Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000847-41 | EudraCT Number |
Not provided
Not provided
Insufficient enrollment.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Seagen Inc. | INDUSTRY |
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether an investigational immuno-therapy combination, nivolumab with Brentuximab vedotin compared to Brentuximab vedotin alone is safe and effective in the treatment of relapsed and refractory Classical Hodgkin Lymphoma. The participants of this trial will comprise of patients who have relapsed or did not respond to treatment and are not eligible for stem cell transplant
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Module A | Experimental | Nivolumab combined with Brentuximab |
|
| Module B | Experimental | Brentuximab alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological | Specified dose on specified days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Progression Free Survival (PFS) is defined as time from date of randomization to death, or disease progression per investigator assessment estimated using the Kaplan-Meier (KM) product-limit method. | From randomization to date of death, or disease progression (up to approximately 45 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate (CRR): | Complete Response Rate (CRR) is defined as the number of participants who have achieved complete response (Lugano 2014 classification) per investigator assessment. Complete response is considered a score of 1, 2, or 3. Per the Lugano criteria: Positron emission tomography (PET) negative scans are defined on the 5-point scale as scores of 1, 2, or 3 (where 1 = no uptake above background; 2 = uptake </= mediastinum; and 3 = uptake > mediastinum but \ |
Not provided
Inclusion Criteria
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
Participants must have a pathologic diagnosis of classical Hodgkin lymphoma (cHL) who are relapsed or refractory with one of the following:.
i) Autologous stem cell transplant (ASCT) ineligible patients.
ii) Patients after failure of ASCT.
- Must have at least one lesion that is > 15 mm (1.5 cm) in the longest diameter and avid by Fluoro Deoxy Glucose (FDG) Positron Emission Tomography (PET) scan.
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | United States | ||
| Pacific Shores Medical Group |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
Not provided
23 participants were randomized for study participation, 22 received at least 1 dose of study drug.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Nivolumab + Brentuximab Vedotin (BV) | Nivolumab 360 mg IV every 3 weeks until progression or unacceptable toxicity (except for patients in CR who can discontinue at 2 years) plus BV 1.8 mg/kg IV every 3 weeks for up to 16 cycles, or until progression or unacceptable toxicity, whichever occurs first. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 8, 2020 | Feb 11, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Brentuximab vedotin | Biological | Specified dose on specified days |
|
|
| From randomization up to approximately 45 months |
| Objective Response Rate (ORR) | Objective Response Rate (ORR) is defined as the number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) (Lugano 2014 classification) per investigator assessment. Complete response is considered a score of 1, 2, or 3. Partial response is considered a score of 4 or 5. Per the Lugano criteria: Positron emission tomography (PET) negative scans are defined on the 5-point scale as scores of 1, 2, or 3 (where 1 = no uptake above background; 2 = uptake </= mediastinum; and 3 = uptake > mediastinum but \ | From randomization up to approximately 45 months |
| Duration of Response (DOR) | The time from first response (Complete response (CR) or partial response (PR)) to the date of initial objectively documented progression (2014 Lugano classification) or death due to any cause per investigator assessment estimated using the Kaplan-Meier (KM) product-limit method. Complete response is considered a score of 1, 2, or 3. Partial response is considered a score of 4 or 5. Per the Lugano criteria: Positron emission tomography (PET) negative scans are defined on the 5-point scale as scores of 1, 2, or 3 (where 1 = no uptake above background; 2 = uptake </= mediastinum; and 3 = uptake > mediastinum but \ | From randomization to date of documented progression or death (up to approximately 45 months) |
| Duration of Complete Response (DOCR) | Duration of complete response (DOR) is defined as the time from first complete response to the date of initial objectively documented progression (2014 Lugano classification) or death due to any cause per investigator assessment estimated using the Kaplan-Meier (KM) product-limit method. Complete response is considered a score of 1, 2, or 3. Per the Lugano criteria: Positron emission tomography (PET) negative scans are defined on the 5-point scale as scores of 1, 2, or 3 (where 1 = no uptake above background; 2 = uptake </= mediastinum; and 3 = uptake > mediastinum but \ | From randomization to date of documented progression or death (up to approximately 45 months) |
| Overall Survival (OS) | Overall Survival (OS) is defined as the time between the date of randomization and the date of death estimated using the Kaplan-Meier (KM) product-limit method | From randomization to the date of death (up to approximately 3 years 7 months) |
| Long Beach |
| California |
| 90813 |
| United States |
| University of Southern California | Los Angeles | California | 90033 | United States |
| UCLA Clinical and Translational Research Center (CTRC) | Los Angeles | California | 90095-1678 | United States |
| Local Institution | Palo Alto | California | 94304 | United States |
| UC Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
| University of California San Diego | San Diego | California | 92122 | United States |
| Hartford Healthcare Cancer Institute at the Hospital of Central Connecticut | Plainville | Connecticut | 06062 | United States |
| Orlando Health, Inc | Orlando | Florida | 32806 | United States |
| Parkview Cancer Center | Fort Wayne | Indiana | 46845 | United States |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | United States |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Dana Farber/Harvard Cancer Center | Boston | Massachusetts | 02215 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Bon Secours Saint Francis Cancer Center | Greenville | South Carolina | 29607 | United States |
| Vanderbilt Ingram Cancer Center | Nashville | Tennessee | 37213 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| The University of Texas MD Anderson Cancer Center-merge | Houston | Texas | 77030 | United States |
| Local Institution | Sendai | Miyagi | 9808574 | Japan |
| Local Institution | San Juan | 00918 | Puerto Rico |
| FDA Safety Alerts and Recalls | View source |
| Brentuximab Vedotin (BV) |
BV alone 1.8 mg/kg every 3 weeks for up to 16 cycles, or until disease progression or unacceptable toxicity, whichever occurs first |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nivolumab + Brentuximab Vedotin (BV) | Nivolumab 360 mg IV every 3 weeks until progression or unacceptable toxicity (except for patients in CR who can discontinue at 2 years) plus BV 1.8 mg/kg IV every 3 weeks for up to 16 cycles, or until progression or unacceptable toxicity, whichever occurs first. |
| BG001 | Brentuximab Vedotin (BV) | BV alone 1.8 mg/kg every 3 weeks for up to 16 cycles, or until disease progression or unacceptable toxicity, whichever occurs first |
| 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/Ethnicity, Customized | 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 | Progression Free Survival (PFS) | Progression Free Survival (PFS) is defined as time from date of randomization to death, or disease progression per investigator assessment estimated using the Kaplan-Meier (KM) product-limit method. | All randomized participants | Posted | Median | 95% Confidence Interval | Months | From randomization to date of death, or disease progression (up to approximately 45 months) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Complete Response Rate (CRR): | Complete Response Rate (CRR) is defined as the number of participants who have achieved complete response (Lugano 2014 classification) per investigator assessment. Complete response is considered a score of 1, 2, or 3. Per the Lugano criteria: Positron emission tomography (PET) negative scans are defined on the 5-point scale as scores of 1, 2, or 3 (where 1 = no uptake above background; 2 = uptake </= mediastinum; and 3 = uptake > mediastinum but \ | All randomized participants | Posted | Count of Participants | Participants | From randomization up to approximately 45 months |
| |||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | Objective Response Rate (ORR) is defined as the number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) (Lugano 2014 classification) per investigator assessment. Complete response is considered a score of 1, 2, or 3. Partial response is considered a score of 4 or 5. Per the Lugano criteria: Positron emission tomography (PET) negative scans are defined on the 5-point scale as scores of 1, 2, or 3 (where 1 = no uptake above background; 2 = uptake </= mediastinum; and 3 = uptake > mediastinum but \ | All randomized participants | Posted | Count of Participants | Participants | From randomization up to approximately 45 months |
| |||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | The time from first response (Complete response (CR) or partial response (PR)) to the date of initial objectively documented progression (2014 Lugano classification) or death due to any cause per investigator assessment estimated using the Kaplan-Meier (KM) product-limit method. Complete response is considered a score of 1, 2, or 3. Partial response is considered a score of 4 or 5. Per the Lugano criteria: Positron emission tomography (PET) negative scans are defined on the 5-point scale as scores of 1, 2, or 3 (where 1 = no uptake above background; 2 = uptake </= mediastinum; and 3 = uptake > mediastinum but \ | All randomized participants | Posted | Median | 95% Confidence Interval | Months | From randomization to date of documented progression or death (up to approximately 45 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Complete Response (DOCR) | Duration of complete response (DOR) is defined as the time from first complete response to the date of initial objectively documented progression (2014 Lugano classification) or death due to any cause per investigator assessment estimated using the Kaplan-Meier (KM) product-limit method. Complete response is considered a score of 1, 2, or 3. Per the Lugano criteria: Positron emission tomography (PET) negative scans are defined on the 5-point scale as scores of 1, 2, or 3 (where 1 = no uptake above background; 2 = uptake </= mediastinum; and 3 = uptake > mediastinum but \ | All randomized participants with objective response of complete response (CR) | Posted | Median | 95% Confidence Interval | Months | From randomization to date of documented progression or death (up to approximately 45 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall Survival (OS) is defined as the time between the date of randomization and the date of death estimated using the Kaplan-Meier (KM) product-limit method | All randomized participants | Posted | Median | 95% Confidence Interval | Months | From randomization to the date of death (up to approximately 3 years 7 months) |
|
|
From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
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 | Nivolumab + Brentuximab Vedotin (BV) | Nivolumab 360 mg IV every 3 weeks until progression or unacceptable toxicity (except for patients in CR who can discontinue at 2 years) plus BV 1.8 mg/kg IV every 3 weeks for up to 16 cycles, or until progression or unacceptable toxicity, whichever occurs first. | 1 | 12 | 6 | 12 | 12 | 12 |
| EG001 | Brentuximab Vedotin (BV) | BV alone 1.8 mg/kg every 3 weeks for up to 16 cycles, or until disease progression or unacceptable toxicity, whichever occurs first | 0 | 10 | 1 | 10 | 10 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-cardiac chest pain | General disorders | 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 23.1 | Systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | 23.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | 23.1 | Systematic Assessment |
| |
| Eye discharge | Eye disorders | 23.1 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | 23.1 | Systematic Assessment |
| |
| Scleral hyperaemia | Eye disorders | 23.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | 23.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Chest pain | General disorders | 23.1 | Systematic Assessment |
| |
| Chills | General disorders | 23.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 23.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | 23.1 | Systematic Assessment |
| |
| Malaise | General disorders | 23.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 23.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 23.1 | Systematic Assessment |
| |
| Pain | General disorders | 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 23.1 | Systematic Assessment |
| |
| Abscess jaw | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Body tinea | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Oral infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Scrotal abscess | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Viral pericarditis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 23.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 23.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | 23.1 | Systematic Assessment |
| |
| Blood bilirubin decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 23.1 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | 23.1 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | 23.1 | Systematic Assessment |
| |
| Breath sounds abnormal | Investigations | 23.1 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | 23.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | 23.1 | Systematic Assessment |
| |
| Influenza B virus test positive | Investigations | 23.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Weight increased | Investigations | 23.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Urine odour abnormal | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Sexual dysfunction | Reproductive system and breast disorders | 23.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Onychoclasis | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 23.1 | Systematic Assessment |
|
Due to a treatment paradigm shift and subsequent low enrollment, the Sponsor chose to terminate the study and consequently there is limited data. These reasons were unrelated to any adverse events (AEs) or safety concerns.
The sample size was smaller than expected, therefore, results should be interpreted with caution. PFS, CRR, and ORR outcomes should be interpreted with caution given large confidence intervals around medians and early study closure.
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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 24, 2017 | Feb 11, 2022 | SAP_001.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 |
| 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 |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| BLACK OR AFRICAN AMERICAN |
|
| JAPANESE |
|
| ASIAN OTHER |
|
| NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER |
|
| OTHER |
|
|
|
|
|
BV alone 1.8 mg/kg every 3 weeks for 16 cycles, or until progression or unacceptable toxicity, whichever occurs first |
|
|
BV alone 1.8 mg/kg every 3 weeks for 16 cycles, or until progression or unacceptable toxicity, whichever occurs first |
|
|
|