Trial in Patients With Relapsed Ovarian Cancer

September 7, 2023 updated by: Nordic Society of Gynaecological Oncology - Clinical Trials Unit

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Syddanmark
      • Vejle, Region Syddanmark, Denmark, 7100
        • VejleSygehus
    • Sjaelland
      • København Ø, Sjaelland, Denmark, 2100
        • Rigshospitalet
  • Finland
      • Tampere, Finland
        • Tampere university Hospital
  • Norway
      • Oslo, Norway, 0310
        • The Norwegian Radium Hospital
    • Haukeland
      • Bergen, Haukeland, Norway, 5021
        • Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Collaborators

European Network of Gynaecological Oncological Trial Groups (ENGOT)
Gynecologic Cancer Intergroup (GCIG)

Investigators

  • Study Director: Mansoor R Mirza, MD, NSGO-CTU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2018

Primary Completion (Actual)

October 19, 2021

Study Completion (Actual)

October 19, 2021

Study Registration Dates

First Submitted

July 5, 2017

First Submitted That Met QC Criteria

August 29, 2017

First Posted (Actual)

August 30, 2017

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENGOT-OV30 / NSGO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon request.

IPD Sharing Time Frame

From December 2023.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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