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

NCT03758781 | Completed Phase 1 FDA Drug

• 1 other identifier: MCC-19491
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experience Dose Limiting Toxicities (DLTs)

  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.

  Up to Day 28

Secondary Outcomes (2)

• Objective Response Rate

  Up to 12 months

• Progression Free Survival of combination therapy

  Up to 12 months

Study Arms (1)

IRX-2 Regimen combined with Nivolumab

EXPERIMENTAL

IRX-2 Regimen (4 ml) combined with Nivolumab (240 mg)

Drug: IRX 2; Drug: Nivolumab

Interventions

IRX 2 DRUG

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.

IRX-2 Regimen combined with Nivolumab

Nivolumab DRUG

Nivolumab 240 mg will be given via IV infusion once every 2 weeks.

IRX-2 Regimen combined with Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Recurrence; Carcinoma, Renal Cell; Carcinoma, Transitional Cell; Carcinoma, Squamous Cell; Carcinoma, Non-Small-Cell Lung; Squamous Cell Carcinoma of Head and Neck

Interventions

IRX 2; Nivolumab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplasms, Squamous Cell; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Head and Neck Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Rohit Jain, MD, MPH

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: November 29, 2018
• Study Start: February 13, 2019
• Primary Completion: February 21, 2021
• Study Completion: August 11, 2021
• Last Updated: April 14, 2023

Record last verified: 2023-04

Locations

US (1)