Clinical Trial: Nivolumab in Treating Patients With Metastatic Adrenocortical Cancer

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief 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 Summary:

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 tu
Sponsor: Northwestern University

Current Primary Outcome: Overall Response Rate [ Time Frame: Every 8 weeks up to 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Progression-free survival (PFS) [ Time Frame: Every 8 weeks from time of first treatment up to 2 years ]
  PFS will be assessed from date of first nivolumab infusion until date of death or evidence of progression of disease by CT imaging every 8 weeks according to RECIST criteria 1.1.
• Overall survival (OS) [ Time Frame: Every 2 weeks while on treatment then every 3 months, up to 2 years ]
  Patients will be assessed for survival (either by routine clinic visit our by phone) every 2 weeks while on treatment and every 3 months for up to 2 years after completion of trial to document survival and disease progression.
• Incidence of adverse events [ Time Frame: Every 2 weeks while on treatment, up to 12 weeks after final dose ]
  To access 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.

Original Secondary Outcome: Same as current

Information By: Northwestern University

Dates:
Date Received: March 16, 2016
Date Started: March 2016
Date Completion: May 2020
Last Updated: May 24, 2017
Last Verified: May 2017