NCT03402880

ALCMI-005: Pembrolizumab and Epacadostat in Treating Patients With Extensive Stage Small Cell Lung Cancer

ALCMI-005: Phase II Study of Pembrolizumab and Epacadostat for Small Cell Lung Cancer After Previous Treatment With Platinum-Based Therapy

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well pembrolizumab and epacadostat work in combination treating patients with extensive stage small cell lung cancer. Monoclonal antibodies, such as pembrolizumab, may assist the immune system in recognizing cancer cells leading to elimination of those cells. Epacadostat may prevent down-regulation of T-cells, which means it can boost the immune system. Giving pembrolizumab and epacadostat together may work better than either drug alone in treating extensive stage small cell lung cancer.

Detailed description

PRIMARY OBJECTIVES: I. To assess the objective response rate (ORR) as measured by a modified Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 in subjects with extensive stage small cell lung cancer undergoing treatment with combination pembrolizumab and epacadostat. SECONDARY OBJECTIVES: I. To assess the progression free survival (PFS) as measured by a modified RECIST v1.1 in subjects with extensive stage small cell lung cancer undergoing treatment with combination pembrolizumab and epacadostat. II. To assess the overall survival in subjects with extensive stage small cell lung cancer undergoing treatment with combination pembrolizumab and epacadostat. III. To assess the \>= grade 3 drug related adverse event profile of combination pembrolizumab and epacadostat in subjects with extensive stage small cell lung cancer. TERTIARY OBJECTIVES: I. To assess tumor genomics, T-cell, myeloid-derived suppressor cells, and receptors (including PD-L1, IDO1, etc) in relation to response rates. II. To assess cell free deoxyribonucleic acid (DNA) (cfDNA), cell free ribonucleic acid (RNA) (cfRNA), micro RNA (miRNA), and exosomes as predictors for outcomes to treatment with pembrolizumab and epacadostat in subjects with extensive stage small cell lung cancer and to evaluate plasma for predictive markers for outcomes to therapy. III. Blood samples will be also be stored for future evaluation. OUTLINE: Patients receive pembrolizumab intravenously (IV) on day 1 and epacadostat orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. Patients benefiting from treatment may continue for an additional 17 courses. After completion of study treatment, patients are followed up at 30 days, then every 12 weeks thereafter.

Conditions

• Extensive Stage Small Cell Lung Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	Given IV
DRUG	Epacadostat	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2018-12-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2018-01-18
• Last updated: 2018-10-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study