A Phase 2 interventional study of Nivolumab in Lymphoma, sponsored by Bristol-Myers Squibb. Completed at 50 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-23.
Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment
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)
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 66 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Inclusion Criteria:
PCNSL subjects should have at least one measurable extranodal brain lesion; PTL subjects should have at least 1 measurable extranodal lesion or nodal lesion
Exclusion Criteria:
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
Specified dose on specified days
Drug: Nivolumab
Specified dose on specified days
Drug: Nivolumab
Also known as: BMS-936558, Opdivo
BICR-Assessed Objective Response Rate (ORR)
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.
Time frame: Up to approximately 51 months
BICR-Assessed Progression Free Survival (PFS)
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.
Time frame: Up to approximately 51 months
Investigator-Assessed Objective Response Rate (ORR)
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.
Time frame: Up to approximately 51 months
Investigator-Assessed Duration of Response (DOR)
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.
Time frame: Up to approximately 51 months
Overall Survival (OS)
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.
Time frame: Up to approximately 51 months
| Milestone | PCNSL Cohort | PTL Cohort |
|---|---|---|
| Started | 47 | 19 |
| Completed | 0 | 0 |
| Not completed | 47 | 19 |
| Withdrew: Disease progression | 34 | 13 |
| Withdrew: Study drug toxicity | 4 | 1 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Adverse event unrelated to study drug | 6 | 2 |
| Withdrew: Participant withdrew consent | 1 | 1 |
| Withdrew: Maximum clinical benefit | 1 | 0 |
| Withdrew: Completed treatment | 0 | 2 |
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.
| Percentage of participants | PCNSL Cohort | PTL Cohort |
|---|---|---|
| BICR-Assessed Objective Response Rate (ORR) | 6.4 (1.3 to 17.5) | 26.3 (9.1 to 51.2) |
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.
| Months | PCNSL Cohort | PTL Cohort |
|---|---|---|
| BICR-Assessed Progression Free Survival (PFS) | 1.41 (1.08 to 1.74) | 1.72 (1.15 to 6.28) |
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.
| Percentage of participants | PCNSL Cohort | PTL Cohort |
|---|---|---|
| Investigator-Assessed Objective Response Rate (ORR) | 10.6 (3.5 to 23.1) | 26.3 (9.1 to 51.2) |
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.
| Months | PCNSL Cohort | PTL Cohort |
|---|---|---|
| Investigator-Assessed Duration of Response (DOR) | 1.71 (0.72 to 7.10) | 20.63 (0.03 to NA) |
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.
| Months | PCNSL Cohort | PTL Cohort |
|---|---|---|
| Overall Survival (OS) | 6.77 (3.68 to 11.99) | 11.17 (2.60 to 24.41) |
Collected over From first dose to 100 days post last dose (up to approximately 48 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PCNSL Cohort Nivolumab 240 mg (Q2W) | 32/47 (68.1%) | 33/47 (70.2%) | 40/47 (85.1%) |
| PTL Cohort Nivolumab 240 mg (Q2W) | 13/19 (68.4%) | 15/19 (78.9%) | 16/19 (84.2%) |
| Event | PCNSL Cohort Nivolumab 240 mg (Q2W) | PTL Cohort Nivolumab 240 mg (Q2W) |
|---|---|---|
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 13/47 | 8/19 |
| Renal failureRenal and urinary disorders | 1/47 | 2/19 |
| SeizureNervous system disorders | 4/47 | 1/19 |
| SepsisInfections and infestations | 3/47 | 0/19 |
| Haemorrhage intracranialNervous system disorders | 3/47 | 0/19 |
| AnaemiaBlood and lymphatic system disorders | 0/47 | 1/19 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/47 | 1/19 |
| General physical health deteriorationGeneral disorders | 2/47 | 1/19 |
| PyrexiaGeneral disorders | 1/47 | 1/19 |
| HepatitisHepatobiliary disorders | 0/47 | 1/19 |
| Event | PCNSL Cohort Nivolumab 240 mg (Q2W) | PTL Cohort Nivolumab 240 mg (Q2W) |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 13/47 | 1/19 |
| PyrexiaGeneral disorders | 9/47 | 5/19 |
| FatigueGeneral disorders | 12/47 | 2/19 |
| HeadacheNervous system disorders | 12/47 | 1/19 |
| Alanine aminotransferase increasedInvestigations | 10/47 | 1/19 |
| ConstipationGastrointestinal disorders | 8/47 | 4/19 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/47 | 4/19 |
| FallInjury, poisoning and procedural complications | 9/47 | 3/19 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 1/47 | 3/19 |
| VomitingGastrointestinal disorders | 7/47 | 0/19 |
| Age, Continuous(Years) | PCNSL Cohort | PTL Cohort | Total |
|---|---|---|---|
| Mean | 65.9 ± 10.1 | 66.7 ± 8.6 | 66.1 ± 9.6 |
| Sex: Female, Male(Participants) | PCNSL Cohort | PTL Cohort | Total |
|---|---|---|---|
| Female | 20 | 0 | 20 |
| Male | 27 | 19 | 46 |
| Ethnicity (NIH/OMB)(Participants) | PCNSL Cohort | PTL Cohort | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 33 | 11 | 44 |
| Unknown or Not Reported | 13 | 8 | 21 |
| Race (NIH/OMB)(Participants) | PCNSL Cohort | PTL Cohort | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 10 | 5 | 15 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 37 | 12 | 49 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 2 | 2 |
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