Last updated on December 2018

A Study of a CD122-Biased Cytokine (NKTR-214) in Combination With Anti-PD-1 (Pembrolizumab) and of NKTR-214 in Combination With Anti-PD-L1 (Atezolizumab) in Patients With Select Advanced or Metastatic Solid Tumors

Brief description of study

This study is to assess the safety and tolerability, and to assess the preliminary clinical benefit of NKTR-214 when combined with pembrolizumab (Keytruda) or atezolizumab (Tecentriq). Approximately 75 patients with stage III or stage IV melanoma, locally advanced or metastatic urothelial carcinoma, or stage IV non-small cell lung cancer (NSCLC) will be enrolled. Patients with melanoma or NSCLC cancer will receive a combination of NKTR-214 and pembrolizumab. Patients with urothelial cancer will receive a combination of NKTR-214 and atezolizumab. All drugs target the immune system and may act synergistically to promote anticancer effects.

Detailed Study Description

NKTR-214 is a cytokine (investigational agent) that is designed to target CD122, a protein which is found on certain immune cells (known as CD8+ T Cells and Natural Killer Cells) to expand these cells to promote their anti-tumor effects. Pembrolizumab is a programmed death receptor -1 (PD-1) blocking antibody and atezolizumab is a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death-ligand 1 (PD-L1) that promotes anti-tumor effects.

The study will evaluate the clinical benefit, safety and tolerability of combining NKTR-214 with pembrolizumab or atezolizumab and will enroll approximately 75 patients into two separate arms concurrently. The first arm will evaluate an every three-week dose regimen (q3w) of NKTR-214 in combination with pembrolizumab in up to 46 patients in approved treatment settings of pembrolizumab, including patients with melanoma or non-small cell lung cancer. The second arm will evaluate a q3w dose regimen of NKTR-214 in combination with atezolizumab in up to 29 patients in approved treatment settings of atezolizumab, including patients with urothelial carcinoma. The NKTR-214 dose to be studied is 0.006 mg/kg q3w based on the safety observed in the monotherapy trial with NKTR-214 (Study 15-214-01, NCT02869295) and an ongoing combination trial (16-214-02, NCT02983045). The dose of pembrolizumab or atezolizumab to be studied will be that in their approved labelling.

For NKTR-214 + Pembrolizumab, eligible patients include:

  • Melanoma: 1st line; PD-L1 Status- all
  • NSCLC: 1st line; PD-L1 Status 50%

For NKTR-214 + Atezolizumab, eligible patients include:

  • Urothelial carcinoma: 1st line; PD-L1 Status - all
  • Disease progression within 12 months of neoadjuvant or adjuvant treatment with chemotherapy
  • Urothelial carcinoma: 2nd line; PD-L1 Status - all
  • Disease progression during or following platinum-containing chemotherapy.

Clinical Study Identifier: NCT03138889

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Investigator Site - Falls Church

Falls Church, VA United States
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Recruitment Status: Open

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