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)

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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. 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)

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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).

Locations
Other Locations
Japan
Fukushima Medical University Hospital
RECRUITING
Fukushima
Saitama Medical University International Medical Center
RECRUITING
Hidaka
Kurume University Hospital
RECRUITING
Kurume
Niigata Cancer Center Hospital
RECRUITING
Niigata
Tohoku University Hospital
RECRUITING
Sendai
Tokushima University Hospital
RECRUITING
Tokushima
The Cancer Institute Hospital Of JFCR
RECRUITING
Tokyo
The Jikei University Hospital
RECRUITING
Tokyo
Mie University Hospital
RECRUITING
Tsu
University of Tsukuba Hospital
RECRUITING
Tsukuba
Republic of Korea
National Cancer Center
RECRUITING
Goyang-si
Bundang Seoul National University Hospital
RECRUITING
Seongnam-si
Asan Medical Center
RECRUITING
Seoul
Korea University Guro Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University
RECRUITING
Seoul
Severance Hospital, Yonsei Health System
RECRUITING
Seoul
Singapore
National University Hospital
NOT_YET_RECRUITING
Singapore
Contact Information
Primary
JUNGYUN LEE, Ph.D.
JUNGYUNLEE@yuhs.ac
82)2-2228-2237
Time Frame
Start Date: 2024-01-22
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 198
Treatments
Experimental: Group A
Dostarlimab monotherapy
Experimental: Group B
Dostarlimab + Bevacizumab combination therapy
Active_comparator: Group C
General chemotherapy (one of Pegylated liposomal doxorubicin, Doxorubicin, Paclitaxel, and Gemcitabine)
Sponsors
Leads: Yonsei University
Collaborators: GlaxoSmithKline

This content was sourced from clinicaltrials.gov