Study on GEN1046 and Pembrolizumab for Patients with Advanced Endometrial Cancer

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What is this study about?

This clinical trial is focused on studying the treatment of advanced endometrial cancer, a type of cancer that begins in the lining of the uterus and has progressed to a more severe stage. The study will explore the effects of a new treatment called GEN1046, also known by its code name DuoBody®-PD-L1x4-1BB. This treatment is being tested in combination with other anticancer agents, including KEYTRUDA, which is a medication used to help the immune system fight cancer.

The purpose of the study is to evaluate how well the combination of GEN1046 and other anticancer therapies works in treating patients with advanced endometrial cancer. Participants in the study will receive these treatments through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will monitor the safety and initial effectiveness of the treatment over a period of up to 24 months.

Throughout the study, researchers will assess how the cancer responds to the treatment, including how long any positive effects last and the time it takes for the treatment to start working. They will also keep track of any side effects or unusual laboratory results that may occur. This information will help determine the potential benefits and risks of using GEN1046 in combination with other anticancer agents for treating advanced endometrial cancer.

1 joining the trial

Upon joining the trial, you will be informed about the study’s purpose, procedures, and potential risks and benefits. You will be asked to provide informed consent, which means you agree to participate after understanding all the information provided.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history and performing necessary tests to ensure you meet the criteria for participation.

3 treatment administration

You will receive two medications: GEN1046 and pembrolizumab. Both are administered through an intravenous infusion, which means they are given directly into your vein.

GEN1046 is part of the study treatment and will be given in combination with other anticancer agents. Pembrolizumab, also known as KEYTRUDA, is a concentrate for solution for infusion. The specific dosage and frequency will be determined by the study team based on your individual needs.

4 monitoring and follow-up

Throughout the trial, regular monitoring will be conducted to assess your response to the treatment. This includes physical exams, blood tests, and imaging studies to evaluate the effect of the medications on your cancer.

You will be asked to report any side effects or changes in your health to the study team. This information is crucial for ensuring your safety and the success of the trial.

5 completion of the trial

At the end of the trial, a final assessment will be conducted to evaluate the overall impact of the treatment. You will receive information about your health status and any further steps that may be necessary.

The study team will discuss the results with you and provide guidance on any additional treatment options if needed.

Who Can Join the Study?

Must have a confirmed diagnosis of advanced endometrial cancer, which means the cancer cannot be removed by surgery, has come back, or has spread to other parts of the body. The cancer must be incurable, and previous standard treatment must have failed.
Before starting the study, there must be documentation of the tumor’s dMMR/MSI-H status. This refers to specific genetic characteristics of the tumor, which should have been tested using approved methods.
Must have had the cancer worsen after receiving at least one, but no more than two, previous treatments with chemotherapy for cancer that cannot be removed or has spread. At least one of these treatments should have included platinum-based chemotherapy, unless the patient cannot tolerate it or is not eligible for it.
For Cohort A: Must not have received any previous treatment with checkpoint inhibitors (CPIs), which are a type of immune therapy, including PD-1 or PD-L1 inhibitors and other similar treatments.
For Cohort B: Must have received and had the cancer worsen after treatment with a PD-1/PD-L1 inhibitor, either alone or in combination with other treatments. The duration of this treatment and the best response to it must be known, and the patient must have received at least two cycles of this treatment.
Must be female.

Who Cannot Join the Study?

Patients who are not diagnosed with advanced endometrial cancer cannot participate.
Only female patients are eligible for the study.
Patients who are under 18 years old cannot participate.
Patients who are part of a vulnerable population may not be eligible. This means groups of people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Katholieke Universiteit te Leuven	Leuven	Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain
Grand Hopital De Charleroi	Charleroi	Belgium
Odense University Hospital	Odense	Denmark
Aalborg University Hospital	Aalborg	Denmark
Rigshospitalet	Copenhagen	Denmark
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centre hospitalier universitaire de Liege	Liege	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Universitario 12 De Octubre	Madrid	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.	Siedlce	Poland
Azienda Ospedaliera Ordine Mauriziano Di Torino	Turin	Italy
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku	Bialystok	Poland
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Ciptqdtyc Uinvubsaadbmbu Sdcfmotrh	Woluwe-Saint-Lambert	Belgium
Akakcwv Ovzhthiyvfj Uikzjvjtznqll Cezghnxvgmlc Dtnuz Staexs E Dulsw Szptssn Da Tipmow	Turin	Italy
Abijwio Utgxv Szcnwvuxu Lasnyr Dm Bthcxke	Bologna	Italy
Hgorpqrw Vogc dpvwwhro	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.07.2023
Denmark	Not recruiting	01.07.2023
Italy	Not recruiting	01.07.2023
Poland	Not recruiting	01.07.2023
Spain	Not recruiting	01.07.2023

Trial locations

Investigated drugs:

GEN1046 is a medication being studied for its potential to help treat advanced endometrial cancer. It is designed to work by targeting specific proteins on cancer cells, which may help the body’s immune system recognize and attack these cells more effectively. This medication is being tested in combination with other anticancer treatments to see if it can improve outcomes for patients with this type of cancer.

Investigated diseases:

Endometrial cancer

Advanced Endometrial Cancer – Endometrial cancer originates in the lining of the uterus, known as the endometrium. In its advanced stages, the cancer has spread beyond the uterus to other parts of the body. The progression of this disease involves the growth and spread of cancerous cells, which can invade nearby tissues and organs. As the disease advances, it may affect the bladder, rectum, and distant organs such as the lungs or liver. The spread of cancer cells occurs through the lymphatic system or bloodstream. Symptoms may include abnormal vaginal bleeding, pelvic pain, and weight loss.

Trial ID:

2022-502453-33-00

Protocol code:

GCT1046-05

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on GEN1046 and Pembrolizumab for Patients with Advanced Endometrial Cancer

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