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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedIRX 2 and Nivolumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 14, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?H. Lee Moffitt Cancer Center and Research Institute

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Interventions being studied: Drug: IRX 2; Drug: Nivolumab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→Recurrent or relapsed→

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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 be greater than 66 pounds.

Reasons someone may not be able to joinExclusion criteria

Prior exposure to a combination of IRX-2 regimen, PD-1/PD-L1 inhibitors and CTLA-4 inhibitors are excluded. Prior exposure to PD-1/PD-L1 inhibitors is allowed.
Radiation therapy with a curable intent within 30 days of first dose of study treatment is excluded. However, radiation therapy with a palliative intent is allowed to treat after 14 days from the last dose of radiation.
Any medical contraindications or previous therapy that would preclude treatment with the IRX-2 Regimen, or nivolumab.
Any unresolved toxicity Grade 2 or greater from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
Participants with irreversible toxicity not reasonably expected to be exacerbated by treatment with IRX-2, or nivolumab may be included only after consultation with the study physician.
Active or prior documented autoimmune or inflammatory disorders
Current or prior use of immunosuppressive medication within 14 days before the first dose of study treatment. Some exceptions apply.
Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study treatment. Note: Local surgery of isolated lesions for palliative intent is acceptable.
History of allogenic organ transplantation.
Symptomatic cardiopulmonary disease, coronary artery disease, serious arrhythmia or chronic lung disease. Participants with these conditions who are stable with relatively minor symptoms and who are appropriate candidates for systemic treatments need not be excluded.
Myocardial infarction within the last 3 months.
Known infection with hepatitis B, hepatitis C, or HIV.
Signs or symptoms of systemic infection (use of antibiotics to treat superficial infection or contamination of tumor shall not, by itself, be considered evidence of infection).
Clinically significant gastritis or peptic ulcer disease
Stroke or other symptoms of cerebral vascular insufficiency within the last 3 months.
Allergy to ciprofloxacin (or other quinolones).
Previous diagnosis of invasive cancer from which the individual is not disease-free AND that has required treatment within the past 3 years, except for superficial skin, cervical cancer in-situ, or early stage prostate or bladder cancer (i.e. treatment with curative intent and long term disease-free expectations).
History of leptomeningeal carcinomatosis
Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
Female participants who are pregnant or breastfeeding or male or female participants of reproductive potential who are not willing to employ effective birth control from screening to 1 year after the last dose of study treatment.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

H Lee Moffitt Cancer Center and Research InstituteTampa, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 14, 2023. Always confirm current availability with the study team.

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