Study of NP137 with carboplatin, paclitaxel and pembrolizumab combination therapy for patients with advanced endometrial or cervical cancer who had prior chemotherapy

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What is this study about?

This study focuses on treating patients with endometrial carcinoma or cervical carcinoma that has spread locally or to other parts of the body (advanced/metastatic) and has gotten worse after previous treatment. The study tests a new combination of medications including a new drug called NP137 (a human antibody that targets a specific protein) together with established cancer drugs carboplatin, paclitaxel, and/or Keytruda (pembrolizumab).

The purpose of this study is to evaluate how safe and effective these drug combinations are for treating these types of cancer. The study is divided into two parts – first checking the safety of the treatment combinations, and then examining how well they work in fighting the cancer.

During the study, participants will receive their assigned treatment combination through intravenous infusion. The treatments will be given in cycles, and patients will be monitored regularly to check their response to the treatment. Doctors will use imaging scans to measure if tumors are shrinking and will track any side effects that may occur. The total treatment period may last up to 24 months, depending on how well patients respond to the treatment.

1 Initial evaluation

Your medical tests must be completed within 7 days before starting treatment to confirm adequate organ function

A pregnancy test will be conducted if applicable (within 72 hours before starting treatment)

Your tumor tissue sample will be collected for analysis

2 Treatment administration

You will receive four medications through intravenous infusion:

– Carboplatin

– Paclitaxel

– NP137 (antibody medication)

– Keytruda (pembrolizumab)

Regular monitoring of your heart function will be performed, including blood pressure checks and heart tests

Blood samples will be collected to monitor your response to treatment

3 Response monitoring

Your response to treatment will be evaluated after 3 months

Regular imaging scans will be performed to assess how your tumor responds to treatment

Your doctor will monitor any side effects using standardized criteria

Additional blood tests will be performed to check your organ function and overall health

4 Follow-up period

You will need to continue using effective contraception for 6 months after completing treatment if applicable

Regular check-ups will continue to monitor your health status

Your survival and disease status will be tracked throughout the study period until September 2026

Who Can Join the Study?

Must be a woman aged 18 years or older
Must have confirmed advanced endometrial cancer (except endometrial sarcoma) or cervical cancer that has spread or come back after previous treatment
Must have received at least one but no more than 3 previous chemotherapy treatments containing platinum drugs
For endometrial cancer patients: Must have available genetic test results (MSI/MSS status) before starting the study
Must have evidence that disease has grown after previous chemotherapy, with at least one tumor that can be measured
Must provide a tumor sample (either stored or newly collected)
Must have a life expectancy of at least 3 months
Must be able to perform daily activities with minimal assistance (ECOG performance status of 0 or 1)
Must have adequate heart function:
– Normal heart rhythm (QTcF less than 470ms)
– Normal blood pressure
– Good heart pumping function (LVEF greater than 50%)
Must have adequate blood cell counts, kidney function, and liver function based on laboratory tests
If able to become pregnant, must have a negative pregnancy test and agree to use two forms of effective birth control during the study and for 6 months after
Must be able to understand and sign the informed consent form
Must be willing and able to attend all study visits and follow study procedures

Who Cannot Join the Study?

Prior treatment with immunotherapy (treatment that helps your immune system fight cancer)
Active or untreated brain metastases (cancer that has spread to the brain)
Uncontrolled high blood pressure or heart disease
Active autoimmune disease (when your immune system attacks healthy cells in your body)
Pregnancy or breastfeeding
Male patients (study is only for female participants)
Age under 18 years
Active infections requiring systemic treatment (medications that affect your whole body)
History of other cancers within the last 3 years (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
Severe kidney or liver problems
Known allergies to study medications
Participation in another clinical trial within 30 days before starting this study
Mental conditions that could interfere with study compliance
HIV, hepatitis B, or hepatitis C infection

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Centr Georges Francois Leclerc	Dijon	France

Other Sites

Site Name	City	Country
Groupe Hospitalier Diaconesses Croix Saint Simon	Paris	France
Hopital Beaujon	Clichy	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Centre Francois Baclesse	Caen	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Ibmxqkwf Rhvguvsb Dh Cmemik Dr Mmptbgwbthh	Montpellier	France
Clffbn Lcjg Bmypho	Lyon	France
Bpbaarpu Ugyavltmse Hvmmtcjm Cikkgx	Besançon	France
Ildglhgm Pvsfdoogetjftkb Cwyrjm Cwnbpn	Marseille	France
Chfaph Oqemp Lnrztgs	Lille	France
Ilmjwovm Cqrlu	Paris	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.09.2020

Trial locations

Investigated drugs:

NP137 (Netrin-1 antibody) is a humanized monoclonal antibody that targets Netrin-1. It is an experimental medication being tested for treating advanced endometrial and cervical cancer. This antibody works by targeting specific proteins involved in cancer growth.

Carboplatin is a chemotherapy medication commonly used to treat various types of cancer. It works by interfering with cancer cell DNA, which helps stop cancer cells from growing and dividing.

Paclitaxel is a chemotherapy medication that works by stopping cancer cells from dividing. It is commonly used in combination with other cancer treatments and is effective against various types of cancer.

Pembrolizumab is an immunotherapy medication that helps the body’s immune system detect and fight cancer cells. It works by blocking a protein that prevents T-cells (immune cells) from attacking cancer cells, allowing the immune system to work more effectively against the cancer.

Investigated diseases:

Endometrial Carcinoma – A cancer that develops in the lining of the uterus (endometrium). It begins when cells in the endometrium start growing abnormally and multiply without control. The cancer can grow locally within the uterus and may spread to nearby tissues. In advanced stages, it can spread to other parts of the body through the lymphatic system or bloodstream.

Cervical Carcinoma – A cancer that forms in the cells of the cervix, which is the lower part of the uterus. It develops gradually, starting as abnormal cell growth in the cervical tissue. These abnormal cells multiply and can spread to surrounding tissues. In advanced stages, the cancer can extend beyond the cervix to nearby organs and may spread to distant parts of the body.

Trial ID:

2024-510714-32-00

Protocol code:

ET-20-049

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of NP137 with carboplatin, paclitaxel and pembrolizumab combination therapy for patients with advanced endometrial or cervical cancer who had prior chemotherapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?