At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Dostarlimab (drug), Bevacizumab (drug), Doxorubicin (drug), Gemcitabine (drug)
- How long the study runs
- Study runs about 71 months (dates as stated)
- About the drug or intervention
- Dostarlimab — drug: Intravenous (IV) infusion · Bevacizumab — drug: Intravenous (IV) infusion · Doxorubicin — drug: Intravenous (IV) infusion · Gemcitabine — drug: Intravenous (IV) infusion · Paclitaxel — drug: Intravenous (IV) infusion · Pegylated liposomal doxorubicin — drug: Intravenous (IV) infusion
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, called DOVE, is for women aged 18 or over whose clear cell cancer of the ovary, womb, cervix, vagina or vulva has come back or continued despite treatment. It compares three treatments: dostarlimab on its own, dostarlimab together with bevacizumab, or standard chemotherapy that does not contain platinum. Participants are put into one of the three groups at random.
Who can take part
- Women aged 18 or over with clear cell cancer of the ovary, womb (endometrium), cervix, vagina or vulva that has come back or persisted, confirmed by a specialist
- Cancer came back or got worse within 12 months of finishing platinum-based chemotherapy
- Have had between 1 and 5 previous courses of treatment
- Well enough for everyday activity (performance status score of 0 or 1)
- Cancer that can be measured on scans
- Able to provide a sample of tumour tissue (a preserved block or at least 20 slides)
- Willing to have fresh tumour biopsies if safe to do so
- Good enough blood, kidney, liver and clotting function on blood tests
- Not pregnant or breastfeeding, and willing to use highly effective contraception (if applicable) during the study and for 180 days after the last dose
Who may not be able to
- Have had 6 or more previous courses of chemotherapy
- Have previously had treatments that target the immune system in the same way as dostarlimab (anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs)
- Recent cancer treatment within 21 days (or less than 5 half-lives) of starting the study
- Uncontrolled high blood pressure, bleeding problems, or a fistula in the abdomen or pelvis
- Another cancer within the last 3 years (apart from non-melanoma skin cancer)
- Uncontrolled cancer spread to the brain, or cancer in the lining of the brain
- Active autoimmune disease needing treatment in the past 2 years
- Active infection including hepatitis (with some exceptions) — HIV may be allowed under strict conditions
- Pregnant, breastfeeding, or planning pregnancy during the study
- Allergy to dostarlimab or bevacizumab
- Recent live vaccines within 28 days, or another experimental drug within 4 weeks
- Still recovering from side effects of previous treatment, or from major surgery within the past 4 weeks
- Serious uncontrolled health problems, such as recent heart attack or uncontrolled seizures
What taking part involves
- • Being assigned at random to one of three groups: dostarlimab alone, dostarlimab with bevacizumab, or chemotherapy without platinum
- • Dostarlimab is given on its own (one group) or together with bevacizumab (second group)
- • The third group receives non-platinum chemotherapy
- • Providing tumour tissue and having fresh tumour biopsies for research
Time commitment: Taking part involves study visits for treatment and checks, blood tests, scans to measure the cancer, and tumour biopsies; the total study duration is not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Female
- Number of participants
- 198
- Started
- 2024-01-22
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for ovarian neoplasms
- • Phase2 - 198 participants
- • Multicenter, randomized, open-label, phase II clinical study comparing Dostarlimab +/- Bevacizumab with standard chemotherapy in patients with gynecological clear cell carcinoma
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with ovarian neoplasms
- • Female only
Where?
- • London - Guy's and St Thomas' NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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. 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 2. 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 3. Group C: General chemotherapy (one of Pegylated liposomal doxorubicin, Doxorubicin, Paclitaxel, and Gemcitabine)
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Female only
Biomarkers mentioned
What the study is looking for
- ✓Female patient is at least 18 years of age,
- ✓Patient has signed the agreement to take part (ICF) and is able to comply with protocol requirements.
- ✓Patient with histologically proven confirmed recurrent or persistent clear cell carcinoma of the ovary, endometrium,...
- ✓Local review by gynecologic pathologist required
- ✓≥50% clear cell histology in case of mixed carcinoma
Who cannot take part
- ✗Patient has had ≥ 6 prior lines of drug treatment. Surgery of the recurrence is allowed.
- ✗Patient has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- ✗Note: Palliative radiotherapy to a small field ≥ 1 week prior to Day 1 of study treatment may be allowed after...
- ✗Patient with safety concern to drug treatment or immune checkpoint inhibitor treatments or anti-angiogenic inhibitor
- ✗Patients with uncontrolled hypertension (defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood...
See the full criteria
Where Is This Study? (1 UK site)
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
How to Get in Touch
JUNGYUN LEE, Ph.D.
Sponsor contactCONTACT
