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Cervical CancerPhase 2NCT04641728

Pembrolizumab Plus Olaparib in Patients With Recurrent Cervical Cancer

A Phase 2 study testing Pembrolizumab and Olaparib in people with Cervical Cancer, run by Saitama Medical University International Medical Center at 1 site in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This trial is a multicenter, single-arm, phase 2 study of pembrolizumab in combination with olaparib in recurrent or metastatic cervical cancer patients who had disease progression during or after platinum-based chemotherapy. Read more about this study

Who is it for?
Ages 20 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Pembrolizumab and Olaparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteJapan
Study dates
1 Jan 2021to 31 Dec 2023
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 20 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants who are at least 20 years of age on the day of signing informed consent with histologically confirmed, recurrent or metastatic cervical cancer (squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma)
  • Participants with confirmed disease progression during or after platinum-based chemotherapy 1 or intolerant to or ineligible for platinum-based chemotherapy or ineligible participants
  • Participants with measurable disease based on RECIST 1.1 at screening
  • Participant is able to provide a core or excisional biopsy of a tumor lesion for testing of PD-L1 status, etc
  • Participants with Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1 upon the screening
  • Participants who may be expected to survive at least for 12 weeks after the first dose of study drug as determined by the principal investigator or a subinvestigator
  • Have adequate organ function

Who cannot join

  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
  • Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to the enrollment.
  • Has received prior radiotherapy within 2 weeks prior to the enrollment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
  • Has received a live vaccine within 28 days prior to the enrollment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the enrollment.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the enrollment.
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  • Has a second malignancy advanced or requiring treatment within the past 3 years.The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, in situ cancers (e.g. in situ breast carcinomas).
  • Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to the enrollment.
  • Has severe hypersensitivity (≥Grade 3) to the study drug and/or any of its excipients.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and participants can be enrolled in the trial.
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • Has an active infection requiring systemic therapy.
  • Has a known history of Human Immunodeficiency Virus (HIV) infection.
  • Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
  • Has a known history of active TB (Bacillus Tuberculosis).
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Participant has received colony-stimulating factors (eg, granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 2 weeks prior to the enrollment.
  • Participant with clinically serious cardiovascular/cerebrovascular diseases including the following: cerebrovascular accident/stroke (less than 6 month prior to enrollment), myocardial infarction (less than 6 month prior to enrollment), unstable angina, congestive heart failure (the New York Heart Association (NYHA) Functional Classification Class 2 or severer), or serious arrhythmia. In addition, participants with history of bleeding tendency or recent major bleeding event in whom study drug administration carries higher risks as determined by the principal investigator will be excluded.
  • Participant who have acute or chronic disease with severe and/or clinical symptoms which may compromise the tolerance to this study or competence to consistently follow the study procedures as determined by the principal investigator
  • Participants with medical history of receiving all the PARP inhibitors
  • Participant is currently receiving either strong (eg, itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued before the study drug initiation. The required washout period prior to starting olaparib is 2 weeks.
  • Participant is currently receiving either strong (eg, phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine, and St John's Wort) or moderate (eg. bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued before the study drug initiation. The required washout period prior to starting olaparib is 5 weeks for phenobarbital and 3 weeks for other agents.
  • Participant is either unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (eg, gastrectomy, partial bowel obstruction, malabsorption).
  • Participant has resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg, unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >500 ms, electrolyte disturbances, etc.), or participant has congenital long QT syndrome.
  • Has a major surgery history 4 weeks prior to the enrollment (e.g.: diagnostic biopsy is not regarded as the major surgery)
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the screening visit within 120 days after the last dose of trial treatment.
  • Participant, in the judgement of the investigator, is unlikely to comply with the study procedures, restrictions, and requirements of the study.
  • Participant has had an allogenic tissue/solid organ transplant

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Saitama Medical Uiversity International Medical Center

    Hidaka, Saitama, 3501298

Other trials in Japan

About this study

Official title: A Phase 2 Study of Pembrolizumab in Combination With Olaparib in Patients With Recurrent or Metastatic Cervical Cancer Who Had Disease Progression During or After Platinum-based Chemotherapy

This trial is a multicenter, single-arm, phase 2 study of pembrolizumab in combination with olaparib in recurrent or metastatic cervical cancer patients who had disease progression during or after platinum-based chemotherapy.

Read the detailed description

This trial is a multicenter, single-arm, phase 2 study of pembrolizumab in combination with olaparib in recurrent or metastatic cervical cancer patients who had disease progression during or after platinum-based chemotherapy.

This study is planned to enroll 28 patients eligible for participation from multiple study sites in Japan.

Conditions
Cervical Cancer
Being tested
Pembrolizumab, Olaparib
Keywords
cervical cancer, pembrolizumab, olaparib
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

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

  • PembrolizumabDrug

    Also called KEYTRUDA

    pembrolizumab 200 mg every three weeks (Q3W)

  • OlaparibDrug

    Also called LYNPARZA

    olaparib 300 mg twice daily (BID)

Study groups in NCT04641728
Study groupRoleWhat they receive
pembrolizumab plus olaparibExperimentalUntil RECIST-based confirmation of progressive disease (PD), death, manifestation of intolerable toxicity, or participant withdrawal from the study, study participants will continue intravenous infusion of pembrolizumab 200 mg every three weeks (Q3W) in combination with oral olaparib 300 mg twice daily (BID) (combination therapy)
Receives: Drug: Pembrolizumab; Drug: Olaparib

What is being measured

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

  1. Objective Response Rate

    Objective Response Rate (ORR) will be evaluated after pembrolizumab in combination with olaparib based on RECIST 1.1.

    Measured: 3 years

Secondary outcomes (10)

  1. Objective Response Rate on iRECIST

    To assess ORR after administration of pembrolizumab in combination with olaparib based on iRECIST.

    Measured: 3 years

  2. Duration of response

    To assess duration of response (DOR) after administration of pembrolizumab in combination with olaparib based on RECIST 1.1 and iRECIST.

    Measured: 3 years

  3. Durable response rate

    To assess durable response rate (DRR) after administration of pembrolizumab in combination with olaparib based on RECIST 1.1 and iRECIST

    Measured: 3 years

  4. Percentage of patients with response to administration of pembrolizumab in combination with olaparib for 6 months and longer

    To assess the percentage of patients with response to administration of pembrolizumab in combination with olaparib for 6 months and longer based on RECIST 1.1 and iRECIST

    Measured: 3 years

  5. PFS after administration of pembrolizumab in combination with olaparib

    To assess progression-free survival (PFS) after administration of pembrolizumab in combination with olaparib based on RECIST 1.1 and iRECIST

    Measured: 3 years

  6. Incidence of treatment-related adverse events after administration of pembrolizumab in combination with olaparib

    To assess the number of participants with treatment-related adverse events after administration of pembrolizumab in combination with olaparib based on CTCAE v5.0

    Measured: 3 years

  7. Objective Response Rate based on PD-L1 status

    ORR will be evaluated after pembrolizumab in combination with olaparib stratified by PD-L1 status based on RECIST 1.1 and iRECIST.

    Measured: 3 years

  8. Duration of response based on PD-L1 status

    To assess DOR after administration of pembrolizumab in combination with olaparib stratified by PD-L1 status based on RECIST 1.1 and iRECIST.

    Measured: 3 years

  9. Durable response rate based on PD-L1 status

    To assess DRR after administration of pembrolizumab in combination with olaparib stratified by PD-L1 status based on RECIST 1.1 and iRECIST.

    Measured: 3 years

  10. PFS based on PD-L1 status

    To assess PFS after administration of pembrolizumab in combination with olaparib stratified by PD-L1 status based on RECIST 1.1 and iRECIST.

    Measured: 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 posted24 Nov 2020
  2. Study start1 Jan 2021
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2023 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04641728
Sponsor's protocol ID
GOTIC-025
Status last verified
Jul 2022
First submitted
2 Nov 2020
Last updated
9 Aug 2022
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ogasawara A, Suzuki S, Oda K, Yunokawa M, Yonemori K, Mori M, Kurosaki A, Mori M, Kitano S, Shintani D, Saigusa Y, Matsushita H, Takeda Y, Hasegawa K. Phase II study of pembrolizumab plus olaparib in recurrent cervical cancer progressing after platinum-based chemotherapy (GOTIC-025). Gynecol Oncol. 2026 May;208:122-130. doi: 10.1016/j.ygyno.2026.04.007. Epub 2026 Apr 20.

    PubMed 42013608

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab and Olaparib in people with Cervical Cancer, run by Saitama Medical University International Medical Center at 1 site in Japan.

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 7 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 9 Aug 2022. 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 Japan. 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?

Results are not available in the source record.

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?

Objective Response Rate (time frame: 3 years). 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 NCT04641728, which also lists 1 linked publication.

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 9 Aug 2022.

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