Nivolumab in Treating Patients With Metastatic Adrenocortical Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT02720484
Phase
PHASE2
Status
Terminated

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Nivolumab — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Mar 30, 2016
Status verified
Feb 2019
Primary completion
Apr 17, 2017
Completion
Nov 2, 2018

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Nivolumab)
    Patients receive nivolumab IV over 30 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall Response Rate [ Time Frame: From the start of treatment and every 8 weeks/2 cycles with a range of cycles attempted 1-15. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611-
The Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

Find similar trials in Chicago, IL

By research site
Northwestern University· Chicago, ILThe Ohio State University Comprehensive Cancer Center· Columbus, OH

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