Actively Recruiting
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)
Led by Yonsei University · Updated on 2026-05-06
198
Participants Needed
27
Research Sites
310 weeks
Total Duration
On this page
Sponsors
Y
Yonsei University
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
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-OV7/ ENGOT-ov80 Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patient is at least 18 years of age
- Signed informed consent and able to comply with protocol requirements
- Histologically confirmed recurrent or persistent clear cell carcinoma of ovary, endometrium, cervix, vagina, or vulva with at least 50% clear cell histology (or WT-1 negative for ovarian cancer)
- ECOG performance status of 0 or 1
- Disease progression within 12 months after platinum-based chemotherapy
- 1 to 5 prior lines of therapies
- Measurable disease based on RECIST 1.1 criteria
- Availability of tumor tissue for translational research (FFPE tumor block or at least 20 unstained slides)
- Consent to fresh tumor biopsies if accessible and safe
- Adequate organ function as defined by blood counts, liver and kidney function, and coagulation parameters
- Negative pregnancy test within 72 hours before first dose unless non-childbearing
- Agreement to use effective contraception during study and for 180 days after last dose if of childbearing potential
You will not qualify if you...
- More than 5 prior lines of chemotherapy
- Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents
- Recent anticancer therapy within 21 days or less than 5 times the half-life of prior therapy before study start
- Contraindications to chemotherapy, immune checkpoint inhibitors, or anti-angiogenic agents
- Uncontrolled hypertension (≥160/100 mmHg)
- Evidence of bleeding disorders or significant coagulopathy without treatment
- Current abdominal or pelvic fistula
- Concomitant malignancy or prior non-gynecological malignancy treated or active within last 3 years (except non-melanoma skin cancer)
- Uncontrolled central nervous system metastases or carcinomatous meningitis
- Known HIV infection unless controlled with criteria met
- Active hepatitis B or C infection unless under specific control measures
- Active autoimmune disease requiring systemic treatment in past 2 years
- Recent immunosuppressive treatment within 7 days prior to first dose except low-dose steroids with approval
- Unresolved adverse events from prior anticancer therapy except specified exceptions
- Unrecovered complications from major surgery within 4 weeks prior to study
- Hypersensitivity to study drugs or components
- Participation in other investigational studies within 4 weeks
- Serious uncontrolled medical disorders or active infections
- History of non-infectious pneumonitis requiring steroids or current pneumonitis
- Use of certain immunomodulatory agents within 28 days prior to first dose
- Pregnancy or lactation during study and 180 days after last dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
Monash Medical Centre
Clayton, Clayton Rd., Australia
Active, Not Recruiting
2
Calvary Mater Newcastle
Waratah, Edith Saint, Australia
Active, Not Recruiting
3
Peter MacCallum Cancer Centre
Melbourne, Grattan Saint, Australia
Active, Not Recruiting
4
University of Hong Kong
Hong Kong, Pok Fu Ram, Hong Kong
Active, Not Recruiting
5
Kurume University Hospital
Kurume, Fukuoka, Japan, 830-0011
Actively Recruiting
6
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan, 960-1295
Actively Recruiting
7
Mie University Hospital
Tsu, Mie-ken, Japan, 514-8507
Actively Recruiting
8
Tohoku University Hospital
Sendai, Miyagi, Japan, 980-8574
Actively Recruiting
9
Niigata Cancer Center Hospital
Niigata, Niigata, Japan, 951-8566
Actively Recruiting
10
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan, 1397-1
Actively Recruiting
11
Tokushima University Hospital
Tokushima, Tokushima, Japan, 770-8501
Actively Recruiting
12
The Jikei University Hospital
Tokyo, Tokyo, Japan, 105-0003
Actively Recruiting
13
The Cancer Institute Hospital Of JFCR
Tokyo, Tokyo, Japan, 135-8550
Actively Recruiting
14
University of Tsukuba Hospital
Tsukuba, ㅊ Ibaraki, Japan, 305-8576
Actively Recruiting
15
National University Hospital
Singapore, Kent Ridge Rd, Singapore
Active, Not Recruiting
16
National University Hospital
Singapore, Singapore
Not Yet Recruiting
17
Severance Hospital, Yonsei Health System
Seoul, Seoul, South Korea, 03722
Actively Recruiting
18
National Cancer Center
Goyang-si, South Korea
Actively Recruiting
19
Bundang Seoul National University Hospital
Seongnam-si, South Korea
Actively Recruiting
20
Asan Medical Center
Seoul, South Korea
Actively Recruiting
21
Korea University Guro Hospital
Seoul, South Korea
Actively Recruiting
22
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
23
Seoul National University
Seoul, South Korea
Actively Recruiting
24
Taipei Veterans General Hospital
Taipei, Beitou District, Taiwan
Active, Not Recruiting
25
Chang Gung Memorial Hospital
Taipei, Songshan District, Taiwan
Active, Not Recruiting
26
National Taiwan University Hospital
Taipei, Zhongzheng, Taiwan
Active, Not Recruiting
27
Guy's and St Thomas' NHS Foundation Trust
London, Monkton, United Kingdom
Active, Not Recruiting
Research Team
J
JUNGYUN LEE, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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