Clinical Trials /

A Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)

NCT02857426

Description:

The purpose of this study is to determine whether Nivolumab is effective in the treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)

Related Conditions:
  • Primary Central Nervous System Lymphoma
  • Testicular Lymphoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)
  • Official Title: A Phase 2, Open-label, Single-arm, Two-cohort Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) or Relapsed/Refractory Primary Testicular Lymphoma (PTL)

Clinical Trial IDs

  • ORG STUDY ID: CA209-647
  • SECONDARY ID: 2016-000894-19
  • NCT ID: NCT02857426

Conditions

  • Lymphoma

Interventions

DrugSynonymsArms
NivolumabBMS-936558, OpdivoNivolumab for population with PCNSL

Purpose

The purpose of this study is to determine whether Nivolumab is effective in the treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)

Trial Arms

NameTypeDescriptionInterventions
Nivolumab for population with PCNSLExperimentalSpecified dose on specified days
  • Nivolumab
Nivolumab for population with PTLExperimentalSpecified dose on specified days
  • Nivolumab

Eligibility Criteria

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Pathologically confirmed PCNSL or PTL who failed or did not respond to at least 1 line
             of systemic therapy

          -  Measurable disease requirements on scans:

        PCNSL subjects should have at least one measurable extranodal brain lesion; PTL subjects
        should have at least 1 measurable extranodal lesion or nodal lesion

          -  Have tumor tissue for PD-L1 expression testing

          -  Must have a Karnofsky performance status of 70-100

        Exclusion Criteria:

          -  a) Intraocular PCNSL without evidence of brain disease b) PCNSL patients who cannot
             undergo MRI assessments c) PCNSL patients with systemic disease

          -  Patients with certain diseases such as active autoimmune disease, type I diabetes,
             hypothyroidism that needs hormone replacement, active infection, psychiatric disorder

          -  Prior malignancy active within the previous 3 years except for locally curable cancers
             that have been apparently cured, such as basal or squamous cell skin cancer,
             superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast

          -  Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4
             antibody, or any other antibody or drug specifically targeting T-cell co-stimulation
             or checkpoint pathways

        PCNSL, and PTL subjects with brain or spinal cord lesion who have received doses of more
        than 2 mg/day of dexamethasone or equivalent within the 14 days period prior to the first
        dose of nivolumab are excluded

        Other protocol defined inclusion/exclusion criteria could apply
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:Approximately 21 months
Safety Issue:
Description:By Blinded Independent Central Review (BICR).

Secondary Outcome Measures

Measure:Progression-free survival (PFS)
Time Frame:Approximately 21 months
Safety Issue:
Description:
Measure:Objective response rate (ORR)
Time Frame:Approximately 21 months
Safety Issue:
Description:Based on investigator assessment
Measure:Duration of response (DOR)
Time Frame:Approximately 21 months
Safety Issue:
Description:
Measure:Overall survival (OS)
Time Frame:Approximately 21 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Bristol-Myers Squibb

Last Updated

October 21, 2019