IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors (NCT03758781) | Clinical Trial Compass
CompletedPhase 1
IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors
United States12 participantsStarted 2019-02-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* At least 18 years of age
* Participants must have histologically or cytologically confirmed renal cell carcinoma,urothelial carcinoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck or melanoma.
* Participants must have recurrent or metastatic disease that is not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
* Must be willing and able to give informed consent and adhere to protocol therapy; written informed consent and any locally required authorization must be obtained from the participant prior to performing any protocol-related procedures, including screening evaluations
* Prior exposure to PD-1/PD-L1 inhibitor monotherapy, or prior exposure to CTLA-4 inhibitor monotherapy is allowed.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Adequate normal organ and marrow function
* Participants who are receiving therapeutic anti-coagulant therapy are eligible.
* Palliative radiation therapy is allowed to non-target lesions at the discretion of the treating physician.
* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as outlined in RECIST version 1.1.
* Life expectancy of greater than 3 months.
* Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to treatment.
* Body weight must …
What they're measuring
1
Number of Participants Who Experience Dose Limiting Toxicities (DLTs)
Timeframe: Up to Day 28
Trial details
NCT IDNCT03758781
SponsorH. Lee Moffitt Cancer Center and Research Institute