IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03758781|
Recruitment Status : Not yet recruiting
First Posted : November 29, 2018
Last Update Posted : November 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: IRX 2 Drug: Nivolumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||February 2019|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||February 2022|
Experimental: IRX-2 Regimen combined with Nivolumab
IRX-2 Regimen (4 ml) combined with Nivolumab (240 mg)
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.
Nivolumab 240 mg will be given via IV infusion once every 2 weeks.
- Number of Participants Who Experience Dose Limiting Toxicities (DLTs) [ Time Frame: Up to Day 28 ]A DLT is defined as any Grade 3 or higher toxicity which occurs during the DLT evaluation period of 4 weeks (during Cycle 1 Day 1 and Cycle 1 Day 28) and considered related to study treatment. Toxicity that is clearly and directly related to the primary disease or to another etiology is excluded.
- Objective Response Rate [ Time Frame: Up to 12 months ]Objective response determined using Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 and Immune Response Evaluation Criteria in Solid Tumors (iRECIST) criteria.
- Progression Free Survival of combination therapy [ Time Frame: Up to 12 months ]Progression free survival defined as the time from Day 1 of treatment to evidence of progression. Progression will be defined by RECIST Version 1.1
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03758781
|United States, Florida|
|H Lee Moffitt Cancer Center and Research Institute||Not yet recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Nevena Ugrenovic 813-745-2025|
|Sub-Investigator: Christine Chung, MD|
|Sub-Investigator: Benjamin Creelan, MD|
|Sub-Investigator: Jhanelle Gray, MD|
|Sub-Investigator: Nikhil Khushalani, MD|
|Sub-Investigator: Michael Shafique, MD|
|Sub-Investigator: Jingsong Zhang, MD, PhD|
|Principal Investigator:||Solmaz Sahebjam, MD||H. Lee Moffitt Cancer Center and Research Institute|