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A Study to Evaluate Safety and Efficacy of Multiple Dosing With VB10.NEO and Bempegaldesleukin (NKTR-214) Immunotherapy in Patients With Locally Advanced or Metastatic Cancer

NCT03548467 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2023-04-21

No results posted yet for this study

Summary

This open labelled first in human dose phase 1/2a study is designed to evaluate safety, feasibility and efficacy of multiple dosing with individualised VB10.NEO and bempegaldesleukin (NKTR-214) immunotherapy in patients with locally advanced or metastatic solid tumours.

Conditions

  • Locally Advanced or Metastatic Solid Tumours

Interventions

BIOLOGICAL

VB10.NEO

VB10.NEO is a vaccine and is supplied as a sterile, ready to use solution (14 vaccinations will be given).

DRUG

Bempegaldesleukin

0.006 mg/kg bempegaldesleukin (NKTR-214) will be administered intravenously q4w for up to 11 doses starting from week 11 or at any dosing visit up to week 34 and for up to week 50 (up to 11 doses). The first 2 doses will be in a Q3W interval and following doses in Q4W intervals.

Sponsors & Collaborators

  • Nektar Therapeutics

    collaborator INDUSTRY

  • Vaccibody AS

    collaborator INDUSTRY

  • Nykode Therapeutics ASA

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-04
Primary Completion
2023-01-30
Completion
2023-01-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

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 NCT03548467 on ClinicalTrials.gov