Trial Overview

Information & Trial Design

Cervical Cancer Trials

ENGOT-CX6

A Single arm, Multicenter, Phase 2b Trial Investigating the Efficacy of Tisotumab Vedotin (HuMax® – TF-ADC) Therapy in Previously treated Patients with Recurrent or Metastatic Cervical Cancer.

ENGOT-CX8

A Phase 1b/2 Open-Label Trial of Tisotumab Vedotin (HuMax® -TF-ADC) Monotherapy and in Combination with Other Agents in Subjects with Recurrent or Stage IVB Cervical Cancer.

ENGOT-CX10/BEATcc

A Randomized Phase III Trial of Platinum Chemotherapy plus Paclitaxel with Bevacizumab and Atezolizumab versus Platinum Chemotherapy plus Paclitaxel and Bevacizumab in Metastatic (stage IVB), Persistent or Recurrent Carcinoma of the Cervix

ENGOT-CX11

A Randomized, Phase 3, Double-Blind Study of Chemoradiotherapy With or Without Pembrolizumab for the Treatment of High-risk, Locally Advanced Cervical Cancer.

ENGOT-CX12

A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator’s Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer.

ENGOT-CX20/TroFuse-020

A Phase 3 Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician’s Choice as Second-line Treatment for Participants with Recurrent or Metastatic Cervical Cancer

Endometrial Cancer Trials

ENGOT-EN1-NSGO/FANDANGO

A randomized phase II trial of first-line combination chemotherapy with Nintedanib/placebo for patients with advanced or recurrent endometrial cancer.

ENGOT-EN2-DGCG

A phase II Trial of postoperative chemotherapy or no further treatment for patietns with node-negative stage I-II intermediate or high risk endometrial cancer.

ENGOT-EN3-NSGO/PALEO

A randomized, double-blind, placebo-controlled, phase II trial of Palbociclib in combination with Letrozole versus Placebo in combination with Letrozole for patients with Estrogen Receptor Positive advanced or recurrent Endometrial cancer.

ENGOT-EN6/NSGO-CTU/RUBY I

A Phase 3 Randomized Open-Label Study of TSR-042, an anti-PD-1 Mono-clonal Antibody vs. Investigator’s Choice Chemotherapy in Advanced/Recurrent Endometrial Cancer

ENGOT-EN6/NSGO-CTU/RUBY II

A Phase 3 Randomized Open-Label Study of TSR-042, an anti-PD-1 Mono-clonal Antibody vs. Investigator’s Choice Chemotherapy in Advanced/Recurrent Endometrial Cancer

ENGOT-EN10/DUO-E

A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination with Durvalumab, Followed by Maintenance Durvalumab with or without Olaparib in Patients with Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E).

ENGOT-EN11/BGOG/KEYNOTE-B21

A Phase 3, Randomized, Double-Blind Study of Pembrolizumab versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent (KEYNOTE-B21 / ENGOT-en11 / GOG-3053).

ENGOT-EN15/MITO

A Phase 3 Randomized, Open-label, Active-comparator Controlled Clinical Study of Pembrolizumab versus Platinum Doublet Chemotherapy in Participants With Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma in the First-line Setting (KEYNOTE-C93/GOG-3064/ENGOT-en15).

MK-2870-005/ENGOT-en23/GOG-3095

Phase 3, randomized, active-controlled, open-label, multicenter study to compare the efficacy and safety of MK-2870 monotherapy versus treament of physician’s choise in participants with endometrial cancer who have received prior platinum-based chemotherapy and immunotherapy.

Ovarian Cancer Trials

ARTISTRY-7

A Phase 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination With Pembrolizumab Versus Investigator’s Choice Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARTISTRY-7)

ENGOT-OV5/INOVATYON

Phase III international, randomized study of Trabectedin plus Pegylated Liposomal Doxorubicin (PLD) versus Carboplatin plus PLD in patients with ovarian cancer progressing withing 6-12 motnhs of last platinum.

ENGOT-OV15/BOOST

A prospective randomized Phase III trial to evaluate optimal treatment duration of first-line bevacizumab in combination with carboplatin and paclitaxel in patients with primary epithelial ovarian, fallopian tube or peritoneal cancer.

ENGOT-OV16/NOVA

Phase 3 Randomized Double-Blind Trial of Maintenance with Niraparib Versus Placebo in Patients with Platinum Sensitive Ovarian Cancer.

ENGOT-OV24-NSGO/AVANOVA

Part 1: AVANOVA1 – A phase I study to evaluate the safety and tolerability of bevacizumab-niraparib combination therapy and determine the Recommended Phase 2 Dose (RP2D) in Women with platinum-sensitive epithelial ovarian, fallopian tube, or peritoneal cancer.
Part 2: AVANOVA2 – A two-arm, open-label, phase II randomized study to evaluate the efficacy of niraparib versus niraparib-bevacizumab combination in Women with platinum-sensitive epithelial ovarian, fallopian tube, or peritoneal cancer.

ENGOT-OV25/PAOLA-1

Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB – IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance.

ENGOT-OV26/PRIMA

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients with HRD-Positive Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy.

ENGOT-OV30/UMBRELLA

A phase II umbrella trial in patients with relapsed ovarian cancer.

ENGOT-OV38/OreO

A Phase IIIb, Randomised, Double-blind, Placebo-controlled, Multicentre Study of Olaparib Maintenance Retreatment in Patients with Epithelial Ovarian Cancer Previously Treated With a PARPi and Responding to Repeat Platinum Chemotherapy (OReO)

ENGOT-OV39/IMAGYN050

A phase III, multicenter, randomized, study of atezolizumab versus placebo administered in combination with paclitaxel, carboplatin, and bevacizumab to patients with paclitaxel, carboplatin, and bevacizumab to patients with newly-diagnosed Stage III or Stage IV ovarian, fallopian tube, or primary peritoneal cancer.

ENGOT-OV44/FIRST

A Randomized, Double-Blind, Phase 3 Comparison of Platinum-Based Therapy with TSR-042 and Niraparib versus Standard of Care Platinum-Based Therapy as First-Line Treatment of Stage III or IV Nonmucinous Epithelal Ovarian Cancer.

ENGOT-OV45/NCRI/ATHENA

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment following Response to Front-Line Platinum-Based Chemotherapy.

ENGOT-OV46/AGO/DUO-O

A Phase III Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combination with Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib in Newly Diagnosed Advanced Ovarian Cancer Patients (DUO-O).

ENGOT-OV56-NSGO-CTU/DOVACC

A Randomized Clinical Trial Investigating Olaparib, Durvalumab (MEDI4736) and UV1 as Maintenance Therapy in BRCAwt Patients with Recurrent Ovarian Cancer.

ENGOT-OV61/GEICO/EPIK-O

EPIK-O: A Phase III, multi-center, randomized (1:1), openlabel, active-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with olaparib as compared to single agent cytotoxic chemotherapy, in participants with no germline BRCA mutation detected, platinum-resistant or refractory, high-grade serous ovarian cancer.

ENGOT-OV65/KEYNOTE-B96

A Phase 3, Randomized, Double-Blind Study of Pembrolizumab versus Placebo in Combination With Paclitaxel With or Without Bevacizumab for the Treatment of Platinum-resistant Recurrent Ovarian Cancer (KEYNOTE-B96).

ENGOT-OV67/A.AGO-OVAR 2.39/UP-LIFT

A Phase 1b/2, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients with Solid Tumors Likely to Express NaPi2b.

ENGOT-OV79/REFRaME-O1

A Phase 2/3 Open-label Study Evaluating the Efficacy and Safety of Luveltamab Tazevibulin (STRO-002) versus Investigator’s Choice (IC) Chemotherapy in Women with Relapsed Platinum-resistant Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing Folate Receptor Alpha (FOLR1) .

KANDOVA

A two-part Phase Ib/IIa study to evaluate the safety and tolerability of KAND567, in combination with carboplatin therapy, and to determine the Recommended Phase II Dose (RPIID) of KAND567. An open-label, multicenter dose escalation study with an expansion cohort in women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Surgical Trials

ENGOT-OV20/DESKTOP III

A randomized multicenter study to compare the efficacy of additional tumor debulking surgery versus chemotherapy alone for recurrent platinum-sensitive ovarian cancer.

ENGOT-OV33/TRUST

Trial of radical upfront surgery in advanced ovarian cancer: amendment for Germany with extended part for fragility and long term quality of life.

ENGOT-OV34/AGO-OVAR 2.29

Atezolizumab in combination with Bevacizumab and Chemotherapy versus Bevacizumab and Chemotherapy in recurrent ovarian cancer – a randomized Phase III trial.

ENGOT-OV52/OVHIPEC-2

Phase III randomized clinical trial for stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy.

Basket Trials

NSGO-CTU/PEACE

Palliation in gynae-oncology: Patients Expectations and Assessment of Care.

NSGO-CTU/HERO

Characterization of Epithelial Ovarian Cancer Patients in Terms of Homologous Recombination Phenotype – A Prospective Observational Study.

For any further information regarding Inclusion lists and Site lists, please contact the relevant Project Manager.

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Privacy Policy for NSGO

NSGO treats personal information and complies with the laws and principles of good data processing practices. Therefore, we have adopted this Privacy Policy, which briefly describes how we treat personal information, so legal and transparent processing is ensured.

We are responsible for processing your personal information:

NSGO is the data controller and you can always contact the organization’s data protection officer:

Mansoor Raza Mirza

Nordic Society of Gynecologic Oncology – Clinical Trial Unit
Copenhagen University Hospital
Department of Oncology, 9431
Blegdamsvej 60
DK-2100 Copenhagen
Office phone: +45 35 45 33 78
fax: +45 3545 2898
nsgo-dpo.rigshospitalet@regionh.dk

We treat the following personal information about members:

  • General personal information: For example, contact information such as name, work address, work phone number, private phone number, date of birth, email address, country, work title, date of membership, date of membership termination and cv in relation to membership application. Parts of credit card number via Epay and, if applicable, Bank account number for reimbursement purposes. When applicable, Board Members may be asked to give NSGO copies of other personal documents (for example passport or tax bill) in relation to the Danish Laundering Act.
  • Other information: For example, positions of trust, board membership and other duties in relation to the organization.

We collect personal information from:

Usually we will get the information from you, when you register to become a member of NSGO and when you apply for reimbursements or pay your membership fee

The organization’s legal basis to process personal information:

  • That we as an organization have a (legitimate) interest in processing your information
  • That it is necessary for us to fulfill an agreement with you
  • You have agreed that we can process your information via becoming a member of the

The purpose of processing personal information:

  • That we can run the organization’s activities, including planning, implementing and following up on them
  • To invite to vote for Board and President Elect elections
  • To distribute newsletters
  • To comply with legislation
  • To deliver services, in the form of the possibility to participate in the Annual Meeting, Investigator Meeting and if applicable Strategic Meetings, Board Meetings, Scientific Committee Meetings, Foundation Meetings.
  • To notify members about other Gynecologic Cancer Managing your relationship with the organization
  • To handle your membership rights
  • For you to fulfill your obligations as a member of the organization, including paying the membership fee, etc.
  • Being able to display situation images from a specific event in the organization for instance from NSGO Annual Meetings
  • To maintain historical value data for statistics and the like

Consent:

When you become a member, we have a legal basis to process your personal information for the (legitimate) interest of the organization. However, it may happen that we judge it necessary to obtain your written consent for other purposes. In that case you will have the opportunity to voluntarily agree, and you may withdraw it at any time by notifying us.

Dispatch of your personal information:

We do not disclose information about you to anyone outside the organization without your consent, however, it should be noted, that if you e.g. accept an invitation to a meeting, your personal information might be forwarded to the meeting location or the meeting organizer. Only personal information relevant for the 3rd party will be disclosed in these circumstances.

Storing and deleting your personal information:

For historical reasons and as your details might be saved in old attendance lists, email correspondence and minutes from meetings, we cannot promise that all personal information about you will be deleted, if you terminate your membership.

Your rights:

You have a number of rights via the General Data Protection Regulation (GDPR):

  • The Right to Information (to be informed what information we process about you)
  • The Right to Rectification (to have false information about you corrected)
  • The Right to Restriction of processing (under certain conditions, to have the processing of your data restricted)
  • The Right to Object (to object to your information being used for wrong purposes)

You may make use of your rights by contacting us. If you submit a request to have your personal information corrected or deleted, we will investigate whether the conditions are met and, in that case, make changes or deletions as soon as possible and, if applicable, also notify our data processors to do so.

You can file a complaint with the supervisory authorities – The Danish ‘Datatilsynet’ – About processing your personal information (www.datatilsynet.dk).

Revision of Privacy Policy:

We reserve the right to change the organization’s privacy policy. When we change privacy policy, we also change the date and version number at the bottom of this document. In case of significant changes, you will receive a notification.

The current privacy policy is always available on our website.

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Newsletter

Sign up to our newsletter

Privacy Policy for NSGO-CTU

NSGO-CTU treats personal information and complies with the laws and principles of good data
processing practices. Therefore, we have adopted this Privacy Policy, which briefly describes how we treat personal information, so legal and transparent processing is ensured.

We are responsible for processing your personal information:

NSGO-CTU is the data controller and you can contact the organization’s data protection officer:

Mansoor Raza Mirza

Nordic Society of Gynecologic Oncology – Clinical Trial Unit
Copenhagen University Hospital
Department of Oncology, 9431
Blegdamsvej 60
DK-2100 Copenhagen
Office phone: +45 35 45 33 78
fax: +45 3545 2898
nsgo-dpo.rigshospitalet@regionh.dk

We treat the following personal information about personnel participating in NSGO-CTU trials:
• General personal information: For example; contact information such as name, work
address, work phone number, date of birth, email address, country, work title, date of start
of participation and termination in a trial and, if applicable, CV, GCP certificates, records of
training and other qualification data.
• If applicable, financial disclosure forms and/or Bank account number for reimbursement
purposes.

We collect personal information from:
• We will ask you to provide us the information yourself, when you in decide to take part
in NSGO-CTU trials.
The organization’s legal basis to process personal information:
• That we as an organization have a (legitimate) interest in processing your information, for
example to secure your qualifications in handling the care of the participants in a trial.
• That it is necessary for us to fulfill an agreement with your employer
• You have agreed that we can process your information via signing the delegation log.
The purpose of processing personal information:
• The participation of an investigator or of other individuals in a clinical trial which is being
conducted according to the principals governing clinical research as set out in the
Declaration of Helsinki and with the acceptance of all involved Regulatory Health
Authorities and involved Ethical Committees, requires collection, recording, storage,
transfer and/or other use of personal data (personal data processing).
• Communicate regarding studies.
• To handle payments and reimbursements.
• To comply with legislation.
• To deliver services, in the form of the possibility to participate in the Annual Meeting,
Investigator Meeting.
• To be able to give you access to IT systems, databases, eCRFs etc. related to the functioning
of each individual trial.

Consent:
When you decide to take part in a NSGO-CTU trial NSGO-CTU either makes a contract with you or
your employer where terms and conditions are described, or if you put your name on the
Delegation Log of a trial, you agree to the information described in this Privacy Policy.
However, it may happen that we judge it necessary to obtain your written consent for other
purposes. In that case you will have the opportunity to voluntarily agree, and you may withdraw it
at any time by notifying us.
Be aware that there are legal bases for certain forms of processing of your data for the abovementioned purposes and that your consent is the only legal basis for other forms of processing.

Dispatch of your personal information:
Depending on your role in a trial, your personal information might be shared with personnel at
other sites, monitors, group staff in other countries, NSGO-CTU office staff, members of NSGO,
CRO staff, Ethics Committees and Competent Authorities, both in Europe, but also in countries
outside the European Economic Area (for example the US). If your data (personal information) has
been transferred, they will be subject to the data protection legislation of the respective country,
also if a less severe data protection law should exist.
We do not disclose information about you to anyone outside the organization without the above
consent, however, it should be noted, that if you e.g. accept an invitation to a meeting, your
personal information might be forwarded to the meeting location or the meeting organizer. Only
personal information relevant for the 3rd party will be disclosed in these circumstances.
Furthermore, your data can be transmitted to public databases for registration, as well as
publication of a trial and your data can be stored and published in those databases.
Storing and deleting your personal information:
For historical reasons and as your details might be saved in old attendance lists, email
correspondence and minutes from meetings, we cannot promise that all personal information
about you will be deleted, when you end your participation in a study. In general, all information
about a trial is deleted at least 20 years after end of study.

Your rights:
You have a number of rights via the General Data Protection Regulation (GDPR):
• The Right to Information (to be informed what information we process about you)
• The Right of Access (to get a print of the information we process about you)
• The Right to Rectification (to have false information about you corrected)
• The Right to Erasure (to delete information we process about you, however, information
already received cannot be deleted)
• The Right to Restriction of processing (under certain conditions, to have the processing of
your data restricted)
• The Right to Object (to object to your information being used for wrong purposes)

You may make use of your rights by contacting us, however, the legality of the processing carried out
prior to e.g., a withdrawal will not be affected. If you submit a request to have your personal
information corrected or deleted, we will investigate whether the conditions are met and, in that
case, make changes or deletions as soon as possible and, if applicable, also notify our data
processors to do so.

If you do not believe that NSGO-CTU handles your data correctly, you can file a complaint with the
supervisory authorities – The Danish ‘Datatilsynet’ – About processing your personal information
(www.datatilsynet.dk).

Revision of Privacy Policy:
We reserve the right to change the organization’s privacy policy. When we change privacy policy,
we also change the date and version number at the bottom of this document. In case of significant
changes, you will receive a notification.

The current privacy policy for NSGO-CTU is always available on our website.

Practice Areas

Newsletter

Sign up to our newsletter

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