ClinicalTrials.gg
CompletedNCT03267589Updated Jul 29, 2025

Trial in Patients With Relapsed Ovarian Cancer

A Phase 2 interventional study of Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562 in Ovarian Cancer, sponsored by Nordic Society of Gynaecological Oncology - Clinical Trials Unit. Completed at 5 sites in 3 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-29.

Sponsored by Nordic Society of Gynaecological Oncology - Clinical Trials Unit · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 103 studies in Ovarian Neoplasms with a site in Denmark — 16 open to participants now, 26 under way, 14 of them phase 3. Ovarian Neoplasms · Denmark.

Enrollment
72nd of 89
25 · median 223
Started
2018
with 5 others
Phase 2
21 of 103
3 open now
Registered
60th of 103
by date
Lead sponsor
7 of 103
Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Among the 103 studies in Ovarian Neoplasms with a site in Denmark, this one is the 72nd largest by enrollment of the 89 interventional ones that give a count, is one of 6 that started in 2018, is one of 21 in phase 2, and was the 60th registered.

Ovarian Neoplasms

3,385 studies on the registry are indexed under Ovarian Neoplasms; 792 are open to participants now.

Browse Ovarian Neoplasms studies →

Open to participants now

16 of the 103 studies in Ovarian Neoplasms with a site in Denmark are open now. Recruiting first, the newest first:

11 more — sign in →

All 16 open studies →

A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →

Who these studies take

Of the 605 Ovarian Neoplasms studies recruiting now, 442 (73%) set no upper age limit and 107 (18%) stop at 75 or younger; 39 take children under 18; 45 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 103 studies in Ovarian Neoplasms with a site in Denmark, or all of them as a file.
02

Study 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).

03

Conditions studied

  • Ovarian Cancer

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Keywords

  • immunotherapy
  • ovarian cancer
  • durvalumab
  • tremelilumab
  • MEDI 9447
  • MEDI 0562
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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- 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 as defined by guidelines. This should not be the same lesion used for .
  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 .
  11. Patients must be at least 18 years of age.
  12. performance status 0-1
  13. Serum albumin >30g/l.
  14. Adequate organ function
  15. of at least 12 weeks.
  16. Patients must be fit to receive medical products (IMPs)

Exclusion criteria

Exclusion Criteria:

  1. Subjects using medications within 14 days.
  2. Immunodeficiency or organ transplant
  3. 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 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, or subarachnoid hemorrhage within the past 6 months.
  11. History of hemorrhage in the past 3 months.
  12. Untreated CNS disease, or cord compression. Subjects with treated dis-ease should have at least 4 weeks of neurologic and radiographic stability and be off 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 to the trial drugs, or to their .
  16. Has had prior exposure to IMPs, or any other immunotherapy.
  17. Active or prior documented 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 is within the institutional range of normal. Use of local anti-coagulation for port maintenance is permitted
Terms in these criteria, in plain language(19)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Cohort A

    Intervention: MEDI9447 (CD73) + durvalumab

    Drug: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562

  • Experimental
    Cohort B

    Intervention: MEDI0562 (OX40) + durvalumab

    Drug: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562

  • Experimental
    Cohort C

    Intervention: MEDI0562 (OX40) + tremelimumab combination

    Drug: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562

Interventions

  • DrugDurvalumab, Tremelilumab, MEDI 9447, MEDI 0562

    Three different combination are being tested. Each cohort has different combination

This study also gives Durvalumab, Tremelimumab. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  1. Disease control rate (DCR)

    Disease control rate (DCR) (CR+PR+SD)

    Time frame: 16 weeks

Secondary outcomes

  1. Progression-Free Survival (PFS) by RECIST v1.1

    PFS by RECIST v1.1

    Time frame: 10 months

  2. PFS by Immune-RECIST

    PFS by Immune-RECIST

    Time frame: 10 months

  3. Overall survival (OS)

    Overall survival (OS)

    Time frame: 36 months

  4. Objective response rate

    Objective response rate according to RECIST v1.1 (ORR)

    Time frame: 10 months

  5. Duration of (Overall) Response (DoR)

    Duration of (Overall) Response (DoR)

    Time frame: 10 months

07

Study locations

5 sites
  • Rigshospitalet
    København Ø, Region Sjælland 2100, Denmark
  • VejleSygehus
    Vejle, Region Syddanmark 7100, Denmark
  • Tampere University Hospital
    Tampere, Finland
  • Haukeland University Hospital
    Bergen, Haukeland 5021, Norway
  • The Norwegian Radium Hospital
    Oslo, 0310, Norway
08

References and documents

Individual participant data

Plan to share: Yes — Upon request.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: From December 2023.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2018 to primary completion in Oct 2021, 41 months.

Of 228 non-industry phase 2 interventional studies under Ovarian Neoplasms, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 80. This study's 41 months is below that.

Counting every sponsor, half of 344 studies reached it within 47 months; a quarter within 33 and three quarters within 72.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 5, 2017
First posted
Aug 30, 2017
StartActual
May 14, 2018
Primary completionActual
Oct 19, 2021
CompletionActual
Oct 19, 2021
Last update
Jul 29, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03267589
Lead sponsor
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Collaborators
Gynecologic Cancer Intergroup (GCIG), European Network of Gynaecological Oncological Trial Groups (ENGOT)
Responsible party
Sponsor
First posted
Aug 30, 2017
Start date
May 14, 2018
Primary completion
Oct 19, 2021
Completion
Oct 19, 2021
Last update
Jul 29, 2025

Study contacts

Mansoor R Mirza, MD
study director · NSGO-CTU

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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