eNERGY Protocole signe V2.0 2017.11.06.pdf


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ENERGY

Trial Code Sponsor 35RC16_9734 / GFPC 08-2015 / BMS CA209-449

4.6. Description of rules for permanent or temporary discontinuation ............................................................. 34
4.6.1. Discontinuation of participation of a person in study ........................................................................ 34
4.6.2. Discontinuation of part or of the entire study..................................................................................... 34
5
SCREENING AND EXCLUSION OF PERSONS FROM THE STUDY ........................................... 35
5.1. Inclusion criteria for persons who are Patients in the study ...................................................................... 35
5.2. Non-inclusion criteria for persons who are patients in the study............................................................... 36
5.3. Methods of recruitment .............................................................................................................................. 36
6
TREATMENTS ADMINISTERED TO PERSONS WHO ARE PATIENTS IN THE STUDY....... 37
6.1. Description of the treatments necessary for conduct of the study ............................................................. 37
6.1.1. Nivolumab - Ipilimumab ..................................................................................................................... 37
6.1.1.1 Description.................................................................................................................................... 37
6.1.1.2 Dosing schedule and Administration ............................................................................................ 37
6.1.1.3 Dosage adjustment ........................................................................................................................ 38
6.1.2. Comparator ......................................................................................................................................... 38
6.1.2.1 Dose Reductions for Investigator’s Choice Chemotherapy .......................................................... 39

Carboplatin/pemetrexed ................................................................................................................ 40

Carboplatin-paclitaxel ................................................................................................................... 42
6.2. Packaging and labelling ............................................................................................................................. 44
6.3 Drug ordering and accountability ............................................................................................................... 44
6.4 Authorised and unauthorised medicinal products and treatments in the setting of the protocol,
including emergency medicinal products ......................................................................................................... 44
6.4.1. Authorised treatments ......................................................................................................................... 44
6.4.2. Unauthorised treatments..................................................................................................................... 44
6.4.3. Interaction with other medicinal products .......................................................................................... 44
6.4.4. Emergency treatment .......................................................................................................................... 45
6.5. Conditions for storage of the investigational medicinal product ............................................................... 45
6.6. Management of Nivolumab and Ipilumumab, resupply and dispensing of Nivolumab and Ipilumumab . 46
6.6.1 Initial Orders ....................................................................................................................................... 46
6.6.2 Re-Supply ............................................................................................................................................. 46
6.6.3 Drug Excursions .................................................................................................................................. 46
6.6.4 Handling and Dispensing .................................................................................................................... 46
6.6.5 Destruction ........................................................................................................................................... 46
7
EVALUATION OF SAFETY .................................................................................................................. 46
7.1 Definitions................................................................................................................................................... 46
7.1.1 Adverse event (AE) ............................................................................................................................... 46
7.1.2 Adverse reaction of an investigational medicinal product (AR) .......................................................... 47
7.1.3 Serious adverse event or serious adverse reaction (SAE/SAR) ........................................................... 47
7.2 Investigator’s role ....................................................................................................................................... 47
7.2.1 Adverse Events to be immediately notified to the sponsor ................................................................... 47
7.2.1.1 Serious Adverse Events ................................................................................................................. 47
7.2.1.2. Potential Drug Induced Liver Injury (DILI) ................................................................................ 47
7.2.1.3 Suspected transmission of an infectious agent.............................................................................. 48
7.2.1.4 Non serious adverse event but critical to safety evaluation ......................................................... 48
7.2.2 Notification to the sponsor and time frame reporting ......................................................................... 48
7.2.2.1 Events not to be notified immediately to the sponsor ................................................................... 49

Specific hospitalizations ............................................................................................................... 49

Specific events related to non-small cell lung cancer progression ............................................... 49

Non serious adverse events ........................................................................................................... 49
7.3 Sponsor’s role ............................................................................................................................................. 49
7.3.1 Analysis of serious adverse events ....................................................................................................... 49
Protocole

Version 2.0 du 06/11/2017

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