Phase 2 Study of Nivolumab in Solid Tumors Induced by Prior Radiation Exposure

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT02864316
Phase
PHASE2
Status
Terminated

Conditions

  • Solid Tumors Induced by Prior Radiation Exposure

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to determine whether Nivolumab is effective in the treatment of radiation-induced solid tumors.

Key Dates

Start date
Dec 31, 2016
Status verified
Aug 2019
Primary completion
Aug 31, 2018
Completion
Sep 30, 2018

Study Design

Enrollment
6 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Radiation-Induced Metastatic Sarcoma
    a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression.
  • Experimental: Radiation-Induced Non-Sarcoma Metastatic Solid Tumors
    a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression.

Primary Outcome Measure

Best Objective Response Rate [ Time Frame: Up to 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Cancer Center @ Johns HopkinsBaltimoreMaryland21231-

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