Study of pembrolizumab and lenvatinib treatment for patients with vulvar cancer

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What is this study about?

This clinical trial focuses on patients with vulvar cancer, a type of cancer that develops in the external part of the female reproductive organs. The study will test a combination of two medications: Pembrolizumab (also known as KEYTRUDA), which is given through an intravenous infusion, and Lenvatinib, which is taken as an oral capsule. The purpose of this research is to determine how well these medications work together and how safe they are for treating vulvar cancer patients.

The study is designed for different groups of patients with vulvar cancer: those with tumors that cannot be removed by surgery, those who have never received chemotherapy for their recurrent or spreading cancer, and those whose cancer has returned after previous treatment or has spread despite chemotherapy. The treatment involves receiving both medications – Pembrolizumab through an infusion into a vein and Lenvatinib as daily capsules.

During the study, doctors will monitor how the cancer responds to the treatment combination and watch for any side effects. Patients will have regular check-ups and medical tests to evaluate their health status. The medication doses are carefully determined – Pembrolizumab will be given at 200 mg through infusion, while Lenvatinib will be given at 20 mg daily in capsule form.

1 Initial examination and tests

A medical examination will be performed to confirm your eligibility for the trial, including blood tests to check organ function and blood counts

Your blood pressure must be ≤140/90 mmHg to participate

A pregnancy test will be required if you are able to become pregnant

A tumor sample analysis will be performed before enrollment

2 Treatment initiation

You will receive two medications during the trial:

Lenvatinib – taken as capsules by mouth daily

Pembrolizumab (KEYTRUDA) – given through an intravenous infusion (into a vein)

3 Treatment cycles and monitoring

Your response to treatment will be evaluated after 4 treatment cycles if you have a primary tumor

Regular assessments will be performed to monitor your condition throughout the treatment period

Blood tests and imaging scans will be conducted to track your progress

Side effects will be monitored using standardized criteria

4 Safety monitoring

Regular check-ups will include:

Blood pressure measurements

Blood tests to monitor organ function

Assessment of any side effects

Completion of questionnaires about your experience with the treatment

5 Long-term follow-up

The study will continue until September 2031

Regular monitoring will continue throughout your participation in the trial

Your response to treatment will be assessed using standardized criteria to measure tumor changes

Who Can Join the Study?

Must be female and at least 18 years old
Must have signed an informed consent form before any study procedures
Must have confirmed vulvar cancer that is either:
– Too large to be removed by surgery, or
– Has come back after previous treatment, or
– Has spread to other parts of the body
Must have at least one tumor that can be measured
Must have good overall physical function (able to carry out all light daily activities)
Must have normal organ and bone marrow function, including:
– Adequate blood count
– Proper liver function
– Good kidney function
Must have well-controlled blood pressure (140/90 or lower)
Must be able to take medications by mouth
Must have a life expectancy of at least 16 weeks
Must provide a tumor tissue sample for testing
If able to become pregnant:
– Must have a negative pregnancy test
– Must use highly effective birth control
– Must not be pregnant or breastfeeding
Must be willing and able to attend all scheduled visits and follow the study plan

Who Cannot Join the Study?

Age below 18 years old
Male patients (study is for females only)
Current pregnancy or breastfeeding
Active or untreated brain metastases (cancer that has spread to the brain)
History of other malignancies (other types of cancer) within 2 years before starting the study
Severe heart conditions including:
- Heart failure
- Unstable angina (chest pain)
- Recent heart attack within last 6 months
Severe kidney disease requiring dialysis (blood filtering treatment)
Active autoimmune disease (condition where immune system attacks healthy cells)
Active infection requiring systemic treatment (medication that affects the whole body)
Previous treatment with similar medications (pembrolizumab or lenvatinib)
Participation in another clinical trial within 30 days before starting this study
Known allergic reactions to the study medications
Psychological or social conditions that would interfere with study participation

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Azienda Unita Locale Socio Sanitaria N 8 Berica	Vicenza	Italy
Azienda Ospedaliera Ordine Mauriziano Di Torino	Turin	Italy
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana	Treviso	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Hdkiuxazk Mqxusrbi Sukksr	Milan	Italy
Iutdfk Icyvhjgy Fgruraaohxqjr Otakujwsxid	Rome	Italy
Iqbfdwkb Rvnnkllri Ptd Lf Slbgha Drn Tyoabj Demg Abiebjk Iqfr Sdkwow	Meldola	Italy
Ahvlveu Ofqklbtsfqf Pjl Litzyusvyxhudpzbn Cgwfmlrwpp	Catania	Italy
Agtmzla Ujq Iccih Dl Rvrqxm Evyohv	Reggio Emilia	Italy
Awyuyfd Ucwtl Smlijehew Lcnqos Dr Bdgqimp	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.09.2025

Trial locations

Investigated drugs:

Pembrolizumab is a type of immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein called PD-1, which allows your body’s immune cells to better recognize and attack cancer cells. This medication is given through an intravenous (IV) infusion.

Lenvatinib is a targeted therapy medication that works by blocking certain proteins that help cancer cells grow and survive. It specifically interferes with the formation of new blood vessels that feed tumors. This medication is taken by mouth in the form of capsules.

The combination of these two medications is being studied to treat vulvar cancer, with the goal of determining how well they work together and how safe this combination is for patients.

Vulvar Cancer – A rare type of cancer that develops in the vulva, which is the external part of the female genitals. The disease typically begins in the outer layer of skin cells of the vulva. It most commonly affects the labia, but can occur on any part of the external female genitalia. The condition usually develops slowly over several years, often starting with precancerous changes in the skin cells. As the disease progresses, it can cause symptoms such as persistent itching, pain, tenderness, or bleeding in the vulvar area. The cancer can appear as a lump or growth on the vulva that might be red, pink, or white in color.

Trial ID:

2023-509180-24-00

Protocol code:

MITO VULVA-01

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of pembrolizumab and lenvatinib treatment for patients with vulvar cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?