Clinical Trials /

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

Description:

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.

Related Conditions:
  • Cutaneous Melanoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence
  • Official Title: A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)

Clinical Trial IDs

  • ORG STUDY ID: 20-214-29/CA045-022
  • NCT ID: NCT04410445

Conditions

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

Interventions

DrugSynonymsArms
BempegaldesleukinNKTR-214, BMS-986321Combination of bempegaldesleukin (NKTR-214) + nivolumab
NivolumabOpdivo®, BMS-936558Combination of bempegaldesleukin (NKTR-214) + nivolumab

Purpose

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.

Detailed Description

      The main purpose of this study is to compare the efficacy, as measured by recurrence-free
      survival (RFS) by blinded independent central review (BICR), of bempegaldesleukin plus
      nivolumab versus nivolumab in patients with completely resected Stage IIIA (lymph node [LN]
      metastasis > 1 mm), Stage IIIB/C/D, or Stage IV (American Joint Committee on Cancer [AJCC]
      8th edition) cutaneous melanoma with no evidence of disease (NED) who are at high risk for
      recurrence.
    

Trial Arms

NameTypeDescriptionInterventions
Combination of bempegaldesleukin (NKTR-214) + nivolumabExperimentalArm A: Participants will receive bempegaldesleukin (NKTR-214) in combination with nivolumab.
  • Bempegaldesleukin
  • Nivolumab
NivolumabActive ComparatorArm B: Participants will receive nivolumab alone.
  • Nivolumab

Eligibility Criteria

        Inclusion Criteria:

          -  Male or female patients, age 12 years or older at the time of signing the informed
             consent form (age 18 years or older where local regulations or institutional policies
             do not allow for patients < 18 years of age to participate).

          -  Histologically confirmed Stage IIIA (LN metastasis > 1 mm), IIIB/C/D, or IV
             (M1a/b/c/d) cutaneous melanoma by AJCC (8th edition) at study entry that has been
             completely surgically resected within 12 weeks prior to randomization.

          -  Tumor tissue from biopsy or resected disease must be provided to central laboratory
             for PD-L1 status analysis. Must have PD-L1 expression classification for
             stratification purposes.

          -  Disease-free status documented by a complete physical examination and imaging studies
             within 28 days prior to randomization.

        Exclusion Criteria:

          -  History of ocular/uveal melanoma or mucosal melanoma.

          -  Active, known or suspected autoimmune disease. Patients with Type I diabetes mellitus,
             hypothyroidism only requiring hormone replacement, skin disorders not requiring
             systemic treatment, or conditions not expected to recur in the absence of an external
             trigger are permitted to enroll.

          -  Conditions requiring systemic treatment with either corticosteroids (> 10 mg daily
             prednisone equivalent) or other immunosuppressive medications within 14 days of
             randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10
             mg daily prednisone equivalent, are permitted in the absence of active autoimmune
             disease.

          -  Prior therapy for melanoma except surgery for the melanoma lesion(s) and/or adjuvant
             radiation therapy for central nervous system lesions.

          -  Prior therapy with interferon, talimogene laherparepvec (Imylgic®), interleukin-2
             (IL-2) directed therapy, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or
             anti-cytotoxic T lymphocyte-associated protein 4 antibody (including ipilimumab or any
             other antibody or drug specifically targeting T cell co-stimulation or checkpoint
             pathways).

          -  Prior malignancy active within the previous 3 years except for locally curable cancers
             that have been apparently cured.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:12 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:To compare the efficacy, as measured by RFS by BICR, of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA), Stage IIIB/C/D, or Stage IV cutaneous melanoma with NED who are at high risk for recurrence
Time Frame:Approximately up to 60 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:To compare the overall survival (OS) of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA (LN metastasis> 1 mm), Stage IIIB/C/D, or Stage IV NED melanoma
Time Frame:Approximately up to 83 months
Safety Issue:
Description:
Measure:To evaluate distant metastasis-free survival (DMFS) by Investigator in patients who have Stage IIIA (LN metastasis > 1 mm) or IIIB/C/D melanoma at study entry
Time Frame:Approximately up to 60 months
Safety Issue:
Description:
Measure:To assess the overall safety and tolerability of bempegaldesleukin plus nivolumab versus nivolumab in study patients
Time Frame:Approximately up to 60 months
Safety Issue:
Description:
Measure:To describe changes in patient-reported outcomes as assessed by the global health/quality of life (GH/QoL) and the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30)
Time Frame:Approximately up to 60 months
Safety Issue:
Description:
Measure:To evaluate the association between programmed cell death ligand 1 (PD-L1) expression status and RFS by BICR
Time Frame:Approximately up to 60 months
Safety Issue:
Description:
Measure:To assess the efficacy, as measured by RFS by Investigator, of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA (LN metastasis > 1 mm), Stage IIIB/C/D, or Stage IV NED melanoma
Time Frame:Approximately up to 60 months
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Nektar Therapeutics

Trial Keywords

  • CD122-Biased Agonist
  • CD122-Biased Cytokine
  • IL-2 Receptor Agonist
  • NKTR-214
  • Bempegaldesleukin
  • IL-2
  • Immunotherapy
  • BEMPEG
  • Nivolumab
  • Opdivo®
  • NIVO
  • Adjuvant
  • Skin Cancer
  • Resectable Melanoma
  • High Risk of Recurrence Melanoma
  • Post Resection
  • Checkpoint Inhibitor

Last Updated

May 27, 2020