IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 100
Summary
- Conditions
- Metastatic Cancer
- Non -Small Cell Lung Cancer
- NSCLC
- Recurrent Cancer
- Renal Cell Carcinoma
- Solid Tumor
- Squamous Cell Carcinoma
- Squamous Cell Carcinoma of the Head and Neck
- Urothelial Carcinoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The first phase of this trial is to establish the safety of IRX-2 Regimen combined with Nivolumab. The IRX-2 Regimen is a 21-day regimen of cyclophosophamide on Day 1 and subcutaneous IRX-2 injections for 10 days between Days 4 and 18. If no dose limiting toxicities (DLTs) are observed during the fi...
The first phase of this trial is to establish the safety of IRX-2 Regimen combined with Nivolumab. The IRX-2 Regimen is a 21-day regimen of cyclophosophamide on Day 1 and subcutaneous IRX-2 injections for 10 days between Days 4 and 18. If no dose limiting toxicities (DLTs) are observed during the first 4 weeks of treatment, the enrollment will continue in a dose expansion phase. If there is a study treatment related DLT in 1 of 6 patients, the same dose will be investigated at the dose expansion cohorts. If study treatment related DLT is observed in 2 of 6 patients, accrual will be stopped and new dose levels or treatment sequences will be considered.
Tracking Information
- NCT #
- NCT03758781
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Solmaz Sahebjam, MD H. Lee Moffitt Cancer Center and Research Institute
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