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Trial in Patients With Relapsed Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT03267589
Recruitment Status : Recruiting
First Posted : August 30, 2017
Last Update Posted : October 9, 2018
Sponsor:
Collaborators:
Gynecologic Cancer Intergroup (GCIG)
European Network of Gynaecological Oncological Trial Groups (ENGOT)
SGCTG: The Scottish Gynaecological Cancer Trials Group, UK
Princess Margaret Hospital, Canada
Belgian Gynaecological Oncology Group
KGOG: Korean Gynaelogical Onology Group, Korea
Gynecologic Oncology Trial & Investigation Consortium
NOGGO: Nord-Ostdeutsche Gesellschaft Fur Gynäkologische Onkologie, Germany
COGI: Cooperative Ovarian Cancer Group for Immunotherapy
Australia New Zealand Gynaecological Oncology Group
Information provided by (Responsible Party):
Nordic Society for Gynaecologic Oncology

Study Description
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Brief Summary:
The overall objectiv is to obtain preliminary evidence of efficacy of novel agents for the management of relapsed ovarian cancer, and in part 2 efficacy of novel agents compared to the standard of care (SoC).

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Part 1: single cohorts of novel agents Part 2: randomized phase 2 against standard of care.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NSGO-OV-UMB1; ENGOT-OV30 / NSGO: A Phase II Umbrella Trial in Patients With Relapsed Ovarian Cancer
Actual Study Start Date : June 16, 2018
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Durvalumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort A
Intervention: MEDI9447 (CD73) + durvalumab
 Drug: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562
Three different combination are being tested. Each cohort has different combination
Experimental: Cohort B
Intervention: MEDI0562 (OX40) + durvalumab
 Drug: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562
Three different combination are being tested. Each cohort has different combination
Experimental: Cohort C
Intervention: MEDI0562 (OX40) + tremelimumab combination
 Drug: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562
Three different combination are being tested. Each cohort has different combination


Outcome Measures
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Primary Outcome Measures :
  1. Disease control rate (DCR) [ Time Frame: 16 weeks ]
    Disease control rate (DCR) (CR+PR+SD)


Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) by RECIST v1.1 [ Time Frame: 10 months ]
    PFS by RECIST v1.1

  2. PFS by Immune-RECIST [ Time Frame: 10 months ]
    PFS by Immune-RECIST

  3. Overall survival (OS) [ Time Frame: 36 months ]
    Overall survival (OS)

  4. Objective response rate [ Time Frame: 10 months ]
    Objective response rate according to RECIST v1.1 (ORR)

  5. Duration of (Overall) Response (DoR) [ Time Frame: 10 months ]
    Duration of (Overall) Response (DoR)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Platinum-sensitive disease: defined as disease progression ≥ 6 months following the last administered dose of platinum-based therapy. Patients must have received atleast one line of chemotherapy for platinum-sensitive disease. OR

  2. Platinum-resistant disease: defined as disease progression < 6 months following the last administered dose of platinum-based therapy.

    OR

  3. Platinum-refractory disease: defined as lack of response or disease progression while receiving the most recent therapy.

    Other key inclusion criteria:

  4. Histological confirmed ovarian, fallopian tube or peritoneal cancers.
  5. Histological types: high-grade serious, high-grade endometriod, undifferentiated, carcinosarcoma or mixed histology.
  6. Subjects must have at least 1 measurable lesion as defined by RECIST guidelines. This should not be the same lesion used for biopsy.
  7. Patients entering cohort A: Archival tumour tissue must be screened for CD73 and only CD73 positive patients (defined as >10% of tumor cells positive) will enter this trial.
  8. Patient agrees to undergo all analysis (blood, serum, tissue); radiological examinations according to protocol.
  9. Mandatory tumour biopsy before treatment (before day 0) and at day 56 of treatment.
  10. Patients must give informed consent.
  11. Patients must be at least 18 years of age.
  12. ECOG performance status 0-1
  13. Serum albumin >30g/l.
  14. Adequate organ function
  15. Life expectancy of at least 12 weeks.
  16. Patients must be fit to receive Investigational medical products (IMPs)

Exclusion Criteria:

  1. Subjects using immunosuppressive medications within 14 days.
  2. Immunodeficiency or organ transplant
  3. Live vaccines within 28 days prior to the first dose.
  4. Major surgery within 28 days prior to the first dose.
  5. Ovarian sarcomas, small cell carcinoma with neuroendocrine differentiation, non-epithelial can-cers.
  6. Cancer therapies (chemotherapy, radiotherapy, surgery, immunotherapy, biologic or hormonal therapy) within 28 days prior to the first dose.
  7. Concurrent treatment with an investigational agent or participation in another clinical trial.
  8. Previous malignant disease: patients are not eligible for the study if actively being treated of inva-sive cancer other than ovarian cancer. Patients with previous malignant disease other than ovarian cancer who are relapse-free and treatment-free for more than three years may enter this study. Pa-tients with previous history of in-situ carcinoma, stage 1A cervical cancer or non-invasive basal cell and squamous cell skin carcinoma can enter this trial.
  9. Active infection including tuberculosis
  10. History of a cerebral vascular accident, transient ischemic attack or subarachnoid hemorrhage within the past 6 months.
  11. History of clinically significant hemorrhage in the past 3 months.
  12. Untreated CNS disease, leptomeningeal disease or cord compression. Subjects with treated dis-ease should have at least 4 weeks of neurologic and radiographic stability and be off steroids for 14 days.
  13. Significant cardiovascular disease's.
  14. Persistance of clinically relevant therapy related toxicity from previous anticancer therapy (any grade 3-4 toxicity or grade ≥2 neuropathy).
  15. Known hypersensitivity to the trial drugs, or to their excipients.
  16. Has had prior exposure to IMPs, or any other immunotherapy.
  17. Active or prior documented autoimmune or inflammatory disorders
  18. For cohorts B and C: Medical condition requiring current systemic anticoagulation, or a history of congenital hypercoagulable condition. Subjects taking aspirin at doses < 325 mg per day are eli-gible provided that prothrombin time is within the institutional range of normal. Use of local anti-coagulation for port maintenance is permitted
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03267589


Contacts
Contact: Mansoor R Mirza, MD +4535459624 mansoor@rh.regionh.dk
Contact: Dorte Nørvang, RN +4535453311 dorte.noervang@regionh.dk

Locations
Denmark
VejleSygehus Not yet recruiting
Vejle, Region Syddanmark, Denmark, 7100
Contact: Jon Henriksen, MD       Jon.Henriksen@rsyd.dk   
Principal Investigator: Jon Henriksen, MD         
Rigshospitalet Recruiting
København Ø, Sjaelland, Denmark, 2100
Contact: MANSOOR RAZA MIRZA    +4535459624    mansoor@rh.regionh.dk   
Finland
Tampere University Hospital Not yet recruiting
Tampere, Finland
Contact: Annika Auranen, MD       anaura@utu.fi   
Principal Investigator: Johanna Maenpaa, MD, PhD         
Norway
Haukeland University Hospital Not yet recruiting
Bergen, Haukeland, Norway, 5021
Contact: Line Bjørge, MD       Line.Bjorge@uib.no   
Principal Investigator: Line Bjørge         
The Norwegian Radium Hospital Not yet recruiting
Oslo, Norway, 0310
Contact: Kristina Lindemann, MD, PhD    +47 22934000 ext 5690    klinde@ous-hf.no   
Principal Investigator: Kristina Lindemann, MD, PhD         
Sponsors and Collaborators
Nordic Society for Gynaecologic Oncology
Gynecologic Cancer Intergroup (GCIG)
European Network of Gynaecological Oncological Trial Groups (ENGOT)
SGCTG: The Scottish Gynaecological Cancer Trials Group, UK
Princess Margaret Hospital, Canada
Belgian Gynaecological Oncology Group
KGOG: Korean Gynaelogical Onology Group, Korea
Gynecologic Oncology Trial & Investigation Consortium
NOGGO: Nord-Ostdeutsche Gesellschaft Fur Gynäkologische Onkologie, Germany
COGI: Cooperative Ovarian Cancer Group for Immunotherapy
Australia New Zealand Gynaecological Oncology Group
More Information
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Responsible Party: Nordic Society for Gynaecologic Oncology
ClinicalTrials.gov Identifier: NCT03267589     History of Changes
Other Study ID Numbers: ENGOT-OV30 / NSGO
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Nordic Society for Gynaecologic Oncology:
immunotherapy
ovarian cancer
durvalumab
 tremelilumab
MEDI 9447
MEDI 0562

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
 Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs