Trial · NCT02329847
A Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Combination of Ibrutinib With Nivolumab in Participants With Hematologic Malignancies
NCT02329847, Phase 1, Phase 2, Completed, Janssen Research & Development, LLC; results first posted 2023-06-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Combination of Ibrutinib With Nivolumab in Participants With Hematologic Malignancies. Trials, record NCT02329847. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02329847
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Combination of Ibrutinib With Nivolumab in Participants With Hematologic Malignancies
- NCT number
- NCT02329847
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 144 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Hematologic Neoplasms
- Interventions
- Ibrutinib, Nivolumab
- First posted
- 2015-01-01
- Last updated
- 2025-05-25
- Other registries' IDs
- eudract:2014-005191-28
- Results first posted
- 2023-06-15
- Limitations and caveats
- Though it was planned to administer Ibrutinib 280 milligrams (mg) to participants in case the toxicity increased, no participants received ibrutinib 280 mg in the study.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) as Assessed International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008: Disease Cohort | Up to 6 years 11 months | ORR is percentage of participants achieving a complete response (CR), CR with incomplete marrow recovery (CRi), nodular partial response (nPR) or PR. IWCLL 2008 criteria: CR- No lymphadenopathy and hepatosplenomegaly, no constitutional symptoms, neutrophils \>1.5\*10\^9/L, platelets \>100\*10\^9/L, Hgb \>11 g/dL and absolute lymphocyte count \<4000/mcL; CRi- CR with incomplete recovery of bone marrow; nPR- participants meet criteria for CR, but the bone marrow biopsy shows B-lymphoid nodules, may represent a clonal infiltrate; PR- \>=50% drop in lymphocyte count from baseline or \<=4.0\*10\^9/L with following: \>=50% decrease in sum products of up to 6 lymph nodes, no new enlarged lymph nodes, When abnormal, \>=50% decrease in enlargement of spleen from baseline or normalization and a response in 1 of following: Neutrophils \>1.5\*10\^9/L, Platelets\>100000/mcL and Hgb\>11 g/dL or \>=50% improvement over baseline in all. This outcome measure was planned to be analyzed for specified arm only. |
| Primary | Overall Response Rate (ORR) as Assessed Non-Hodgkin Lymphoma (NHL), Cheson 2014: Disease Cohort | Up to 6 years 11 months | ORR defined as percentage of participants achieving a CR, CRi, nPR or PR. As per Non-Hodgkin Lymphoma, Cheson 2014, CR is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. PR is \>= 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. Progressive disease (PD) \>= 50% increase from nadir in the sum of the products of at least two lymph nodes, or appearance of a new lesion greater than 1.5 cm in any axis even if other lesions are decreasing in size. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. This outcome measure was planned to be analyzed for specified arms only. |
| Primary | Percentage of Participants With Treatment-emergent Adverse Event (TEAEs): Study Cohort | Up to 6 years 10 months | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs for the treatment phase included events with an onset date/time on or after the start of study intervention through end of study were considered as treatment-emergent. |
| Secondary | Duration of Response (DoR): Study Cohort | Up to 6 years 11 months | DOR is defined as the interval between the date of initial documentation of a response including partial response with lymphocytosis (PRL) and date of first documented evidence of progressive disease or death or date of censoring. iWCLL 2008 criteria for progressive disease: New enlarged nodes \>1.5 cm, new hepatomegaly or splenomegaly, or other organ infiltrates; \>= 50% increase from nadir in existing lymph node or \>=50% increase from nadir in sum of product of diameters of multiple nodes; \>=50% increase from nadir in enlargement of liver or spleen; \>=50% increase from baseline in lymphocyte count (\>=5\*10\^9/L) unless considered treatment-related lymphocytosis; new cytopenia (Hemoglobin b or platelets) attributable to CLL; transformation to a more aggressive histology. |
| Secondary | Duration of Stable Disease or Better: Study Cohort | Up to 6 years and 11 months | Duration of stable disease or better was defined as duration from the start of the treatment until the criteria for progression were met. IWCLL 2008 criteria for progressive disease: New enlarged nodes \>1.5 cm, new hepatomegaly or splenomegaly, or other organ infiltrates; \>= 50% increase from nadir in existing lymph node or \>=50% increase from nadir in sum of product of diameters of multiple nodes; \>=50% increase from nadir in enlargement of liver or spleen; \>=50% increase from baseline in lymphocyte count (and to \>=5\*10\^9/L) unless considered treatment-related lymphocytosis; new cytopenia (Hemoglobin b or platelets) attributable to CLL; transformation to a more aggressive histology. |
| Secondary | Progression-free Survival (PFS): Study Cohort | Up to 6 years 11 months | PFS is defined as the duration from the date of first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death, whichever comes first. Participants who were progression-free and alive or had unknown status were censored at the last tumor assessment. IWCLL 2008 criteria for progressive disease: New enlarged nodes \>1.5 cm, new hepatomegaly or splenomegaly, or other organ infiltrates; \>= 50% increase from nadir in existing lymph node or \>=50% increase from nadir in sum of product of diameters of multiple nodes; \>=50% increase from nadir in enlargement of liver or spleen; \>=50% increase from baseline in lymphocyte count (and to \>=5\*10\^9/L) unless considered treatment-related lymphocytosis; new cytopenia (Hemoglobin b or platelets) attributable to CLL; transformation to a more aggressive histology. |
| Secondary | Overall Survival (OS): Study Cohort | Up to 6 years 11 months | OS was defined as duration from the date of first dose of study drug to the date of the participant's death. |
| Secondary | Percentage of Participants With Lymphoma-related Symptoms: Study Cohort | Up to 6 years 11 months | Percentage of participants with lymphoma-related symptoms were reported. These symptoms included B-symptoms, recurrent fever, night sweats, weight loss, other disease-related symptoms, itching, fatigue, physical discomfort and any other. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) as Assessed International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008: Disease Cohort | Up to 6 years 11 months | The all-treated population included all participants who had received at least 1 dose of study drugs (either ibrutinib or nivolumab). The ORR evaluation criteria were disease specific and hence the analysis was done as per disease cohorts for this outcome measure as pre-planned. | Percentage of Participants | NUMBER |
| PRIMARY | Overall Response Rate (ORR) as Assessed Non-Hodgkin Lymphoma (NHL), Cheson 2014: Disease Cohort | Up to 6 years 11 months | The all-treated population included all participants who had received at least 1 dose of study drugs (either ibrutinib or nivolumab). The ORR evaluation criteria were disease specific and hence the analysis was done as per disease cohorts for this outcome measure as pre-planned. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Treatment-emergent Adverse Event (TEAEs): Study Cohort | Up to 6 years 10 months | The safety population included all participants who received at least 1 dose of study drugs (either ibrutinib or nivolumab). | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DoR): Study Cohort | Up to 6 years 11 months | The all-treated population included all participants who had received at least 1 dose of study drugs (either ibrutinib or nivolumab) and achieved either PR or better (including PRL only for CLL participants). | Months | MEDIAN |
| SECONDARY | Duration of Stable Disease or Better: Study Cohort | Up to 6 years and 11 months | The all-treated population included all participants who had received at least 1 dose of study drugs (either ibrutinib or nivolumab) and met criteria for progressive disease. Here 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS): Study Cohort | Up to 6 years 11 months | The all-treated population included all participants who had received at least 1 dose of study drugs (either ibrutinib or nivolumab) and met criteria for progressive disease. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS): Study Cohort | Up to 6 years 11 months | The all-treated population included all participants who had received at least 1 dose of study drugs (either ibrutinib or nivolumab) and were responders. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Lymphoma-related Symptoms: Study Cohort | Up to 6 years 11 months | The all-treated population included all participants who had received at least 1 dose of study drugs (either ibrutinib or nivolumab). | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) as Assessed International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008: Disease Cohort | Ibrutinib and Nivolumab: Chronic Lymphocytic Leukemia (CLL) | 63.3 | Percentage of Participants | ||
| Overall Response Rate (ORR) as Assessed Non-Hodgkin Lymphoma (NHL), Cheson 2014: Disease Cohort | Ibrutinib and Nivolumab: Small Lymphocytic Lymphoma (SLL) | 50.0 | Percentage of Participants | ||
| Overall Response Rate (ORR) as Assessed Non-Hodgkin Lymphoma (NHL), Cheson 2014: Disease Cohort | Ibrutinib and Nivolumab: Follicular Lymphoma (FL) | 32.5 | Percentage of Participants | ||
| Overall Response Rate (ORR) as Assessed Non-Hodgkin Lymphoma (NHL), Cheson 2014: Disease Cohort | Ibrutinib and Nivolumab: Diffuse Large B-cell Lymphoma (DLBCL) | 37.8 | Percentage of Participants | ||
| Overall Response Rate (ORR) as Assessed Non-Hodgkin Lymphoma (NHL), Cheson 2014: Disease Cohort | Ibrutinib and Nivolumab: Richter | 65.0 | Percentage of Participants | ||
| Percentage of Participants With Treatment-emergent Adverse Event (TEAEs): Study Cohort | Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | 100 | Percentage of Participants | ||
| Percentage of Participants With Treatment-emergent Adverse Event (TEAEs): Study Cohort | Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | 100 | Percentage of Participants | ||
| Percentage of Participants With Treatment-emergent Adverse Event (TEAEs): Study Cohort | Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | 100 | Percentage of Participants | ||
| Percentage of Participants With Treatment-emergent Adverse Event (TEAEs): Study Cohort | Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | 100 | Percentage of Participants | ||
| Percentage of Participants With Treatment-emergent Adverse Event (TEAEs): Study Cohort | Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | 97.3 | Percentage of Participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | 7 | |
| Overall Study | STARTED | Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | 7 | |
| Overall Study | STARTED | Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | 36 | |
| Overall Study | STARTED | Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | 35 | |
| Overall Study | STARTED | Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | 39 | |
| Overall Study | STARTED | Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg | 20 | |
| Overall Study | Treated (Safety Analysis Set) | Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | 7 | |
| Overall Study | Treated (Safety Analysis Set) | Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | 7 | |
| Overall Study | Treated (Safety Analysis Set) | Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | 35 | |
| Overall Study | Treated (Safety Analysis Set) | Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | 35 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events1,866
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 | Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | 1 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | 2 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | 9 | 35 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | 5 | 35 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | 11 | 37 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg | 8 | 20 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | 0 | 7 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | 0 | 7 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | 2 | 35 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | 0 | 35 |
1 to 10 of 1,866Source ClinicalTrials.gov
See all 1,866 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | 4 | 7 |
| Total, all-cause mortality | Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | 4 | 7 |
| Total, all-cause mortality | Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | 22 | 36 |
| Total, all-cause mortality | Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | 12 | 35 |
| Total, all-cause mortality | Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | 20 | 39 |
| Total, all-cause mortality | Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg | 13 | 20 |
| Total, other adverse events | Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | 7 | 7 |
| Total, other adverse events | Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | 7 | 7 |
| Total, other adverse events | Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | 35 | 35 |
| Total, other adverse events | Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | 35 | 35 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02329847
GET https://conductscience.org/api/trials/v1/NCT02329847/results?page=2