18 and older, any sex, with Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response Rate (ORR) as Determined by IRRCPrimary· From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
ORR is determined by an independent radiologic review committee (IRRC) according to the revised International Working Group Criteria for non-Hodgkin Lymphoma. ORR is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) and expressed as a percentage of all treated participants.
CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement.
PR=Regression of measurable disease and no new sites; no increase in size of liver or
Group
Value
95% CI
Arm 1: Nivolumab
4.3
1.2 – 10.8
Duration of Response (DOR) Based on IRRC AssessmentsSecondary· From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
DOR is defined as the time from first remission (CR or PR) to the date of initial objectively documented progression as determined using the revised International Working Group Criteria for non-Hodgkin Lymphoma, or death due to any cause, whichever occurs first.
CR definition includes the complete disappearance of all evidence of disease, the definition of PR includes at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, and PD is defined as any new lesion or increase by \>50% of previously involved sites from nadir, a
Group
Value
95% CI
Arm 1: Nivolumab
10.94
8.31 – 13.57
Complete Remission Rate (CRR) Based on IRRC AssessmentSecondary· From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
CRR is defined as the number of subjects with a BOR of CR according to the revised International Working Group Criteria for non-Hodgkin Lymphoma, divided by the number of treated participants and expressed as a percentage.
CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement.
Group
Value
95% CI
Arm 1: Nivolumab
1.1
0.0 – 5.9
Partial Remission (PR) Rate Based on IRRC AssessmentSecondary· From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
PR rate is defined as the number of participants with a best overall response (BOR) of PR according to the 2007 International Working Group (IWG) criteria, based on IRRC assessment, divided by the number of treated participants and expressed as a percentage.
PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. \>=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions)
Group
Value
95% CI
Arm 1: Nivolumab
3.3
0.7 – 9.2
Progression Free Survival (PFS) Based on IRRC AssessmentSecondary· From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
PFS was summarized descriptively using the Kaplan-Meier (KM) product-limit method. Median values of PFS, along with the two-sided 95% CIs were calculated using a method based on log-log transformation.
Group
Value
95% CI
Arm 1: Nivolumab
2.20
1.91 – 3.58
Overall Response Rate (ORR) Based on Investigator AssessmentsSecondary· From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
ORR is determined by investigator assessments according to the revised International Working Group Criteria for non-Hodgkin Lymphoma. ORR is defined as the number of subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) and is expressed as a percentage of all treated participants.
CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement.
PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. \>=50% decrease i
Group
Value
95% CI
Arm 1: Nivolumab
10.9
5.3 – 19.1
Adverse events — posted to ClinicalTrials.gov
Time frame: AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Nivolumab 3 mg/kg
Serious: 46/92 (50%)
Deaths: 36/92
Serious adverse events (68 terms)
Reaction
System
Nivolumab 3 mg/kg
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to assess the clinical benefit of Nivolumab, as measured by independent radiologic review committee (IRRC)-assessed objective response rate (ORR) in subjects with FL lymphoma who have failed therapy with both CD20 antibody and an alkylating agent.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· not yet recruiting
NCT07444619 — A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young A
· Phase 1
· not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
NCT07420439 — Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease
· Phase 2
· not yet recruiting
NCT07510334 — VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma
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· not yet recruiting
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Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 4 January 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02038946.