Trial in Patients With Relapsed Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

NSGO-OV-UMB1; ENGOT-OV30 / NSGO: A Phase II Umbrella Trial in Patients With Relapsed Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03267589
• Other study ID #: ENGOT-OV30 / NSGO
• Status: Completed
• Phase: Phase 2
• Start date: May 14, 2018
• Est. completion date: October 19, 2021

Study information

• Verified date: September 2023
• Source: Nordic Society of Gynaecological Oncology - Clinical Trials Unit
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 19, 2021
• Est. primary completion date: October 19, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562
Three different combination are being tested. Each cohort has different combination

Locations

Country	Name	City	State
Denmark	Rigshospitalet	København Ø	Sjaelland
Denmark	VejleSygehus	Vejle	Region Syddanmark
Finland	Tampere University Hospital	Tampere
Norway	Haukeland University Hospital	Bergen	Haukeland
Norway	The Norwegian Radium Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Nordic Society of Gynaecological Oncology - Clinical Trials Unit	European Network of Gynaecological Oncological Trial Groups (ENGOT), Gynecologic Cancer Intergroup (GCIG)

Countries where clinical trial is conducted

Denmark,  Finland,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease control rate (DCR)	Disease control rate (DCR) (CR+PR+SD)	16 weeks
Secondary	Progression-Free Survival (PFS) by RECIST v1.1	PFS by RECIST v1.1	10 months
Secondary	PFS by Immune-RECIST	PFS by Immune-RECIST	10 months
Secondary	Overall survival (OS)	Overall survival (OS)	36 months
Secondary	Objective response rate	Objective response rate according to RECIST v1.1 (ORR)	10 months
Secondary	Duration of (Overall) Response (DoR)	Duration of (Overall) Response (DoR)	10 months