Hodgkin Disease
Conditions
Brief summary
The purpose of this study is to determine whether nivolumab plus brentuximab vedotin (followed by brentuximab vedotin plus bendamustine in patient with suboptimal response) is safe and effective in treating patients with Hodgkin's lymphoma (cHL). Eligible patients are children, adolescents, and young adults relapsed or refractory to first line.
Interventions
BIOLOGICALNivolumab
Specified Dose on Specified Days
BIOLOGICALbrentuximab vedotin
Specified Dose on Specified Days
BIOLOGICALbendamustine
Specified Dose on Specified Days
Sponsors
Seagen Inc.
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* Classic Hodgkin Lymphoma (cHL), relapsed or refractory * Minimal limitation on activities of daily living as measured by Karnofsky ≥ 50 for participants \> 16 years of age or Lansky ≥ 50 for participants ≤ 16 years of age. * One prior anti-cancer therapy that did not work
Exclusion criteria
* Active, known, or suspected autoimmune disease or infection * Active cerebral/meningeal disease related to the underlying malignancy * More than one line of anti-cancer therapy or no treatment at all * Received a stem cell transplant for Hodgkin Lymphoma and/or a solid organ transplant * Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors) Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Metabolic Response (CMR) Rate at Any Time Prior to Radiation Therapy by Blinded Independent Centralized Review (BICR) - Cohort 1 | From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks). | The complete metabolic response (CMR) rate is defined as the percent of all response-evaluable participants who, assessed by the BICR, achieved best response of CMR. Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Participants who stopped study treatment early for toxicity without a CMR were evaluable. Confidence interval is based on the Clopper and Pearson method |
| Event-free Survival (EFS) Rate at 3 Years by Blinded Independent Centralized Review (BICR) - Cohort 1 | At 3 years post first dose of study therapy | Event Free Survival (EFS) is the time from the first treatment to the earliest occurrence of composite events including: Disease progression (PD), Failure to achieve complete metabolic response (CMR) after 4 cycles of N+Bv and 2 cycles of Bv+B, Secondary malignancy, Death . PD : Lymph Nodes and Lesions: new growth or increase of \>= 50% in size from nadir. New or growing lesions outside the lymph nodes. Spleen: Significant increase in spleen size, either from a previously enlarged state or from normal size. New Lesions: Yes Bone Marrow: New or returning FDG-avid disease CMR: Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale New lesions: No Bone marrow: No FDG-avid disease Participants without an event were censored at the last tumor assessment. Those who started subsequent anticancer therapy without a prior event were censored at the last tumor assessment prior to or upon starting subsequent therapy. Based on Kaplan-Meier Estimates. |
| Complete Metabolic Response (CMR) Rate at Any Time Prior to High Dose Chemotherapy Followed by Autologous Stem Cell Treatment (HDCT/ASCT) by Blinded Independent Centralized Review (BICR) - Cohort 2 | From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks) | The complete metabolic response (CMR) rate is defined as the percent of all response-evaluable participants who, assessed by the BICR, achieved best response of CMR. Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Participants who came off study treatment early for toxicity without a CMR were evaluable. Confidence interval is based on the Clopper and Pearson method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Metabolic Response (CMR) Rate at Any Time Prior to Radiation Therapy by Investigator - Cohort 1 | From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks). | The complete metabolic response (CMR) rate is defined as the percent of all response-evaluable participants who, assessed by the investigator, achieved best response of CMR. Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Participants who come off early for toxicity without a CMR were evaluable. Confidence interval is based on the Clopper and Pearson method |
| Event-free Survival (EFS) Rate at 3 Years by Investigator - Cohort 1 | At 3 years post first dose of study therapy | Event Free Survival (EFS) is the time from the first treatment to the earliest occurrence of composite events including: Disease progression (PD), Failure to achieve complete metabolic response (CMR) after 4 cycles of N+Bv and 2 cycles of Bv+B, Secondary malignancy, Death . PD : Lymph Nodes and Lesions: new growth or increase of \>= 50% in size from nadir. New or growing lesions outside the lymph nodes. Spleen: Significant increase in spleen size, either from a previously enlarged state or from normal size. New Lesions: Yes Bone Marrow: New or returning FDG-avid disease CMR: Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale New lesions: No Bone marrow: No FDG-avid disease Participants without an event were censored at the last tumor assessment. Those who started subsequent anticancer therapy without a prior event were censored at the last tumor assessment prior to or upon starting subsequent therapy. Based on Kaplan-Meier Estimates. |
| Complete Metabolic Response (CMR) Rate at Any Time Prior to High Dose Chemotherapy Followed by Autologous Stem Cell Treatment (HDCT/ASCT) by Investigator - Cohort 2 | From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks) | The complete metabolic response (CMR) rate is defined as the percent of all response-evaluable participants who, assessed by the investigator, achieved best response of CMR. Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Participants who came off study treatment early for toxicity without a CMR were evaluable. Confidence interval is based on the Clopper and Pearson method. |
| Overall Response Rate (ORR) Following 4 Cycles of Nivolumab + Brentuximab Vedotin Treatment by Investigator | From first dose to PMR or CMR within 4 cycles of therapy, or the completion of four cycles of therapy (N+Bv x4) (up to approximately 12 weeks). | Overall response rate (ORR) is defined as the percent of all response-evaluable participants who, assessed by the investigator, achieve a best response of complete metabolic response (CMR) or partial metabolic response (PMR). Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Partial metabolic response: * Lymph nodes/extralymphatic: Score 4 or 5, reduced uptake from baseline * New lesions: None * Bone marrow: Residual uptake higher than normal, reduced from baseline Participants who came off early for toxicity without CMR or PMR were evaluable. |
| Progression Free Survival (PFS) Rate at 3 Years by Investigator | At 3 years post first dose | Progression Free Survival (PFS) is the time from the date of first treatment to the date of first documented disease progression by investigator or death. Progressive Disease (PD): Lymph Nodes and Lesions: new growth or increase of \>= 50% in size from nadir. New or growing lesions outside the lymph nodes. Spleen: Significant increase in spleen size, either from a previously enlarged state or from normal size. New Lesions: Yes Bone Marrow: New or returning FDG-avid disease. Participants who neither progressed nor died were be censored at the last adequate tumor assessment. Participants who started subsequent anticancer therapy (that is not part of high dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT) Consolidation Therapy forR2 Cohort) without a prior reported progression or death were censored at the last tumor assessment prior to initiation of the subsequent anticancer therapy. Based on Kaplan-Meier Estimates. |
| Overall Response Rate (ORR) Following 4 Cycles of Nivolumab + Brentuximab Vedotin Treatment by Blinded Independent Centralized Review (BICR) | From first dose to PMR or CMR within 4 cycles of therapy, or the completion of four cycles of therapy (N+Bv x4) (up to approximately 12 weeks). | Overall response rate (ORR) is defined as the percent of all response-evaluable participants who, assessed by the BICR, achieved a best response of complete metabolic response (CMR) or partial metabolic response (PMR). Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Partial metabolic response (PMR): * Lymph nodes/extralymphatic: Score 4 or 5, reduced uptake from baseline * New lesions: None * Bone marrow: Residual uptake higher than normal, reduced from baseline. Participants who came off early for toxicity without CMR or PMR were evaluable. |
| The Number of Participants With Adverse Events (AEs) | From first dose to 30 days post last dose (an average of 4 months up until a maximum of 7 months). | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. |
| The Number of Participants With Serious Adverse Events (SAEs) | From first dose to 30 days post last dose (an average of 4 months up until a maximum of 7 months) | A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: * Results in death * Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe) * Requires inpatient hospitalization or causes prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Is an important medical event. |
| The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests | From first dose to 30 days post last dose (an average of 4 months up until a maximum of 7 months) | The Number of Participants with Abnormal Laboratory Values for Specific Thyroid Tests. |
| The Number of Participants With Abnormal Laboratory Values for Liver Tests | From first dose to 30 days post last dose (an average of 4 months up until a maximum of 7 months) | The Number of Participants with Abnormal Laboratory Values for Liver Tests. |
| Number of Participants With Abnormal Vital Signs Reported as Adverse Events | From first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months). | Temperature, blood pressure, and heart rate abnormalities reported as adverse events. |
| Duration of Response (DOR) by Investigator | From first dose until disease progression, start of subsequent anti-cancer therapy, or or death due to any cause (up to approximately 86 months) | Duration of response (DOR) is the time from first complete metabolic response or partial metabolic response (CMR or PMR) to event free survival EFS (Cohort 1)/progression free survival PFS (Cohort 2) event. For participants with no event, the DOR was censored on the date of last tumor assessment. Participants who started subsequent anticancer therapy (not part of high-dose chemotherapy followed by autologous stem cell transplant HDCT/ASCT) without a prior reported EFS/PFS event were censored at the last tumor assessment prior to initiation of the subsequent anticancer therapy. Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Partial metabolic response: * Lymph nodes/extralymphatic: Score 4 or 5, reduced uptake from baseline * New lesions: None * Bone marrow: Residual uptake higher than normal, reduced from baseline. Based on Kaplan-Meier estimates. |
| Progression Free Survival (PFS) Rate at 3 Years by Blinded Independent Centralized Review (BICR) | At 3 years post first dose of study therapy | Progression Free Survival (PFS) is the time from the date of first treatment to the date of first documented disease progression by BICR or death. Progressive Disease (PD): Lymph Nodes and Lesions: new growth or increase of \>= 50% in size from nadir. New or growing lesions outside the lymph nodes. Spleen: Significant increase in spleen size, either from a previously enlarged state or from normal size. New Lesions: Yes Bone Marrow: New or returning FDG-avid disease. Participants who neither progressed nor died were censored at the last adequate tumor assessment. Participants who started subsequent anticancer therapy (that is not part of high dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT) Consolidation Therapy for R2 Cohort) without a prior reported progression or death were censored at the last tumor assessment prior to initiation of the subsequent anticancer therapy. Based on Kaplan-Meier Estimates. |
| Duration of Response (DOR) by Blinded Independent Centralized Review (BICR) | From first dose until disease progression, start of subsequent anti-cancer therapy, or or death due to any cause (up to approximately 86 months) | Duration of response (DOR) is the time from first complete metabolic response or partial metabolic response (CMR or PMR) to event free survival EFS (Cohort 1)/progression free survival PFS (Cohort 2) event. For participants with no event, DOR was censored on the date of last tumor assessment. Participants who started subsequent anticancer therapy (not part of high-dose chemotherapy followed by autologous stem cell transplant HDCT/ASCT) without a prior reported EFS/PFS event were censored at the last tumor assessment prior to initiation of the subsequent therapy. Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Partial metabolic response (PMR): * Lymph nodes/extralymphatic: Score 4 or 5, reduced uptake from baseline * New lesions: None * Bone marrow: Residual uptake higher than normal, reduced from baseline. Based on Kaplan-Meier estimates |
Countries
Canada, Czechia, France, Germany, Ireland, Italy, Netherlands, Poland, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
All participants entered the Induction phase and received treatment with nivolumab + brentuximab vedotin (N+ Bv) Participants moved into the Intensification phase if they received treatment with brentuximab + bendamustine (Bv + B). Participants moved into the Consolidation Phase if they received radiation therapy (Cohort 1) or high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (Cohort 2).
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase).
* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).
* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up. | 28 |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.
* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).
* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).
* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).
* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.
* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up. | 44 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Induction Phase | Disease progression | 0 | 1 |
| Induction Phase | Study drug toxicity | 1 | 1 |
| Intensification Phase | Study drug toxicity | 1 | 0 |
Baseline characteristics
| Characteristic | Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | Total | Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse |
|---|---|---|---|
| Age, Continuous | 16.2 Years STANDARD_DEVIATION 3.7 | 16.5 Years STANDARD_DEVIATION 4 | 17.0 Years STANDARD_DEVIATION 4.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 4 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 28 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 23 Participants | 40 Participants | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 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 | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 41 Participants | 66 Participants | 25 Participants |
| Sex: Female, Male Female | 15 Participants | 33 Participants | 18 Participants |
| Sex: Female, Male Male | 29 Participants | 39 Participants | 10 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 / 22 | 0 / 6 | 0 / 33 | 1 / 11 |
| other Total, other adverse events | 18 / 22 | 6 / 6 | 33 / 33 | 11 / 11 |
| serious Total, serious adverse events | 6 / 22 | 3 / 6 | 11 / 33 | 4 / 11 |
Outcome results
Primary
Complete Metabolic Response (CMR) Rate at Any Time Prior to High Dose Chemotherapy Followed by Autologous Stem Cell Treatment (HDCT/ASCT) by Blinded Independent Centralized Review (BICR) - Cohort 2
The complete metabolic response (CMR) rate is defined as the percent of all response-evaluable participants who, assessed by the BICR, achieved best response of CMR. Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Participants who came off study treatment early for toxicity without a CMR were evaluable. Confidence interval is based on the Clopper and Pearson method
Time frame: From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks)
Population: All treated participants in Cohort 2. Prespecified to be collected for Cohort 2 only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | Complete Metabolic Response (CMR) Rate at Any Time Prior to High Dose Chemotherapy Followed by Autologous Stem Cell Treatment (HDCT/ASCT) by Blinded Independent Centralized Review (BICR) - Cohort 2 | 88.6 Percent of participants |
Primary
Complete Metabolic Response (CMR) Rate at Any Time Prior to Radiation Therapy by Blinded Independent Centralized Review (BICR) - Cohort 1
The complete metabolic response (CMR) rate is defined as the percent of all response-evaluable participants who, assessed by the BICR, achieved best response of CMR. Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Participants who stopped study treatment early for toxicity without a CMR were evaluable. Confidence interval is based on the Clopper and Pearson method
Time frame: From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks).
Population: All treated participants in Cohort 1. Prespecified to be collected for Cohort 1 only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | Complete Metabolic Response (CMR) Rate at Any Time Prior to Radiation Therapy by Blinded Independent Centralized Review (BICR) - Cohort 1 | 92.9 Percent of participants |
Primary
Event-free Survival (EFS) Rate at 3 Years by Blinded Independent Centralized Review (BICR) - Cohort 1
Event Free Survival (EFS) is the time from the first treatment to the earliest occurrence of composite events including: Disease progression (PD), Failure to achieve complete metabolic response (CMR) after 4 cycles of N+Bv and 2 cycles of Bv+B, Secondary malignancy, Death . PD : Lymph Nodes and Lesions: new growth or increase of \>= 50% in size from nadir. New or growing lesions outside the lymph nodes. Spleen: Significant increase in spleen size, either from a previously enlarged state or from normal size. New Lesions: Yes Bone Marrow: New or returning FDG-avid disease CMR: Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale New lesions: No Bone marrow: No FDG-avid disease Participants without an event were censored at the last tumor assessment. Those who started subsequent anticancer therapy without a prior event were censored at the last tumor assessment prior to or upon starting subsequent therapy. Based on Kaplan-Meier Estimates.
Time frame: At 3 years post first dose of study therapy
Population: All treated participants in Cohort 1. Prespecified to be collected for Cohort 1 only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | Event-free Survival (EFS) Rate at 3 Years by Blinded Independent Centralized Review (BICR) - Cohort 1 | 87.5 Percent of participants |
Secondary
Complete Metabolic Response (CMR) Rate at Any Time Prior to High Dose Chemotherapy Followed by Autologous Stem Cell Treatment (HDCT/ASCT) by Investigator - Cohort 2
The complete metabolic response (CMR) rate is defined as the percent of all response-evaluable participants who, assessed by the investigator, achieved best response of CMR. Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Participants who came off study treatment early for toxicity without a CMR were evaluable. Confidence interval is based on the Clopper and Pearson method.
Time frame: From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks)
Population: All treated participants in Cohort 2. Prespecified to be collected for Cohort 2 only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | Complete Metabolic Response (CMR) Rate at Any Time Prior to High Dose Chemotherapy Followed by Autologous Stem Cell Treatment (HDCT/ASCT) by Investigator - Cohort 2 | 86.4 Percent of participants |
Secondary
Complete Metabolic Response (CMR) Rate at Any Time Prior to Radiation Therapy by Investigator - Cohort 1
The complete metabolic response (CMR) rate is defined as the percent of all response-evaluable participants who, assessed by the investigator, achieved best response of CMR. Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Participants who come off early for toxicity without a CMR were evaluable. Confidence interval is based on the Clopper and Pearson method
Time frame: From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks).
Population: All treated participants in Cohort 1. Prespecified to be collected for Cohort 1 only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | Complete Metabolic Response (CMR) Rate at Any Time Prior to Radiation Therapy by Investigator - Cohort 1 | 89.3 Percent of participants |
Secondary
Duration of Response (DOR) by Blinded Independent Centralized Review (BICR)
Duration of response (DOR) is the time from first complete metabolic response or partial metabolic response (CMR or PMR) to event free survival EFS (Cohort 1)/progression free survival PFS (Cohort 2) event. For participants with no event, DOR was censored on the date of last tumor assessment. Participants who started subsequent anticancer therapy (not part of high-dose chemotherapy followed by autologous stem cell transplant HDCT/ASCT) without a prior reported EFS/PFS event were censored at the last tumor assessment prior to initiation of the subsequent therapy. Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Partial metabolic response (PMR): * Lymph nodes/extralymphatic: Score 4 or 5, reduced uptake from baseline * New lesions: None * Bone marrow: Residual uptake higher than normal, reduced from baseline. Based on Kaplan-Meier estimates
Time frame: From first dose until disease progression, start of subsequent anti-cancer therapy, or or death due to any cause (up to approximately 86 months)
Population: All treated participants with a response of complete metabolic response (CMR) or partial metabolic response (PMR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | Duration of Response (DOR) by Blinded Independent Centralized Review (BICR) | NA Months |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | Duration of Response (DOR) by Blinded Independent Centralized Review (BICR) | NA Months |
Secondary
Duration of Response (DOR) by Investigator
Duration of response (DOR) is the time from first complete metabolic response or partial metabolic response (CMR or PMR) to event free survival EFS (Cohort 1)/progression free survival PFS (Cohort 2) event. For participants with no event, the DOR was censored on the date of last tumor assessment. Participants who started subsequent anticancer therapy (not part of high-dose chemotherapy followed by autologous stem cell transplant HDCT/ASCT) without a prior reported EFS/PFS event were censored at the last tumor assessment prior to initiation of the subsequent anticancer therapy. Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Partial metabolic response: * Lymph nodes/extralymphatic: Score 4 or 5, reduced uptake from baseline * New lesions: None * Bone marrow: Residual uptake higher than normal, reduced from baseline. Based on Kaplan-Meier estimates.
Time frame: From first dose until disease progression, start of subsequent anti-cancer therapy, or or death due to any cause (up to approximately 86 months)
Population: All treated participants with a response of complete metabolic response (CMR) or partial metabolic response (PMR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | Duration of Response (DOR) by Investigator | NA Months |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | Duration of Response (DOR) by Investigator | NA Months |
Secondary
Event-free Survival (EFS) Rate at 3 Years by Investigator - Cohort 1
Event Free Survival (EFS) is the time from the first treatment to the earliest occurrence of composite events including: Disease progression (PD), Failure to achieve complete metabolic response (CMR) after 4 cycles of N+Bv and 2 cycles of Bv+B, Secondary malignancy, Death . PD : Lymph Nodes and Lesions: new growth or increase of \>= 50% in size from nadir. New or growing lesions outside the lymph nodes. Spleen: Significant increase in spleen size, either from a previously enlarged state or from normal size. New Lesions: Yes Bone Marrow: New or returning FDG-avid disease CMR: Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale New lesions: No Bone marrow: No FDG-avid disease Participants without an event were censored at the last tumor assessment. Those who started subsequent anticancer therapy without a prior event were censored at the last tumor assessment prior to or upon starting subsequent therapy. Based on Kaplan-Meier Estimates.
Time frame: At 3 years post first dose of study therapy
Population: All treated participants in Cohort 1. Prespecified to be collected for Cohort 1 only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | Event-free Survival (EFS) Rate at 3 Years by Investigator - Cohort 1 | 88.5 Percent of participants |
Secondary
Number of Participants With Abnormal Vital Signs Reported as Adverse Events
Temperature, blood pressure, and heart rate abnormalities reported as adverse events.
Time frame: From first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
Population: All treated participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | Number of Participants With Abnormal Vital Signs Reported as Adverse Events | Pyrexia | 7 Participants |
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | Number of Participants With Abnormal Vital Signs Reported as Adverse Events | Tachycardia | 2 Participants |
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | Number of Participants With Abnormal Vital Signs Reported as Adverse Events | Sinus Bradycardia | 0 Participants |
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | Number of Participants With Abnormal Vital Signs Reported as Adverse Events | Hypertension | 0 Participants |
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | Number of Participants With Abnormal Vital Signs Reported as Adverse Events | Hypotension | 0 Participants |
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | Number of Participants With Abnormal Vital Signs Reported as Adverse Events | Orthostatic hypotension | 0 Participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | Number of Participants With Abnormal Vital Signs Reported as Adverse Events | Hypotension | 6 Participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | Number of Participants With Abnormal Vital Signs Reported as Adverse Events | Pyrexia | 23 Participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | Number of Participants With Abnormal Vital Signs Reported as Adverse Events | Hypertension | 4 Participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | Number of Participants With Abnormal Vital Signs Reported as Adverse Events | Tachycardia | 1 Participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | Number of Participants With Abnormal Vital Signs Reported as Adverse Events | Orthostatic hypotension | 1 Participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | Number of Participants With Abnormal Vital Signs Reported as Adverse Events | Sinus Bradycardia | 2 Participants |
Secondary
Overall Response Rate (ORR) Following 4 Cycles of Nivolumab + Brentuximab Vedotin Treatment by Blinded Independent Centralized Review (BICR)
Overall response rate (ORR) is defined as the percent of all response-evaluable participants who, assessed by the BICR, achieved a best response of complete metabolic response (CMR) or partial metabolic response (PMR). Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Partial metabolic response (PMR): * Lymph nodes/extralymphatic: Score 4 or 5, reduced uptake from baseline * New lesions: None * Bone marrow: Residual uptake higher than normal, reduced from baseline. Participants who came off early for toxicity without CMR or PMR were evaluable.
Time frame: From first dose to PMR or CMR within 4 cycles of therapy, or the completion of four cycles of therapy (N+Bv x4) (up to approximately 12 weeks).
Population: All treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | Overall Response Rate (ORR) Following 4 Cycles of Nivolumab + Brentuximab Vedotin Treatment by Blinded Independent Centralized Review (BICR) | 96.4 Percent of participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | Overall Response Rate (ORR) Following 4 Cycles of Nivolumab + Brentuximab Vedotin Treatment by Blinded Independent Centralized Review (BICR) | 93.2 Percent of participants |
Secondary
Overall Response Rate (ORR) Following 4 Cycles of Nivolumab + Brentuximab Vedotin Treatment by Investigator
Overall response rate (ORR) is defined as the percent of all response-evaluable participants who, assessed by the investigator, achieve a best response of complete metabolic response (CMR) or partial metabolic response (PMR). Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Partial metabolic response: * Lymph nodes/extralymphatic: Score 4 or 5, reduced uptake from baseline * New lesions: None * Bone marrow: Residual uptake higher than normal, reduced from baseline Participants who came off early for toxicity without CMR or PMR were evaluable.
Time frame: From first dose to PMR or CMR within 4 cycles of therapy, or the completion of four cycles of therapy (N+Bv x4) (up to approximately 12 weeks).
Population: All treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | Overall Response Rate (ORR) Following 4 Cycles of Nivolumab + Brentuximab Vedotin Treatment by Investigator | 100.0 Percent of participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | Overall Response Rate (ORR) Following 4 Cycles of Nivolumab + Brentuximab Vedotin Treatment by Investigator | 90.9 Percent of participants |
Secondary
Progression Free Survival (PFS) Rate at 3 Years by Blinded Independent Centralized Review (BICR)
Progression Free Survival (PFS) is the time from the date of first treatment to the date of first documented disease progression by BICR or death. Progressive Disease (PD): Lymph Nodes and Lesions: new growth or increase of \>= 50% in size from nadir. New or growing lesions outside the lymph nodes. Spleen: Significant increase in spleen size, either from a previously enlarged state or from normal size. New Lesions: Yes Bone Marrow: New or returning FDG-avid disease. Participants who neither progressed nor died were censored at the last adequate tumor assessment. Participants who started subsequent anticancer therapy (that is not part of high dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT) Consolidation Therapy for R2 Cohort) without a prior reported progression or death were censored at the last tumor assessment prior to initiation of the subsequent anticancer therapy. Based on Kaplan-Meier Estimates.
Time frame: At 3 years post first dose of study therapy
Population: All treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | Progression Free Survival (PFS) Rate at 3 Years by Blinded Independent Centralized Review (BICR) | 95.2 Percent of participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | Progression Free Survival (PFS) Rate at 3 Years by Blinded Independent Centralized Review (BICR) | 91.1 Percent of participants |
Secondary
Progression Free Survival (PFS) Rate at 3 Years by Investigator
Progression Free Survival (PFS) is the time from the date of first treatment to the date of first documented disease progression by investigator or death. Progressive Disease (PD): Lymph Nodes and Lesions: new growth or increase of \>= 50% in size from nadir. New or growing lesions outside the lymph nodes. Spleen: Significant increase in spleen size, either from a previously enlarged state or from normal size. New Lesions: Yes Bone Marrow: New or returning FDG-avid disease. Participants who neither progressed nor died were be censored at the last adequate tumor assessment. Participants who started subsequent anticancer therapy (that is not part of high dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT) Consolidation Therapy forR2 Cohort) without a prior reported progression or death were censored at the last tumor assessment prior to initiation of the subsequent anticancer therapy. Based on Kaplan-Meier Estimates.
Time frame: At 3 years post first dose
Population: All treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | Progression Free Survival (PFS) Rate at 3 Years by Investigator | 95.8 Percent of participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | Progression Free Survival (PFS) Rate at 3 Years by Investigator | 88.1 Percent of participants |
Secondary
The Number of Participants With Abnormal Laboratory Values for Liver Tests
The Number of Participants with Abnormal Laboratory Values for Liver Tests.
Time frame: From first dose to 30 days post last dose (an average of 4 months up until a maximum of 7 months)
Population: All treated participants with at least one on treatment measurement.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Liver Tests | ALT OR AST> 10XULN | 0 Participants |
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Liver Tests | TOTAL BILIRUBIN > 2XULN | 1 Participants |
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Liver Tests | ALT OR AST> 5XULN | 3 Participants |
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Liver Tests | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY | 0 Participants |
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Liver Tests | ALT OR AST > 20XULN | 0 Participants |
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Liver Tests | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS | 0 Participants |
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Liver Tests | ALT OR AST > 3XULN | 8 Participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Liver Tests | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS | 0 Participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Liver Tests | ALT OR AST > 3XULN | 5 Participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Liver Tests | ALT OR AST> 5XULN | 1 Participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Liver Tests | ALT OR AST> 10XULN | 0 Participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Liver Tests | ALT OR AST > 20XULN | 0 Participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Liver Tests | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Liver Tests | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY | 0 Participants |
Secondary
The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests
The Number of Participants with Abnormal Laboratory Values for Specific Thyroid Tests.
Time frame: From first dose to 30 days post last dose (an average of 4 months up until a maximum of 7 months)
Population: All treated participants with at least one on treatment TSH measurement.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests | TSH > ULN | 6 Participants |
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 5 Participants |
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 1 Participants |
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 4 Participants |
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests | TSH > ULN WITH FT3/FT4 TEST MISSING | 1 Participants |
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests | TSH < LLN | 4 Participants |
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests | TSH <LLN WITH TSH >= LLN AT BASELINE | 4 Participants |
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 3 Participants |
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 1 Participants |
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests | TSH < LLN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 1 Participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests | TSH > ULN | 8 Participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests | TSH < LLN | 1 Participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 4 Participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests | TSH < LLN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 0 Participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests | TSH <LLN WITH TSH >= LLN AT BASELINE | 1 Participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 5 Participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 0 Participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests | TSH > ULN WITH FT3/FT4 TEST MISSING | 3 Participants |
Secondary
The Number of Participants With Adverse Events (AEs)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
Time frame: From first dose to 30 days post last dose (an average of 4 months up until a maximum of 7 months).
Population: All treated participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | The Number of Participants With Adverse Events (AEs) | 26 Participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | The Number of Participants With Adverse Events (AEs) | 42 Participants |
Secondary
The Number of Participants With Serious Adverse Events (SAEs)
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: * Results in death * Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe) * Requires inpatient hospitalization or causes prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Is an important medical event.
Time frame: From first dose to 30 days post last dose (an average of 4 months up until a maximum of 7 months)
Population: All treated participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse | The Number of Participants With Serious Adverse Events (SAEs) | 8 Participants |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse | The Number of Participants With Serious Adverse Events (SAEs) | 9 Participants |