Recruiting PHASE2 Ovarian Neoplasms

Compares treatment options for Ovarian Neoplasms

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)

ClinicalTrials.gov ID: NCT06023862

What this study is testing

What is Dostarlimab?

Dostarlimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ovarian neoplasms.

Also referred to as Jemperli.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing: 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.

Phase 2: a mid-size study of how well it works
Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older, women only

You may be able to join if

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

You likely can't join if

Patient has had ≥ 6 prior lines of chemotherapy. Surgery of the recurrence is allowed.
Patient has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
Patient has received prior anticancer therapy (chemotherapy, targeted therapies, hormonal therapy, radiotherapy) within 21 days or \< 5 times the...
Patient with contraindication to chemotherapy or immune checkpoint inhibitor treatments or anti-angiogenic inhibitor
Patients with uncontrolled hypertension (defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥100 mmHg) based on an average...
Patients with evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)

See the full eligibility criteria

Who can join

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...
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...

What rules you out

Patient has had ≥ 6 prior lines of chemotherapy. Surgery of the recurrence is allowed.
Patient has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
Patient has received prior anticancer therapy (chemotherapy, targeted therapies, hormonal therapy, radiotherapy) within 21 days or \< 5 times the half-life of the most recent therapy prior to Study Day 1, whichever is...
Patient with contraindication to chemotherapy or immune checkpoint inhibitor treatments or anti-angiogenic inhibitor
Patients with uncontrolled hypertension (defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥100 mmHg) based on an average of ≥ 3 BP readings on ≥ 2 sessions.
Patients with evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
Patients with current abdominal/pelvic fistula
Patient has a concomitant malignancy, or patient has a prior non-gynecological malignancy who has been disease-free for \< 3 years or who received any active treatment in the last 3 years for that malignancy...
Patient has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both. Note: Patients with previously treated brain metastases may participate provided they are stable (without evidence of...
Patient has a known history of human immunodeficiency virus (HIV; HIV ½ antibodies). Participants with known human immunodeficiency virus(HIV) are allowed if they meet all of the following criteria:
Cluster of differentiation 4(CD4) ≥350/μL and viral load \<50 copies/mL.
No history of acquired immunodeficiency syndrome-defining opportunistic infections within 12 months before enrollment.
No history of HIV-associated malignancy for the past 5 years.
Concurrent antiretroviral therapy as per the most current National Institutes of Health (NIH) Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV started \>4 weeks before study enrollment.
Patient with presence of hepatitis B surface antigen or a positive hepatitis C antibody test result at screening or within 3 months before first dose of dostarlimab treatment.
Participants who are hepatitis B surface antigen positive may be enrolled if their HBV-DNA level is below the institutional lower limit.
Participants with chronic hepatitis B virus (HBV) infection who meet the criteria for anti-HBV therapy may be eligible if the participant is on a suppressive antiviral therapy before initiation of cancer therapy.
Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA polymerase chain reaction is obtained. Hepatitis C participants may be...
Patient has an active autoimmune disease that required systemic treatment in the past 2 years. Replacement therapy is not considered a form of (eg, thyroid hormone or insulin).
diagnosis immunodeficiency receiving steroid any other immunosuppressive within 7 days prior to first dose study treatment. Patients who have received acute and\>/or low-dose systemic immunosuppressive medications...
Patient has not recovered (to Grade ≤ 1) from previous anti-cancer therapy-induced adverse events (AEs). Note: Patients with Grade ≤ 2 neuropathy, Grade ≤ 2 alopecia, or Grade ≤ 2 fatigue are an exception to this...
Patient has not recovered adequately from AEs or complications from any major surgery prior to starting therapy. Major surgical procedures, other than for diagnosis, within 4 weeks prior to initiation of study treatment
Patient has a known hypersensitivity to bevacizumab or dostarlimab components or excipients.
Patient is currently participating and receiving study treatment or has participated in a study of an investigational agent and received study treatment or used an investigational device within 4 weeks of the first dose...
Patient is considered a poor medical condition due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active infection requiring systemic therapy. Specific examples include, but are not...
Patients with known history of non-infectious pneumonitis that required steroids or has current pneumonitis.
Use of any of the following immunomodulatory agents within 28 days prior to the first dose of study drug:
Interferons
Interleukins
Live vaccine Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, and typhoid vaccine. mRNA and adenoviral-based COVID-19...
Patient who are pregnant or lactating, or plan to become pregnant or lactate during the expected duration of the study, from screening through 180 days after the last dose of study drug.

The study team makes the final eligibility decision.

Where it's taking place

Clayton, Clayton Rd., Australia
Waratah, Edith Saint, Australia
Melbourne, Grattan Saint, Australia
Hong Kong, Pok Fu Ram, Hong Kong
Kurume, Fukuoka, Japan
Fukushima, Fukushima, Japan
Tsu, Mie-ken, Japan
Sendai, Miyagi, Japan
Niigata, Niigata, Japan
Hidaka, Saitama, Japan
Tokushima, Tokushima, Japan
Tokyo, Tokyo, Japan
Tsukuba, ㅊ Ibaraki, Japan
Singapore, Kent Ridge Rd, Singapore
Singapore, Singapore
Seoul, Seoul, South Korea
Goyang-si, South Korea
Seongnam-si, South Korea
Seoul, South Korea
Taipei, Beitou District, Taiwan

+ 3 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Clayton, Clayton Rd., Australia; Waratah, Edith Saint, Australia; Melbourne, Grattan Saint, Australia; Hong Kong, Pok Fu Ram, Hong Kong; Kurume, Fukuoka, Japan; Fukushima, Fukushima, Japan and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.