A Phase 1/2 interventional study of Ibrutinib and Nivolumab in Hematologic Neoplasms, sponsored by Janssen Research & Development, LLC. Completed at 18 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-25.
Sponsored by Janssen Research & Development, LLC · Phase 1/2, Interventional, and Treatment
The purpose of this study is to determine the safety and to establish the recommended phase 2 dose (RP2D) for the combination of ibrutinib and nivolumab in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), follicular cell lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). Once the dose is optimized, the combination will be assessed for Pharmacokinetics, Pharmacodynamics, and preliminary efficacy, further safety in participants with CLL/SLL, FL or DLBCL and in participants with Richter syndrome.
This is an open-label study, which consists of Part A (Dose Optimization Cohorts) and Part B (Expansion Cohorts). Part A consists of two dose optimization cohorts (cohort A1 and cohort A2) will determine the RP2D for the combination based on safety, pharmacokinetic, and pharmacodynamic assessments in participants with relapsed/refractory CLL/SLL or B-cell non-Hodgkin lymphoma (B-NHL). Part B consists 3 participant populations to further evaluate the safety and clinical activity of ibrutinib in combination with nivolumab: Cohort B1 (participants with CLL/SLL with del 17p or del 11q), Cohort B2 (participants with FL), Cohort B3 (participants with DLBCL) and Cohort B4 (participants with Richter syndrome). Part A and B will consist of Screening Period (28 days before enrollment), Treatment Period and Follow up Period (every 3 months until death or the end of study). Participants will receive nivolumab intravenously (Day 1 of every cycle) and ibrutinib orally once daily on a 14-day cycle. Efficacy will primarily be evaluated by International Workshop on Chronic Lymphocytic Leukemia (IWCLL) and International Working Group (IWG) for lymphoma guidelines. Participants' safety will be monitored throughout the study. Further exploration of pharmacokinetic/pharmacodynamic and biomarker information will be assessed throughout the trial.
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Exclusion Criteria:
Participants will receive ibrutinib 420 milligram (mg) capsule orally once daily and nivolumab intravenously as 3 milligram/kilogram (mg/kg) every 2 weeks for 14-daily dosing cycles and will be continued until disease progression or unacceptable toxicity.
Drug: Ibrutinib · Drug: Nivolumab
Participants will receive ibrutinib 560 mg capsule orally once daily and nivolumab intravenously as 3 mg/kg every 2 weeks for 14-daily dosing cycles and will be continued until disease progression or unacceptable toxicity.
Drug: Ibrutinib · Drug: Nivolumab
Participants will receive ibrutinib recommended Phase 2 dose (RP2D) orally once daily and nivolumab intravenously as 3 mg/kg every 2 weeks for 14-daily dosing cycles and will be continued until disease progression or unacceptable toxicity.
Drug: Ibrutinib · Drug: Nivolumab
Participants will receive ibrutinib recommended Phase 2 dose (RP2D) orally once daily and nivolumab intravenously as 3 mg/kg every 2 weeks for 14-daily dosing cycles and will be continued until disease progression or unacceptable toxicity.
Drug: Ibrutinib · Drug: Nivolumab
Participants will receive ibrutinib recommended Phase 2 dose (RP2D) orally once daily and nivolumab intravenously as 3 mg/kg every 2 weeks for 14-daily dosing cycles and will be continued until disease progression or unacceptable toxicity.
Drug: Ibrutinib · Drug: Nivolumab
Participants will receive ibrutinib recommended Phase 2 dose (RP2D) orally once daily and nivolumab intravenously as 3 mg/kg every 2 weeks for 14-daily dosing cycles and will be continued until disease progression or unacceptable toxicity.
Drug: Ibrutinib · Drug: Nivolumab
Participants will receive oral capsule of ibrutinib once daily as either 420 mg or 560 mg or at recommended Phase 2 dose in any of the cohort.
Also known as: JNJ54179060
Participants will receive nivolumab intravenously as 3 mg/kg on Day 1 every cycle of 14 days.
Also known as: BMS-936558
Overall Response Rate (ORR) as Assessed International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008: Disease Cohort
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.
Time frame: Up to 6 years 11 months
Overall Response Rate (ORR) as Assessed Non-Hodgkin Lymphoma (NHL), Cheson 2014: Disease Cohort
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.
Time frame: Up to 6 years 11 months
Percentage of Participants With Treatment-emergent Adverse Event (TEAEs): Study Cohort
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.
Time frame: Up to 6 years 10 months
Duration of Response (DoR): Study Cohort
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.
Time frame: Up to 6 years 11 months
Duration of Stable Disease or Better: Study Cohort
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.
Time frame: Up to 6 years and 11 months
Progression-free Survival (PFS): Study Cohort
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.
Time frame: Up to 6 years 11 months
Overall Survival (OS): Study Cohort
OS was defined as duration from the date of first dose of study drug to the date of the participant's death.
Time frame: Up to 6 years 11 months
Percentage of Participants With Lymphoma-related Symptoms: Study Cohort
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.
Time frame: Up to 6 years 11 months
| Milestone | Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg |
|---|---|---|---|---|---|---|
| Started | 7 | 7 | 36 | 35 | 39 | 20 |
| Treated (safety analysis set) | 7 | 7 | 35 | 35 | 37 | 20 |
| Completed | 0 | 0 | 1 | 0 | 0 | 0 |
| Not completed | 7 | 7 | 35 | 35 | 39 | 20 |
| Withdrew: Death | 4 | 4 | 22 | 12 | 20 | 13 |
| Withdrew: Lost to follow-up | 0 | 0 | 2 | 3 | 0 | 1 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 2 | 1 | 5 | 7 | 8 | 3 |
| Withdrew: Other | 1 | 2 | 6 | 13 | 10 | 3 |
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.
| Percentage of Participants | Ibrutinib and Nivolumab: Chronic Lymphocytic Leukemia (CLL) |
|---|---|
| Overall Response Rate (ORR) as Assessed International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008: Disease Cohort | 63.3 |
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.
| Percentage of Participants | Ibrutinib and Nivolumab: Small Lymphocytic Lymphoma (SLL) | Ibrutinib and Nivolumab: Follicular Lymphoma (FL) | Ibrutinib and Nivolumab: Diffuse Large B-cell Lymphoma (DLBCL) | Ibrutinib and Nivolumab: Richter |
|---|---|---|---|---|
| Overall Response Rate (ORR) as Assessed Non-Hodgkin Lymphoma (NHL), Cheson 2014: Disease Cohort | 50.0 | 32.5 | 37.8 | 65.0 |
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.
| Percentage of Participants | Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg |
|---|---|---|---|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Event (TEAEs): Study Cohort | 100 | 100 | 100 | 100 | 97.3 | 95.0 |
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.
| Months | Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg |
|---|---|---|---|---|---|---|
| Duration of Response (DoR): Study Cohort | 11.5 (2.4 to 20.7) | NA (NA to NA) | 19.2 (9.4 to 19.4) | 10.2 (5.1 to 17.8) | NA (4.6 to NA) | 6.9 (1.3 to NA) |
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.
| Months | Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg |
|---|---|---|---|---|---|---|
| Duration of Stable Disease or Better: Study Cohort | 24.8 (24.8 to 24.8) | 20.8 (20.8 to 20.8) | 17.38 (14.0 to 21.6) | 14.55 (12.7 to 20.4) | 14.1 (14.1 to 14.1) | — |
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.
| Months | Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg |
|---|---|---|---|---|---|---|
| Progression-free Survival (PFS): Study Cohort | 2.0 (1.1 to 24.8) | 9.1 (0.7 to 20.8) | 21.6 (12.0 to 21.6) | 7.6 (2.9 to 12.7) | 3.2 (2.1 to NA) | 5.0 (2.4 to NA) |
OS was defined as duration from the date of first dose of study drug to the date of the participant's death.
| Months | Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg |
|---|---|---|---|---|---|---|
| Overall Survival (OS): Study Cohort | 12.4 (2.0 to 28.8) | NA (0.8 to NA) | NA (21.6 to NA) | NA (NA to NA) | 19.0 (7.7 to NA) | 10.3 (4.8 to NA) |
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.
| Percentage of Participants | Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg |
|---|---|---|---|---|---|---|
| Percentage of Participants With Lymphoma-related Symptoms: Study Cohort | 14.3 | 42.9 | 74.3 | 25.7 | 54.1 | 60.0 |
Collected over Up to 6 years 11 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | 4/7 (57.1%) | 4/7 (57.1%) | 7/7 (100%) |
| Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | 4/7 (57.1%) | 3/7 (42.9%) | 7/7 (100%) |
| Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | 22/36 (61.1%) | 23/35 (65.7%) | 35/35 (100%) |
| Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | 12/35 (34.3%) | 15/35 (42.9%) | 35/35 (100%) |
| Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | 20/39 (51.3%) | 23/37 (62.2%) | 35/37 (94.6%) |
| Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg | 13/20 (65%) | 15/20 (75%) | 19/20 (95%) |
| Event | Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg |
|---|---|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 0/7 | 1/7 | 2/35 | 0/35 | 3/37 | 0/20 |
| Atrial FibrillationCardiac disorders | 1/7 | 0/7 | 1/35 | 0/35 | 1/37 | 0/20 |
| DiarrhoeaGastrointestinal disorders | 1/7 | 0/7 | 0/35 | 1/35 | 1/37 | 0/20 |
| Oesophageal CompressionGastrointestinal disorders | 1/7 | 0/7 | 0/35 | 0/35 | 0/37 | 0/20 |
| Chest PainGeneral disorders | 1/7 | 0/7 | 0/35 | 1/35 | 0/37 | 0/20 |
| General Physical Health DeteriorationGeneral disorders | 1/7 | 0/7 | 1/35 | 0/35 | 0/37 | 0/20 |
| Multiple Organ Dysfunction SyndromeGeneral disorders | 0/7 | 1/7 | 0/35 | 0/35 | 0/37 | 1/20 |
| Bile Duct StoneHepatobiliary disorders | 1/7 | 0/7 | 0/35 | 0/35 | 0/37 | 0/20 |
| CholecystitisHepatobiliary disorders | 1/7 | 0/7 | 0/35 | 0/35 | 0/37 | 1/20 |
| BacteraemiaInfections and infestations | 1/7 | 0/7 | 0/35 | 1/35 | 0/37 | 0/20 |
| Event | Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg |
|---|---|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 5/7 | 1/7 | 13/35 | 12/35 | 12/37 | 5/20 |
| NeutropeniaBlood and lymphatic system disorders | 2/7 | 0/7 | 20/35 | 7/35 | 10/37 | 8/20 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/7 | 4/7 | 4/35 | 11/35 | 5/37 | 4/20 |
| FatigueGeneral disorders | 2/7 | 3/7 | 6/35 | 14/35 | 11/37 | 1/20 |
| AnaemiaBlood and lymphatic system disorders | 1/7 | 2/7 | 9/35 | 5/35 | 11/37 | 8/20 |
| Upper Respiratory Tract InfectionInfections and infestations | 2/7 | 1/7 | 11/35 | 10/35 | 7/37 | 7/20 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/7 | 0/7 | 11/35 | 5/35 | 7/37 | 3/20 |
| PyrexiaGeneral disorders | 2/7 | 2/7 | 10/35 | 5/35 | 9/37 | 6/20 |
| RashSkin and subcutaneous tissue disorders | 1/7 | 1/7 | 6/35 | 8/35 | 11/37 | 4/20 |
| DyspepsiaGastrointestinal disorders | 2/7 | 1/7 | 3/35 | 3/35 | 2/37 | 0/20 |
The all-treated population included all participants who had received at least 1 dose of study drugs (either ibrutinib or nivolumab).
| Age, Continuous(years) | Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Total |
|---|---|---|---|---|---|---|---|
| Mean | 61 ± 18.08 | 65.9 ± 13.96 | 64.3 ± 9.57 | 61.3 ± 11.94 | 59.2 ± 15.99 | 64.9 ± 11.19 | 62.2 ± 12.94 |
| Sex: Female, Male(Participants) | Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Total |
|---|---|---|---|---|---|---|---|
| Female | 4 | 4 | 9 | 15 | 10 | 12 | 54 |
| Male | 3 | 3 | 26 | 20 | 27 | 8 | 87 |
| Ethnicity (NIH/OMB)(Participants) | Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 1 | 3 | 0 | 0 | 4 |
| Not Hispanic or Latino | 7 | 7 | 34 | 31 | 35 | 20 | 134 |
| Unknown or Not Reported | 0 | 0 | 0 | 1 | 2 | 0 | 3 |
| Race/Ethnicity, Customized(Participants) | Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 2 | 0 | 1 | 2 | 0 | 5 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 7 | 5 | 35 | 33 | 34 | 20 | 134 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Other | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Region of Enrollment(Participants) | Cohort A1 (CLL/FL/DLBCL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort A2 (FL/DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B1 (CLL/SLL): Ibrutinib 420 mg + Nivolumab 3 mg/kg | Cohort B2 (FL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B3 (DLBCL): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Cohort B4 (Richter Syndrome): Ibrutinib 560 mg + Nivolumab 3 mg/kg | Total |
|---|---|---|---|---|---|---|---|
| AUSTRALIA | 0 | 0 | 2 | 1 | 8 | 1 | 12 |
| ISRAEL | 6 | 1 | 4 | 8 | 6 | 0 | 25 |
| POLAND | 0 | 0 | 18 | 6 | 6 | 10 | 40 |
| SPAIN | 1 | 3 | 5 | 6 | 2 | 4 | 21 |
| TURKEY | 0 | 0 | 6 | 6 | 8 | 1 | 21 |
| UNITED STATES | 0 | 3 | 0 | 8 | 7 | 4 | 22 |
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