Evaluation of COM701 as Maintenance Therapy for Patients with Relapsed Platinum-Sensitive Ovarian Cancer

1 1

What is this study about?

This clinical trial aims to evaluate the effect of COM701 on survival without disease progression in patients with relapsed platinum sensitive ovarian cancer (PSOC). PSOC refers to ovarian cancer that has returned after initial treatment but still responds to platinum-based chemotherapy. The study will also include patients with fallopian tube cancer or primary peritoneal cancer who have undergone at least two previous rounds of platinum-containing therapy.

The study will assess COM701 as a maintenance treatment, which means it will be given after the main cancer treatment to help keep the cancer from returning. Some participants will receive COM701 while others will receive placebo. The research will measure how long patients remain without disease progression while receiving the maintenance therapy.

The safety of COM701 will be carefully monitored throughout the study by tracking side effects, laboratory test results, vital signs, and heart activity. The trial will also track how long it takes before patients need to start a new cancer treatment.

1 Randomization

After you complete your platinum-containing therapy for relapsed platinum sensitive ovarian cancer, you will be randomly assigned to receive either COM701 (a humanised monoclonal antibody against PVRIG) or a placebo (saline injection).

This assignment happens by chance, similar to flipping a coin, to create comparable groups for the study.

2 Treatment Administration

You will receive regular injections of either COM701 or placebo as a maintenance therapy (treatment given to help keep cancer from returning after it has responded to initial treatment).

The treatment will be administered on a set schedule determined by your doctor, which will continue until your disease progresses or you experience unacceptable side effects.

3 Monitoring and Assessments

Throughout the study, you will have regular visits to assess how your cancer is responding to treatment.

These assessments include imaging scans to measure tumor size according to standard criteria (RECIST 1.1).

Blood tests, vital signs measurements, and heart monitoring (ECG) will be performed regularly to check for any effects of the treatment.

Your doctor will monitor you for any side effects or adverse events and rate their severity using a standardized scale (CTCAE 5.0).

4 End of Treatment

Your participation in the treatment phase will end if your cancer progresses, you experience unacceptable side effects, or you decide to withdraw from the study.

If your cancer progresses, your doctor will discuss next treatment options with you, and the study will track the time until you start a new anti-cancer treatment.

5 Follow-up Period

After completing treatment, you will enter a follow-up period where your health and cancer status will continue to be monitored.

The study is expected to run until July 2025, with final data collection completed by February 2026.

Who Can Join the Study?

Has relapsed platinum sensitive epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (these are types of reproductive system cancers that respond well to platinum-based chemotherapy)
Has completed at least 2 previous courses (lines) of platinum-containing therapy (treatments that contain platinum drugs like cisplatin or carboplatin)
Has received prior maintenance therapy with bevacizumab (a drug that blocks blood vessel growth) or a PARP inhibitor (a type of targeted therapy) if eligible for these treatments
Is able to provide written, informed consent before starting any study procedures
Is able, in the investigator’s opinion, to comply with all the requirements of the study

Who Cannot Join the Study?

You cannot participate if you have a type of cancer that is not platinum-sensitive ovarian cancer (PSOC).
You cannot participate if your cancer has progressed during or within 6 months of your most recent platinum-based chemotherapy treatment.
You cannot participate if you have another type of cancer that requires treatment.
You cannot participate if you have had certain types of cancer treatments in the recent past, such as immunotherapy or experimental drugs.
You cannot participate if you have certain active infections, like hepatitis B, hepatitis C, HIV, or tuberculosis.
You cannot participate if you have an autoimmune disease (a condition where your immune system attacks your own body).
You cannot participate if you’ve had an organ transplant and are taking medications to prevent rejection.
You cannot participate if you are pregnant or breastfeeding.
You cannot participate if you have certain heart problems or uncontrolled high blood pressure.
You cannot participate if you have severe liver or kidney problems.
You cannot participate if you have a history of certain lung conditions or breathing problems.
You cannot participate if you’ve had a recent major surgery.
You cannot participate if you are currently enrolled in another clinical trial.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier Lyon Sud	Pierre Benite	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Bdvsbzks Uzbovvuakf Hplqjval Chuzur	Besançon	France
Ivinlgqg Pqalgpmylruhztz Closut Cdsngj	Marseille	France
Clunas Oltut Lrzrmsy	Lille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.07.2025

Trial locations

Investigated drugs:

COM701 is an experimental medication that works with your immune system to help it recognize and attack cancer cells. It blocks a specific protein that cancer cells use to hide from the immune system. In this study, it is being investigated as a maintenance therapy for ovarian cancer, which means it would be given after other treatments to help keep the cancer from returning.

Ovarian Cancer – A disease where abnormal cells develop in the ovaries, which are female reproductive glands responsible for producing eggs and female hormones. These abnormal cells grow uncontrollably, forming tumors that can invade nearby tissues and organs. As the cancer progresses, it may spread (metastasize) to other parts of the body, such as the pelvis, abdomen, or distant organs. Symptoms often appear only in advanced stages and may include abdominal bloating, pelvic pain, difficulty eating, and frequent urination. The disease typically advances through several stages, with higher stages indicating more extensive spread beyond the ovaries.

Recurrent Ovarian Cancer – A condition where ovarian cancer returns after a period of remission following initial treatment. The cancer may recur in the same location as the original cancer or in other areas of the body. Recurrence can happen months or years after the initial treatment is completed. Each recurrence may be more difficult to control than the previous occurrence, as cancer cells can develop resistance to previously effective treatments. Symptoms of recurrent ovarian cancer are similar to those of the initial disease and may include abdominal pain, bloating, and changes in bowel or bladder habits.

Trial ID:

2025-521125-33-00

Protocol code:

CPG-01-201

NCT ID:

NCT06888921

Trial Phase:

Human Pharmacology (Phase I) – Other

Other Trials to Consider

#1 Clinical Trials Search in Europe

Evaluation of COM701 as Maintenance Therapy for Patients with Relapsed Platinum-Sensitive Ovarian Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?