AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

COLOMBE - A multicentre, single arm, phase 1/2 study, aiming to assess the safety and efficacy of nivolumab and imiquimod combination in vulvar squamous cell carcinoma patients

This research, called COLOMBE, is a study for women with vulvar squamous cell carcinoma. It's investigating a new treatment approach that combines two medicines: OPDIVO (nivolumab), given through a drip, and ALDARA (imiquimod) cream. The main goals are to understand how safe this combination is and how well it works to shrink the cancer. In the first phase, we'll carefully watch for any side effects. In the second phase, we'll measure how much the tumours shrink. We'll also look at things like how quickly the cancer responds, whether it comes back, overall survival, and the impact on quality of life.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Centre Leon Berard

Enrolment target

Start

22 Apr 2026

Vulvar Squamous Cell Carcinoma (VSCC) patients

What is this study about?

This study, called COLOMBE, is designed for women who have vulvar squamous cell carcinoma. This is a type of cancer that develops on the outer part of the female genitals. The research aims to explore a new way of treating this condition by combining two different medications: nivolumab, which is given through a drip, and imiquimod, which is a cream applied to the skin. The hope is that by using these two treatments together, we can find a more effective way to fight the cancer.

The study has two main parts. The first part, called Phase 1, focuses on safety. Doctors will be looking very carefully at any side effects people might experience when taking this combination of medicines for the first time. They want to make sure the treatment is as safe as possible before moving on. The second part, Phase 2, will then look at how well the treatment works. This involves measuring if and how much the tumours shrink after treatment.

Beyond safety and initial tumour shrinkage, the study will also look at other important details. This includes understanding the treatment's full effect on the cancer cells, checking if the cancer completely disappears from the treated area, and whether it spreads to nearby lymph nodes. Researchers will also be monitoring how patients recover after surgery, how long people live after treatment, and if the cancer returns. Importantly, they will also be asking about patients' quality of life to understand how the treatment impacts their daily living.

Key takeaways

Tests a new combination treatment (nivolumab and imiquimod cream) for vulvar squamous cell carcinoma.
First, checks treatment safety, then how well it shrinks tumours.
Involves regular hospital visits, blood tests, and scans.
Includes assessments at the time of surgery to see treatment effects.
Also monitors overall survival, cancer recurrence, and quality of life.

Who may be eligible?

To be able to join this study, you need to be an adult woman, at least 18 years old, and have been diagnosed with vulvar squamous cell carcinoma. The study is specifically looking for people with this particular type of cancer.

There will be other specific medical requirements that your doctor will discuss with you. These usually involve your general health, how well your organs are working, and any other medications you might be taking. These detailed checks are important to make sure the study treatment is suitable and safe for you.

It's important to remember that not everyone with vulvar squamous cell carcinoma will be able to join, as studies have strict rules to ensure the safety of participants and the accuracy of the results. Your specialist will be able to tell you if this study might be an option for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult woman, aged 18 or over?
Have you been diagnosed with vulvar squamous cell carcinoma?
Are you able to attend regular hospital appointments for tests and treatment?
Are you willing to apply a cream as part of the treatment?

Answer every question to see your result.

What does participation involve?

If you decide to participate in this study, you would receive two different medications: nivolumab, given as a drip into your vein, and imiquimod, which is a cream you would apply. The first six weeks are particularly important for checking safety, where doctors will closely monitor you for any side effects. After this initial period, the study will continue to track how well the treatment works to shrink the tumour, likely involving regular checks and scans. At the time of surgery, further assessments will be made, including photographs and measurements of the tumour. Throughout the study, you'll have regular hospital visits, blood tests, and scans. You'll also be asked to fill out questionnaires about your quality of life. The exact number of visits and the full duration of your participation will be explained in detail by the study team, and there will be follow-up appointments to track your health and if the cancer returns.

Potential risks and benefits

Taking part in a clinical study means you might be among the first to receive a new combination treatment that could potentially offer a new way to treat vulvar squamous cell carcinoma. While there's a chance the treatment might help shrink your cancer or improve your condition, there's no guarantee it will work for everyone, or that it will be better than standard treatments. As with all medications, there's a risk of side effects from both nivolumab and imiquimod, some of which could be serious. The study team will carefully monitor you for any reactions and explain all potential risks. You have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What type of cancer is this study for?

This study is for women who have vulvar squamous cell carcinoma, a type of cancer affecting the outer female genitals.

What treatments are being tested?

The study is testing a combination of two medicines: nivolumab, given through a drip, and imiquimod cream.

What are the main goals of the study?

The main goals are to find out how safe this combination treatment is and how well it works to shrink the cancer.

Will I need surgery if I join the study?

Yes, part of the study involves assessing the tumour at the time of surgery to see how well the treatment has worked.

How long will I be in the study?

The exact duration will depend on individual circumstances, but you will have follow-up appointments to monitor your health and any cancer recurrence.