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Ovarian CancerPhase 3MONO-OLA1NCT04884360

D9319C00001- 1L OC Mono Global RCT

A Phase 3 study testing Olaparib in people with Ovarian Cancer, run by AstraZeneca at 89 sites in 10 countries.

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 is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of maintenance olaparib compared with placebo in BRCAwt participants with Stage III to IV high grade serous or endometroid ovarian cancer (including fallopian tube cancer or primary… 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
366 participants
Where
89 sitesin 10 countries
Study dates
31 May 2021to 27 Jul 2027
Phase
Phase 3
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

  • Participants must be ≥18 years at the time of (pre-)screening
  • Histological and staging criteria:Female participants who must have histologically newly diagnosed high-grade serous or high-grade endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that is Stage III or IV according to the International FIGO 2014.
  • Participants are eligible if they fulfil any of the following surgical criteria:
  • Stage III: primary debulking surgery with macroscopic residual disease post-surgery, neoadjuvant chemotherapy, or inoperable.
  • Stage IV: primary debulking surgery regardless of residual disease, neoadjuvant chemotherapy, or inoperable.
  • Chemotherapy criteria:
Show all 17Show fewer
  • Participants must have received platinum-based chemotherapy consisting of a minimum of 6 treatment cycles and a maximum of 9, however, if platinum-based therapy must be discontinued early as a result of toxicities specifically related to the platinum regimen, participants must have received a minimum of 4 cycles of the platinum regimen.
  • Participants must have, in the opinion of the investigator, clinical CR or PR as per RECIST 1.1 criteria with no measurable lesion > 2 cm on the post-treatment scan and have no clinical evidence of disease progression or a rising CA-125 level (see inclusion criterion 5), following completion of this chemotherapy course.
  • A participant who received interval debulking surgery must have had ≥ 2 postoperative cycles of platinum-based therapy.
  • Participants must meet one of the criteria specified below for pre-treatment CA-125 measurements as follows:
  • CA-125 in the normal range or
  • CA-125 decrease by ≥ 90% during their front-line therapy that is stable for at least 7 days (ie, no increase > 15% from nadir). During screening, if the first CA-125 value is greater than the upper limit of normal (ULN), a second assessment must be performed at least 7 days after the first. If the second assessment is > 15% more than the first value, the participant is not eligible).
  • Participants should not have received bevacizumab with first-line chemotherapy or be planned to receive bevacizumab maintenance therapy.
  • Participants must be randomised within a maximum of 12 weeks from the last day of chemotherapy infusion (but no earlier than 3 weeks).
  • 8. ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to randomisation.
  • 9, Provision, at pre-screening, of a formalin-fixed, paraffin-embedded (FFPE) tumour sample to assess tBRCA status and for HRD testing centrally. The centrally performed tBRCA test results must be available prior to randomisation and must indicate that the participant has a BRCAwt tumour, defined by the absence of a deleterious or suspected deleterious BRCA mutation by central testing.
  • 10, Adequate organ and marrow function.

Who cannot join

  • 1, Participants with stable disease or progressive disease on the post-treatment scan or clinical evidence of progression at the end of the participant's first-line chemotherapy treatment, or any evidence of progressive disease prior to randomization.
  • 2, Participant has mucinous or clear cell subtypes of epithelial ovarian cancer, carcinosarcoma, undifferentiated ovarian cancer, non-epithelial ovarian cancer, borderline tumours or low grade epithelial ovarian tumours (applies to fallopian tube and primary peritoneal tumours where applicable).
  • 3, Participants with Stage III disease who have had complete cytoreduction (ie, no macroscopic residual disease) at their primary debulking surgery.
  • 4, Participants who have undergone ˃ 2 debulking (cytoreductive) surgeries.
  • 5, History of another primary malignancy except for: malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention and of low potential risk for recurrence; Adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), and Stage 1, Grade 1 endometrial carcinoma. Participants with a history of localised triple negative breast cancer, provided they completed their adjuvant chemotherapy more than three years prior to registration, and that the participant remains free of recurrent or metastatic disease.
  • 6, Persistent toxicities (CTCAE Grade ≥2) caused by previous anticancer therapy, excluding alopecia and CTCAE Grade 2 peripheral neuropathy. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included after consultation with the AstraZeneca study physician.
Show all 10Show fewer
  • 7, Participant is immunocompromised
  • 8, Prior exposure to a PARP inhibitor, including olaparib
  • 9, Any concurrent anticancer treatment
  • 10, Currently pregnant or breast-feeding

Trial locations and contacts

89 sites in 10 countries.

89 sites in 10 countries

China41 sites

  • Research Site

    Baoji, 721008

  • Research Site

    Beijing, 100034

  • Research Site

    Beijing, 100142

  • Research Site

    Changchun, 130021

  • Research Site

    Changsha, 410013

  • Research Site

    Chengdu, 610041

  • Research Site

    Chengdu, 610072

  • Research Site

    Chongqing, 400038

  • Research Site

    Chongqing, 400042

  • Research Site

    Guangzhou, 510095

  • Research Site

    Guangzhou, 510120

  • Research Site

    Guiyang, 550004

  • Research Site

    Haikou, 570311

  • Research Site

    Hangzhou, 310022

  • Research Site

    Hefei, 230001

  • Research Site

    Hefei, 230601

  • Research Site

    Jiaxing, 314001

  • Research Site

    Jining, 272029

  • Research Site

    Lanzhou, 730030

  • Research Site

    Linyi, 276000

  • Research Site

    Nanjing, 210009

  • Research Site

    Qingdao, 266034

  • Research Site

    Rui’an, 325200

  • Research Site

    Shanghai, 200011

  • Research Site

    Shanghai, 200032

  • Research Site

    Shenyang, 110042

  • Research Site

    Suzhou, 215004

  • Research Site

    Tianjin, 300050

  • Research Site

    Tianjin, 300060

  • Research Site

    Ürümqi, 830000

  • Research Site

    Ürümqi, 830054

  • Research Site

    Wenzhou, 325027

  • Research Site

    Wenzhou, CN-325000

  • Research Site

    Wuhan, 430000

  • Research Site

    Wuhan, 430022

  • Research Site

    Wuxi, 214062

  • Research Site

    Xuzhou, 221000

  • Research Site

    Xuzhou, 221009

  • Research Site

    Yanji, 133000

  • Research Site

    Zibo, 255200

  • Research Site

    Zunyi, 563100

Other trials in China

India8 sites

  • Research Site

    Gūrgaon, 122001

  • Research Site

    Jaipur, 302017

  • Research Site

    Kolkata, 700160

  • Research Site

    Madurai, 625107

  • Research Site

    Namakkal, 637001

  • Research Site

    Nashik, 422002

  • Research Site

    New Delhi, 110085

  • Research Site

    New Delhi, 11029

Other trials in India

Russia8 sites

  • Research Site

    Arkhangelsk, 163045

  • Research Site

    Chelyabinsk, 454087

  • Research Site

    Moscow, 115478

  • Research Site

    Moscow, 117997

  • Research Site

    Saint Petersburg, 197758

  • Research Site

    Saint Petersburg, 198255

  • Research Site

    Tomsk, 634028

  • Research Site

    Yekaterinburg, 620905

Other trials in Russia

Ukraine8 sites

  • Research Site

    Chernihiv, 14029

  • Research Site

    Dnipro, 49102

  • Research Site

    Ivano-Frankivsk, 76018

  • Research Site

    Kharkiv, 61103

  • Research Site

    Kryvyi Rih, 50048

  • Research Site

    Kyiv, 03022

  • Research Site

    Kyiv, 04050

  • Research Site

    Zaporizhzhya

Other trials in Ukraine

Turkey (Türkiye)6 sites

  • Research Site

    Adana, 01120

  • Research Site

    Ankara, 06100

  • Research Site

    Ankara, 06800

  • Research Site

    Cordaleo, 35575

  • Research Site

    Istanbul, 34010

  • Research Site

    Samsun, 55139

Other trials in Turkey (Türkiye)

Chile5 sites

  • Research Site

    Santiago, 8241479

  • Research Site

    Santiago, 8420383

  • Research Site

    Temuco, 4800827

  • Research Site

    Temuco, 4810218

  • Research Site

    Viña del Mar, 2540488

Other trials in Chile

Peru5 sites

  • Research Site

    Arequipa, AREQUIPA01

  • Research Site

    Lima, 15036

  • Research Site

    Lima, LIMA 29

  • Research Site

    Lima, LIMA 34

  • Research Site

    San Isidro, 27

Other trials in Peru

Vietnam4 sites

  • Research Site

    Hà Nội, 100000

  • Research Site

    Hanoi, 100000

  • Research Site

    Ho Chi Minh City, 700000

  • Research Site

    Ho Chi Minh City

Other trials in Vietnam

Colombia3 sites

  • Research Site

    Bogotá, 110221

  • Research Site

    Bogotá

  • Research Site

    Medellín, 50030

Other trials in Colombia

South Africa1 site

  • Research Site

    Port Elizabeth, 6045

Other trials in South Africa

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Phase III Study of Olaparib Maintenance Monotherapy in Participants With BRCA Wild Type Advanced High Grade Serous or Endometrioid Ovarian Cancer Following Response to Standard First-line Platinum-based Chemotherapy (MONO-OLA1)

This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of maintenance olaparib compared with placebo in BRCAwt participants with Stage III to IV high grade serous or endometroid ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who are in complete or partial response following treatment with standard first-line platinum-based chemotherapy.

Conditions
Ovarian Cancer
Being tested
Olaparib, Matching placebo
Keywords
BRCA Wild Type;, Double-blind;, Randomized;, Placebo-controlled;
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • OlaparibDrug

    Olaparib tablets 300 mg oral twice daily

  • Matching placeboOther

    Matching placebo tablets taken orally at a dose of 300 mg twice daily

Study groups in NCT04884360
Study groupRoleWhat they receive
Group A: Olaparib tablets 300 mg oral twice daily (n=238).ExperimentalParticipants in Group A will receive olaparib tablets taken orally at a dose of 300 mg twice daily for up to 2 years or until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator, whichever is earlier, and as long as in the investigator's opinion they are benefiting from treatment and do not meet any other discontinuation criteria.
Receives: Drug: Olaparib
Group B: Placebo tablets 300 mg oral twice daily (n=118)Placebo comparatorParticipants in Group B will receive matching placebo tablets taken orally at a dose of 300 mg twice daily for up to 2 years or until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator, whichever is earlier, and as long as in the investigator's opinion they are benefiting from treatment and do not meet any other discontinuation criteria.
Receives: Other: Matching placebo

What is being measured

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

  1. Superiority of olaparib as maintenance treatment relative to placebo by assessment of PFS in participants with Stage III/IV ovarian cancer with a BRCAwt HRD positive tumour and a CR/PR following standard 1st line platinum based chemotherapy treatment.

    PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by the investigator at the local site, or death due to any cause.

    Measured: Approximately 3 years

  2. Superiority of olaparib as maintenance treatment relative to placebo by assessment of PFS in participants with Stage III/IV ovarian cancer with a BRCAwt tumour and a CR/PR following standard 1st line platinum-based chemotherapy treatment.

    PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by the investigator at the local site, or death due to any cause.

    Measured: Approximately 3 years

Secondary outcomes (14)

  1. Superiority of olaparib as maintenance treatment relative to placebo by assessment of OS in participants with Stage III/IV ovarian cancer with a BRCAwt HRD positive tumour and a CR/PR following standard first line platinum based chemotherapy treatment.

    OS is defined as time from randomisation until the date of death due to any cause.

    Measured: Approximately 4 years

  2. Superiority of olaparib as maintenance treatment relative to placebo by assessment of OS in participants with Stage III/IV ovarian cancer with a BRCAwt tumour and a CR/PR following standard first-line platinum-based chemotherapy treatment.

    OS is defined as time from randomisation until the date of death due to any cause.

    Measured: Approximately 4 years

  3. Superiority of olaparib as maintenance treatment relative to placebo by assessment of TFST in participants with a BRCAwt HRD positive tumour and a CR or PR following standard first-line platinum-based chemotherapy treatment.

    TFST is defined as time from randomisation until the start date of the first subsequent anti-cancer therapy after discontinuation of randomised treatment, or death due to any cause.

    Measured: Approximately 4 years

  4. Superiority of olaparib as maintenance treatment relative to placebo by assessment of TFST in participants with a BRCAwt tumour and a CR or PR following standard first line platinum based chemotherapy treatment.

    TFST is defined as time from randomisation until the start date of the first subsequent anti-cancer therapy after discontinuation of randomised treatment, or death due to any cause.

    Measured: Approximately 4 years

  5. Superiority of olaparib as maintenance treatment relative to placebo by assessment of PFS2 in participants with a BRCAwt HRD positive tumour and a CR or PR following standard first-line platinum based chemotherapy treatment.

    PFS2 is defined as the time from the randomisation to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy or death.

    Measured: Approximately 4 years

  6. Superiority of olaparib as maintenance treatment relative to placebo by assessment of PFS2 in participants with a BRCAwt tumour and a CR or PR following standard first-line platinum based chemotherapy treatment.

    PFS2 is defined as the time from the randomisation to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy or death.

    Measured: Approximately 4 years

  7. Superiority of olaparib as maintenance treatment relative to placebo by assessment of TSST in participants with a BRCAwt HRD positive tumour and a CR or PR following standard first-line platinum based chemotherapy treatment.

    TSST is defined as time from randomisation until the start date of the second subsequent anti-cancer therapy after discontinuation of first subsequent treatment, or death due to any cause.

    Measured: Approximately 4 years

  8. Superiority of olaparib as maintenance treatment relative to placebo by assessment of TSST in participants with a BRCAwt tumour and a CR or PR following standard first-line platinum based chemotherapy treatment.

    TSST is defined as time from randomisation until the start date of the second subsequent anti-cancer therapy after discontinuation of first subsequent treatment, or death due to any cause.

    Measured: Approximately 4 years

  9. Superiority of olaparib as maintenance treatment relative to placebo by assessment of time to TDT in participants with a BRCAwt HRD positive tumour and a CR/PR following standard first-line platinum based chemotherapy treatment.

    TDT is defined as time from randomisation until discontinuation of treatment for any reason, including disease progression, toxicity and death.

    Measured: Approximately 3 years

  10. To demonstrate superiority of olaparib as maintenance treatment relative to placebo by assessment of time to TDT in participants with a BRCAwt tumour and a CR or PR following standard first-line platinum based chemotherapy treatment.

    TDT is defined as time from randomisation until discontinuation of treatment for any reason, including disease progression, toxicity and death.

    Measured: Approximately 3 years

  11. Superiority of olaparib as maintenance treatment relative to placebo by assessment of time to earliest progression by RECIST 1.1/CA 125/death in participants with a BRCAwt HRD positive tumour and a CR/PR following 1st line platinum based chemotherapy

    Time to earliest progression by RECIST 1.1/CA 125 or death will be measured from time of randomisation to the earlier date of RECIST 1.1/CA-125 progression or death by any cause.

    Measured: Approximately 3 years

  12. Superiority of olaparib as maintenance treatment relative to placebo by assessment of time to earliest progression by RECIST 1.1/CA 125/death in participants with a BRCAwt tumour and a CR/PR following first-line platinum based chemotherapy.

    Time to earliest progression by RECIST 1.1 or CA 125 or death will be measured from time of randomisation to the earlier date of RECIST 1.1 or CA-125 progression or death by any cause.

    Measured: Approximately 3 years

  13. Assess Health-related quality of life in participants treated with olaparib compared with placebo in participants with a BRCAwt HRD positive tumour and a CR or PR following standard first-line platinum based chemotherapy treatment

    Change from baseline in EORTC QLQ C30.

    Measured: Approximately 3 years

  14. Assess Health-related quality of life in participants treated with olaparib compared with placebo in participants with BRCAwt tumour and a CR or PR following standard first-line platinum based chemotherapy treatment

    Change from baseline in EORTC QLQ C30.

    Measured: Approximately 3 years

Timeline

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

  1. First posted13 May 2021
  2. Study start31 May 2021
  3. Primary completion27 Jul 2026 (estimated)
  4. Study completion27 Jul 2027 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
366 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04884360
Sponsor's protocol ID
D9319C00001
Other IDs
2020-005960-68
Acronym
MONO-OLA1
Status last verified
Feb 2026
First submitted
20 Apr 2021
Last updated
2 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Olaparib in people with Ovarian Cancer, run by AstraZeneca at 89 sites in 10 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 17 inclusion and 10 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 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in China, India, Russia, Ukraine, Turkey (Türkiye) and 5 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Superiority of olaparib as maintenance treatment relative to placebo by assessment of PFS in participants with Stage III/IV ovarian cancer with a BRCAwt HRD positive tumour and a CR/PR following standard 1st line platinum based chemotherapy treatment. (time frame: Approximately 3 years). The study lists 2 primary outcomes in all. 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 NCT04884360.

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 2 Mar 2026.

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