Not recruiting

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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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
Step 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
Step 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
Step 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 trial?

13 criteria

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 trial?

14 criteria

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

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Besancon University Hospital Center
Verified
Besançon, France
Centr Georges Francois Leclerc
Verified
Dijon, France
Centre De Lutte Contre Le Cancer Eugene Marquis
Verified
Rennes, France

Trial locations

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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.

What is already known about the treatment

NP137
A humanized monoclonal antibody targeting Netrin-1, currently being investigated in clinical trials for gynecological cancers. This medication is administered intravenously in combination with carboplatin, paclitaxel, and/or pembrolizumab for patients with advanced or metastatic endometrial and cervical carcinomas. The drug works by targeting Netrin-1, a protein involved in cancer cell survival and progression, and is being evaluated for its safety and clinical effectiveness in patients who have progressed after prior chemotherapy treatments.
Carboplatin
A platinum-based chemotherapy drug administered intravenously to treat various types of cancer. This medication works by binding to DNA in cancer cells, interfering with their ability to divide and multiply, ultimately leading to cell death. It belongs to the alkylating agents class of chemotherapy drugs and is commonly used in combination therapy for gynecological cancers.
Paclitaxel
An intravenously administered chemotherapy medication derived from the Pacific yew tree. It works by preventing cancer cell division through stabilization of microtubules, essential cellular structures involved in cell division. This drug belongs to the taxane family of medications and is widely used in combination therapy for various cancers, particularly gynecological malignancies.
Pembrolizumab
An immunotherapy medication administered through intravenous infusion that helps the immune system fight cancer cells. It works by blocking the PD-1 pathway, which cancer cells often use to evade immune system detection, thereby allowing the body's T-cells to recognize and attack cancer cells more effectively. This medication belongs to the class of drugs known as checkpoint inhibitors and is used in various cancer treatments.

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.