RecruitingPHASE2INTERVENTIONAL

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)

This research study, called DOVE, is exploring new ways to treat specific gynaecological cancers that have returned or continued to grow after earlier treatments. It focuses on 'clear cell carcinoma' found in the ovary, womb, cervix, vagina, or vulva. The study will compare two new drug combinations (Dostarlimab alone or with Bevacizumab) against current standard chemotherapy options. Doctors want to see if these newer treatments are more effective for patients. It's a 'Phase II' study, which means it builds on earlier research to gather more information on safety and how well the treatments work in a larger group of people.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Yonsei University

Enrolment target

198

Start

22 Jan 2024

Estimated completion

31 Dec 2029

Ovarian Neoplasms Endometrial Neoplasms Uterine Cervical Neoplasms Vulvar Cancer Vagina Neoplasm Clear Cell Carcinoma

What is this study about?

This study is designed for women who have a specific type of cancer called 'clear cell carcinoma' in their ovaries, womb, cervix, vagina, or vulva. This cancer is considered 'recurrent' or 'persistent,' meaning it has either come back after previous treatment or hasn't gone away completely. The main goal of this study is to find better ways to treat this condition.

The study will look at two new treatment approaches: one uses a drug called Dostarlimab by itself, and the other combines Dostarlimab with another drug called Bevacizumab. These treatments will be compared against standard chemotherapy, which is a common way these cancers are treated currently. Researchers want to see if the new drug combinations are more effective at shrinking the cancer or stopping it from growing, and they will also monitor any side effects.

Taking part in a study like this helps doctors learn more about diseases and develop new and potentially better treatments for patients in the future. By comparing different treatments, they can figure out which ones offer the most benefits.

Key takeaways

Tests new treatments (Dostarlimab alone or with Bevacizumab) for specific gynaecological cancers.
Compares new treatments to standard chemotherapy for recurrent 'clear cell carcinoma'.
Involves 198 patients, randomly assigned to one of three treatment groups.
Participation includes regular IV treatments and medical check-ups for up to 2 years.
Aims to find more effective and safer treatments for this type of cancer.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you must be a woman aged 18 or older. You need to have a confirmed diagnosis of clear cell carcinoma in your ovary, womb, cervix, vagina, or vulva, and the cancer must have returned or continued to grow within 12 months after you finished your last platinum-based chemotherapy.

You should also be generally well enough to take part, as measured by a doctor's assessment (known as an ECOG score of 0 or 1). Your doctors will need to be able to measure your cancer, and sometimes a fresh tissue sample might be required. You also need to have healthy organ function, which will be checked through blood tests.

Your medical team will review all your information to ensure this study is a good fit for you. They will explain everything clearly and answer any questions you have before you decide to participate.

Quick self-check

Are you a woman aged 18 or older?
Do you have recurrent or persistent clear cell carcinoma of the ovary, womb, cervix, vagina, or vulva?
Did your cancer return within 12 months of finishing platinum-based chemotherapy?
Are you generally well and active enough for a clinical trial (ECOG score 0 or 1)?
Are your organs, such as kidneys and liver, functioning well?
Are you willing for doctors to take a tissue sample if needed, and to have regular scans and blood tests?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you'll be one of 198 patients, and you'll be randomly assigned to one of three treatment groups by chance, like flipping a coin. You won't get to choose which group you're in.

* **Group A (Dostarlimab alone):** You'll receive Dostarlimab as an IV drip every 3 weeks for the first 3 cycles. After that, you'll receive it every 6 weeks for up to 2 years. * **Group B (Dostarlimab + Bevacizumab):** You'll receive Dostarlimab just like Group A. In addition, you'll get Bevacizumab as an IV drip every 3 weeks, continuing for as long as the treatment is working or until side effects are too much. * **Group C (Standard Chemotherapy):** Your doctor will choose one of several common chemotherapy drugs (Doxorubicin, Gemcitabine, Paclitaxel, or Pegylated liposomal doxorubicin) for you, based on what's best for your situation.

Throughout the study, you'll have regular hospital visits for your treatments, check-ups, blood tests, and scans to see how you're responding. The total duration of your active treatment could be up to 24 months, or longer for Bevacizumab if you're in that group, depending on how you respond.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to new treatments before they are widely available, and close monitoring of your health by a medical team. While there's no guarantee the new treatments will work better for you, they could be more effective or have different side effects than standard care. However, there are also potential risks; all medications have side effects, and some might be serious or unexpected. Your doctors will discuss all known side effects with you, and you will be carefully monitored. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (27)

Monash Medical Centre
Clayton, Australia· Active not recruiting
Calvary Mater Newcastle
Waratah, Australia· Active not recruiting
Peter MacCallum Cancer Centre
Melbourne, Australia· Active not recruiting
University of Hong Kong
Hong Kong, Hong Kong· Active not recruiting
Kurume University Hospital
Kurume, Japan· Recruiting
Fukushima Medical University Hospital
Fukushima, Japan· Recruiting
Mie University Hospital
Tsu, Japan· Recruiting
Tohoku University Hospital
Sendai, Japan· Recruiting
Niigata Cancer Center Hospital
Niigata, Japan· Recruiting
Saitama Medical University International Medical Center
Hidaka, Japan· Recruiting
Tokushima University Hospital
Tokushima, Japan· Recruiting
The Jikei University Hospital
Tokyo, Japan· Recruiting

+15 more sites — see the official record for the full list.

Common questions

What is 'clear cell carcinoma'?

It's a specific type of cancer that can develop in the ovaries, womb, cervix, vagina, or vulva. This study is specifically looking at treatments for this particular kind of cancer.

What is a 'Phase II' study?

Phase II studies are a stage of research where doctors test new treatments in a larger group of people to see if they are safe and effective, following earlier, smaller studies.

What does 'randomized' mean?

It means you'll be assigned to one of the treatment groups by chance, like drawing straws. This helps make the study fair and ensures the results are reliable.

What are Dostarlimab and Bevacizumab?

Dostarlimab is a type of immunotherapy that helps your body's immune system fight cancer. Bevacizumab is a different type of drug that works by stopping blood vessels from forming in the tumour.

Will I know which treatment I am receiving?

Yes, this is an 'open-label' study, which means both you and your medical team will know which treatment group you are in.

How to find out more

JUNGYUN LEE, Ph.D.

JUNGYUNLEE@yuhs.ac 82)2-2228-2237 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.