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Protocol No. UW16116

Principal Investigator McNeel, Douglas

Phase I

Age Group Adult

Scope National

Sponsor Type Industry

Title A Phase I/Ib Study of Subcutaneous Recombinant Human NIZ985 ((hetIL-15) (IL15/sIL-15Rα)) alone and in combination with PDR001 in Adults with Metastatic Cancers

Objective The purpose of this study is to determine the doses of two investigational drugs, heterodimeric human interleukin-15 (also called NIZ985 and het IL-15 solution) and PDR001 which is an antibody that is being developed by a company named Novartis. This is the first time that this combination will be studied in humans. Patients will be enrolled onto either the dose escalation or dose expansion parts of the study.

Treatment Heterodimeric human interleukin-15 (also called NIZ985 and het IL-15 solution) which is a man-made (synthetic) version of a protein (cytokine) normally produced by your white blood cells (WBCs) that might increase your WBCs and immune system's ability to help fight your cancer. The other, PDR001, blocks a protein called PD-1 which is found on specific white blood cells called T- lymphocytes, which are involved in the immune response. By blocking PD-1, PDR001 may increase the activity of T-lymphocytes which may reduce the growth of your tumor. Patients will be enrolled onto either the dose escalation or dose expansion parts of the study. Your doctor will tell you which part of the study you will be enrolled in and whether you will receive NIZ985 (hetIL-15) alone or in combination with PDR001, and the dose of each drug.

Description Dose escalation is the first part of this study. Patients will be enrolled in groups and will receive either NIZ985 (hetIL-15) alone or in combination with PDR001. If no significant problems or side effects are observed in the patients who received the combination, a second group of patients will be given higher doses of NIZ985 (hetIL-15), the dose of PDR001 will always be the same. At the end of this step-wise process, the maximum tolerated dose (MTD) or recommended dose for expansion (RDE) will be identified. In the second part of the study (called dose expansion), patients will receive either NIZ985 (hetIL-15) alone or in combination with PDR001 based on what tumor types usually respond to PD-1 inhibitors. The treatment that patients receive on these two groups will be the same, the only difference is whether they have a cancer that is usually more sensitive to PD-1 inhibitors. NIZ985 (het IL-15) solution will be given as a shot under the skin (subcutaneous [SC] injection). PDR001 is given as an infusion. The infusion will be given on day 1 of each treatment cycle. The infusion usually will take 30 minutes to complete.

Key Eligibility
  • Patients must have histologically confirmed solid tumor malignancy that is metastatic or unresectable and have progressed on at least 1 prior therapy and for whom standard curative or palliative measures do not exist or are associated with minimal patient survival benefit
  • Patients must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines
  • Patients on bisphosphonates for any cancer or on hormone therapy for prostate cancer may continue this therapy. However, patients with prostate cancer must have confirmed metastatic disease that has progressed despite hormonal therapy producing castrate levels of testosterone
  • Secondary (metastatic) CNS tumors are allowed provided that they are clinically stable for a period of 30 days prior to study entry and there is not a requirement for 10 mg or more of prednisone or equivalent steroid per day or anti-convulsant therapy
  • Patients are not eligible if they have received any prior IL-15 treatment. No cytotoxic therapy, immunotherapy, radiotherapy, major surgery or antitumor vaccines are allowed within 4 weeks prior to enrollment. Patients may have had prior checkpoint inhibitors (such as anti- CTLA-4 or anti-PD1/PD-L1) or nitrosoureas or mitomycin C and must be > 6 weeks prior to C1D1
  • Patients with primary brain cancers or active CNS metastases should be excluded from this clinical trial
  • Patients with documented HIV infection or positive serology, active bacterial infections, serologic or PCR evidence for active or chronic hepatitis B or hepatitis C are excluded
  • Patients with a history of severe asthma or absolute requirement for chronic oral corticosteroid medications are excluded
  • Patients with active, known or suspected autoimmune disease are excluded
  • Patients requiring chronic treatment with systemic steroid therapy ≥10 mg/day prednisone or similar, other than replacement dose steroids in the setting of adrenal insufficiency are excluded
  • Pregnant or nursing (lactating) women are excluded

Applicable Disease Sites Anal; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Kidney; Liver; Lung; Melanoma/Skin cancer; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Uterus

Therapies Involved Immunotherapy

Drugs Involved NIZ985; PDR001; hetlL-15 (NIZ985)

Status Open

Participating Institutions UW Hospital and Clinics