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 |
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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 | 16.1 |
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 rituximab and an alkylating agent. |
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E.2.2 | Secondary objectives of the trial |
• To assess the duration of response based on IRRC assessments
• To assess the complete remission rate based on IRRC assessment
• To assess the progression free survival based on IRRC assessment
• To assess the ORR, based on investigator assessments.
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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 rituximab and/or an alkylating agent
• ECOG PS 0-1
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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 or autologous stem cell transplant.
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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 based on IRRC assessment
• To assess the progression free survival based on IRRC assessment
• To assess the ORR, based on investigator assessments.
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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 |
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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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
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 |
Belgium |
Canada |
France |
Italy |
Norway |
Sweden |
Australia |
Germany |
Spain |
Singapore |
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 |