Hepatitis B, Chronic
Conditions
Brief summary
The purpose of this study is to evaluate efficacy of the study intervention, based on hepatitis B surface antigen (HBsAg) levels at follow-up (FU) Week 24.
Detailed description
JNJ-73763989 (JNJ-3989) is a small interfering ribonucleic acid (siRNA) targeting all hepatitis B virus (HBV) messenger ribonucleic acid (mRNAs). The programmed cell death protein receptor-1 (PD-1) inhibitor aims at preventing the interaction of PD-1 with its ligands. The purpose of this study to determine whether at least one of the combination regimens of JNJ-3989 + PD-1 inhibitor + Nucleos(t)ide analog (NA) is more efficacious than JNJ-3989 + NA treatment. This study will be conducted in 3 periods: screening period, treatment period and follow-up (FU) period. Safety assessments will include adverse events (AEs), serious AEs, clinical safety laboratory tests, electrocardiograms (ECGs), vital signs, and physical examinations. Total duration of individual participation will be up to 78 weeks (including screening period).
Interventions
DRUGJNJ-73763989
JNJ-73763989 will be administered subcutaneously.
DRUGPD-1 inhibitor
PD-1 inhibitor will be administered as IV infusion.
DRUGTenofovir Disoproxil
Tenofovir disoproxil film-coated tablets will be administered orally.
DRUGTenofovir Alafenamide
TAF film-coated tablets will be administered orally.
DRUGEntecavir
ETV film-coated tablets will be administered orally.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Participants must have chronic hepatitis B virus (HBV) infection * Participants must have fibroscan liver stiffness measurement less than or equal to (\<=) 9.0 kilopascal (kPa) or a liver biopsy result classified as metavir F0-F2
Exclusion criteria
* Participants with evidence of hepatitis A virus infection (hepatitis A antibody immunoglobulin IgM), hepatitis C virus (HCV) infection (HCV antibody), hepatitis D virus (HDV) infection (HDV antibody), hepatitis E virus (HEV) infection (hepatitis E antibody IgM), or human immunodeficiency virus type 1 (HIV-1) or human immunodeficiency virus type 2 (HIV-2) infection (laboratory confirmed) at screening * History or evidence of clinical signs or symptoms of hepatic decompensation, including but not limited to portal hypertension, ascites, hepatic encephalopathy, esophageal varices * Participants with history or signs of cirrhosis or portal hypertension or signs of hepatocellular carcinoma (HCC) or clinically relevant renal abnormalities * Participants with personal/familial history/indicative of immune-mediated disease risk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Hepatitis B Surface Antigen (HBsAg) Seroclearance at Follow-up (FU) Week 24 | At FU Week 24 | Percentage of participants who achieved HBsAg seroclearance at FU Week 24 were reported. Seroclearance of HBsAg was defined as a (quantitative) HBsAg level less than (\<) lower limit of quantification (LLOQ) (0.05 international unit per milliliters \[IU/mL\]). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With TEAEs by Severity | IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 | Number of participants with TEAEs by severity were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that did not necessarily had a causal relationship with the pharmaceutical/biological agent under study. Any AE occurring at or after the initial administration of study intervention was considered to be treatment emergent. Severity of AE were graded by using Division of Acquired Immunodeficiency Syndrome (DAIDS) grading scale that ranges from Grade 1 to Grade 5. Grade 1 indicates a mild event, Grade 2 indicates a moderate event, Grade 3 indicates a severe event, Grade 4 indicated a potentially life-threatening event, Grade 5 indicated death. |
| Number of Participants With Immune Related TEAEs | IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 | Number of participants with immune related TEAEs were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that did not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. Any AE occurring at or after the initial administration of study intervention was considered to be treatment emergent. Immune-related AEs (irAEs) were alanine aminotransferase/alanine aminotransferase (ALT/AST) elevations including immune-related hepatic AEs, infusion-related reaction (IRRs) and other irAEs (including gastrointestinal AEs, neurological AEs, pulmonary AEs, renal AEs, endocrinopathies, rash, uveitis and visual complaints, lipase/amylase elevations, and infection), hematological abnormalities and injection site reactions. |
| Number of Participants With Abnormalities in Vital Signs | IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 | Number of participants with abnormalities in vital signs measurements (including pulse rate: abnormally low: less than or equal to \[\<=\] 45 beats per minute \[bpm\], abnormally high: greater than or equal to \[\>=\] 120 bpm; diastolic blood pressure \[BP\]: abnormally low: \<=50 millimeters of mercury \[mmHg\], mild: \>90 to \<100 mmHg, moderate: \>=100 to \<110 mmHg, and severe: \>=110 mmHg; systolic BP: abnormally low: \<=90 mmHg, mild: \>140 to \<160 mmHg, moderate: \>=160 to \<180 mmHg, and severe: \>=180 mmHg) were reported. |
| Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 | Number of participants with abnormalities in 12-lead ECGs: heart rate (abnormally low: \<45 beats per minute \[bpm\], abnormally high: greater than or equal \[\>=\] 120 bpm), PR interval (abnormally high: greater than \[\>\] 220 millisecond \[msec\]), QRS interval (abnormally high: \>=120 msec), QTc interval Fridericia (Borderline prolonged QT: 450\< QTc \<=480 msec; Prolonged QT: 480 \< QTc \<=500; Pathologically prolonged QT: QTc \>500) were reported. |
| Number of Participants With Abnormalities in Physical Examinations | IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 | Number of participants with abnormalities in physical examinations were reported. |
| Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 | Percentage of participants with abnormalities in hematology parameters (including basophils/Leukocytes high, erythrocytes mean corpuscular volume high, erythrocytes high and low, lymphocytes/leukocytes high and low, monocytes/leukocytes high and low, neutrophils, segmented+band form high and low, reticulocytes/erythrocytes high and low, basophils/leukocytes, eosinophils/leukocytes high, erythrocyte mean corpuscular hemoglobin low, reticulocytes/erythrocytes high and low, lymphocytes atypical/leukocytes high, lymphocytes atypical high, hematocrit high, monocytes low and high) were reported. Abnormalities with at least 1 participant is included. Low and high categorization depend on investigator's discretion. |
| Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 | Number of participants with abnormalities in clinical chemistry parameters (including C reactive protein high, cystatin C low and high, gamma glutamyl transferase low, high density lipoprotein \[HDL\] cholesterol low and high, indirect bilirubin high, lactate dehydrogenase high, protein high, thyrotropin low and high, free thyroxine high, free triiodothyronine low and high, and urea nitrogen high) were reported. Abnormalities with at least 1 participant is included. Low and high categorization depend on investigator's discretion. |
| Number of Participants With Abnormalities in Clinical Laboratory Parameters: Urinalysis | IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 | Number of participants with abnormalities in clinical laboratory parameters (including specific gravity high and urine hyaline casts high) were reported. Abnormalities with at least 1 participant is included. Low and high categorization depend on investigator's discretion. |
| Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | IP: Baseline, Weeks 1, 2, 3, 4, 8, 12, 16, 20, and End of Study Intervention (EOSI; Week 24); FU Phase: FU Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48) | Change from baseline in HBsAg levels were reported. International units per milliliters=IU/mL. End of Study Intervention (EOSI) was the last post-baseline visit in study intervention period. End of study (EOS) was the last visit in the study. |
| Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) of Special Interest | IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 | An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily had a causal relationship with the pharmaceutical/biological agent under study. Any AE occurring at or after the initial administration of study intervention was considered to be treatment emergent. AEs of interest were significant AEs that are judged to be of special interest because of clinical importance, known class effects or based on nonclinical signals. |
| Percentage of Participants With HBsAg Seroclearance | IP: Week 0 to Week 24; FU Phase: FU Week 1 up to FU Week 48 | Percentage of participants with HBsAg seroclearance were reported. Seroclearance of HBsAg was defined as a HBsAg level \<lower limit of quantification (LLOQ) (0.05 IU/mL). |
| Percentage of Participants With HBsAg Seroconversion | IP: Week 0 to Week 24; FU Phase: FU Week 1 up to FU Week 48 | Percentage of participants with HBsAg seroconversion were reported. Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance and appearance of anti-HBs antibodies (baseline anti-HBs antibodies \<LLOQ and a post-baseline assessment \>=LLOQ). |
| Time to Achieve HBsAg Seroclearance | Week 0 up to FU Week 48 (up to Week 72) | Time to achieve HBsAg seroclearance was reported. Seroclearance of HBsAg was defined as a (quantitative) HBsAg level \<LLOQ (0.05 IU/mL). |
| Time to Achieve HBsAg Seroconversion | Week 0 up to FU Week 48 (up to Week 72) | Time to achieve HBsAg seroconversion were reported. Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance and appearance of anti-HBs antibodies (baseline anti-HBs antibodies \<LLOQ and a post-baseline assessment \>=LLOQ). |
| Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | IP: Baseline, Weeks 2, 4, 8, 12, 16, 20 and EOSI (Week 24); FU Phase: FU Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48) | HBV DNA levels over time were reported. EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study. |
| Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Baseline, Weeks 2, 4, 8, 12, 16, 20, and EOSI (Week 24); FU Phase: FU Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48) | Percentage of participants with HBV DNA level below/above different cut-offs over time were reported. HBV DNA cut offs: \<LLOQ target detected (TD): that is, traces of HBV DNA were detected/found but were too low to be quantified; \<LLOQ target not detected (TND): that is, no traces of HBV DNA were detected/found. EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study. The LLOQ for HBV DNA was 20 IU/mL. As indicated in the data table, the sum of percentage values of each sub-categories within the specific timepoints IP: Week 2 and FU Phase: Week 4, shows a slight deviation from 100% due to rounding. |
| Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time | IP: Baseline, Weeks 2, 4, 8, 12, 20, and EOSI (Week 24); FU Phase: FU Weeks 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48) | Percentage of participants with HBeAg level below/above different cut-offs over time were reported. HBeAg cut-offs: \<LLOQ (0.11 IU/mL). EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study. |
| Percentage of Participants With Virologic Breakthrough | IP: Week 0 to Week 24; FU Phase: FU Week 1 up to FU Week 48 | Percentage of participants with virologic breakthrough (confirmed on-treatment HBV DNA increase by \>1 log10 IU/mL from nadir in participants who did not have on-treatment HBV DNA level below LLOQ or a confirmed on-treatment HBV DNA level \>200 IU/mL in participants who had on-treatment HBV DNA level below LLOQ) were reported. |
| Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Baseline, Weeks 1, 2, 3, 4, 8, 12, 16, 20, and EOSI (Week 24); FU Phase: FU Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48) | Percentage of participants with change in HBsAg levels below/above different cut-offs (\<0.05 IU/mL, \<1 U/mL, \<10 IU/mL, \<100 IU/mL , \<1000 IU/mL) over time were reported. EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study. |
Countries
Canada, Czechia, France, Italy, Spain, Taiwan, Turkey (Türkiye), United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide \[TAF\] 25 mg or entecavir \[ETV\] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72). | 18 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72). | 19 |
| Total | 37 |
Baseline characteristics
| Characteristic | JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | JNJ-3989 + Nivolumab (3 Infusions) + NA | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 19 Participants | 37 Participants |
| AgeContinuous | 40.7 years STANDARD_DEVIATION 7.75 | 47.9 years STANDARD_DEVIATION 5.05 | 44.4 years STANDARD_DEVIATION 7.38 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 5 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 14 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 7 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 11 Participants | 22 Participants |
| Region of Enrollment CANADA | 3 Participants | 2 Participants | 5 Participants |
| Region of Enrollment FRANCE | 0 Participants | 2 Participants | 2 Participants |
| Region of Enrollment ITALY | 3 Participants | 2 Participants | 5 Participants |
| Region of Enrollment SPAIN | 2 Participants | 5 Participants | 7 Participants |
| Region of Enrollment TAIWAN | 3 Participants | 4 Participants | 7 Participants |
| Region of Enrollment TURKEY | 6 Participants | 3 Participants | 9 Participants |
| Region of Enrollment UNITED KINGDOM | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 15 Participants | 15 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 19 | 0 / 18 | 0 / 19 |
| other Total, other adverse events | 6 / 18 | 12 / 19 | 8 / 18 | 8 / 19 |
| serious Total, serious adverse events | 0 / 18 | 0 / 19 | 0 / 18 | 0 / 19 |
Outcome results
Primary
Percentage of Participants Who Achieved Hepatitis B Surface Antigen (HBsAg) Seroclearance at Follow-up (FU) Week 24
Percentage of participants who achieved HBsAg seroclearance at FU Week 24 were reported. Seroclearance of HBsAg was defined as a (quantitative) HBsAg level less than (\<) lower limit of quantification (LLOQ) (0.05 international unit per milliliters \[IU/mL\]).
Time frame: At FU Week 24
Population: Full analysis set (FAS) included all participants who were randomly assigned to an intervention arm in this intervention-specific appendix (ISA) and received at least 1 dose of study intervention within this ISA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants Who Achieved Hepatitis B Surface Antigen (HBsAg) Seroclearance at Follow-up (FU) Week 24 | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants Who Achieved Hepatitis B Surface Antigen (HBsAg) Seroclearance at Follow-up (FU) Week 24 | 0 Percentage of participants |
Secondary
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels
Change from baseline in HBsAg levels were reported. International units per milliliters=IU/mL. End of Study Intervention (EOSI) was the last post-baseline visit in study intervention period. End of study (EOS) was the last visit in the study.
Time frame: IP: Baseline, Weeks 1, 2, 3, 4, 8, 12, 16, 20, and End of Study Intervention (EOSI; Week 24); FU Phase: FU Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48)
Population: FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | IP: Baseline | 3.25 log10 IU/mL | Standard Deviation 0.472 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | IP: Week 1 | -0.19 log10 IU/mL | Standard Deviation 0.185 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | IP: Week 2 | -0.26 log10 IU/mL | Standard Deviation 0.293 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | IP: Week 3 | -0.34 log10 IU/mL | Standard Deviation 0.335 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | IP: Week 4 | -0.40 log10 IU/mL | Standard Deviation 0.4 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | IP: Week 8 | -0.80 log10 IU/mL | Standard Deviation 0.576 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | IP: Week 12 | -1.32 log10 IU/mL | Standard Deviation 0.513 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | IP: Week 16 | -1.77 log10 IU/mL | Standard Deviation 0.361 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | IP: Week 20 | -1.97 log10 IU/mL | Standard Deviation 0.376 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | IP: EOSI (Week 24) | -2.01 log10 IU/mL | Standard Deviation 0.385 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | FU Phase: Week 4 | -1.93 log10 IU/mL | Standard Deviation 0.515 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | FU Phase: Week 8 | -1.99 log10 IU/mL | Standard Deviation 0.417 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | FU Phase: Week 12 | -1.93 log10 IU/mL | Standard Deviation 0.393 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | FU Phase: Week 16 | -1.85 log10 IU/mL | Standard Deviation 0.42 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | FU Phase: Week 20 | -1.77 log10 IU/mL | Standard Deviation 0.418 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | FU Phase: Week 24 | -1.70 log10 IU/mL | Standard Deviation 0.507 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | FU Phase: Week 32 | -1.64 log10 IU/mL | Standard Deviation 0.616 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | FU Phase: Week 40 | -1.38 log10 IU/mL | Standard Deviation 0.568 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | FU Phase: Week 48 | -1.23 log10 IU/mL | Standard Deviation 0.527 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | FU Phase: EOS | -1.26 log10 IU/mL | Standard Deviation 0.53 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | FU Phase: Week 40 | -1.69 log10 IU/mL | Standard Deviation 0.904 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | IP: Baseline | 3.14 log10 IU/mL | Standard Deviation 0.542 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | FU Phase: Week 4 | -1.98 log10 IU/mL | Standard Deviation 0.59 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | IP: Week 1 | -0.17 log10 IU/mL | Standard Deviation 0.135 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | FU Phase: Week 24 | -1.85 log10 IU/mL | Standard Deviation 0.616 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | IP: Week 2 | -0.31 log10 IU/mL | Standard Deviation 0.33 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | FU Phase: Week 8 | -2.12 log10 IU/mL | Standard Deviation 0.613 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | IP: Week 3 | -0.44 log10 IU/mL | Standard Deviation 0.405 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | FU Phase: EOS | -1.54 log10 IU/mL | Standard Deviation 0.929 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | IP: Week 4 | -0.52 log10 IU/mL | Standard Deviation 0.525 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | FU Phase: Week 12 | -1.99 log10 IU/mL | Standard Deviation 0.574 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | IP: Week 8 | -0.87 log10 IU/mL | Standard Deviation 0.695 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | FU Phase: Week 32 | -1.75 log10 IU/mL | Standard Deviation 0.606 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | IP: Week 12 | -1.41 log10 IU/mL | Standard Deviation 0.687 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | FU Phase: Week 16 | -2.01 log10 IU/mL | Standard Deviation 0.648 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | IP: Week 16 | -1.84 log10 IU/mL | Standard Deviation 0.548 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | FU Phase: Week 48 | -1.54 log10 IU/mL | Standard Deviation 0.929 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | IP: Week 20 | -2.07 log10 IU/mL | Standard Deviation 0.549 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | FU Phase: Week 20 | -2.02 log10 IU/mL | Standard Deviation 0.584 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | IP: EOSI (Week 24) | -2.10 log10 IU/mL | Standard Deviation 0.563 |
Secondary
Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time
HBV DNA levels over time were reported. EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study.
Time frame: IP: Baseline, Weeks 2, 4, 8, 12, 16, 20 and EOSI (Week 24); FU Phase: FU Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48)
Population: FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | IP: Week 12 | 0.88 log10 IU/mL | Standard Deviation 0.239 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | FU Phase: Week 8 | 0.83 log10 IU/mL | Standard Deviation 0.22 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | FU Phase: Week 12 | 0.93 log10 IU/mL | Standard Deviation 0.257 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | IP: Week 4 | 0.83 log10 IU/mL | Standard Deviation 0.22 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | FU Phase: Week 16 | 0.78 log10 IU/mL | Standard Deviation 0.183 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | IP: Week 16 | 0.91 log10 IU/mL | Standard Deviation 0.244 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | FU Phase: Week 20 | 0.86 log10 IU/mL | Standard Deviation 0.231 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | IP: Week 2 | 0.87 log10 IU/mL | Standard Deviation 0.26 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | FU Phase: Week 24 | 0.86 log10 IU/mL | Standard Deviation 0.231 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | IP: Week 20 | 0.86 log10 IU/mL | Standard Deviation 0.231 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | FU Phase: Week 32 | 0.88 log10 IU/mL | Standard Deviation 0.239 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | IP: Week 8 | 0.88 log10 IU/mL | Standard Deviation 0.239 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | FU Phase: Week 40 | 0.91 log10 IU/mL | Standard Deviation 0.244 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | IP: EOSI (Week 24) | 0.96 log10 IU/mL | Standard Deviation 0.281 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | FU Phase: Week 48 | 0.84 log10 IU/mL | Standard Deviation 0.224 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | IP: Baseline | 0.83 log10 IU/mL | Standard Deviation 0.22 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | FU Phase: EOS | 0.83 log10 IU/mL | Standard Deviation 0.22 |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | FU Phase: Week 4 | 0.83 log10 IU/mL | Standard Deviation 0.22 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | FU Phase: EOS | 0.82 log10 IU/mL | Standard Deviation 0.216 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | IP: Baseline | 0.80 log10 IU/mL | Standard Deviation 0.2 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | IP: Week 2 | 0.72 log10 IU/mL | Standard Deviation 0.109 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | IP: Week 4 | 0.85 log10 IU/mL | Standard Deviation 0.228 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | IP: Week 8 | 0.82 log10 IU/mL | Standard Deviation 0.216 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | IP: Week 12 | 0.82 log10 IU/mL | Standard Deviation 0.216 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | IP: Week 16 | 0.82 log10 IU/mL | Standard Deviation 0.216 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | IP: Week 20 | 0.80 log10 IU/mL | Standard Deviation 0.2 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | IP: EOSI (Week 24) | 0.77 log10 IU/mL | Standard Deviation 0.179 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | FU Phase: Week 4 | 0.90 log10 IU/mL | Standard Deviation 0.288 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | FU Phase: Week 12 | 0.91 log10 IU/mL | Standard Deviation 0.244 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | FU Phase: Week 16 | 0.85 log10 IU/mL | Standard Deviation 0.228 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | FU Phase: Week 20 | 0.90 log10 IU/mL | Standard Deviation 0.242 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | FU Phase: Week 24 | 0.87 log10 IU/mL | Standard Deviation 0.236 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | FU Phase: Week 32 | 0.75 log10 IU/mL | Standard Deviation 0.15 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | FU Phase: Week 40 | 0.85 log10 IU/mL | Standard Deviation 0.228 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | FU Phase: Week 48 | 0.82 log10 IU/mL | Standard Deviation 0.216 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | FU Phase: Week 8 | 0.80 log10 IU/mL | Standard Deviation 0.2 |
Secondary
Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs)
Number of participants with abnormalities in 12-lead ECGs: heart rate (abnormally low: \<45 beats per minute \[bpm\], abnormally high: greater than or equal \[\>=\] 120 bpm), PR interval (abnormally high: greater than \[\>\] 220 millisecond \[msec\]), QRS interval (abnormally high: \>=120 msec), QTc interval Fridericia (Borderline prolonged QT: 450\< QTc \<=480 msec; Prolonged QT: 480 \< QTc \<=500; Pathologically prolonged QT: QTc \>500) were reported.
Time frame: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Population: Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA. Here, 'n' (number analyzed) refers to number of participants evaluable at specified parameter.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | IP: QRS interval: Abnormally high | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | FU Phase: Heart rate: Abnormally low | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | IP: Heart rate: Abnormally low | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | FU Phase: Heart rate: Abnormally high | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | IP: QTc interval: Borderline prolonged QT | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | FU Phase: PR interval: Abnormally high | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | IP: PR interval: Abnormally high | 1 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | FU Phase: QRS interval: Abnormally high | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | IP: QTc interval: prolonged QT | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | FU Phase: QTc interval Borderline prolonged QT | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | IP: Heart rate: Abnormally high | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | IP: QTc interval: Pathologically prolonged QT | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | FU Phase:QTc interval: Pathologically prolonged QT | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | FU Phase: QTc interval: prolonged QT | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | FU Phase:QTc interval: Pathologically prolonged QT | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | IP: Heart rate: Abnormally low | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | IP: Heart rate: Abnormally high | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | IP: PR interval: Abnormally high | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | IP: QRS interval: Abnormally high | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | IP: QTc interval: Borderline prolonged QT | 1 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | IP: QTc interval: prolonged QT | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | IP: QTc interval: Pathologically prolonged QT | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | FU Phase: Heart rate: Abnormally low | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | FU Phase: Heart rate: Abnormally high | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | FU Phase: PR interval: Abnormally high | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | FU Phase: QRS interval: Abnormally high | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | FU Phase: QTc interval Borderline prolonged QT | 1 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | FU Phase: QTc interval: prolonged QT | 0 Participants |
Secondary
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
Number of participants with abnormalities in clinical chemistry parameters (including C reactive protein high, cystatin C low and high, gamma glutamyl transferase low, high density lipoprotein \[HDL\] cholesterol low and high, indirect bilirubin high, lactate dehydrogenase high, protein high, thyrotropin low and high, free thyroxine high, free triiodothyronine low and high, and urea nitrogen high) were reported. Abnormalities with at least 1 participant is included. Low and high categorization depend on investigator's discretion.
Time frame: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Population: Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA. Here, 'n' (number analyzed) signifies number of participants analyzed at each specified timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: C Reactive Protein: High | 3 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: Cystatin C: Low | 2 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: Cystatin C: High | 1 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: Gamma Glutamyl Transferase: Low | 4 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: HDL Cholesterol: Low | 6 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: HDL Cholesterol: High | 3 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: Indirect Bilirubin: High | 1 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: Lactate Dehydrogenase: High | 2 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: Protein: High | 1 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: Thyrotropin: Low | 2 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: Thyrotropin: High | 1 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: Free Thyroxine: High | 3 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: Triiodothyronine, Free: Low | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: Triiodothyronine, Free: High | 5 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: Urea Nitrogen: High | 1 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: C Reactive Protein: High | 2 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: Chloride: Low | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: Cystatin C: Low | 1 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: Cystatin C: High | 2 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: Gamma Glutamyl Transferase: Low | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: HDL Cholesterol: Low | 6 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: HDL Cholesterol: High | 2 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: Indirect Bilirubin: High | 1 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: Lactate Dehydrogenase: High | 2 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: Protein: High | 1 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: Thyrotropin: Low | 1 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: Thyrotropin: High | 1 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: Free Thyroxine: Low | 1 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: Free Thyroxine: High | 2 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: Free Triiodothyronine: High | 6 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: Urea Nitrogen: High | 1 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: C Reactive Protein: High | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: C Reactive Protein: High | 2 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: Lactate Dehydrogenase: High | 2 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: Cystatin C: Low | 1 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: Chloride: Low | 1 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: Cystatin C: High | 1 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: Free Thyroxine: Low | 1 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: Gamma Glutamyl Transferase: Low | 4 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: Cystatin C: Low | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: HDL Cholesterol: Low | 3 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: Protein: High | 1 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: HDL Cholesterol: High | 4 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: Cystatin C: High | 3 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: Indirect Bilirubin: High | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: Free Triiodothyronine: High | 3 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: Lactate Dehydrogenase: High | 2 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: Gamma Glutamyl Transferase: Low | 1 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: Protein: High | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: Thyrotropin: Low | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: Thyrotropin: Low | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: HDL Cholesterol: Low | 2 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: Thyrotropin: High | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: Free Thyroxine: High | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: Free Thyroxine: High | 1 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: HDL Cholesterol: High | 4 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: Triiodothyronine, Free: Low | 1 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: Thyrotropin: High | 1 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: Triiodothyronine, Free: High | 4 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: Indirect Bilirubin: High | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | IP: Urea Nitrogen: High | 2 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | FU Phase: Urea Nitrogen: High | 1 Participants |
Secondary
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Urinalysis
Number of participants with abnormalities in clinical laboratory parameters (including specific gravity high and urine hyaline casts high) were reported. Abnormalities with at least 1 participant is included. Low and high categorization depend on investigator's discretion.
Time frame: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Population: Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA. Here, N (number of participants analyzed) signifies number of participants analyzed for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Urinalysis | IP: Specific Gravity: High | 2 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Urinalysis | IP: Urine Hyaline Casts: High | 1 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Urinalysis | FU Phase: Specific Gravity: High | 1 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Urinalysis | FU Phase: Urine Hyaline Casts: High | 2 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Urinalysis | FU Phase: Urine Hyaline Casts: High | 2 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Urinalysis | IP: Specific Gravity: High | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Urinalysis | FU Phase: Specific Gravity: High | 1 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Urinalysis | IP: Urine Hyaline Casts: High | 1 Participants |
Secondary
Number of Participants With Abnormalities in Physical Examinations
Number of participants with abnormalities in physical examinations were reported.
Time frame: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Population: Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Physical Examinations | IP | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Physical Examinations | FU Phase | 2 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Physical Examinations | IP | 2 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Physical Examinations | FU Phase | 1 Participants |
Secondary
Number of Participants With Abnormalities in Vital Signs
Number of participants with abnormalities in vital signs measurements (including pulse rate: abnormally low: less than or equal to \[\<=\] 45 beats per minute \[bpm\], abnormally high: greater than or equal to \[\>=\] 120 bpm; diastolic blood pressure \[BP\]: abnormally low: \<=50 millimeters of mercury \[mmHg\], mild: \>90 to \<100 mmHg, moderate: \>=100 to \<110 mmHg, and severe: \>=110 mmHg; systolic BP: abnormally low: \<=90 mmHg, mild: \>140 to \<160 mmHg, moderate: \>=160 to \<180 mmHg, and severe: \>=180 mmHg) were reported.
Time frame: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Population: Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Vital Signs | IP: Pulse: Abnormally Low | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Vital Signs | IP: Pulse: Abnormally High | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Vital Signs | IP: Diastolic BP: Abnormally Low | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Vital Signs | IP: Diastolic BP: Mild | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Vital Signs | IP: Diastolic BP: Moderate | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Vital Signs | IP: Diastolic BP: Severe | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Vital Signs | IP: Systolic BP: Abnormally low | 2 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Vital Signs | IP: Systolic BP: Mild | 2 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Vital Signs | IP: Systolic BP: Moderate | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Vital Signs | IP: Systolic BP: Severe | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Vital Signs | FU Phase: Pulse: Abnormally low | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Vital Signs | FU Phase: Pulse: Abnormally high | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Vital Signs | FU Phase: Diastolic BP: Abnormally low | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Vital Signs | FU Phase: Diastolic BP: Mild | 1 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Vital Signs | FU Phase: Diastolic BP: Moderate | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Vital Signs | FU Phase: Diastolic BP: Severe | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Vital Signs | FU Phase: Systolic BP: Abnormally low | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Vital Signs | FU Phase: Systolic BP: Mild | 2 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Vital Signs | FU Phase: Systolic BP: Moderate | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Abnormalities in Vital Signs | FU Phase: Systolic BP: Severe | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Vital Signs | FU Phase: Systolic BP: Mild | 2 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Vital Signs | IP: Pulse: Abnormally Low | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Vital Signs | FU Phase: Pulse: Abnormally low | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Vital Signs | IP: Pulse: Abnormally High | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Vital Signs | FU Phase: Diastolic BP: Severe | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Vital Signs | IP: Diastolic BP: Abnormally Low | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Vital Signs | FU Phase: Pulse: Abnormally high | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Vital Signs | IP: Diastolic BP: Mild | 1 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Vital Signs | FU Phase: Systolic BP: Severe | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Vital Signs | IP: Diastolic BP: Moderate | 1 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Vital Signs | FU Phase: Diastolic BP: Abnormally low | 1 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Vital Signs | IP: Diastolic BP: Severe | 1 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Vital Signs | FU Phase: Systolic BP: Abnormally low | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Vital Signs | IP: Systolic BP: Abnormally low | 2 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Vital Signs | FU Phase: Diastolic BP: Mild | 1 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Vital Signs | IP: Systolic BP: Mild | 1 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Vital Signs | FU Phase: Systolic BP: Moderate | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Vital Signs | IP: Systolic BP: Moderate | 1 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Vital Signs | FU Phase: Diastolic BP: Moderate | 1 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Abnormalities in Vital Signs | IP: Systolic BP: Severe | 0 Participants |
Secondary
Number of Participants With Immune Related TEAEs
Number of participants with immune related TEAEs were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that did not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. Any AE occurring at or after the initial administration of study intervention was considered to be treatment emergent. Immune-related AEs (irAEs) were alanine aminotransferase/alanine aminotransferase (ALT/AST) elevations including immune-related hepatic AEs, infusion-related reaction (IRRs) and other irAEs (including gastrointestinal AEs, neurological AEs, pulmonary AEs, renal AEs, endocrinopathies, rash, uveitis and visual complaints, lipase/amylase elevations, and infection), hematological abnormalities and injection site reactions.
Time frame: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Population: Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Immune Related TEAEs | IP | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With Immune Related TEAEs | FU Phase | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Immune Related TEAEs | IP | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With Immune Related TEAEs | FU Phase | 1 Participants |
Secondary
Number of Participants With TEAEs by Severity
Number of participants with TEAEs by severity were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that did not necessarily had a causal relationship with the pharmaceutical/biological agent under study. Any AE occurring at or after the initial administration of study intervention was considered to be treatment emergent. Severity of AE were graded by using Division of Acquired Immunodeficiency Syndrome (DAIDS) grading scale that ranges from Grade 1 to Grade 5. Grade 1 indicates a mild event, Grade 2 indicates a moderate event, Grade 3 indicates a severe event, Grade 4 indicated a potentially life-threatening event, Grade 5 indicated death.
Time frame: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Population: Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With TEAEs by Severity | IP: Grade 1 | 5 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With TEAEs by Severity | IP: Grade 2 | 1 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With TEAEs by Severity | IP: Grade 3 | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With TEAEs by Severity | IP: Grade 4 | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With TEAEs by Severity | IP: Grade 5 | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With TEAEs by Severity | FU Phase: Grade 1 | 7 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With TEAEs by Severity | FU Phase: Grade 2 | 1 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With TEAEs by Severity | FU Phase: Grade 3 | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With TEAEs by Severity | FU Phase: Grade 4 | 0 Participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Number of Participants With TEAEs by Severity | FU Phase: Grade 5 | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With TEAEs by Severity | FU Phase: Grade 3 | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With TEAEs by Severity | IP: Grade 1 | 7 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With TEAEs by Severity | FU Phase: Grade 1 | 6 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With TEAEs by Severity | IP: Grade 2 | 5 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With TEAEs by Severity | FU Phase: Grade 5 | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With TEAEs by Severity | IP: Grade 3 | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With TEAEs by Severity | FU Phase: Grade 2 | 2 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With TEAEs by Severity | IP: Grade 4 | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With TEAEs by Severity | FU Phase: Grade 4 | 0 Participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Number of Participants With TEAEs by Severity | IP: Grade 5 | 0 Participants |
Secondary
Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) of Special Interest
An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily had a causal relationship with the pharmaceutical/biological agent under study. Any AE occurring at or after the initial administration of study intervention was considered to be treatment emergent. AEs of interest were significant AEs that are judged to be of special interest because of clinical importance, known class effects or based on nonclinical signals.
Time frame: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Population: Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) of Special Interest | IP | 11.1 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) of Special Interest | FU Phase | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) of Special Interest | IP | 5.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) of Special Interest | FU Phase | 5.3 Percentage of participants |
Secondary
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
Percentage of participants with abnormalities in hematology parameters (including basophils/Leukocytes high, erythrocytes mean corpuscular volume high, erythrocytes high and low, lymphocytes/leukocytes high and low, monocytes/leukocytes high and low, neutrophils, segmented+band form high and low, reticulocytes/erythrocytes high and low, basophils/leukocytes, eosinophils/leukocytes high, erythrocyte mean corpuscular hemoglobin low, reticulocytes/erythrocytes high and low, lymphocytes atypical/leukocytes high, lymphocytes atypical high, hematocrit high, monocytes low and high) were reported. Abnormalities with at least 1 participant is included. Low and high categorization depend on investigator's discretion.
Time frame: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Population: Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA. Here, 'n' (number analyzed) refers to number of participants evaluable at specified parameter. n=0 indicates that there was no evaluable participant for specified parameter.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | IP: Neutrophils, Segmented+Band Form: Low | 22.2 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Erythrocyte: Low | 11.1 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | IP: Erythrocytes Mean Corpuscular Volume: High | 16.7 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Erythrocyte: High | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | IP: Neutrophils, Segmented+Band Form: High | 11.1 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Lymphocytes/Leukocytes: Low | 11.1 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | IP: Lymphocytes/Leukocytes: High | 11.1 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Lymphocytes/Leukocytes: High | 22.2 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | IP: Reticulocytes/Erythrocytes: Low | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Monocytes/Leukocytes: Low | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | IP: Erythrocytes: High | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Monocytes/Leukocytes: High | 5.6 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | IP: Reticulocytes/Erythrocytes: High | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Neutrophils, Segmented + Band Form: Low | 38.9 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | IP: Monocytes/Leukocytes: Low | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Neutrophils, Segmented + Band Form: High | 11.1 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Basophils/Leukocytes: High | 11.1 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Reticulocytes/Erythrocytes: Low | 16.7 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | IP: Erythrocytes: Low | 16.7 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Reticulocytes/Erythrocytes: High | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Eosinophils/Leukocytes: High | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | IP: Monocytes/Leukocytes: High | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Erythrocyte Mean Corpuscular Hemoglobin: Low | 5.6 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Hematocrit: High | 5.6 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | IP: Lymphocytes/Leukocytes: Low | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Monocytes: Low | 5.6 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Erythrocyte Mean Corpuscular Volume: High | 27.8 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Monocytes: High | 5.6 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | IP: Basophils/Leukocytes: High | 11.1 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Hematocrit: High | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Monocytes: Low | 10.5 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Monocytes: High | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | IP: Basophils/Leukocytes: High | 42.1 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | IP: Erythrocytes Mean Corpuscular Volume: High | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | IP: Erythrocytes: Low | 26.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | IP: Erythrocytes: High | 5.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | IP: Lymphocytes/Leukocytes: Low | 5.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | IP: Lymphocytes/Leukocytes: High | 5.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | IP: Monocytes/Leukocytes: Low | 5.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | IP: Monocytes/Leukocytes: High | 5.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | IP: Neutrophils, Segmented+Band Form: Low | 26.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | IP: Neutrophils, Segmented+Band Form: High | 10.5 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | IP: Reticulocytes/Erythrocytes: Low | 10.5 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | IP: Reticulocytes/Erythrocytes: High | 10.5 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Basophils/Leukocytes: High | 5.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Eosinophils/Leukocytes: High | 15.8 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Erythrocyte Mean Corpuscular Hemoglobin: Low | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Erythrocyte Mean Corpuscular Volume: High | 15.8 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Erythrocyte: Low | 21.1 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Erythrocyte: High | 5.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Lymphocytes/Leukocytes: Low | 5.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Lymphocytes/Leukocytes: High | 5.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Monocytes/Leukocytes: Low | 10.5 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Monocytes/Leukocytes: High | 15.8 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Neutrophils, Segmented + Band Form: Low | 31.6 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Neutrophils, Segmented + Band Form: High | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Reticulocytes/Erythrocytes: Low | 42.1 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Reticulocytes/Erythrocytes: High | 5.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Lymphocytes Atypical/Leukocytes: High | 100 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | FU Phase: Lymphocytes Atypical: High | 100 Percentage of participants |
Secondary
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
Percentage of participants with change in HBsAg levels below/above different cut-offs (\<0.05 IU/mL, \<1 U/mL, \<10 IU/mL, \<100 IU/mL , \<1000 IU/mL) over time were reported. EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study.
Time frame: IP: Baseline, Weeks 1, 2, 3, 4, 8, 12, 16, 20, and EOSI (Week 24); FU Phase: FU Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48)
Population: FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 4: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 2: HBsAg <100 IU/mL | 5.6 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 4: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 8: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 4: HBsAg <10 IU/mL | 16.7 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 1: HBsAg <10 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 4: HBsAg <100 IU/mL | 83.3 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 8: HBsAg <10 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 4: HBsAg <1000 IU/mL | 100.0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 2: HBsAg <1000 IU/mL | 38.9 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 8: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 8: HBsAg <100 IU/mL | 27.8 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 8: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Baseline: HBsAg <1000 IU/mL | 38.9 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 8: HBsAg <10 IU/mL | 33.3 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 8: HBsAg <1000 IU/mL | 66.7 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 8: HBsAg <100 IU/mL | 88.9 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 3: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 8: HBsAg <1000 IU/mL | 100.0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 12: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 12: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 1: HBsAg <100 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 12: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 12: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 12: HBsAg <10 IU/mL | 29.4 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 3: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 12: HBsAg <100 IU/mL | 88.2 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 12: HBsAg <10 IU/mL | 11.1 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 12: HBsAg <1000 IU/mL | 100.0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Baseline: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 16: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 12: HBsAg <100 IU/mL | 55.6 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 16: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 3: HBsAg <10 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 16: HBsAg <10 IU/mL | 22.2 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 12: HBsAg <1000 IU/mL | 100.0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 16: HBsAg <100 IU/mL | 83.3 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 1: HBsAg <1000 IU/mL | 44.4 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 16: HBsAg <1000 IU/mL | 100.0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 16: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 20: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 3: HBsAg <100 IU/mL | 11.1 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 20: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 16: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 20: HBsAg <10 IU/mL | 22.2 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 1: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 20: HBsAg <100 IU/mL | 83.3 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 16: HBsAg <10 IU/mL | 16.7 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 20: HBsAg <1000 IU/mL | 94.4 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 3: HBsAg <1000 IU/mL | 50.0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 24: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 16: HBsAg <100 IU/mL | 83.3 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 24: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 2: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 24: HBsAg <10 IU/mL | 16.7 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 16: HBsAg <1000 IU/mL | 100.0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 24: HBsAg <100 IU/mL | 72.2 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 4: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 24: HBsAg <1000 IU/mL | 88.9 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 20: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 32: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Baseline: HBsAg <100 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 32: HBsAg <1 IU/mL | 5.6 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 20: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 32: HBsAg <10 IU/mL | 16.7 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 4: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 32: HBsAg <100 IU/mL | 72.2 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 20: HBsAg <10 IU/mL | 22.2 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 32: HBsAg <1000 IU/mL | 88.9 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 2: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 40: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 20: HBsAg <100 IU/mL | 83.3 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 40: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 4: HBsAg <10 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 40: HBsAg <10 IU/mL | 11.1 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 20: HBsAg <1000 IU/mL | 100.0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 40: HBsAg <100 IU/mL | 66.7 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 1: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 40: HBsAg <1000 IU/mL | 88.9 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: EOSI (Week 24): HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 48: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 4: HBsAg <100 IU/mL | 11.1 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 48: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: EOSI (Week 24): HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 48: HBsAg <10 IU/mL | 11.8 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 2: HBsAg <10 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 48: HBsAg <100 IU/mL | 64.7 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: EOSI (Week 24): HBsAg <10 IU/mL | 33.3 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 48: HBsAg <1000 IU/mL | 82.4 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 4: HBsAg <1000 IU/mL | 61.1 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: EOS: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: EOSI (Week 24): HBsAg <100 IU/mL | 88.9 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: EOS: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Baseline: HBsAg <10 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: EOS: HBsAg <10 IU/mL | 11.1 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: EOSI (Week 24): HBsAg <1000 IU/mL | 100.0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: EOS: HBsAg <100 IU/mL | 66.7 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 8: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: EOS: HBsAg <1000 IU/mL | 83.3 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Baseline: HBsAg < 0.05 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: EOS: HBsAg <1000 IU/mL | 89.5 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Baseline: HBsAg < 0.05 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Baseline: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Baseline: HBsAg <10 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Baseline: HBsAg <100 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Baseline: HBsAg <1000 IU/mL | 42.1 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 1: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 1: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 1: HBsAg <10 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 1: HBsAg <100 IU/mL | 10.5 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 1: HBsAg <1000 IU/mL | 57.9 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 2: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 2: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 2: HBsAg <10 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 2: HBsAg <100 IU/mL | 15.8 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 2: HBsAg <1000 IU/mL | 63.2 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 3: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 3: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 3: HBsAg <10 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 3: HBsAg <100 IU/mL | 15.8 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 3: HBsAg <1000 IU/mL | 63.2 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 4: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 4: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 4: HBsAg <10 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 4: HBsAg <100 IU/mL | 15.8 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 4: HBsAg <1000 IU/mL | 73.7 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 8: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 8: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 8: HBsAg <10 IU/mL | 10.5 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 8: HBsAg <100 IU/mL | 42.1 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 8: HBsAg <1000 IU/mL | 78.9 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 12: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 12: HBsAg <1 IU/mL | 5.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 12: HBsAg <10 IU/mL | 15.8 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 12: HBsAg <100 IU/mL | 68.4 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 12: HBsAg <1000 IU/mL | 94.7 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 16: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 16: HBsAg <1 IU/mL | 5.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 16: HBsAg <10 IU/mL | 21.1 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 16: HBsAg <100 IU/mL | 89.5 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 16: HBsAg <1000 IU/mL | 100.0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 20: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 20: HBsAg <1 IU/mL | 5.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 20: HBsAg <10 IU/mL | 42.1 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 20: HBsAg <100 IU/mL | 94.7 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: Week 20: HBsAg <1000 IU/mL | 100.0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: EOSI (Week 24): HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: EOSI (Week 24): HBsAg <1 IU/mL | 5.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: EOSI (Week 24): HBsAg <10 IU/mL | 52.6 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: EOSI (Week 24): HBsAg <100 IU/mL | 94.7 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | IP: EOSI (Week 24): HBsAg <1000 IU/mL | 100.0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 4: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 4: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 4: HBsAg <10 IU/mL | 57.1 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 4: HBsAg <100 IU/mL | 85.7 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 4: HBsAg <1000 IU/mL | 100.0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 8: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 8: HBsAg <1 IU/mL | 10.5 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 8: HBsAg <10 IU/mL | 52.6 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 8: HBsAg <100 IU/mL | 94.7 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 8: HBsAg <1000 IU/mL | 100.0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 12: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 12: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 12: HBsAg <10 IU/mL | 50.0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 12: HBsAg <100 IU/mL | 93.8 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 12: HBsAg <1000 IU/mL | 100.0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 16: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 16: HBsAg <1 IU/mL | 5.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 16: HBsAg <10 IU/mL | 47.4 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 16: HBsAg <100 IU/mL | 94.7 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 16: HBsAg <1000 IU/mL | 100.0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 20: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 20: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 20: HBsAg <10 IU/mL | 52.9 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 20: HBsAg <100 IU/mL | 100.0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 20: HBsAg <1000 IU/mL | 100.0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 24: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 24: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 24: HBsAg <10 IU/mL | 42.1 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 24: HBsAg <100 IU/mL | 84.2 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 24: HBsAg <1000 IU/mL | 94.7 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 32: HBsAg <0.05 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 32: HBsAg <1 IU/mL | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 32: HBsAg <10 IU/mL | 26.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 32: HBsAg <100 IU/mL | 78.9 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 32: HBsAg <1000 IU/mL | 94.7 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 40: HBsAg <0.05 IU/mL | 5.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 40: HBsAg <1 IU/mL | 5.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 40: HBsAg <10 IU/mL | 15.8 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 40: HBsAg <100 IU/mL | 78.9 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 40: HBsAg <1000 IU/mL | 89.5 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 48: HBsAg <0.05 IU/mL | 5.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 48: HBsAg <1 IU/mL | 5.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 48: HBsAg <10 IU/mL | 15.8 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 48: HBsAg <100 IU/mL | 78.9 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: Week 48: HBsAg <1000 IU/mL | 89.5 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: EOS: HBsAg <0.05 IU/mL | 5.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: EOS: HBsAg <1 IU/mL | 5.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: EOS: HBsAg <10 IU/mL | 15.8 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | FU Phase: EOS: HBsAg <100 IU/mL | 78.9 Percentage of participants |
Secondary
Percentage of Participants With HBsAg Seroclearance
Percentage of participants with HBsAg seroclearance were reported. Seroclearance of HBsAg was defined as a HBsAg level \<lower limit of quantification (LLOQ) (0.05 IU/mL).
Time frame: IP: Week 0 to Week 24; FU Phase: FU Week 1 up to FU Week 48
Population: FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With HBsAg Seroclearance | IP | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With HBsAg Seroclearance | FU Phase | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With HBsAg Seroclearance | IP | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With HBsAg Seroclearance | FU Phase | 5.3 Percentage of participants |
Secondary
Percentage of Participants With HBsAg Seroconversion
Percentage of participants with HBsAg seroconversion were reported. Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance and appearance of anti-HBs antibodies (baseline anti-HBs antibodies \<LLOQ and a post-baseline assessment \>=LLOQ).
Time frame: IP: Week 0 to Week 24; FU Phase: FU Week 1 up to FU Week 48
Population: FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, 'N' (number of participants analyzed) signifies number of participants analyzed for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed for specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With HBsAg Seroconversion | IP Phase | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With HBsAg Seroconversion | FU Phase | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With HBsAg Seroconversion | IP Phase | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With HBsAg Seroconversion | FU Phase | 5.6 Percentage of participants |
Secondary
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time
Percentage of participants with HBeAg level below/above different cut-offs over time were reported. HBeAg cut-offs: \<LLOQ (0.11 IU/mL). EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study.
Time frame: IP: Baseline, Weeks 2, 4, 8, 12, 20, and EOSI (Week 24); FU Phase: FU Weeks 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48)
Population: FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, 'n' (number analyzed) signifies number of participants analyzed at each specified timepoint. Here, n=0 signifies no participant was analyzed at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time | IP: Baseline | 100.0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time | IP: Week 12 | 100.0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time | IP: EOSI (Week 24) | 100.0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 12 | 100.0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 24 | 100.0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 40 | 100.0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 48 | 94.1 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time | FU Phase: EOS | 94.4 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 32 | 100.0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time | IP: EOSI (Week 24) | 100.0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 48 | 100.0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 12 | 100.0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 16 | 100.0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time | FU Phase: EOS | 100.0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time | IP: Baseline | 94.7 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time | IP: Week 2 | 100 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time | IP: Week 4 | 100.0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time | IP: Week 8 | 100.0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 24 | 100.0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time | IP: Week 12 | 100.0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time | IP: Week 20 | 100.0 Percentage of participants |
Secondary
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
Percentage of participants with HBV DNA level below/above different cut-offs over time were reported. HBV DNA cut offs: \<LLOQ target detected (TD): that is, traces of HBV DNA were detected/found but were too low to be quantified; \<LLOQ target not detected (TND): that is, no traces of HBV DNA were detected/found. EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study. The LLOQ for HBV DNA was 20 IU/mL. As indicated in the data table, the sum of percentage values of each sub-categories within the specific timepoints IP: Week 2 and FU Phase: Week 4, shows a slight deviation from 100% due to rounding.
Time frame: IP: Baseline, Weeks 2, 4, 8, 12, 16, 20, and EOSI (Week 24); FU Phase: FU Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48)
Population: FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, 'n' (number analyzed) signifies number of participants analyzed at each specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Week 12: HBV DNA < LLOQ TD | 38.9 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Baseline: HBV DNA < LLOQ TD | 27.8 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Week 2: HBV DNA < LLOQ TND | 66.7 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Week 2: HBV DNA < LLOQ TD | 27.8 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Week 2: HBV DNA > LLOQ | 5.6 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Week 4: HBV DNA < LLOQ TND | 72.2 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Week 4: HBV DNA < LLOQ TD | 27.8 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Week 8: HBV DNA < LLOQ TND | 61.1 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Week 8: HBV DNA < LLOQ TD | 38.9 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Week 12: HBV DNA < LLOQ TND | 61.1 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Baseline: HBV DNA < LLOQ TND | 72.2 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Week 16: HBV DNA <LLOQ TND | 55.6 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Week 16: HBV DNA <LLOQ TD | 44.4 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Week 20: HBV DNA <LLOQ TND | 66.7 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Week 20: HBV DNA <LLOQ TD | 33.3 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: EOSI(Week 24): HBV DNA <LLOQ TND | 50.0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: EOSI(Week 24): HBV DNA <LLOQ TD | 38.9 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: EOSI(Week 24): HBV DNA > LLOQ | 11.1 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 4: HBV DNA <LLOQ TND | 72.2 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 4: HBV DNA <LLOQ TD | 27.8 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 4: HBV DNA > LLOQ | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 8: HBV DNA <LLOQ TND | 72.2 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 8: HBV DNA <LLOQ TD | 27.8 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 12: HBV DNA <LLOQ TND | 52.9 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 12: HBV DNA <LLOQ TD | 41.2 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 12: HBV DNA > LLOQ | 5.9 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 16: HBV DNA <LLOQ TND | 83.3 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 16: HBV DNA <LLOQ TD | 16.7 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 20: HBV DNA <LLOQ TND | 66.7 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 20: HBV DNA <LLOQ TD | 33.3 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 24: HBV DNA <LLOQ TND | 66.7 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 24: HBV DNA <LLOQ TD | 33.3 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 32: HBV DNA <LLOQ TND | 61.1 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 32: HBV DNA <LLOQ TD | 38.9 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 40: HBV DNA <LLOQ TND | 55.6 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 40: HBV DNA <LLOQ TD | 44.4 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 48: HBV DNA <LLOQ TND | 70.6 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 48: HBV DNA <LLOQ TD | 29.4 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: EOS: HBV DNA <LLOQ TND | 72.2 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: EOS: HBV DNA <LLOQ TD | 27.8 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 48: HBV DNA <LLOQ TD | 26.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Baseline: HBV DNA < LLOQ TND | 78.9 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 4: HBV DNA > LLOQ | 5.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Baseline: HBV DNA < LLOQ TD | 21.1 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 24: HBV DNA <LLOQ TND | 63.2 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Week 2: HBV DNA < LLOQ TND | 94.7 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 8: HBV DNA <LLOQ TND | 78.9 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Week 2: HBV DNA < LLOQ TD | 5.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 40: HBV DNA <LLOQ TD | 31.6 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Week 2: HBV DNA > LLOQ | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 8: HBV DNA <LLOQ TD | 21.1 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Week 4: HBV DNA < LLOQ TND | 68.4 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 24: HBV DNA <LLOQ TD | 36.8 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Week 4: HBV DNA < LLOQ TD | 31.6 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 12: HBV DNA <LLOQ TND | 55.6 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Week 8: HBV DNA < LLOQ TND | 73.7 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: EOS: HBV DNA <LLOQ TD | 26.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Week 8: HBV DNA < LLOQ TD | 26.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 12: HBV DNA <LLOQ TD | 44.4 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Week 12: HBV DNA < LLOQ TND | 73.7 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 32: HBV DNA <LLOQ TND | 89.5 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Week 12: HBV DNA < LLOQ TD | 26.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 12: HBV DNA > LLOQ | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Week 16: HBV DNA <LLOQ TND | 73.7 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 48: HBV DNA <LLOQ TND | 73.7 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Week 16: HBV DNA <LLOQ TD | 26.3 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 16: HBV DNA <LLOQ TND | 68.4 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Week 20: HBV DNA <LLOQ TND | 78.9 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 32: HBV DNA <LLOQ TD | 10.5 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: Week 20: HBV DNA <LLOQ TD | 21.1 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 16: HBV DNA <LLOQ TD | 31.6 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: EOSI(Week 24): HBV DNA <LLOQ TND | 84.2 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: EOS: HBV DNA <LLOQ TND | 73.7 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: EOSI(Week 24): HBV DNA <LLOQ TD | 15.8 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 20: HBV DNA <LLOQ TND | 58.8 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | IP: EOSI(Week 24): HBV DNA > LLOQ | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 40: HBV DNA <LLOQ TND | 68.4 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 4: HBV DNA <LLOQ TND | 63.2 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 20: HBV DNA <LLOQ TD | 41.2 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | FU Phase: Week 4: HBV DNA <LLOQ TD | 31.6 Percentage of participants |
Secondary
Percentage of Participants With Virologic Breakthrough
Percentage of participants with virologic breakthrough (confirmed on-treatment HBV DNA increase by \>1 log10 IU/mL from nadir in participants who did not have on-treatment HBV DNA level below LLOQ or a confirmed on-treatment HBV DNA level \>200 IU/mL in participants who had on-treatment HBV DNA level below LLOQ) were reported.
Time frame: IP: Week 0 to Week 24; FU Phase: FU Week 1 up to FU Week 48
Population: FAS included all participants who were randomly assigned to an intervention arm in this intervention-specific appendix (ISA) and received at least 1 dose of study intervention within this ISA.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Virologic Breakthrough | IP | 0 Percentage of participants |
| JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | Percentage of Participants With Virologic Breakthrough | FU Phase | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Virologic Breakthrough | IP | 0 Percentage of participants |
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Percentage of Participants With Virologic Breakthrough | FU Phase | 0 Percentage of participants |
Secondary
Time to Achieve HBsAg Seroclearance
Time to achieve HBsAg seroclearance was reported. Seroclearance of HBsAg was defined as a (quantitative) HBsAg level \<LLOQ (0.05 IU/mL).
Time frame: Week 0 up to FU Week 48 (up to Week 72)
Population: FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. N=0 signifies that data could not be collected and analyzed as no participant had event.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Time to Achieve HBsAg Seroclearance | NA Days |
Secondary
Time to Achieve HBsAg Seroconversion
Time to achieve HBsAg seroconversion were reported. Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance and appearance of anti-HBs antibodies (baseline anti-HBs antibodies \<LLOQ and a post-baseline assessment \>=LLOQ).
Time frame: Week 0 up to FU Week 48 (up to Week 72)
Population: FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, N=0 signifies that data could not be collected and analyzed as no participant had event.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| JNJ-3989 + Nivolumab (3 Infusions) + NA | Time to Achieve HBsAg Seroconversion | NA Days |