E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029547 |
E.1.2 | Term | Non-Hodgkin's lymphoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The purpose of this study is to assess the clinical benefit of nivolumab,
as measured by independent radiologic review committee (IRRC)-
assessed objective response rate (ORR) in subjects with FL lymphoma
who have failed therapy with both CD20 antibody and an alkylating
agent. |
|
E.2.2 | Secondary objectives of the trial |
•To assess the duration of response based on IRRC assessments
•To assess the complete remission rate and the duration of complete
remission based on IRRC assessment
•To assess the partial remission rate and the duration of partial
remission based on IRRC assessment
•To assess the progression free survival based on IRRC assessment
•To assess the ORR, based on investigator assessments. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Grade 1, 2, or 3a FL without pathologic evidence of transformation.
•Male and female, ages 18 and above, with relapsed or refractory FL
lymphoma after > or = 2 prior treatment lines; each of the 2 prior
treatment lines must include at least CD20 antibody and/or an alkylating
agent
•ECOG PS 0-1 |
|
E.4 | Principal exclusion criteria |
•Known central nervous system lymphoma.
•History of interstitial lung disease
•Subjects with active, known or suspected autoimmune disease.
•Prior allogeneic stem cell transplant.
•Prior autologous stem cell transplant ≤ 12 weeks prior to first dose of
study drug |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is ORR as determined by an IRRC according to the revised International Working Group Criteria for non-Hodgkin Lymphoma. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Assessments (CT/MRI) begin 8 weeks after the start of nivolumab and continue at 8 weeks intervals through Month 8, 12-week intervals Month 9 to 2 years and then every 6 months after 2 years |
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E.5.2 | Secondary end point(s) |
•To assess the duration of response based on IRRC assessments
•To assess the complete remission rate and the duration of complete
remission based on IRRC assessment
•To assess the partial remission rate and the duration of partial
remission based on IRRC assessment
•To assess the progression free survival based on IRRC assessment
•To assess the ORR, based on investigator assessments. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Assessed at the same timepoints as the primary endpoint |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Biomarker Assessments, Outcomes Research Assessments, Immunogenicity Assessments, Results of Central Assessments |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Belgium |
Canada |
France |
Germany |
Italy |
Norway |
Singapore |
Spain |
Sweden |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last follow-up visit of the Last subject |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |