Phase IIB Study of Nivolumab in subjects with Hodgkin's Lymphoma (registrational)

Phase 1

Conditions: Hodgkin Disease
MedDRA version: 17.0Level: HLGTClassification code 10025319Term: Lymphomas Hodgkin's diseaseSystem Organ Class: 10005329 - Blood and lymphatic system disorders
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2014-001509-42-IT

Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 150

Inclusion Criteria

- ECOG performance status 0 or 1
- Must have received prior high-dose conditioning chemotherapy followed by autologous stem cell transplant (ASCT) as a part of salvage therapy for cHL
- Subjects may be brentuximab vedotin- naïve, or may have had prior brentuximab vedotin treatment as a salvage therapy after failure of ASCT
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 145
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- Known central nervous system lymphoma
- Subjects with nodular lymphocyte-predominant Hodgkin Lymphoma
- Prior treatment history with brentuximab vedotin before ASCT
- Prior allogeneic SCT
- Chest radiation = 24 weeks prior to first dose
- Carmustine = 600 mg/m² received as part of the pre-transplant conditioning regimen

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the clinical benefit of nivolumab, as measured by objective response rate (ORR) based on independent radiologic review committee (IRRC) assessment, and defined as proportion of subjects achieving either a partial remission (PR) or complete remission (CR).;Secondary Objective: - Duration of response (DOR)<br>- Complete remission (CR) rate and duration<br>- Partial remission (PR) rate and duration<br>- Investigator-assessed Objective Response Rate and Duration of Response<br>;Primary end point(s): It is defined as the number of subjects with a best overall response (BOR) of CR or PR, according to the 2007 IWG criteria, based on Independent Radiographic Review Committee assessment, divided by the number of treated subjects.;Timepoint(s) of evaluation of this end point: CT or MRI scans every 12 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Duration of response (DOR)<br>- Complete remission (CR) rate and duration<br>- Partial remission (PR) rate and duration<br>- Investigator-assessed Objective Response Rate and Duration of Response<br>;Timepoint(s) of evaluation of this end point: CT or MRI scans every 12 weeks