Study of Nemvaleukin Alfa and Pembrolizumab for Patients with Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.

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What is this study about?

This clinical trial is focused on studying a type of cancer known as platinum-resistant epithelial ovarian cancer, which can also affect the fallopian tubes or the peritoneum, the lining of the abdomen. The study is testing a new treatment combination of two drugs: nemvaleukin alfa and pembrolizumab. Nemvaleukin alfa, also known by its code name ALKS 4230, is a protein-based drug, while pembrolizumab is a well-known medication used in cancer treatment. The trial will compare this combination to standard chemotherapy options chosen by the doctors involved in the study.

The purpose of the study is to evaluate how well the combination of nemvaleukin alfa and pembrolizumab works compared to chemotherapy in improving the survival of patients with this type of cancer. Participants in the study will receive either the new drug combination or chemotherapy, which may include drugs like topotecan hydrochloride, gemcitabine hydrochloride, paclitaxel, or doxorubicin hydrochloride. The treatment will be given through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein.

Throughout the study, participants will have regular visits to monitor their health and the effects of the treatment. The study aims to gather information on overall survival, how long patients live without the cancer getting worse, and the response of the cancer to the treatment. Safety will also be closely monitored by checking for any side effects or changes in health. The study is expected to continue until 2027, providing valuable insights into the effectiveness of this new treatment approach for patients with platinum-resistant ovarian cancer.

1 enrollment

Upon joining the study, the patient will be randomly assigned to one of two groups: one receiving a combination of nemvaleukin alfa and pembrolizumab, and the other receiving chemotherapy chosen by the investigator.

The patient will provide a tumor tissue sample for testing, which may be from a previous biopsy or a new biopsy conducted during the screening phase.

2 treatment initiation

The patient will begin treatment according to the assigned group. If assigned to the combination therapy group, the patient will receive nemvaleukin alfa and pembrolizumab via intravenous infusion.

If assigned to the chemotherapy group, the patient will receive one of the following medications via intravenous infusion: topotecan hydrochloride, gemcitabine hydrochloride, paclitaxel, doxorubicin hydrochloride, or topotecan hydrochloride.

3 treatment schedule

The treatment will be administered in cycles, with specific dosages and frequencies determined by the study protocol. The duration of each cycle and the number of cycles will depend on the patient’s response to the treatment and the specific medication regimen.

4 monitoring and assessments

Throughout the study, the patient will undergo regular assessments to monitor the effectiveness of the treatment and any side effects. These assessments will include physical examinations, blood tests, imaging studies, and evaluations of cancer markers.

The patient’s response to treatment will be evaluated using criteria such as progression-free survival, objective response rate, and disease control rate.

5 completion of treatment

The treatment will continue until the patient experiences disease progression, unacceptable side effects, or chooses to withdraw from the study.

Upon completion of the treatment, the patient will undergo a final assessment to evaluate the overall outcome and any long-term effects of the treatment.

Who Can Join the Study?

The patient must be a female who is 18 years of age or older.
The patient must have provided written informed consent, either personally or through a legal representative.
The patient must be willing and able to attend scheduled visits, follow the treatment schedule, and undergo laboratory tests and other study requirements.
The patient must have a confirmed diagnosis of one of the following cancers: epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. The cancer type must be high-grade serous, endometrioid of any grade, or clear cell.
The patient must have platinum-resistant or refractory disease, meaning the cancer has progressed within 180 days after the last dose of platinum therapy beyond the first treatment setting.
The patient must have received at least one prior line of platinum-based therapy and no more than five prior lines of systemic anticancer therapy. At least one line of therapy must have included bevacizumab.
The patient must have at least one measurable tumor lesion that can be used to assess the response to treatment.
The patient must be willing to provide a tumor tissue sample, either from a previous biopsy or surgery or from a new biopsy at the time of screening.
The patient must have recovered from the effects of any previous cancer treatments, such as chemotherapy or surgery, with no severe side effects remaining.
If the patient has received prior cancer treatments, they must wait a certain period before joining the study, depending on the type of treatment.
The patient must have a good general health status, with an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1, and an expected life expectancy of at least three months.
The patient must have adequate blood cell counts and hemoglobin levels, which may be supported by certain medications if needed.
The patient must have proper liver function, with specific limits on liver enzyme and bilirubin levels.
The patient must have proper kidney function, as shown by a creatinine clearance rate or serum creatinine level within acceptable limits.
The patient must have normal blood clotting times unless they are on blood-thinning medication, in which case the levels must be within the desired range for that medication.
The patient must agree to follow specific contraceptive guidelines during the study.
Women who can become pregnant must have a negative pregnancy test before starting the study.

Who Cannot Join the Study?

Patients who are not female cannot participate in the study.
Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important to check if you fall within the eligible age group.
Patients who are part of a vulnerable population may not be eligible. This means people who might need special protection or care, like those with certain disabilities or conditions.
Patients with medical conditions other than Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Institut Gustave Roussy	Villejuif	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Oslo Universitetssykehus HF	Oslo	Norway
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Medical University Of Vienna	Vienna	Austria
Hospital Clinico San Carlos	Madrid	Spain
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Medical University Of Graz	Graz	Austria

Other Sites

Site Name	City	Country
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Algemeen Ziekenhuis Klina	Brasschaat	Belgium
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
CHU Saint Pierre	Brussels	Belgium
Hospital Universitario 12 De Octubre	Madrid	Spain
Masarykuv Onkologicky Ustav	Brno-Stred	Czechia
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos	Kaunas	Lithuania
Fakultni Nemocnice Bulovka	Prague	Czechia
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Azienda Ospedaliera Ordine Mauriziano Di Torino	Turin	Italy
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana	Treviso	Italy
Institut De Cancerologie Strasbourg Europe	STRASBOURG, Alsace	France
Sørlandet sykehus Kristiansand	Kristiansand	Norway
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Saarland University Hospital	Homburg	Germany
Universitaetsklinikum Mannheim GmbH	Mannheim	Germany
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Klinik Hietzing	Vienna	Austria
Azienda USL Toscana Centro	Prato	Italy
CHC MontLegia	Liege	Belgium
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Groupe Hospitalier Diaconesses Croix Saint Simon	Paris	France
Rigshospitalet	Copenhagen	Denmark
Azienda Sanitaria Locale Della Provincia Di Biella	Ponderano	Italy
Vilnius University Hospital	Vilnius	Lithuania
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Region Sjaelland	Holbæk	Denmark
Curadewsd Unxoaqqdllzudv Syffldgbk	Woluwe-Saint-Lambert	Belgium
Hdqagf Dsp Hveqz Sqvjdcc Kdfjftds Wvlboecws Gzgw	Wiesbaden	Germany
Cbcdkk Ldgs Bxjvrd	Lyon	France
Iannqfge Catyua Dtoimpqgrxhojyble	L'hospitalet De Llobregat	Spain
Cnjdgyxs Hloxlqvaaoek Uvjqovgvihbxp Dw Vbfq	Vigo	Spain
Frvzfnboo Pzcv Lx Ibaevviwzfdju Brlequzyo Dau Hnylgedv Uoibapyojtobf Lt Pxu	Madrid	Spain
Kgmnxeqw Extiwmnaucqvvlekxcuwcrne Hdxumafeglfsequjy	Essen	Germany
Imlrmbqx Pnlmoertyhxmwkl Cdpcof Ccqsrj	Marseille	France

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	02.06.2023
Belgium	Not recruiting	02.06.2023
Czechia	Not recruiting	02.06.2023
Denmark	Not recruiting	02.06.2023
France	Not recruiting	02.06.2023
Germany	Not recruiting	02.06.2023
Italy	Not recruiting	02.06.2023
Lithuania	Not recruiting	02.06.2023
Norway	Not recruiting	02.06.2023
Spain	Not recruiting	02.06.2023

Trial locations

Investigated drugs:

Nemvaleukin Alfa is a medication being studied for its potential to help the immune system fight cancer. It is used in combination with another drug to see if it can improve survival in patients with certain types of ovarian cancer that have not responded to previous treatments.

Pembrolizumab is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. It is being tested in combination with nemvaleukin alfa to determine if this combination is more effective than standard chemotherapy in treating specific ovarian cancers.

Chemotherapy refers to the use of drugs to kill or slow the growth of cancer cells. In this study, chemotherapy is used as a comparison to see if the combination of nemvaleukin alfa and pembrolizumab offers better outcomes for patients with certain types of ovarian cancer.

Investigated diseases:

Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer – This type of cancer occurs when cancerous cells form in the tissues of the ovaries, fallopian tubes, or the lining of the abdomen, known as the peritoneum. It is termed “platinum-resistant” because the cancer does not respond to chemotherapy treatments that contain platinum-based drugs. The disease often progresses as the cancer cells grow and spread to other parts of the body. Symptoms may include abdominal bloating, pain, and changes in bowel habits. As the disease advances, it can lead to more severe symptoms and complications.

Trial ID:

2024-513230-38-00

Protocol code:

ALKS 4230-007

NCT ID:

NCT05092360

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Nemvaleukin Alfa and Pembrolizumab for Patients with Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?