NCT03138889

Bempegaldesleukin and Pembrolizumab With or Without Chemotherapy in Locally Advanced or Metastatic Solid Tumors

A Phase 1/2, Open-Label, Multicenter Study to Investigate the Safety and Preliminary Efficacy of Combined Bempegaldesleukin (NKTR-214) and Pembrolizumab With or Without Chemotherapy in Patients With Locally Advanced or Metastatic Solid Tumors

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Nektar Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to assess the safety and tolerability, and to assess the preliminary clinical benefit of NKTR-214 when combined with pembrolizumab (KEYTRUDA®) with or without chemotherapy. The study is comprised of two groups; dose optimization and dose expansion cohorts. Dose Optimization included first-line and second-line advanced or metastatic solid tumors including non-small cell lung cancer (NSCLC) The dose expansion cohort will include first-line NSCLC patients.

Detailed 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, fully humanized, engineered monoclonal antibody of IgG1 isotype that promotes anti-tumor effects. The study will evaluate the clinical benefit, safety and tolerability of combining NKTR-214 with pembrolizumab with or without chemotherapy. Each dose expansion cohort will enroll approximately 100 new patients. Dose Optimization evaluated an every three-week dose regimen (q3w) of NKTR-214 in combination with pembrolizumab given that the optimal dose and dosing schedule of NKTR-214 in combination with pembrolizumab remains unknown. The previously established recommended Phase 2 dose (0.006 mg/kg) of NKTR-214 was studied in combination with nivolumab. Dose Expansion: NKTR-214 in combination with pembrolizumab will be evaluated in first-line non-small cell lung cancer (NSCLC). The NKTR-214 dose to be studied is 0.006 mg/kg q3w. This dose is based on the recommended phase 2 dose noted in the monotherapy trial with NKTR-214 (Study 15-214-01, NCT02869295) and an ongoing combination trial (16-214-02, NCT02983045). Pembrolizumab will be administered at a dose of 200mg q3w. Following data review for safety and efficacy, additional patients may be dosed using the findings from the dose optimization cohorts.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	NKTR-214	NKTR-214: The dose will be 0.008 mg/kg intravenous (IV) infusion administered over 30 (± 5) minutes q3w. The maximum dose of NKTR-214 will be 0.012 mg/kg. This will include a fixed 3+3 dose escalation followed by intra-patient step-up dose escalation based on tolerability.
DRUG	Pembrolizumab	Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.
DRUG	NKTR-214	NKTR-214: The dose will be 0.006 mg/kg intravenous (IV) infusion.
DRUG	NKTR-214	NKTR-214: The dose will be 0.010 mg/kg intravenous (IV) infusion.
DRUG	Cisplatin	Cisplatin will be dosed per the pharmacy manual
DRUG	Carboplatin	Carboplatin will be dosed per the pharmacy manual
DRUG	Nab paclitaxel	Nab-paclitaxel will be dosed per local practice and label
DRUG	Paclitaxel	Paclitaxel will be dosed per local practice and label
DRUG	Pemetrexed	Pemetrexed will be dosed per the pharmacy manual
DRUG	Atezolizumab	Atezolizumab will be dosed per current label indication

Timeline

• Start date: 2017-06-09
• Primary completion: 2022-07-05
• Completion: 2022-08-24
• First posted: 2017-05-03
• Last updated: 2023-03-10
• Results posted: 2023-03-09

Locations

38 sites across 5 countries: United States, Australia, France, Germany, Spain

Regulatory

• FDA-regulated drug study