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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002347-41 | EudraCT Number |
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| Name | Class |
|---|---|
| Seagen Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab + brentuximab vedotin | Experimental |
| |
| brentuximab vedotin + bendamustine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological | Specified Dose on Specified Days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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):
Confidence interval is based on the Clopper and Pearson method | From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks). |
| 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. | At 3 years post first dose of study therapy |
| 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):
Confidence interval is based on the Clopper and Pearson method |
| Measure | Description | Time Frame |
|---|---|---|
| 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):
Partial metabolic response (PMR):
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Phoenix Children'S Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39745739 | Derived | Daw S, Cole PD, Hoppe BS, Hodgson D, Beishuizen A, Garnier N, Buffardi S, Mascarin M, Lissat A, Mauz-Korholz C, Krajewski J, Akyol A, Crowe R, Anderson B, Xu Y, Drachtman RA, Kelly KM, Leblanc T, Harker-Murray P. Transplant-Free Approach in Relapsed Hodgkin Lymphoma in Children, Adolescents, and Young Adults: A Nonrandomized Clinical Trial. JAMA Oncol. 2025 Mar 1;11(3):249-257. doi: 10.1001/jamaoncol.2024.5627. | |
| 36564047 |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
Not provided
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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).
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Induction Phase |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 26, 2021 |
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| brentuximab vedotin | Biological | Specified Dose on Specified Days |
|
| bendamustine | Biological | Specified Dose on Specified Days |
|
| From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks) |
| 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). |
| 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. | At 3 years post first dose of study therapy |
| 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):
Partial metabolic response (PMR):
| From first dose until disease progression, start of subsequent anti-cancer therapy, or or death due to any cause (up to approximately 86 months) |
| 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):
| From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks). |
| 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. | At 3 years post first dose of study therapy |
| 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):
Confidence interval is based on the Clopper and Pearson method. | From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks) |
| 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):
Partial metabolic response:
| 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). |
| 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. | At 3 years post first dose |
| 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):
Partial metabolic response:
| From first dose until disease progression, start of subsequent anti-cancer therapy, or or death due to any cause (up to approximately 86 months) |
| 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. | 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 Serious Adverse Events (SAEs) | A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose:
| 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 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 Liver 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) |
| Number of Participants With Abnormal Vital Signs Reported as Adverse Events | Temperature, blood pressure, and heart rate abnormalities 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). |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| Loma Linda University Cancer Center | Loma Linda | California | 92350 | United States |
| Valley Children's Hospital | Madera | California | 93636 | United States |
| Children'S Hospital & Research Center At Oakland | Oakland | California | 94609 | United States |
| Children'S Hospital Of Orange County | Orange | California | 92868 | United States |
| Lucile Packard Children'S Research Hospital/Stanford Univ | Palo Alto | California | 94304 | United States |
| Local Institution - 0091 | San Diego | California | 92109 | United States |
| Childrens Hospital of Colorado | Aurora | Colorado | 80045 | United States |
| Smilow Cancer Hospital At Yale New Haven Hospital | New Haven | Connecticut | 06520 | United States |
| Nemours / A. I. duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| Children'S National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Local Institution - 0062 | Jacksonville | Florida | 32207 | United States |
| Local Institution - 0069 | St. Petersburg | Florida | 33701 | United States |
| Children's Healthcare Of Atlanta | Atlanta | Georgia | 30322 | United States |
| University Of Iowa | Iowa City | Iowa | 52242 | United States |
| Local Institution - 0070 | Baltimore | Maryland | 21287 | United States |
| Dana Farber Cancer Institute. | Boston | Massachusetts | 02215 | United States |
| Local Institution - 0097 | Detroit | Michigan | 48201 | United States |
| Local Institution - 0049 | Jackson | Mississippi | 39216 | United States |
| Local Institution - 0085 | Kansas City | Missouri | 64108 | United States |
| Washington University School Of Medicine | St Louis | Missouri | 63110 | United States |
| Nevada Cancer Research Foundation | Las Vegas | Nevada | 89135 | United States |
| Local Institution - 0067 | Hackensack | New Jersey | 07601 | United States |
| Local Institution - 0047 | New Brunswick | New Jersey | 08903 | United States |
| Local Institution - 0068 | Buffalo | New York | 14263 | United States |
| Local Institution | Chapel Hill | North Carolina | 27599 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| Cincinnati Children'S Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | United States |
| Local Institution - 0089 | Columbus | Ohio | 43205 | United States |
| University Of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Local Institution - 0090 | Hershey | Pennsylvania | 17033-0850 | United States |
| Childrens Hospital Of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Childrens Hospital Of Pittsburgh Of Upmc | Pittsburgh | Pennsylvania | 15224 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232-6310 | United States |
| Local Institution - 0042 | Austin | Texas | 78723 | United States |
| Local Institution - 0071 | Dallas | Texas | 75235 | United States |
| Baylor College Of Medicine | Houston | Texas | 77030 | United States |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | United States |
| Children'S Hosp-Kings Daughter | Norfolk | Virginia | 23507-1910 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23219 | United States |
| Local Institution - 0048 | Seattle | Washington | 98105 | United States |
| Local Institution - 0065 | Milwaukee | Wisconsin | 53226 | United States |
| Local Institution | Calgary | Alberta | T3B 6A8 | Canada |
| Local Institution - 0092 | Toronto | Ontario | M5G 1X8 | Canada |
| The Montreal Children's Hospital of the MUHC | Montreal | Quebec | H4A 3J1 | Canada |
| Klinika detske hematologie a onkologie | Prague | 150 06 | Czechia |
| Local Institution - 0034 | Vandœuvre-lès-Nancy | Meurthe-et-Moselle | 54511 | France |
| Local Institution - 0030 | Lille | 59037 | France |
| Local Institution - 0029 | Lyon | 69008 | France |
| Local Institution - 0032 | Marseille | 13011 | France |
| Local Institution - 0028 | Nantes | 44093 | France |
| Local Institution - 0031 | Paris | 75012 | France |
| Local Institution - 0026 | Paris | 75019 | France |
| Local Institution - 0033 | Toulouse | 31059 | France |
| Local Institution - 0027 | Villejuif | 94805 | France |
| Local Institution - 0056 | Berlin | 13353 | Germany |
| Local Institution - 0055 | Giessen | 35392 | Germany |
| Local Institution - 0057 | Hanover | 30625 | Germany |
| Local Institution - 0102 | München | 80337 | Germany |
| Local Institution - 0017 | Dublin | Dublin 8 | Ireland |
| Local Institution - 0024 | Aviano (PN) | 33081 | Italy |
| Local Institution - 0020 | Bologna | 40138 | Italy |
| Local Institution - 0021 | Genova | 16147 | Italy |
| Local Institution - 0019 | Monza (mb) | 20900 | Italy |
| Local Institution - 0023 | Naples | 80123 | Italy |
| Local Institution - 0022 | Roma | 00161 | Italy |
| Local Institution - 0001 | Rotterdam | 3015 CN | Netherlands |
| Local Institution - 0006 | Utrecht | 3584 CS | Netherlands |
| Local Institution | Gdansk | 80-952 | Poland |
| Local Institution | Krakow | 30-663 | Poland |
| Local Institution - 0082 | Barcelona | 08950 | Spain |
| Local Institution - 0084 | Madrid | 28009 | Spain |
| Local Institution - 0035 | Leeds | North Yorkshire | LS1 3EX | United Kingdom |
| Local Institution | Leeds | Yorkshire | LS9 7TF | United Kingdom |
| Local Institution | Birmingham | B15 2TH | United Kingdom |
| Local Institution | Glasgow | G51 4TF | United Kingdom |
| Local Institution - 0002 | London | NW1 2BU | United Kingdom |
| Local Institution - 0012 | Manchester | M13 9WL | United Kingdom |
| Derived |
| Harker-Murray P, Mauz-Korholz C, Leblanc T, Mascarin M, Michel G, Cooper S, Beishuizen A, Leger KJ, Amoroso L, Buffardi S, Rigaud C, Hoppe BS, Lisano J, Francis S, Sacchi M, Cole PD, Drachtman RA, Kelly KM, Daw S. Nivolumab and brentuximab vedotin with or without bendamustine for R/R Hodgkin lymphoma in children, adolescents, and young adults. Blood. 2023 Apr 27;141(17):2075-2084. doi: 10.1182/blood.2022017118. |
| BMS Clinical Trial Patient Recruiting | View source |
| FG001 | 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).
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Consolidation Phase |
|
| Intensification Phase |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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).
|
| BG001 | 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).
|
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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):
Confidence interval is based on the Clopper and Pearson method | All treated participants in Cohort 1. Prespecified to be collected for Cohort 1 only. | Posted | Number | 90% Confidence Interval | Percent of participants | From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks). |
|
|
| |||||||||||||||||||||||||
| 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. | All treated participants in Cohort 1. Prespecified to be collected for Cohort 1 only. | Posted | Number | 90% Confidence Interval | Percent of participants | At 3 years post first dose of study therapy |
| |||||||||||||||||||||||||||
| 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):
Confidence interval is based on the Clopper and Pearson method | All treated participants in Cohort 2. Prespecified to be collected for Cohort 2 only. | Posted | Number | 90% Confidence Interval | Percent of participants | From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks) |
| |||||||||||||||||||||||||||
| 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):
Partial metabolic response (PMR):
| All treated participants. | Posted | Number | 90% Confidence Interval | Percent of participants | 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). |
| |||||||||||||||||||||||||||
| 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. | All treated participants. | Posted | Number | 90% Confidence Interval | Percent of participants | At 3 years post first dose of study therapy |
| |||||||||||||||||||||||||||
| 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):
Partial metabolic response (PMR):
| All treated participants with a response of complete metabolic response (CMR) or partial metabolic response (PMR). | Posted | Median | 95% Confidence Interval | Months | From first dose until disease progression, start of subsequent anti-cancer therapy, or or death due to any cause (up to approximately 86 months) |
| |||||||||||||||||||||||||||
| 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):
| All treated participants in Cohort 1. Prespecified to be collected for Cohort 1 only. | Posted | Number | 90% Confidence Interval | Percent of participants | From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks). |
| |||||||||||||||||||||||||||
| 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. | All treated participants in Cohort 1. Prespecified to be collected for Cohort 1 only. | Posted | Number | 90% Confidence Interval | Percent of participants | At 3 years post first dose of study therapy |
| |||||||||||||||||||||||||||
| 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):
Confidence interval is based on the Clopper and Pearson method. | All treated participants in Cohort 2. Prespecified to be collected for Cohort 2 only. | Posted | Number | 95% Confidence Interval | Percent of participants | From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks) |
| |||||||||||||||||||||||||||
| 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):
Partial metabolic response:
| All treated participants. | Posted | Number | 90% Confidence Interval | Percent of participants | 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). |
| |||||||||||||||||||||||||||
| 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. | All treated participants. | Posted | Number | 90% Confidence Interval | Percent of participants | At 3 years post first dose |
| |||||||||||||||||||||||||||
| 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):
Partial metabolic response:
| All treated participants with a response of complete metabolic response (CMR) or partial metabolic response (PMR). | Posted | Median | 95% Confidence Interval | Months | From first dose until disease progression, start of subsequent anti-cancer therapy, or or death due to any cause (up to approximately 86 months) |
| |||||||||||||||||||||||||||
| 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. | All treated participants. | Posted | Count of Participants | Participants | From first dose to 30 days post last dose (an average of 4 months up until a maximum of 7 months). |
| ||||||||||||||||||||||||||||
| 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:
| All treated participants. | Posted | Count of Participants | Participants | From first dose to 30 days post last dose (an average of 4 months up until a maximum of 7 months) |
| ||||||||||||||||||||||||||||
| 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. | All treated participants with at least one on treatment TSH measurement. | Posted | Count of Participants | Participants | From first dose to 30 days post last dose (an average of 4 months up until a maximum of 7 months) |
| ||||||||||||||||||||||||||||
| Secondary | The Number of Participants With Abnormal Laboratory Values for Liver Tests | The Number of Participants with Abnormal Laboratory Values for Liver Tests. | All treated participants with at least one on treatment measurement. | Posted | Count of Participants | Participants | From first dose to 30 days post last dose (an average of 4 months up until a maximum of 7 months) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Vital Signs Reported as Adverse Events | Temperature, blood pressure, and heart rate abnormalities reported as adverse events. | All treated participants. | Posted | Count of Participants | Participants | 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). |
|
Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in:
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse (Nivo + Bv) | 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). | 0 | 22 | 6 | 22 | 18 | 22 |
| EG001 | Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse (Nivo + Bv) + (Bv + B) | 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).
| 0 | 6 | 3 | 6 | 6 | 6 |
| EG002 | Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse (Nivo + Bv) | 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. | 0 | 33 | 11 | 33 | 33 | 33 |
| EG003 | Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse (Nivo + Bv)+(Bv + B) | 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).
| 1 | 11 | 4 | 11 | 11 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Chest pain | General disorders | 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 27.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | 27.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | 27.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | 27.0 | Systematic Assessment |
| |
| Blood phosphorus increased | Investigations | 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Pulmonary veno-occlusive disease | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | 27.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 27.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Coating in mouth | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 27.0 | Systematic Assessment |
| |
| Face oedema | General disorders | 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 27.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | 27.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | 27.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 27.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 27.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | 27.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | 27.0 | Systematic Assessment |
| |
| Infusion related hypersensitivity reaction | Immune system disorders | 27.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Epstein-Barr virus infection reactivation | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Radiation associated pain | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Vascular access site pruritus | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 27.0 | Systematic Assessment |
| |
| Body temperature increased | Investigations | 27.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Heart rate increased | Investigations | 27.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | 27.0 | Systematic Assessment |
| |
| Lipase decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypouricaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | 27.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 27.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 27.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
| Nov 1, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000079963 | Brentuximab Vedotin |
| D000069461 | Bendamustine Hydrochloride |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
| OG001 | 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).
|
|
|
| OG001 | 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).
|
|
|
| OG001 | 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).
|
|
|
|
|
|
|
|
|
| OG001 | 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).
|
|
|
| OG001 | 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).
|
|
|
| OG001 | 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).
|
|
|
| OG001 | 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).
|
|
|
| OG001 | 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).
|
|
|
| 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).
|
|
|
| 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).
|
|
|
| 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).
|
|
|