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)
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
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab | BMS-936558, Opdivo | Nivolumab 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
Name | Type | Description | Interventions |
---|
Nivolumab for population with PCNSL | Experimental | Specified dose on specified days | |
Nivolumab for population with PTL | Experimental | Specified dose on specified days | |
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: | BICR-assessed Objective Response Rate (ORR) |
Time Frame: | up to 2 years |
Safety Issue: | |
Description: | 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 Outcome Measures
Measure: | Progression-free Survival (PFS) Based on BICR Assessment |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | Progression-free survival (PFS) is defined as the time from first dosing date to the date of the first documented progression using the IPCG Criteria for PCNSL and Lugano 2014 response evaluation for PTL, as determined by BICR, or death due to any cause, whichever occurs first. |
Measure: | Investigator-assessed Objective Response Rate (ORR) |
Time Frame: | up to 2 years |
Safety Issue: | |
Description: | Percentage of participants with a confirmed objective response rate (ORR) by investigator 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. |
Measure: | Investigator-assessed Duration of Response (DOR) |
Time Frame: | up to 2 years |
Safety Issue: | |
Description: | Duration of response (DOR) by investigator assessment was analyzed and reported for both PCNSL and PTL patient populations.
This endpoint is further defined as the time from first response (CR or PR) to the date of initial objectively documented progression as determined using the IPCG Criteria for PCNSL and Lugano 2014 response evaluation for PTL, as determined by BICR, or death due to any cause, whichever occurs first. |
Measure: | Overall Survival (OS) |
Time Frame: | up to 2 years |
Safety Issue: | |
Description: | Overall survival (OS) was analyzed and reported for both PCNSL and PTL patient populations.
OS is defined as the time from first dosing date to the date of death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
December 17, 2020