Hodgkin Lymphoma Lymphoma
Conditions
Interventions
Nivolumab, brentuximab vedotin, and bendamustine in this study are considered
investigational products.
Patients will initially receive nivolumab at a dose of 3 mg/kg and brentuximab
vedotin at 1.8
Sponsors
Bristol-Myers Squibb
Eligibility
Age
2 Years to 64 Years
Inclusion criteria
Inclusion criteria: -Patients must provide written informed consent, children and adolescents should also give assent -Males and females aged between 5 and 30 years, inclusive. Please note in the Netherlands, only patients aged between 5 to 18 inclusive will be included in the study. -Women of child bearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study treatment -Patients must have measurable classic Hodgkin lymphoma as documented by pathological and radiographic criteria -Performance Level: Karnofsky above or equal to 50% for participants > 16 years of age or Lansky 50 for participants equal or less than16 years of age -Patients must have received first line anti-cancer therapy that failed -Patients must have adequate bone marrow, renal and hepatic function
Exclusion criteria
Exclusion criteria: -Active, known, or suspected autoimmune disease, immunodeficiency or infection -Active cerebral/meningeal disease related to the underlying malignancy -Patients who failed more than one line of anti-cancer therapy or are treatment naive -Patients who previously received an allogeneic and/or autologous stem cell transplant for classic Hodgkin lymphoma -Prior exposure to anti-PD1, anti-PDL1, anti-PD-L2, anti-CD137 or anti- CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways -Prior exposure to bendamustine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Low Risk group: To describe the proportion of patients who remain free of certain cancer related complications, events and death at 3 years. This will be assessed by an independent blinded review group. -Standard Risk group: To describe the proportion of patients who achieve a complete metabolic response (measured by medical imaging) before receiving high-dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT). This will be assessed by an independent blinded review group. | — |
Secondary
| Measure | Time frame |
|---|---|
| -To measure the overall response rate (ORR) (the proportion of patients whose cancer reduces or disappears after treatment) following 4 cycles of nivolumab and brentuximab vedotin. This will be assessed by an independent blinded review group. -To measure the proportion of patients whose disease does not progress at 3 years. This will be assessed by an independent blinded review group. -Duration response (time from tumour response to disease progression) will be evaluated for patients who achieved a response to treatment. -The safety profile of nivolumab and brentuximab vedotin in children and young adults with classic Hodgkin Lymphoma who have failed standard frontline chemotherapy will be described. | — |
Countries
Netherlands
Outcome results
None listed