Trials / Completed
CompletedNCT03758781
IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors
The IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors: A Phase 1b Study to Evaluate the Safety, Determine Recommended Phase 2 Dose (RP2D), and Investigate the Biologic and Clinical Activity
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed 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 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.
Conditions
- Metastatic Cancer
- Recurrent Cancer
- Solid Tumor
- Renal Cell Carcinoma
- Urothelial Carcinoma
- NSCLC
- Squamous Cell Carcinoma
- Non-Small Cell Lung Cancer
- Squamous Cell Carcinoma of the Head and Neck
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IRX 2 | 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. |
| DRUG | Nivolumab | Nivolumab 240 mg will be given via IV infusion once every 2 weeks. |
Timeline
- Start date
- 2019-02-13
- Primary completion
- 2021-02-21
- Completion
- 2021-08-11
- First posted
- 2018-11-29
- Last updated
- 2023-04-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03758781. Inclusion in this directory is not an endorsement.