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Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence

NCT04410445 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 765

Last updated 2023-04-21

Study results available
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Summary

The main purpose of this study is to compare the efficacy of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA/B/C/D, or Stage IV cutaneous melanoma who are at high risk for recurrence.

Conditions

  • Melanoma
  • Melanoma Stage III
  • Melanoma Stage IV
  • Melanoma (Skin)

Interventions

BIOLOGICAL

Bempegaldesleukin

Specified dose on specified days

BIOLOGICAL

Nivolumab

Specified dose on specified days

Sponsors & Collaborators

Principal Investigators

  • Study Director · Nektar Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-27
Primary Completion
2022-09-22
Completion
2022-09-22
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Czechia
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Netherlands
  • New Zealand
  • Poland
  • Portugal
  • Romania
  • Russia
  • Spain
  • United Kingdom

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 NCT04410445 on ClinicalTrials.gov