NCT02720484

Nivolumab in Treating Patients With Metastatic Adrenocortical Cancer

Phase II Study of Nivolumab (Anti-PD-1 Antibody) for Treatment of Metastatic Adrenocortical Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective will be to assess overall response rate of nivolumab in patients with metastatic or locally advanced adrenocortical carcinoma. Nivolumab was recently approved by U.S. Food and Drug Administration (FDA) for the treatment of advanced melanoma, non-small cell lung cancer and renal cell carcinoma. It is considered investigational for the treatment of advanced or refractory adrenocortical carcinoma. "Investigational" means that the drug is not approved by the USFDA or not approved for the indication under investigation. Nivolumab could shrink adrenocortical carcinoma but it could also cause side effects. Researchers hope to learn if the study drug will shrink the cancer and hopefully to relieve symptoms that are related to the cancer.

Detailed description

PRIMARY OBJECTIVES: I. To assess overall response rate of nivolumab in patients with metastatic or locally advanced adrenocortical carcinoma (ACC). SECONDARY OBJECTIVES: I. To assess the progression free survival defined as time from date of first nivolumab infusion until date of death or evidence of progression of disease as assessed by computed tomography (CT) imaging every 8 weeks according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1. II. To assess the overall survival defined as time from date of first nivolumab infusion until death of patients with metastatic or locally advanced ACC. III. To assess the safety and tolerability profile of nivolumab described by number, frequency, and severity of adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.3 assessed every 2 weeks while patients are on therapy. TERTIARY OBJECTIVES: I. To assess the overall response rate, progression free survival and overall survival according to tumor programmed cell death 1 ligand 1 (PD-L1) and programmed cell death 1 ligand 2 (PD-L2) expression. II. To assess the overall response rate, progression free survival and overall survival according to serum interleukin levels and peripheral T cell profile levels. III. To measure humoral and cellular responses to tumor antigens on serum samples by measuring the levels of cytokines (ie, interleukin \[IL\] -2, IL-6, IL-8, IL-10, IL-18, interferon \[IFN\] gamma and tumor necrosis factor \[TNF\]-alpha) and peripheral blood lymphocyte phenotype. OUTLINE: Patients receive nivolumab intravenously (IV) over 30 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity, or withdrawal of consent. After completion of study treatment, patients are followed up every 3 months for up to 2 years.

Conditions

• Metastatic Carcinoma in the Adrenal Cortex
• Recurrent Adrenal Cortex Carcinoma
• Stage III Adrenal Cortex Carcinoma
• Stage IV Adrenal Cortex Carcinoma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Nivolumab	Given IV

Timeline

• Start date: 2016-03-30
• Primary completion: 2017-04-17
• Completion: 2018-11-02
• First posted: 2016-03-28
• Last updated: 2019-05-01
• Results posted: 2019-05-01

Locations

2 sites across 1 country: United States