Trial in Patients With Relapsed Ovarian Cancer

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Estimated Study Start Date :	March 16, 2018
Estimated Primary Completion Date :	March 30, 2019
Estimated Study Completion Date :	September 30, 2022

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, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

GCIG: Gynecologic Cancer InterGroup

European Network of Gynaecological Oncological Trial Groups (ENGOT)

SGCTG: The Scottish Gynaecological Cancer Trials Group, UK

PMHC: The Princess Margaret Hospital Consortium, Canada

BGOG: Belgian Gynaelogical Onology Group, Belgium

KGOG: Korean Gynaelogical Onology Group, Korea

GOTIC: Gynecologic Oncology Trial and Investigation Consortium, Japan

NOGGO: Nord-Ostdeutsche Gesellschaft Fur Gynäkologische Onkologie, Germany

COGI: Cooperative Ovarian Cancer Group for Immunotherapy

ANZGOG: The Australia New Zealand Gynaecological Oncology Group

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Last Update Posted:	February 2, 2018
Last Verified:	February 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; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female	Genital Neoplasms, Female; Urogenital Neoplasms; Endocrine System Diseases; Gonadal Disorders; Antibodies, Monoclonal; Immunologic Factors; Physiological Effects of Drugs