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

Extensive Stage Small Cell Lung Carcinoma Clinical Trial

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

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Extensive Stage Small Cell Lung Carcinoma
• Lung Neoplasms
• Small Cell Lung Carcinoma

• NCT number: NCT03402880
• Study type: Interventional
• Source: City of Hope Medical Center
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 2018
• Completion date: December 2019