Risk-based, response-adapted, Phase II open-label trial of nivolumab + brentuximab vedotin (N + Bv) for children, adolescents, and young adults with relapsed/refractory (R/R) CD30 + classic Hodgkin lymphoma (cHL) after failure of first-line therapy, followed by brentuximab + bendamustine (Bv + B) for participants with a suboptimal response.

Phase 2

Recruiting

Conditions: Hodgkin Lymphoma
Lymphoma
10025319

Registration Number: NL-OMON53072

Lead Sponsor: Bristol-Myers Squibb

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 4

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

-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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>-Low Risk group: To describe the proportion of patients who remain free of<br /><br>certain cancer related complications, events and death at 3 years. This will be<br /><br>assessed by an independent blinded review group.<br /><br><br /><br>-Standard Risk group: To describe the proportion of patients who achieve a<br /><br>complete metabolic response (measured by medical imaging) before receiving<br /><br>high-dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT).<br /><br>This will be assessed by an independent blinded review group. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-To measure the overall response rate (ORR) (the proportion of patients whose<br /><br>cancer reduces or disappears after treatment) following 4 cycles of nivolumab<br /><br>and brentuximab vedotin. This will be assessed by an independent blinded review<br /><br>group.<br /><br>-To measure the proportion of patients whose disease does not progress at 3<br /><br>years. This will be assessed by an independent blinded review group.<br /><br>-Duration response (time from tumour response to disease progression) will be<br /><br>evaluated for patients who achieved a response to treatment.<br /><br>-The safety profile of nivolumab and brentuximab vedotin in children and young<br /><br>adults with classic Hodgkin Lymphoma who have failed standard frontline<br /><br>chemotherapy will be described. </p><br>