Clinical Trial 18880

Cancer Type: Malignant Hematology
Interventions:BMS-936558 (Nivolumab); Nivolumab

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Celeste Bello

Overview

Study 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)

Summary

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).

Objective

Primary Objectives: To assess the clinical benefit of nivolumab in subjects with elapsed/refractory PCNSL or relapsed/refractory PTL as measured by overall response rate (ORR) by blinded Independent Central Review (BICR). Secondary Objectives: To assess progression-free survival (PFS) based on BICR assessment for PCNSL or PTL, respectively. To assess ORR and duration of response (DOR) based on investigator assessment for PCNSL or PTL, respectively. To assess overall survival (OS) for PCNSL or PTL, respectively.

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 participants should have at least one measurable extranodal brain lesion; PTL participants should have at least 1 measurable extranodal lesion.
  • Have tumor tissue for PD-L1 expression testing.
  • Must have a Karnofsky performance status of 70-100.
  • Additional criteria may apply.

  • Exclusion Criteria

  • a) Intraocular PCNSL without evidence of brain disease; b) PCNSL patients who cannot undergo MRI assessments; c) PCNSL patients with systemic disease.
  • Potential participants 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.
  • Additional criteria may apply.