IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT03758781
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • IRX 2 — DRUG
    IRX-2 Regimen: 21 day regimen of cyclophosphamide on Day 1 and subcutaneous IRX-2 injections for 10 days between Days 4 and 18. This 21 day regimen will be given every 12 weeks.
  • Nivolumab — DRUG
    Nivolumab 240 mg will be given via IV infusion once every 2 weeks.

Study Details

This study is to determine the safety of IRX-2 Regimen combined with Nivolumab in patients with recurrent metastatic solid tumors. Researchers believe that this combination will have a tolerable safety profile and will increase the response rate in comparison to Nivolumab alone.

Key Dates

Start date
Feb 13, 2019
Status verified
Apr 2023
Primary completion
Feb 21, 2021
Completion
Aug 11, 2021

Study Design

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

Arms

  • Experimental: IRX-2 Regimen combined with Nivolumab
    IRX-2 Regimen (4 ml) combined with Nivolumab (240 mg)

Primary Outcome Measure

Number of Participants Who Experience Dose Limiting Toxicities (DLTs) [ Time Frame: Up to Day 28 ]

Locations (1)

FacilityCityStateZIPSite coordinators
H Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-

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By research site
H Lee Moffitt Cancer Center and Research Institute· Tampa, FL

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