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Ovarian NeoplasmsPhase 2DOVENCT06023862

A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)

A Phase 2 study testing Dostarlimab, Bevacizumab and Doxorubicin in people with Ovarian Neoplasms and Endometrial Neoplasms, run by Yonsei University at 27 sites in 7 countries.

Active, not recruiting

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

Official record
Search all trials

Trial summary

Multicenter, randomized, open-label, phase II clinical study comparing Dostarlimab +/- Bevacizumab with standard chemotherapy in patients with gynecological clear cell carcinoma. 198 subjects will be enrolled in this study and will be assigned to three groups in a 1:1:1 ratio. 1. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Dostarlimab, Bevacizumab and Doxorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
198 participants
Where
27 sitesin 7 countries
Study dates
22 Jan 2024to 31 Dec 2029
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

  • Female patient is at least 18 years of age,
  • Patient has signed the Informed Consent (ICF) and is able to comply with protocol requirements.
  • Patient with histologically proven confirmed recurrent or persistent clear cell carcinoma of the ovary, endometrium, cervix, vagina, and vulva
  • Local review by gynecologic pathologist required
  • ≥50% clear cell histology in case of mixed carcinoma
  • WT-1 neg (Only in case of ovarian cancer) Note: In the case of including non-ovarian clear cell carcinoma with more than 20 cases, the decision is made through discussion with the SPONSOR.
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  • Patient with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Disease progression within 12 months of completing platinum-based chemotherapy
  • 1-5 prior lines of therapies
  • Patient with measurable disease according RECIST 1.1 criteria
  • Availability of Tumor tissue for translational research . - A formalin-fixed paraffin-embedded (FFPE) tumor block(preferred) or at least 20 slides (unstained, freshly cut, serial sections) must be submitted.
  • Patients who consent to fresh tumor biopsies
  • Confirmed with at least one lesion with location accessible to safely biopsy per the clinical judgement of the investigator
  • Note: If mandatory biopsies cannot be performed as per investigator's clinical judgement, discussion and agreement between investigator and Sponsor are required.
  • Patient has adequate organ function, defined as follows:
  • Absolute neutrophil count ≥ 1,500 cells/μL
  • Platelets ≥ 100,000 cells/μL
  • Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L
  • Serum creatinine ≤ 1.5× upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault equation for patients with creatinine levels > 1.5× institutional ULN
  • Total bilirubin ≤ 1.5× ULN (≤ 2.0 x ULN in patients with known Gilbert's syndrome) or direct bilirubin ≤ 1× ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5× ULN unless liver metastases are present, in which case they must be ≤ 5× ULN
  • International normalized ratio or prothrombin time (PT) ≤1.5× ULN and activated partial thromboplastin time ≤1.5× ULN.Participants taking anticoagulants may be included on a stable dose with a therapeutic INR <3.5. .
  • Patient must have a negative serum pregnancy test within 72 hours of the first dose of study medication, unless they are of non-childbearing potential. If a negative result cannot be confirmed by a urine test, a serum pregnancy test is required. Non-childbearing potential is defined as follows:
  • Patient is ≥ 45 years of age and has not had menses for > 1 year.
  • A follicle-stimulating hormone value in the postmenopausal range upon screening evaluation if amenorrhoeic for < 2 years without a hysterectomy and oophorectomy.
  • Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation:
  • Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound, MRI, or CT scan.
  • Tubal ligation must be confirmed with medical records of the actual procedure.
  • Information must be captured appropriately within the site's source documents.
  • Patient of childbearing potential must agree to use a highly effective method of contraception with their partners starting from time of consent through 180 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient (Information must be captured appropriately within the site's source documents).

Who cannot join

  • Patient has had ≥ 6 prior lines of chemotherapy. Surgery of the recurrence is allowed.
  • Patient has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
  • Patient has received prior anticancer therapy (chemotherapy, targeted therapies, hormonal therapy, radiotherapy) within 21 days or < 5 times the half-life of the most recent therapy prior to Study Day 1, whichever is shorter.
  • Note: Palliative radiation therapy to a small field ≥ 1 week prior to Day 1 of study treatment may be allowed after discussion with the SPONSOR.
  • Patient with contraindication to chemotherapy or immune checkpoint inhibitor treatments or anti-angiogenic inhibitor
  • Patients with uncontrolled hypertension (defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥100 mmHg) based on an average of ≥ 3 BP readings on ≥ 2 sessions.
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  • Patients with evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
  • Patients with current abdominal/pelvic fistula
  • Patient has a concomitant malignancy, or patient has a prior non-gynecological malignancy who has been disease-free for < 3 years or who received any active treatment in the last 3 years for that malignancy. Non-melanoma skin cancer is allowed.
  • Patient has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both. Note: Patients with previously treated brain metastases may participate provided they are stable (without evidence of disease progression by imaging [using the identical imaging modality for each assessment, either MRI or CT scan] for at least 4 weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and have not been using steroids for at least 7 days prior to study treatment. Carcinomatous meningitis precludes a patient from study participation regardless of clinical stability.
  • Patient has a known history of human immunodeficiency virus (HIV; HIV ½ antibodies). Participants with known human immunodeficiency virus(HIV) are allowed if they meet all of the following criteria:
  • Cluster of differentiation 4(CD4) ≥350/μL and viral load <50 copies/mL.
  • No history of acquired immunodeficiency syndrome-defining opportunistic infections within 12 months before enrollment.
  • No history of HIV-associated malignancy for the past 5 years.
  • Concurrent antiretroviral therapy as per the most current National Institutes of Health (NIH) Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV started >4 weeks before study enrollment.
  • Patient with presence of hepatitis B surface antigen or a positive hepatitis C antibody test result at screening or within 3 months before first dose of dostarlimab treatment.
  • Participants who are hepatitis B surface antigen positive may be enrolled if their HBV-DNA level is below the institutional lower limit.
  • Participants with chronic hepatitis B virus (HBV) infection who meet the criteria for anti-HBV therapy may be eligible if the participant is on a suppressive antiviral therapy before initiation of cancer therapy.
  • Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA polymerase chain reaction is obtained. Hepatitis C participants may be eligible if they both have completed curative therapy and have a hepatitis C viral load <!-- Not Allowed Tag Filtered --><quantifiable limit.
  • Patient has an active autoimmune disease that required systemic treatment in the past 2 years. Replacement therapy is not considered a form of (eg, thyroid hormone or insulin).
  • diagnosis immunodeficiency receiving steroid any other immunosuppressive within 7 days prior to first dose study treatment. Patients who have received acute and>/or low-dose systemic immunosuppressive medications (e.g,, a one-time dose of dexamethasone for nausea or chronic use of ≤ 10 mg/day of prednisone or dose equivalent corticosteroid) may be enrolled in the study after discussion with and approval by the Sponsor. The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed.
  • Patient has not recovered (to Grade ≤ 1) from previous anti-cancer therapy-induced adverse events (AEs).
  • Note: Patients with Grade ≤ 2 neuropathy, Grade ≤ 2 alopecia, or Grade ≤ 2 fatigue are an exception to this criterion and may qualify for the study.
  • Patient has not recovered adequately from AEs or complications from any major surgery prior to starting therapy. Major surgical procedures, other than for diagnosis, within 4 weeks prior to initiation of study treatment
  • Patient has a known hypersensitivity to bevacizumab or dostarlimab components or excipients.
  • Patient is currently participating and receiving study treatment or has participated in a study of an investigational agent and received study treatment or used an investigational device within 4 weeks of the first dose of treatment.
  • Patient is considered a poor medical condition due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active infection requiring systemic therapy. Specific examples include, but are not limited to, active, non-infectious pneumonitis; uncontrolled ventricular arrhythmia; recent (within 90 days) myocardial infarction; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study (including obtaining informed consent).
  • Patients with known history of non-infectious pneumonitis that required steroids or has current pneumonitis.
  • Use of any of the following immunomodulatory agents within 28 days prior to the first dose of study drug:
  • Interferons
  • Interleukins
  • Live vaccine Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, and typhoid vaccine. mRNA and adenoviral-based COVID-19 vaccines are considered non-live and are not exclusionary. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed as other killed vaccines, if done at least 2 weeks prior the first dose of study drug; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
  • Patient who are pregnant or lactating, or plan to become pregnant or lactate during the expected duration of the study, from screening through 180 days after the last dose of study drug.

Trial locations and contacts

27 sites in 7 countries.

27 sites in 7 countries

Japan10 sites

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295

  • Saitama Medical University International Medical Center

    Hidaka, Saitama, 1397-1

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011

  • Niigata Cancer Center Hospital

    Niigata, Niigata, 951-8566

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Tokushima University Hospital

    Tokushima, Tokushima, 770-8501

  • The Jikei University Hospital

    Tokyo, Tokyo, 105-0003

  • The Cancer Institute Hospital Of JFCR

    Tokyo, Tokyo, 135-8550

  • Mie University Hospital

    Tsu, Mie-ken, 514-8507

  • University of Tsukuba Hospital

    Tsukuba, ㅊ Ibaraki, 305-8576

Other trials in Japan

South Korea7 sites

  • National Cancer Center

    Goyang-si

  • Bundang Seoul National University Hospital

    Seongnam-si

  • Severance Hospital, Yonsei Health System

    Seoul, Seoul, 03722

  • Asan Medical Center

    Seoul

  • Korea University Guro Hospital

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University

    Seoul

Other trials in South Korea

Australia3 sites

  • Monash Medical Centre

    Clayton, Clayton Rd.

  • Peter MacCallum Cancer Centre

    Melbourne, Grattan Saint

  • Calvary Mater Newcastle

    Waratah, Edith Saint

Other trials in Australia

Taiwan3 sites

  • Taipei Veterans General Hospital

    Taipei, Beitou District

  • Chang Gung Memorial Hospital

    Taipei, Songshan District

  • National Taiwan University Hospital

    Taipei, Zhongzheng

Other trials in Taiwan

Singapore2 sites

  • National University Hospital

    Singapore, Kent Ridge Rd

  • National University Hospital

    Singapore

Other trials in Singapore

Hong Kong1 site

  • University of Hong Kong

    Hong Kong, Pok Fu Ram

Other trials in Hong Kong

United Kingdom1 site

  • Guy's and St Thomas' NHS Foundation Trust

    London, Monkton

Other trials in United Kingdom

About this study

Official title: A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV07/ ENGOT-ov80 Study)

Multicenter, randomized, open-label, phase II clinical study comparing Dostarlimab +/- Bevacizumab with standard chemotherapy in patients with gynecological clear cell carcinoma.

198 subjects will be enrolled in this study and will be assigned to three groups in a 1:1:1 ratio.

Read more
  1. Group A: Dostarlimab monotherapy
  • First 3 cycles: Dostalimab 500mg every 3 weeks, IV
  • 4 cycles ~ up to 24 months: Dostalimab 1000mg every 6 weeks, IV
  1. Group B: Dostarlimab + Bevacizumab combination therapy
  • First 3 cycles: Dostalimab 500mg every 3 weeks, IV
  • 4 cycles ~ up to 24 months: Dostalimab 1000mg every 6 weeks, IV
  • Bevacizumab administered IV at 15 mg/kg every 3 weeks until disease progression or unacceptable toxicity
  1. Group C: General chemotherapy (one of Pegylated liposomal doxorubicin, Doxorubicin, Paclitaxel, and Gemcitabine)
Being tested
Dostarlimab, Bevacizumab, Doxorubicin, Gemcitabine, Paclitaxel
Medical subject headings
Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, Adenocarcinoma, Clear Cell

What participants receive

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

  • DostarlimabDrug

    Also called Jemperli

    Intravenous (IV) infusion

  • BevacizumabDrug

    Intravenous (IV) infusion

  • DoxorubicinDrug

    Intravenous (IV) infusion

  • GemcitabineDrug

    Intravenous (IV) infusion

  • PaclitaxelDrug

    Intravenous (IV) infusion

  • Pegylated liposomal doxorubicinDrug

    Intravenous (IV) infusion

Study groups in NCT06023862
Study groupRoleWhat they receive
Group AExperimentalDostarlimab monotherapy
Receives: Drug: Dostarlimab
Group BExperimentalDostarlimab + Bevacizumab combination therapy
Receives: Drug: Dostarlimab; Drug: Bevacizumab
Group CActive comparatorGeneral chemotherapy (one of Pegylated liposomal doxorubicin, Doxorubicin, Paclitaxel, and Gemcitabine)
Receives: Drug: Doxorubicin; Drug: Gemcitabine; Drug: Paclitaxel; Drug: Pegylated liposomal doxorubicin

What is being measured

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

  1. Progression Free Survival

    The time from the date of randomization until first documentation of disease progression, as determined by investigator assessment based on RECIST 1.1, or death due to any cause, whichever occurs first.

    Measured: Up to approximately 48 months

Secondary outcomes (9)

  1. Objective Response Rate

    the proportion of patients who have best overall response of either complete response (CR) or partial response (PR), as investigator assessment based on RECIST 1.1

    Measured: Up to approximately 48 months

  2. Disease control rate

    the proportion of patients who have best overall response of CR, PR, or stable disease (SD) by investigator assessment per RECIST 1.1 . SD must be achieved at ≥ 7 weeks after randomization to be considered best overall response.

    Measured: Up to approximately 48 months

  3. Clinical benefit rate

    the proportion of patients who have best overall response of CR, PR, or stable disease (SD) by investigator assessment per RECIST 1.1 . (duration of SD ≥ 23 weeks after randomization)

    Measured: Up to approximately 48 months

  4. Progression Free Survival 2

    the time from initial randomization to the second objective disease progression (ie, after the first subsequent therapy) or death.

    Measured: Up to approximately 72 months

  5. Overall survival

    the time from the date of randomization until death due to any cause

    Measured: Up to approximately 72 months

  6. Duration of Response Rate

    Measured from the time of initial response until documented tumor progression.

    Measured: Up to approximately 48 months

  7. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Assessed by CTCAE v5.0 (by investigators).

    Measured: Up to approximately 72 months

  8. Time to first and second Subsequent Treatment

    the time from the date of randomization to date of the first and second subsequent anticancer therapy or death.

    Measured: Up to approximately 72 months

  9. Response rate of subsequent therapies

    the proportion of patients who have best overall response of either complete response (CR) or partial response (PR), as investigator assessment based on RECIST 1.1

    Measured: Up to approximately 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 Sep 2023
  2. Study start22 Jan 2024
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Dec 2029 (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
Masking
None (open label)
Enrolment
198 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06023862
Sponsor's protocol ID
4-2023-0794
Acronym
DOVE
Status last verified
Apr 2026
First submitted
23 Aug 2023
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lee JY, Tan D, Ray-Coquard I, Lee JB, Kim BG, Van Nieuwenhuysen E, Huang RY, Tse KY, Gonzalez-Martin A, Scott C, Hasegawa K, Wilkinson K, Yang EY, Lheureux S, Kristeleit R. Phase II randomized study of dostarlimab alone or with bevacizumab versus non-platinum chemotherapy in recurrent gynecological clear cell carcinoma (DOVE/APGOT-OV7/ENGOT-ov80). J Gynecol Oncol. 2025 Jan;36(1):e51. doi: 10.3802/jgo.2025.36.e51. Epub 2024 Dec 16.

    PubMed 39710508

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dostarlimab, Bevacizumab and Doxorubicin in people with Ovarian Neoplasms and Endometrial Neoplasms, run by Yonsei University at 27 sites in 7 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 30 inclusion and 33 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 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Japan, South Korea, Australia, Taiwan, Singapore and 2 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. 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 (time frame: Up to approximately 48 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 NCT06023862, 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 2 Nov 2026.

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