A Study of a CD122-Biased Cytokine (NKTR-214) in Combination With Anti-PD-L1 (Atezolizumab) in Patients With Metastatic Urothelial Bladder Cancer or Metastatic Non-Small Cell Lung Cancer (PROPEL)
|Non-Small Cell Lung Cancer Urinary Bladder Neoplasms Neoplasm Metastasis||Drug: Combination of NKTR-214 + atezolizumab||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase 1b, Open-label, Multicenter Study to Investigate the Safety and Preliminary Efficacy of NKTR 214 and Anti-PD-L1 (Atezolizumab) in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer or Metastatic Non-Small Cell Lung Cancer|
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of NKTR-214 in combination with atezolizumab (Tecentriq) [ Time Frame: 100 days after last dose ]Safety and Tolerability of NKTR-214 in combination with atezolizumab (Tecentriq) as evaluated by incidence of drug-related Adverse Events (AEs), Serious Adverse Events (SAEs), and adverse events leading to discontinuation, deaths, and clinical laboratory test abnormalities
- Recommended Phase 2 Dose (RP2D) of NKTR-214 in combination with atezolizumab (Tecentriq) [ Time Frame: 100 days after last dose ]To define the Recommended Phase 2 Dose (RP2D), or Maximum Tolerated Dose (MTD), of NKTR-214 in combination with atezolizumab (Tecentriq), by evaluating the incidence of Dose Limiting Toxicities (DLTs), drug-related AEs, SAEs, adverse events leading to discontinuation, deaths and clinical laboratory test abnormalities.
- Efficacy of NKTR-214 in combination with atezolizumab (Tecentriq) [ Time Frame: Through study completion, an expected average of 2 years ]Efficacy, or the preliminary anti-tumor activity, of NKTR-214 in combination with atezolizumab (Tecentriq), as assessed by the Objective Response Rate (ORR) based on RECIST 1.1
- Progression-Free Survival (PFS) [ Time Frame: Through study completion, an expected average of 2 years ]PFS is defined as the time from date of first dose to the date of the first objectively documented tumor progression or death due to any cause
- Overall Survival (OS) [ Time Frame: Through study completion, an expected average of 2 years ]Overall survival is defined as the time from date of first dose to the date of death.
|Actual Study Start Date:||June 9, 2017|
|Estimated Study Completion Date:||May 30, 2020|
|Estimated Primary Completion Date:||May 30, 2018 (Final data collection date for primary outcome measure)|
Experimental: Combination of NKTR-214 + Atezolizumab
NKTR-214 in escalating doses, will be combined with atezolizumab in several cohorts.
Drug: Combination of NKTR-214 + atezolizumab
NKTR-214: The starting dose will be a 0.006 mg/kg intravenous (IV) infusion administered over 15 (± 5) minutes q3w.
Atezolizumab (anti-PD-L1) will be dosed as per label.
Other Name: Tecentriq (atezolizumab)
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. 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.
NKTR-214 will be combined with atezolizumab. The first NKTR-214 dose to be studied will be 0.006 mg/kg based on the safety observed in the ongoing monotherapy trial with NKTR-214 (Study 15-214-01, NCT02869295). It is estimated that approximately 36 patients will be enrolled to the study to different dose cohorts with doses of NKTR-214 up to 0.009 mg/kg administered IV every 3 weeks (q3w).
Please refer to this study by its ClinicalTrials.gov identifier: NCT03138889
|Contact: Nektar Recruitment||855-482-8676||StudyInquiry@nektar.com|
|United States, Tennessee|
|Investigator Site - Germantown||Recruiting|
|Memphis, Tennessee, United States, 38138|
|United States, Washington|
|Investigator Site - Tacoma||Not yet recruiting|
|Tacoma, Washington, United States, 98405|
|Study Director:||Michael Imperial, MD||Nektar Therapeutics|