Nivolumab With Ipilimumab in Subjects With Neuroendocrine Tumors

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT03420521
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a single arm open-label design study looking at Nivolumab plus Ipilimumab in patients with Advanced Neuroendocrine Tumors. Patients will be dosed Nivolumab 240mg IV over 60 minutes every 2 weeks (Q2W) and Ipilimumab 1mg/kg IV over 30 minutes every 6 weeks (Q6W). One cycle will include 3 doses of Nivolumab and 1 dose of Ipilimumab. The objective of this study is to evaluate the objective response rate of combination Nivolumab and Ipilimumab in advanced, well-differentiated neuroendocrine tumors. Durability of response, and progression free survival (PFS) will also be described.

Key Dates

Start date
Mar 9, 2018
Status verified
Dec 2023
Primary completion
Nov 24, 2021
Completion
Nov 24, 2021

Study Design

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

Arms

  • Other: Nivolumab plus Ipilimumab
    Nivolumab 240 mg IV over 60 minutes every 2 weeks (Q2W) Ipilimumab 1mg/kg IV over 30 minutes every 6 weeks (Q6W)

Primary Outcome Measure

Objective Response Rate (ORR) of Neuroendocrine Tumor (NET) of the Lung, Pancreas, and Gastrointestinal (GI) Tract [ Time Frame: up to 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Medical InstitutionBaltimoreMaryland21287-

Find similar trials in Baltimore, MD

By condition
Neuroendocrine tumors
By specialty
Oncology
By research site
Johns Hopkins Medical Institution· Baltimore, MD

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