Spots Global Cancer Trial Database for IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors

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Trial Identification

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

Official Title: 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

Study ID: NCT03758781

Conditions

Squamous Cell Carcinoma

Non-Small Cell Lung Cancer

Squamous Cell Carcinoma of the Head and Neck

Interventions

IRX 2

Nivolumab

Study Description

Brief 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.