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)

Recruiting Phase 2 Interventional Study
Ovarian Neoplasms Endometrial Neoplasms Uterine Cervical Neoplasms Vulvar Cancer Vagina Neoplasm Clear Cell Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
198 (estimated)
Sponsor
Yonsei University · Other
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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 m…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Female patient is at least 18 years of age, 2. Patient has signed the Informed Consent (ICF) and is able to comply with protocol requirements. 3. Patient with histologically proven confirmed recurrent or persistent clear cell carcinoma of the ovary, endometrium, cervix, vagin…
Contacts

JUNGYUN LEE, Ph.D.

82)2-2228-2237

JUNGYUNLEE@yuhs.ac

CONTACT