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Ovarian CancerPhase 2DOVACCNCT04742075

Olaparib, Durvalumab and UV1 in Relapsed Ovarian Cancer

A Phase 2 study testing Olaparib + durvalumab + UV1 in people with Ovarian Cancer, run by Nordic Society of Gynaecological Oncology - Clinical Trials Unit at 1 site in Denmark.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This prospective, multicenter, open-label, randomized phase II maintenance study is evaluating the efficacy of UV1-olaparib-durvalumab combination as maintenance therapy after platinum combination therapy for BRCAwt patients with relapsed ovarian cancer. 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?
Olaparib + durvalumab + UV1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
1 siteDenmark
Study dates
15 Dec 2021to 31 Dec 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. The consent must be signed before the time of inclusion.
  • Histologically diagnosed with epithelial ovarian, fallopian tube or primary peritoneal cancer, excluding mucinous or low-grade serous histology.
  • Radiological or histological confirmation of relapse disease ≥ 6 months after penultimate chemotherapy.
  • Patients who are non-gBRCAmut or tBRCAwt.
  • Have completed at least two lines, but no more than 3 lines, of chemotherapy, which means that patients at first or second relapse with treatment free interval of more than 6 months on penultimate chemotherapy are eligible. See Figure 3.
  • Patients must have completed at least 4 cycles of the latest platinum-containing chemotherapy.
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  • Be either:
  • PARPi naive.
  • Earlier treated with PARPi and not progressed during 6 months of PARPi therapy.
  • Must not, in the opinion of the investigator, have progressed on, or after, latest platinumcontaining chemotherapy. This means that patients with CR, PR, SD or no evidence of disease are eligible. It should be documented on the post-treatment scan following completion of the last chemotherapy course.
  • Patient consents to HRD test (Acceptable HRD tests: Myriad myChoice® CDx, Leuven HRD test, NOGGO GISv1, and TSO 500 HRD).
  • Must be randomized in the study within 10 weeks of completion of the final dose of platinum-containing chemotherapy.
  • Age ≥18 years.
  • Body weight > 30 kg.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Appendix 3)
  • Must have a life expectancy ≥ 16 weeks.
  • Must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
  • Haemoglobin ≥ 10.0 g/dL (6,2 mmol/L) with no blood transfusion in the past 28 days.
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
  • Platelet count ≥ 100 x 109/L.
  • Total bilirubin ≤ 1.5 x institutional ULN.
  • Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case, they must be ≤ 5x ULN.
  • Must have creatinine clearance estimated of ≥ 51 ml/min using the Cockcroft-Gault equation or based on a urine test: o Estimated creatinine clearance = [[140 - age(yr)] x weight(kg)] / [72 x serum Cr (mg/dL)] (multiply by 0.85 for women).
  • Ability to swallow oral medications (tablets) without chewing, breaking, crushing, opening, or otherwise altering the product formulation.
  • Post-menopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1.
  • Post-menopausal is defined as:
  • Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments.
  • Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the postmenopausal range for women under 50.
  • radiation-induced oophorectomy with last menses > 1 year ago.
  • chemotherapy-induced menopause with > 1 year interval since last menses.
  • surgical sterilisation (bilateral oophorectomy or hysterectomy).

Who cannot join

  • Previous use of immune checkpoint inhibitors.
  • In case the patient has participated in an immune checkpoint inhibitor blinded study, the patient may be enrolled without unblinding.
  • Other malignancy unless curatively treated with no evidence of disease for ≥ 5 years except adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma.
  • Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation ≥ 470 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.
  • Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML.
  • Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study if these were started at least 4 weeks prior to treatment.
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  • Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
  • Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection. Examples include but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan.
  • Concomitant treatment with bevacizumab within the last 3 weeks.
  • Concomitant therapy with any other anticancer therapy or chronic use of systemic corticosteroids of more than 10mg prednisolone daily.
  • Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting study treatment is 2 weeks.
  • Concomitant use of known strong CYP3A inducers (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil). The required washout period prior to starting study treatment is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
  • Previous allogeneic bone marrow transplant or double umbilical cord blood transplantation.
  • Major surgery or significant traumatic injury within 28 days of randomization.
  • Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV), patients with active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C.
  • Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti- HBc] antibody test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
  • Pregnancy, lactation, or intention to become pregnant during the study or/and within 1 month after the last dose of olaparib. If the patient can become pregnant, the patient must be on acceptable birth control listed in Appendix 5.
  • Participation in a clinical study within 28 days or 5 half-lives of the drug, whichever is longest.
  • Patients unable to swallow orally administered medication and/or patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
  • Patients with a history of allergy or hypersensitivity to any of the study drugs (including human granulocyte-macrophage colony stimulating factor), yeast-derived products or any constituent of the products.
  • Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy except for alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
  • Patients with Grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the Sponsor.
  • Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Lead Clinician.
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
  • Patients with vitiligo or alopecia.
  • Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.
  • Any chronic skin condition that does not require systemic therapy.
  • Patients without active disease in the last 5 years may be included but only after consultation with the Sponsor.
  • Patients with celiac disease controlled by diet alone.
  • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
  • Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart). A single ECG ≥ 470 ms is sufficient.
  • History of active primary immunodeficiency.
  • Active infection including tuberculosis (TB) (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice).
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of IMP. Note:
  • Patients, if enrolled, should not receive live vaccine whilst receiving IMP and up to 30 days after the last dose of IMP.
  • Has active infection with SARS-CoV-2 (antigen test).
  • Patients unable to be regularly followed for any reason (geographic, familiar, social, psychologic, housed in an institution e.g., prison because of a court agreement or administrative order according § 40 Abs. 1 S. 3 Nr. 4 AMG.).
  • Patients that are depending on the sponsor/CRO or investigational site as well as on the investigator.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Rigshospitalet

    København Ø, Region Sjælland, 2100

Other trials in Denmark

About this study

Official title: A Randomized Clinical Trial Investigating Olaparib, Durvalumab (MEDI4736) and UV1 as Maintenance Therapy in BRCAwt Patients With Recurrent Ovarian Cancer

This prospective, multicenter, open-label, randomized phase II maintenance study is evaluating the efficacy of UV1-olaparib-durvalumab combination as maintenance therapy after platinum combination therapy for BRCAwt patients with relapsed ovarian cancer.

Read the detailed description

STUDY DESIGN This prospective, multicenter, open-label, randomized phase II maintenance study is evaluating the efficacy of UV1-olaparib-durvalumab combination as maintenance therapy after platinum combination therapy for BRCAwt patients with relapsed ovarian cancer.

Number of total subjects to be included in the trial:

184 patients will be enrolled in the study.

Patients are randomized into one of the three treatment arms, (A:B:C), in a 1:1:2 randomization:

  • Arm A (olaparib): 46 subjects
  • Arm B (olaparib plus durvalumab): 46 subjects
  • Arm C (olaparib plus durvalumab plus UV1): 92 subjects

Patients are stratified according to:

  • HRD status
  • Previous use of PARP inhibitor (yes/no)

Primary objective:

  • To compare the preliminary efficacy of maintenance treatment with olaparib (arm A) to that of olaparib plus durvalumab and UV1 (arm C)

Secondary objectives:

  • To compare the preliminary efficacy of maintenance treatment with olaparib plus durvalumab (arm B) to that of olaparib plus durvalumab and UV1 (arm C)
  • To compare the preliminary efficacy of maintenance treatment with olaparib plus durvalumab to that of olaparib plus durvalumab and UV1 according to stratification factors
  • To evaluate Patient Reported Outcomes (PROs) in treatment arms
  • To compare the preliminary efficacy of maintenance treatment according to PD-L1 status
  • To evaluate safety in treatment arms

Exploratory objectives:

  • To describe genetic, molecular, and immunological mechanisms in blood and tumor of maintenance treatment.
  • To explore the efficacy of maintenance treatment in the molecular subgroups based on homologous recombination deficiency (HRD) status.
Conditions
Ovarian Cancer
Being tested
Olaparib + durvalumab + UV1
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Olaparib + durvalumab + UV1Drug

    Also called Olaparib + durvalumab, Olaparib (active comparator)

    The subjects are randomized 1:1:2 to receive treatment until progression of disease or untorable toxicity.

Study groups in NCT04742075
Study groupRoleWhat they receive
(A) OlaparibActive comparatorOlaparib 300 mg tablets twice daily until progressive disease or unacceptable toxicity.
Receives: Drug: Olaparib + durvalumab + UV1
(B) Olaparib + durvalumabExperimentalOlaparib 300 mg tablets twice daily until progressive disease or unacceptable toxicity. Durvalumab 1500 mg IV every 4 weeks for 24 months or until disease progression or unacceptable toxicity.
Receives: Drug: Olaparib + durvalumab + UV1
(C) Olaparib + durvalumab + UV1ExperimentalOlaparib 300 mg tablets twice daily until disease progression or unacceptable toxicity. Durvalumab 1500 mg IV every 4 weeks for 24 months or until disease progression or unacceptable toxicity. Eight UV1 vaccinations during the first 5 month: Four UV1 vaccinations 300 μg (+ 75 μg of sargramostim) during the first 10 days with a minimum of 2 days apart. From cycle 2-5 subjects will receive one UV1 (+ sargramostim) vaccination every 4th week.
Receives: Drug: Olaparib + durvalumab + UV1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    PFS is compared between arm A versus C

    Measured: 72 months

Secondary outcomes (5)

  1. PFS

    PFS is compared between arm B versus C

    Measured: 72 months

  2. PFS assessed by blinded independent central review (BICR)

    PFS is compared in each arm

    Measured: 72 months

  3. Overall survival (OS)

    OS is compared in each arm

    Measured: 72 months

  4. Patient reported outcomes (PROs) - QLQ-OV28

    Quality of life measured by EORTC QLQ - OV28;These are the validated questionnaires to be answered by patients. Results to be reported as descriptive and on a scale of 1-10

    Measured: 72 months

  5. Patient reported outcomes (PROs) - QLQ-C30

    Quality of life measured by EORTC QLQ - C30;These are the validated questionnaires to be answered by patients. Results to be reported as descriptive and on a scale of 1-10

    Measured: 72 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2021
  2. Study start15 Dec 2021
  3. Primary completion1 May 2026 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Open-label randomized phase 2 trial
Masking
None (open label)
Enrolment
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04742075
Sponsor's protocol ID
ENGOT-OV56/NSGO-CTU-DOVACC
Acronym
DOVACC
Status last verified
Feb 2026
First submitted
9 Oct 2020
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Can be requested

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Olaparib + durvalumab + UV1 in people with Ovarian Cancer, run by Nordic Society of Gynaecological Oncology - Clinical Trials Unit at 1 site in Denmark.

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 31 inclusion and 38 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: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. 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?

This study is still under way. Results are not available in the source record yet.

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?

Progression-free survival (PFS) (time frame: 72 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04742075.

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 27 Feb 2026.

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