NCT02857426
Completed
Phase 2
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)
Bristol-Myers Squibb27 sites in 9 countries66 target enrollmentStarted: October 21, 2016Last updated:
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 66
- Locations
- 27
- Primary Endpoint
- BICR-Assessed Objective Response Rate (ORR)
Overview
Brief 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)
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Nivolumab for population with PTL
Experimental
Specified dose on specified days
Intervention: Nivolumab (Drug)
Nivolumab for population with PCNSL
Experimental
Specified dose on specified days
Intervention: Nivolumab (Drug)
Outcomes
Primary Outcomes
BICR-Assessed Objective Response Rate (ORR)
Time Frame: Up to approximately 51 months
Percentage of participants with a confirmed objective response rate (ORR) by blinded independent central review (BICR) assessment was analyzed and reported for both PCNSL and PTL patient populations. This endpoint is further defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), based on the IPCG Criteria for PCNSL and Lugano 2014 response evaluation for PTL, divided by the number of treated participants within each cohort.
Secondary Outcomes
- BICR-Assessed Progression Free Survival (PFS)(Up to approximately 51 months)
- Investigator-Assessed Objective Response Rate (ORR)(Up to approximately 51 months)
- Investigator-Assessed Duration of Response (DOR)(Up to approximately 51 months)
- Overall Survival (OS)(Up to approximately 51 months)
Investigators
Study Sites (27)
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