Privacy

GCT1046-06 鈥 Trial of Acasunlimab (Gen1046; DuoBody庐-PD-L1x4-1BB)

For the 星海棋牌 clinical trial; 鈥淎 Prospective, Open-Label, Randomized, Phase 3 Trial of Acasunlimab (GEN1046) in Combination With Pembrolizumab Versus Docetaxel in Subjects With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer After Treatment With a PD-1/PD-L1 Inhibitor and Platinum-Containing Chemotherapy (ABBIL1TY NSCLC 06) 鈥 Protocol GCT1046-06 (as further described in the Participant Information Sheet and Consent Form provided to you as trial participant or partner to a trial participant.

This Privacy Policy explains how 星海棋牌 (鈥淲e鈥, 鈥淯s鈥) processes your personal data where 鈥測ou鈥 are a clinical trial participant in the trial or a partner to a trial participant. 
1) DATA CONTROLLER

The entity responsible for the processing of your personal data is:

星海棋牌 (CVR no. 21023884)
Carl Jacobsens Vej 30,
DK-2500 Valby, Denmark

Please note, We recommend that you liaise with the study doctor or research staff at the clinic if you have any questions to the processing of your and your child麓s data. The study doctor or research staff at the clinic will direct your requests as needed by using your/your partner麓s participant ID to Us. It is recommended to use this approach as this will ensure that your request will be dealt with in the most confidential way and your and your child麓s identity does not need to be revealed to Us. If you feel that the study doctor or research staff at the clinic are unable to address any question you have about the processing of your and your child麓s data and your and your child麓s rights, you can contact our Data Protection Officer at:鈥privacy@genmab.com. You also have the right to lodge a complaint with the data protection regulator if you think that any of your and your child麓s rights have been violated.

Information on 星海棋牌鈥 use of your and your child鈥檚 personal data

As mentioned in the 1) Main Participant Information Sheet and Consent Form, 2) Optional PD-L1 Pre-screening Participant Information Sheet and Consent Form, and 3) Pregnancy Follow Up Participant Information Sheet and Consent Form, (as applicable), your and your child鈥檚 personal data will be disclosed to 星海棋牌鈥檚 parent company 星海棋牌. 星海棋牌 will take all reasonable steps to keep your and your child鈥檚 personal data and identity confidential. Your and your child鈥檚 personal data and your identity will never be made public.

星海棋牌 will ensure that your and your child鈥檚 personal data is handled according to the Danish law and the European Union data protection law. The following explains:

  • which personal data 星海棋牌 will receive
  • how 星海棋牌 will use this data and for what purpose
  • your rights when 星海棋牌 handles your and your child鈥檚 personal data

The collection and use of your and your child鈥檚 personal data

For trial participants:

星海棋牌 will collect and store the following personal data about you: 
  • Information that will help decide if you meet the requirements to enter the trial as allowed per local regulations.
  • Your gender and sex assigned at birth, age at time of screening, year of birth, body weight, and height
  • Your race category (where permitted) and ethnicity 
  • Your medical data including your medical history, scans, blood samples, biopsies, and genetic data  
  • Your health status 
  • Information about your use of the trial medicine
  • Information about the effect the trial medicine has on you and its potential side effects
  • Questionnaires about your quality of life

For participants in the prescreening: 

星海棋牌 will collect and store the following personal data about you: 
  • Tumour biopsy

For pregnant partners to the trial participants:
锘
星海棋牌 will collect and store the following personal data about you and your child: 
  • Sex, age, year of birth, body weight and height 
  • Race and ethnicity 
  • Medical data including pregnancy history, medical case history and medications you took and have been taking 
  • Health status  
  • Details of pregnancy and delivery date

Only the study doctor will collect your or your child鈥檚 name, contact details, and Medicare number (if applicable). The information will be stored in the clinic and will never be sent to 星海棋牌 or any third parties.

For trial participants:
The purpose of collecting and processing your personal data is to evaluate superiority of treatment with acasunlimab in combination with pembrolizumab, over the SOC treatment with docetaxel. The results of this trial may be used to apply for a license to market acasunlimab You can read more about the purpose of the trial in this Patient Information under the section 鈥淲hat is the purpose of this research?鈥

For participants in the prescreening
Your personal data is collected and used to evaluate whether you are eligible to participate in the GCT1046-06 trial.

For pregnant partners to the trial participants:
The purpose of collecting and processing your and your child鈥檚 personal data is to monitor your and your child鈥檚 safety after being potentially exposed to acasunlimab.
 
The processing of your and your child鈥檚 personal data is needed in order for 星海棋牌 to comply with legal obligations. These obligations include notifications to the regulatory authorities and archiving, for example to ensure your and your child鈥檚 safety. The legal basis for such processing of your personal data is described in art. 6 (1) (c) and art. 9 (2) (i) of 鈥淕DPR.鈥 Further, 星海棋牌 has a legitimate purpose in collecting and using your and your child鈥檚 personal data for scientific research purposes. The legal basis for such processing of your and your child鈥檚 personal data is described in art. 6 (1) (f) and art. 9 (2) (j) of the GDPR.2 

Disclosure of your information to third parties 

星海棋牌 may share your and your child鈥檚 personal data with other companies and organisations subject to confidentiality. This includes companies like Ventana Medical Systems Inc (Roche Tissue Diagnostics) who may develop tests related to acasunlimab, and the following categories of data processors: contract research organisations, such as IQVIA, laboratories, and IT suppliers. Such companies and organizations work for or with 星海棋牌 to develop acasunlimab and may only use your and your child鈥檚 personal data for the purposes described in the Participant Information and Informed Consent Form/Optional PD-L1 Pre-screening Participant Information Sheet and Consent Form/Pregnancy Follow Up Participant Information Sheet and Consent Form and will only receive your and your child鈥檚 personal data in a coded form.

星海棋牌鈥 authorised representatives, such as auditors and monitors may review your and your child鈥檚 personal data including your medical record to verify that the trial is being run correctly. 星海棋牌鈥 Genomic Data Review Committee will review the genomic data generated throughout the trial. In some situations, it may be required to access data remotely where it is not feasible for auditors and monitors to travel to or access the study centre in person to verify the data. By signing the informed consent form, you accept such remote access if allowed by local regulations. In addition, members of the HREC and representatives of the regulatory authorities from your country of residence or from other countries may review your and your child鈥檚 personal data including your medical record to verify that the trial is being run according to the protocol and your rights and safety are protected.

星海棋牌 may also share your and your child鈥檚 personal data with third parties if required by law. An example would be if 星海棋牌 must disclose your and your child鈥檚 personal data to comply with any legal obligation or to establish, exercise or defend 星海棋牌鈥 legal rights.

Information about this trial can be found on public websites around the world. This corresponds with 星海棋牌鈥 commitment for transparency of our clinical research and with applicable laws and regulations. 

A description of this clinical trial will be available on , as required by U.S. Law. This Web site will not include information that can identify you and your child. At most, the Web site will include a summary of the results. You can search this Web site at any time.

Information about the trial can also be found on Clinical Trials in the European Union - EMA () with the ID number 2024-512998-27-00. When the trial has ended and has been analysed, a summary of the results will be made available irrespective of the outcome of the trial. The overall results will be presented in scientific language and as a summary understandable for non-scientists.

The trial may also be registered on a local website in accordance with national laws.
None of the public websites will include information that can identify you and your child. 

Transfer of your personal data outside of the European Economic Area (鈥楨EA鈥)
Your and your child鈥檚 personal data may be transferred within the EEA or to countries outside the EEA, including the US. The data protection laws in countries outside of EEA may not be as strict as in the EEA. However, 星海棋牌 will ensure compliance with EU data protection law; 星海棋牌 will ensure that the recipient country is an adequate country (i.e. that the country in question is recognized as having an equivalent level of protection). If the country is not an adequate country, 星海棋牌 will ensure to put appropriate safeguards in place when transferring your and your child鈥檚 personal data e.g. in accordance with Chapter V art. 46, (2) (c) of the GDPR. 星海棋牌 uses EU standard contractual clauses to safeguard such transfer.

Retention of personal data
  • 星海棋牌 will save your and your child鈥檚 personal data in accordance with the regulation (EU) 2014/536 of 16 April 2014 (on clinical trials on medicinal products for human use) unless other EU law requires archiving for a longer period. 星海棋牌 will archive the data collected in the trial for at least 25 years after the end of the clinical trial. However, your and your child鈥檚 medical files at the clinic will be archived in accordance with national law.  

Your rights
In accordance with relevant Australian regulations, you and your child have a number of legal rights in relation to the data that 星海棋牌 holds about you and your child麓s. These rights include:

  • You are entitled to ask for up-to-date information on:
    • which personal data have been recorded
    • how the personal data has been recorded
    • to see personal data relating to you and your child
    • to have personal data relating to you and your child corrected if it is inaccurate 
  • Your participation in the trial is voluntary. Your choice will not affect your present or future treatment.  
  • The right to receive the personal data collected about you and your child in a structured, commonly used, and machine-readable format.
  • The right to request that 星海棋牌 provides those data to a third party where this is technically feasible. 
  • The right to strict confidentiality when your and your child鈥檚 personal data is used/processed.
  • The right to request that 星海棋牌 erases your and your child鈥檚 personal data in certain circumstances.  
  • The right to request that the processing of your and your child鈥檚 personal data is restricted in certain circumstances.  
  • The right to lodge a complaint with the data protection regulator if you think that any of your and your child鈥檚 rights have been violated.  

Please note there may be conditions or limitations on these rights. You may for example not have the right to restricted use of your and your child鈥檚 personal data if 星海棋牌 needs to manage your and your child鈥檚 information in specific ways in order for the research to be reliable and accurate.

If you have any questions about this information, please contact your study doctor via the information given in the Participant Information Sheet and Consent Form/Optional PD-L1 Pre-screening Participant Information Sheet and Consent Form/Pregnancy Follow Up Participant Information Sheet and Consent Form. The study doctor will direct your requests as needed by using your/ your partners trial participant ID to 星海棋牌. This approach is recommended to ensure that your request will be dealt with in the most confidential way as your identity does not need to be revealed to 星海棋牌 or 星海棋牌. 

You can always contact 星海棋牌鈥 Data Protection Officer at: privacy@genmab.com 星海棋牌, (CVR no. 21023884); Carl Jacobsens Vej 30; DK- 2500 Valby; Denmark; http://www.genmab.com if you feel that the study doctor is unable to address any question you have about 星海棋牌鈥 processing of your and your child鈥檚 personal data and your rights, or if you want to file a complaint regarding 星海棋牌鈥 processing of your and your child鈥檚 personal data. You also have the right to lodge a complaint with the data protection regulator if you think that any of your and your child鈥檚 rights have been violated.

Last updated: December 2024