Clinical Trials /

Trial in Patients With Relapsed Ovarian Cancer

NCT03267589

Description:

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).

Related Conditions:
  • Fallopian Tube Carcinoma
  • Fallopian Tube Carcinosarcoma
  • Fallopian Tube Endometrioid Adenocarcinoma
  • Fallopian Tube Undifferentiated Carcinoma
  • High Grade Fallopian Tube Serous Adenocarcinoma
  • High Grade Ovarian Serous Adenocarcinoma
  • Malignant Ovarian Mixed Epithelial Tumor
  • Malignant Ovarian Neoplasm
  • Malignant Peritoneal Neoplasm
  • Ovarian Carcinoma
  • Ovarian Carcinosarcoma
  • Ovarian Endometrioid Tumor
  • Primary Peritoneal Carcinosarcoma
  • Primary Peritoneal Endometrioid Adenocarcinoma
  • Primary Peritoneal Serous Adenocarcinoma
  • Primary Peritoneal Undifferentiated Carcinoma
  • Undifferentiated Ovarian Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: ENGOT-OV30 / NSGO
  • NCT ID: NCT03267589

Conditions

  • Ovarian Cancer

Interventions

DrugSynonymsArms
Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562Cohort A

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Cohort AExperimentalIntervention: MEDI9447 (CD73) + durvalumab
  • Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562
Cohort BExperimentalIntervention: MEDI0562 (OX40) + durvalumab
  • Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562
Cohort CExperimentalIntervention: MEDI0562 (OX40) + tremelimumab combination
  • Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562

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.

             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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Disease control rate (DCR)
Time Frame:16 weeks
Safety Issue:
Description:Disease control rate (DCR) (CR+PR+SD)

Secondary Outcome Measures

Measure:Progression-Free Survival (PFS) by RECIST v1.1
Time Frame:10 months
Safety Issue:
Description:PFS by RECIST v1.1
Measure:PFS by Immune-RECIST
Time Frame:10 months
Safety Issue:
Description:PFS by Immune-RECIST
Measure:Overall survival (OS)
Time Frame:36 months
Safety Issue:
Description:Overall survival (OS)
Measure:Objective response rate
Time Frame:10 months
Safety Issue:
Description:Objective response rate according to RECIST v1.1 (ORR)
Measure:Duration of (Overall) Response (DoR)
Time Frame:10 months
Safety Issue:
Description:Duration of (Overall) Response (DoR)

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Nordic Society for Gynaecologic Oncology

Trial Keywords

  • immunotherapy
  • ovarian cancer
  • durvalumab
  • tremelilumab
  • MEDI 9447
  • MEDI 0562

Last Updated

October 30, 2019