Trial · NCT02857426
A Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)
NCT02857426, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2020-10-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL). Trials, record NCT02857426. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02857426
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)
- NCT number
- NCT02857426
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 66 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Lymphoma
- Interventions
- Nivolumab
- First posted
- 2016-08-05
- Last updated
- 2021-12-23
- Other registries' IDs
- eudract:2016-000894-19
- Results first posted
- 2020-10-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | BICR-Assessed Objective Response Rate (ORR) | 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 | BICR-Assessed Progression Free Survival (PFS) | Up to approximately 51 months | 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. |
| Secondary | Investigator-Assessed Objective Response Rate (ORR) | Up to approximately 51 months | 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. |
| Secondary | Investigator-Assessed Duration of Response (DOR) | Up to approximately 51 months | 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. |
| Secondary | Overall Survival (OS) | Up to approximately 51 months | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | BICR-Assessed Objective Response Rate (ORR) | Up to approximately 51 months | All treated PCNSL and PTL participants | Percentage of participants | NUMBER |
| SECONDARY | BICR-Assessed Progression Free Survival (PFS) | Up to approximately 51 months | All treated PCNSL and PTL participants | Months | MEDIAN |
| SECONDARY | Investigator-Assessed Objective Response Rate (ORR) | Up to approximately 51 months | All treated PCNSL and PTL participants | Percentage of participants | NUMBER |
| SECONDARY | Investigator-Assessed Duration of Response (DOR) | Up to approximately 51 months | All responders PCNSL and PTL participants | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to approximately 51 months | All treated PCNSL and PTL participants | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| BICR-Assessed Objective Response Rate (ORR) | PCNSL Cohort | 6.4 | 95% Confidence Interval 1.3 to 17.5 | Percentage of participants | |
| BICR-Assessed Objective Response Rate (ORR) | PTL Cohort | 26.3 | 95% Confidence Interval 9.1 to 51.2 | Percentage of participants | |
| BICR-Assessed Progression Free Survival (PFS) | PCNSL Cohort | 1.41 | 95% Confidence Interval 1.08 to 1.74 | Months | |
| BICR-Assessed Progression Free Survival (PFS) | PTL Cohort | 1.72 | 95% Confidence Interval 1.15 to 6.28 | Months | |
| Investigator-Assessed Objective Response Rate (ORR) | PCNSL Cohort | 10.6 | 95% Confidence Interval 3.5 to 23.1 | Percentage of participants | |
| Investigator-Assessed Objective Response Rate (ORR) | PTL Cohort | 26.3 | 95% Confidence Interval 9.1 to 51.2 | Percentage of participants | |
| Investigator-Assessed Duration of Response (DOR) | PCNSL Cohort | 1.71 | 95% Confidence Interval 0.72 to 7.10 | Months | |
| Investigator-Assessed Duration of Response (DOR) | PTL Cohort | 20.63 | 95% Confidence Interval 0.03 to NA | Months | |
| Overall Survival (OS) | PCNSL Cohort | 6.77 | 95% Confidence Interval 3.68 to 11.99 | Months | |
| Overall Survival (OS) | PTL Cohort | 11.17 | 95% Confidence Interval 2.60 to 24.41 | Months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PCNSL Cohort | 47 | |
| Overall Study | STARTED | PTL Cohort | 19 | |
| Overall Study | COMPLETED | PCNSL Cohort | 0 | |
| Overall Study | COMPLETED | PTL Cohort | 0 | |
| Overall Study | NOT COMPLETED | PCNSL Cohort | 47 | |
| Overall Study | NOT COMPLETED | PTL Cohort | 19 |
Source ClinicalTrials.gov
Adverse events336
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | PCNSL Cohort Nivolumab 240 mg (Q2W) | 13 | 47 | |
| other | Anaemia | Blood and lymphatic system disorders | PTL Cohort Nivolumab 240 mg (Q2W) | 1 | 19 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | PCNSL Cohort Nivolumab 240 mg (Q2W) | 4 | 47 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | PTL Cohort Nivolumab 240 mg (Q2W) | 1 | 19 | |
| other | Bradycardia | Cardiac disorders | PCNSL Cohort Nivolumab 240 mg (Q2W) | 2 | 47 | |
| other | Bradycardia | Cardiac disorders | PTL Cohort Nivolumab 240 mg (Q2W) | 1 | 19 | |
| other | Tachycardia | Cardiac disorders | PCNSL Cohort Nivolumab 240 mg (Q2W) | 0 | 47 | |
| other | Tachycardia | Cardiac disorders | PTL Cohort Nivolumab 240 mg (Q2W) | 1 | 19 | |
| other | Tinnitus | Ear and labyrinth disorders | PCNSL Cohort Nivolumab 240 mg (Q2W) | 1 | 47 | |
| other | Tinnitus | Ear and labyrinth disorders | PTL Cohort Nivolumab 240 mg (Q2W) | 1 | 19 |
1 to 10 of 336Source ClinicalTrials.gov
See all 336 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PCNSL Cohort Nivolumab 240 mg (Q2W) | 32 | 47 |
| Total, all-cause mortality | PTL Cohort Nivolumab 240 mg (Q2W) | 13 | 19 |
| Total, other adverse events | PCNSL Cohort Nivolumab 240 mg (Q2W) | 40 | 47 |
| Total, other adverse events | PTL Cohort Nivolumab 240 mg (Q2W) | 16 | 19 |
| Total, serious adverse events | PCNSL Cohort Nivolumab 240 mg (Q2W) | 33 | 47 |
| Total, serious adverse events | PTL Cohort Nivolumab 240 mg (Q2W) | 15 | 19 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PCNSL Cohort Nivolumab 240 mg (Q2W) vs PTL Cohort Nivolumab 240 mg (Q2W): deaths from any cause | Trial comparisons |
| PCNSL Cohort Nivolumab 240 mg (Q2W) vs PTL Cohort Nivolumab 240 mg (Q2W): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02857426
GET https://conductscience.org/api/trials/v1/NCT02857426/events?page=2