Status:
COMPLETED
Trial in Patients With Relapsed Ovarian Cancer
Lead Sponsor:
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Collaborating Sponsors:
Gynecologic Cancer Intergroup (GCIG)
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 car...
Eligibility Criteria
Inclusion
- 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
- Platinum-resistant disease: defined as disease progression \< 6 months following the last administered dose of platinum-based therapy.
- OR
- Platinum-refractory disease: defined as lack of response or disease progression while receiving the most recent therapy.
- Other key inclusion criteria:
- Histological confirmed ovarian, fallopian tube or peritoneal cancers.
- Histological types: high-grade serious, high-grade endometriod, undifferentiated, carcinosarcoma or mixed histology.
- Subjects must have at least 1 measurable lesion as defined by RECIST guidelines. This should not be the same lesion used for biopsy.
- 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.
- Patient agrees to undergo all analysis (blood, serum, tissue); radiological examinations according to protocol.
- Mandatory tumour biopsy before treatment (before day 0) and at day 56 of treatment.
- Patients must give informed consent.
- Patients must be at least 18 years of age.
- ECOG performance status 0-1
- Serum albumin \>30g/l.
- Adequate organ function
- Life expectancy of at least 12 weeks.
- Patients must be fit to receive Investigational medical products (IMPs)
Exclusion
- Subjects using immunosuppressive medications within 14 days.
- Immunodeficiency or organ transplant
- Live vaccines within 28 days prior to the first dose.
- Major surgery within 28 days prior to the first dose.
- Ovarian sarcomas, small cell carcinoma with neuroendocrine differentiation, non-epithelial can-cers.
- Cancer therapies (chemotherapy, radiotherapy, surgery, immunotherapy, biologic or hormonal therapy) within 28 days prior to the first dose.
- Concurrent treatment with an investigational agent or participation in another clinical trial.
- 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.
- Active infection including tuberculosis
- History of a cerebral vascular accident, transient ischemic attack or subarachnoid hemorrhage within the past 6 months.
- History of clinically significant hemorrhage in the past 3 months.
- 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.
- Significant cardiovascular disease's.
- Persistance of clinically relevant therapy related toxicity from previous anticancer therapy (any grade 3-4 toxicity or grade ≥2 neuropathy).
- Known hypersensitivity to the trial drugs, or to their excipients.
- Has had prior exposure to IMPs, or any other immunotherapy.
- Active or prior documented autoimmune or inflammatory disorders
- 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
Key Trial Info
Start Date :
May 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 19 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03267589
Start Date
May 14 2018
End Date
October 19 2021
Last Update
July 29 2025
Active Locations (5)
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1
Rigshospitalet
København Ø, Region Sjælland, Denmark, 2100
2
VejleSygehus
Vejle, Region Syddanmark, Denmark, 7100
3
Tampere University Hospital
Tampere, Finland
4
Haukeland University Hospital
Bergen, Haukeland, Norway, 5021