Ovarian CancerPhase 2NCT03267589
Trial in Patients With Relapsed Ovarian Cancer
A Phase 2 study testing Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562 in people with Ovarian Cancer, run by Nordic Society of Gynaecological Oncology - Clinical Trials Unit at 5 sites in 3 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 14 May 2018to 19 Oct 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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.
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- 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
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Denmark2 sites
Rigshospitalet
København Ø, Region Sjælland, 2100
VejleSygehus
Vejle, Region Syddanmark, 7100
Norway2 sites
Haukeland University Hospital
Bergen, Haukeland, 5021
The Norwegian Radium Hospital
Oslo, 0310
About this study
Official title: 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).
- Conditions
- Ovarian Cancer
- Being tested
- Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562
- Keywords
- immunotherapy, ovarian cancer, durvalumab, tremelilumab, MEDI 9447, MEDI 0562
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562Drug
Three different combination are being tested. Each cohort has different combination
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Intervention: MEDI9447 (CD73) + durvalumab Receives: Drug: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562 |
| Cohort B | Experimental | Intervention: MEDI0562 (OX40) + durvalumab Receives: Drug: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562 |
| Cohort C | Experimental | Intervention: MEDI0562 (OX40) + tremelimumab combination Receives: Drug: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate (DCR)
Disease control rate (DCR) (CR+PR+SD)
Measured: 16 weeks
Secondary outcomes (5)
Progression-Free Survival (PFS) by RECIST v1.1
PFS by RECIST v1.1
Measured: 10 months
PFS by Immune-RECIST
PFS by Immune-RECIST
Measured: 10 months
Overall survival (OS)
Overall survival (OS)
Measured: 36 months
Objective response rate
Objective response rate according to RECIST v1.1 (ORR)
Measured: 10 months
Duration of (Overall) Response (DoR)
Duration of (Overall) Response (DoR)
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start14 May 2018
- Primary completion19 Oct 2021
- Study completion19 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Part 1: single cohorts of novel agents Part 2: randomized phase 2 against standard of care.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Society of Gynaecological Oncology - Clinical Trials Unit
- Sponsor type
- University, hospital or other
- Collaborators
- Gynecologic Cancer Intergroup (GCIG), European Network of Gynaecological Oncological Trial Groups (ENGOT)
- Responsible party
- Sponsor
- Investigators
- Mansoor R Mirza, MD, Study director, NSGO-CTU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267589
- Sponsor's protocol ID
- ENGOT-OV30 / NSGO
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2017
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NSGO-OV-UMB1; ENGOT-OV30 / NSGO: A Phase II Umbrella Trial in Patients With Relapsed Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03267589
- Acronym / sponsor ID
- ENGOT-OV30 / NSGO
- Conditions
- Ovarian Cancer
- Keywords
- immunotherapy, ovarian cancer, durvalumab, tremelilumab, MEDI 9447, MEDI 0562
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Nordic Society of Gynaecological Oncology - Clinical Trials UnitUniversity, hospital or other
- Collaborators
- Gynecologic Cancer Intergroup (GCIG), European Network of Gynaecological Oncological Trial Groups (ENGOT)
- Study start
- 14 May 2018 (actual)
- Primary completion
- 19 Oct 2021 (actual)
- Study completion
- 19 Oct 2021 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Part 1: single cohorts of novel agents Part 2: randomized phase 2 against standard of care.
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562Intervention: MEDI9447 (CD73) + durvalumab |
| Cohort B | Experimental | Drug: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562Intervention: MEDI0562 (OX40) + durvalumab |
| Cohort C | Experimental | Drug: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562Intervention: MEDI0562 (OX40) + tremelimumab combination |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
- Histological confirmed ovarian, fallopian tube or peritoneal cancers.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562Three different combination are being tested. Each cohort has different combination | Drug | Cohort A, Cohort B, Cohort C |
Primary outcome
Disease control rate (DCR)
Time frame: 16 weeks
Disease control rate (DCR) (CR+PR+SD)
5 secondary outcomes
Progression-Free Survival (PFS) by RECIST v1.1
Time frame: 10 months
PFS by Immune-RECIST
Time frame: 10 months
Overall survival (OS)
Time frame: 36 months
Objective response rate
Time frame: 10 months
Duration of (Overall) Response (DoR)
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: Yes. Upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mansoor R Mirza, MD study director
NSGO-CTU
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562 in people with Ovarian Cancer, run by Nordic Society of Gynaecological Oncology - Clinical Trials Unit at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark, Norway, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control rate (DCR) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.