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Clinical Trial 19356

Cancer Type: Head & Neck
Study Type: Treatment
NCT#: NCT03381183

Phase: Phase I
Prinicipal Investigator: Christine Chung

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Overview

Study Title

A Phase 1b Trial of the IRX-2 Regimen and Durvalumab (MEDI4736), in Patients with Incurable Head and Neck Squamous Cell Carcinoma

Summary

The purpose of this study is to see if the IRX-2 regimen and Durvalumab will have a tolerable safety profile and will increase the intratumoral immune profile compared with the pretreatment tumors.

Objective

Primary Objectives: To determine the safety profile of a combination of the IRX-2 regimen, durvalumab and tremelimumab (IDT). To evaluate the biological effects of IDT determined by changes in the expression of PD-L1 in the tumor cells and immune cells in tumor microenvironment. To evaluate the biological effects of IDT determined by changes in the density of lymphocyte infiltration in the tumor and tumor microenvironment. Secondary Objective(s): To evaluate the objective clinical response rate of IDT. To evaluate the progression-free survival of IDT at 6 months.

Treatments

Therapies

Medications

AMP-514 (Durvalumab); Durvalumab (); IRX-2 (); MEDI4736 (Durvalumab); cyclophosphamide (); cytoxan (cyclophosphamide)

Inclusion Criteria

  • Participants must have histologically or cytologically confirmed squamous cell carcinoma of oral cavity, oropharynx, paranasal sinuses, nasal cavity, hypopharynx, or larynx. Squamous cell carcinoma of unknown primary in cervical lymph node can be included only if p16 status is positive.
  • Must have recurrent or metastatic HNSCC that is not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy). Participants with persistent disease following radiation therapy administered with or without a chemotherapy sensitizer may also be included.
  • 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 patient prior to performing any protocol-related procedures, including screening evaluations
  • At least 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) 0-2
  • Adequate normal organ and marrow function as outlined in protocol documentation
  • 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 Response Evaluation Criteria in Solid Tumors (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 enrollment.
  • Body weight must be > 30 Kg.
  • Participants must have a mass that is accessible and safe for repeat biopsy Note: if a participant is considered to be amendable to biopsy at the time of enrollment but is then unable to undergo a post-treatment biopsy this will not be considered an ineligible subject, although the missed biopsy will still constitute a protocol deviation.

  • Exclusion Criteria

  • Prior exposure to a combination of IRX-2 regimen, and PD-1/PD-L1 inhibitors
  • 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 and durvalumab
  • Any unresolved toxicity NCI Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria, and except toxicities the investigator deems irreversible.
  • Grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician
  • Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with the IRX- regiemtn or durvalumab may be included only after consultation with the study physician.
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion: Patients with vitiligo or alopecia; Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement. Any chronic skin condition that does not require systemic therapy; Patients without active disease in the last 2 years may be included but only after consultation with the study physician; Patients with celiac disease controlled by diet alone.
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion: Intranasal, inhaled, topical steroid, or local steroid injections (e.g., intra articular injection); Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent; Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
  • Concomitant anticoagulation with oral anticoagulants (such as warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (such as clopidogrel) that cannot be safely stopped.
  • Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of durvalumab. Note: Local surgery of isolated lesions for palliative intent is acceptable.
  • History of allogenic organ transplantation.
  • Symptomatic cardiopulmonary disease (including congestive heart failure and hypertension), coronary artery disease, serious arrhythmia or chronic lung disease. Patients 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 bacterial 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).
  • Other exclusions apply

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