MedTrace Logo

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

NCT03138889 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2023-03-10

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Study Director · Nektar Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-09
Primary Completion
2022-07-05
Completion
2022-08-24
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03138889 on ClinicalTrials.gov