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

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


  • Org Study ID: MCC-19491
  • Secondary ID: N/A
  • NCT ID: NCT03758781
  • Sponsor: H. Lee Moffitt Cancer Center and Research Institute


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


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.

  • Overall Status
  • Start Date
    February 5, 2019
  • Phase
    Phase 1
  • Study Type


Primary Outcome 1 - Measure: Number of Participants Who Experience Dose Limiting Toxicities (DLTs)

Primary Outcome 1 - Timeframe: Up to Day 28


  • Metastatic Cancer
  • Recurrent Cancer
  • Solid Tumor
  • Renal Cell Carcinoma
  • Urothelial Carcinoma
  • Squamous Cell Carcinoma
  • Non-Small Cell Lung Cancer
  • Squamous Cell Carcinoma of the Head and Neck


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

- 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.

Exclusion 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

- 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

- 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

- 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.

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No


Name: Solmaz Sahebjam, MD

Role: Principal Investigator

Affiliation: H. Lee Moffitt Cancer Center and Research Institute

Overall Contact

Name: Solmaz Sahebjam, MD

Phone: N/A

Email: N/A


Facility Status Contact
Facility: H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida 33612
United States
Status: Recruiting Contact: Julia Ida