Trial in Patients With Relapsed Ovarian Cancer

NCT ID: NCT03267589

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-14
• Study Completion Date: 2021-10-19

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).

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A

Intervention: MEDI9447 (CD73) + durvalumab

Group Type: EXPERIMENTAL

Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562

Intervention Type: DRUG

Three different combination are being tested. Each cohort has different combination

Cohort B

Intervention: MEDI0562 (OX40) + durvalumab

Group Type: EXPERIMENTAL

Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562

Intervention Type: DRUG

Three different combination are being tested. Each cohort has different combination

Cohort C

Intervention: MEDI0562 (OX40) + tremelimumab combination

Group Type: EXPERIMENTAL

Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562

Intervention Type: DRUG

Three different combination are being tested. Each cohort has different combination

Interventions

Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562

Three different combination are being tested. Each cohort has different combination

Intervention Type: DRUG

Eligibility 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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gynecologic Cancer Intergroup (GCIG)

OTHER

Sponsor Role: collaborator

European Network of Gynaecological Oncological Trial Groups (ENGOT)

OTHER

Sponsor Role: collaborator

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mansoor R Mirza, MD

Role: STUDY_DIRECTOR

NSGO-CTU

Locations

Rigshospitalet

København Ø, Region Sjælland, Denmark

VejleSygehus

Vejle, Region Syddanmark, Denmark

Tampere University Hospital

Tampere, , Finland

Haukeland University Hospital

Bergen, Haukeland, Norway

The Norwegian Radium Hospital

Oslo, , Norway

Countries

Denmark; Finland; Norway

Other Identifiers

ENGOT-OV30 / NSGO

Identifier Type: -

Identifier Source: org_study_id