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Trial record 27 of 604 for:    Recruiting, Not yet recruiting, Available Studies | Ovarian cancer

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 31, 2019
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 of Gynaecological Oncology - Clinical Trials Unit ( Nordic Society for Gynaecologic Oncology )

Tracking Information
First Submitted Date  ICMJE July 5, 2017
First Posted Date  ICMJE August 30, 2017
Last Update Posted Date October 31, 2019
Actual Study Start Date  ICMJE June 16, 2018
Estimated Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2017)
Disease control rate (DCR) [ Time Frame: 16 weeks ]
Disease control rate (DCR) (CR+PR+SD)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03267589 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2017)
  • Progression-Free Survival (PFS) by RECIST v1.1 [ Time Frame: 10 months ]
    PFS by RECIST v1.1
  • PFS by Immune-RECIST [ Time Frame: 10 months ]
    PFS by Immune-RECIST
  • Overall survival (OS) [ Time Frame: 36 months ]
    Overall survival (OS)
  • Objective response rate [ Time Frame: 10 months ]
    Objective response rate according to RECIST v1.1 (ORR)
  • Duration of (Overall) Response (DoR) [ Time Frame: 10 months ]
    Duration of (Overall) Response (DoR)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial in Patients With Relapsed Ovarian Cancer
Official Title  ICMJE NSGO-OV-UMB1; ENGOT-OV30 / NSGO: A Phase II Umbrella Trial in Patients With Relapsed Ovarian Cancer
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE Drug: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562
Three different combination are being tested. Each cohort has different combination
Study Arms  ICMJE
  • Experimental: Cohort A
    Intervention: MEDI9447 (CD73) + durvalumab
    Intervention: Drug: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562
  • Experimental: Cohort B
    Intervention: MEDI0562 (OX40) + durvalumab
    Intervention: Drug: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562
  • Experimental: Cohort C
    Intervention: MEDI0562 (OX40) + tremelimumab combination
    Intervention: Drug: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 29, 2017)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2023
Estimated Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mansoor R Mirza, MD +4535459624 mansoor@rh.regionh.dk
Contact: Dorte Nørvang, RN +4535453311 dorte.noervang@regionh.dk
Listed Location Countries  ICMJE Denmark,   Finland,   Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03267589
Other Study ID Numbers  ICMJE ENGOT-OV30 / NSGO
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Nordic Society of Gynaecological Oncology - Clinical Trials Unit ( Nordic Society for Gynaecologic Oncology )
Study Sponsor  ICMJE Nordic Society for Gynaecologic Oncology
Collaborators  ICMJE
  • 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
Investigators  ICMJE Not Provided
PRS Account Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP