understand their safety.678910
How is the drug combination of Ipilimumab and Nivolumab unique for treating small cell lung cancer?
Research Team
Anne Chiang, MD, PhD
Principal Investigator
Yale University
Eligibility Criteria
This trial is for patients with recurrent extensive stage small cell lung cancer (SCLC) after platinum-based chemotherapy. Eligible participants may have treated brain metastases, an ECOG performance status of 0 to 2, and measurable disease. Excluded are those with HIV/HBV/HCV, recent major surgery or trauma, pregnant or lactating women, active autoimmune diseases requiring treatment in the past 3 months, untreated symptomatic CNS metastases, and recent other treatments.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive combination therapy with nivolumab and ipilimumab, starting with 4 doses of each, followed by nivolumab every 2 weeks until progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of response rate, progression-free survival, and changes in tumor microenvironment
Treatment Details
Interventions
- Ipilimumab and Nivolumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania