Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Recurrence

Ovarian Neoplasms

Uterine Cervical Neoplasms

Endometrial Neoplasms

Vaginal Neoplasms

Vulvar Neoplasms

Adenocarcinoma, Clear Cell

Adenomyoepithelioma

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Genital Neoplasms, Female

Urogenital Neoplasms

Vulvar Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Endocrine System Diseases

Gonadal Disorders

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Vaginal Diseases

Ovarian Cancer

Vaginal Cancer

Vulvar Cancer

Epithelial-myoepithelial Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Gemcitabine

Paclitaxel

Bevacizumab

Doxorubicin

Liposomal doxorubicin

Albumin-Bound Paclitaxel

Dostarlimab

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Dostarlimab + Bevacizumab combination therapy

General chemotherapy (one of Pegylated liposomal doxorubicin, Doxorubicin, Paclitaxel, and Gemcitabine)

Pegylated liposomal doxorubicin

JUNGYUN LEE, Ph.D.

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)

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 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)

Translational research including NGS as well as MMRd, MSI-H, PD1/L1, TMB, Immune signature, and Tie-2.

By comparing RECIST 1.1 and iRECIST, evaluate the accuracy of iRECIST for assessing the therapeutic efficacy of ICIs.

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.

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

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.

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)

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

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

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

Assessed by CTCAE v5.0 (by investigators).

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

Yonsei University

Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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)	NCT06023862	Ovarian Neoplas... Endometrial Neo... Uterine Cervica... Vulvar Cancer Vagina Neoplasm Clear Cell Carc...	Dostarlimab Bevacizumab Doxorubicin Gemcitabine Paclitaxel Pegylated lipos...	18 Years -	Yonsei University
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)	NCT06023862	Ovarian Neoplas... Endometrial Neo... Uterine Cervica... Vulvar Cancer Vagina Neoplasm Clear Cell Carc...	Dostarlimab Bevacizumab Doxorubicin Gemcitabine Paclitaxel Pegylated lipos...	18 Years -	Yonsei University

Spots Global Cancer Trial Database for vagina neoplasm