Study on Niraparib and Dostarlimab for Patients with Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Not Suitable for Platinum Treatment

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What is this study about?

This clinical trial is focused on studying treatments for recurrent ovarian, fallopian tube, or primary peritoneal cancer. These are types of cancer that affect the female reproductive system and the lining of the abdomen. The study is comparing a combination of two medications, niraparib and dostarlimab, against a selection of chemotherapy treatments chosen by a doctor. Niraparib is a medication taken orally, while dostarlimab is given as an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how these treatments affect the overall survival of patients, which means the length of time patients live after starting the treatment. Participants in the study will be randomly assigned to receive either the niraparib-dostarlimab combination or one of the chemotherapy options. The chemotherapy options may include medications such as doxorubicin hydrochloride, gemcitabine hydrochloride, bevacizumab, topotecan, or paclitaxel. These are all anti-cancer agents that work in different ways to stop the growth of cancer cells.

The study will take place over a period of up to 24 months, during which participants will receive their assigned treatment and be monitored regularly. The goal is to determine which treatment option provides the best outcomes for patients with these specific types of cancer. Participants will receive either the active treatment or a placebo, and their health will be closely observed throughout the study to ensure safety and effectiveness.

1 randomization

Upon joining the study, the participant is randomly assigned to one of two groups. One group receives the combination of niraparib and dostarlimab, while the other group receives a chemotherapy treatment chosen by the physician.

2 treatment administration

Participants in the niraparib and dostarlimab group take niraparib orally once daily. Dostarlimab is administered as an intravenous infusion every three weeks.

Participants in the chemotherapy group receive one of the following treatments, as determined by their physician: doxorubicin, gemcitabine, bevacizumab, topotecan, or paclitaxel. These medications are administered intravenously, with the specific schedule and dosage depending on the chosen drug.

3 monitoring and assessments

Throughout the trial, participants undergo regular health assessments to monitor their response to the treatment. This includes blood tests, imaging studies, and other evaluations as needed to assess the disease status and any side effects.

4 follow-up

After completing the treatment phase, participants enter a follow-up period. During this time, their health and disease status continue to be monitored at regular intervals to assess long-term outcomes and overall survival.

Who Can Join the Study?

The participant must have recurrent ovarian, fallopian tube, or primary peritoneal cancer and cannot be treated again with platinum-based drugs. This includes patients who are resistant to platinum (meaning the cancer came back 1-6 months after the first platinum treatment) or those who cannot take platinum due to allergies or side effects.
The participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
The participant must have a measurable disease or be evaluable based on RECIST 1.1 criteria, which is a way to measure how cancer responds to treatment. Patients with only an increase in CA 125 (a protein that can be a sign of cancer) without other evidence of disease are not included.
The participant must be 18 years of age or older.
The participant must have adequate organ function, which includes specific levels of blood cells and liver and kidney function. This means having enough white blood cells, platelets, and hemoglobin, and normal levels of creatinine, bilirubin, and liver enzymes.
If the participant has high blood pressure (hypertension), it should be controlled before starting the study treatment.
The participant must agree not to donate blood during the study and for 90 days after the last dose of the study treatment.
The participant must agree to provide a sample of their tumor tissue, either newly obtained or from an archived specimen.
If the participant is a woman of childbearing potential, she must have a negative pregnancy test before starting the study and agree to avoid pregnancy during the study and for 180 days after the last dose. Women who cannot become pregnant must meet specific criteria, such as being postmenopausal or having had certain surgeries.
The participant must agree not to breastfeed during the study and for 180 days after the last dose of the study treatment.
The participant must be able to understand the study procedures and agree to participate by providing written informed consent.

Who Cannot Join the Study?

Patients who do not have recurrent ovarian, fallopian tube, or primary peritoneal cancer cannot participate. This means the study is only for those who have these specific types of cancer that have come back after treatment.
Only female patients are eligible. Male patients cannot participate in this study.
Patients who are considered part of a vulnerable population are not eligible. This generally refers to groups who may need special protection or care, such as children or those unable to make decisions for themselves.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Centre Jean Perrin	Clermont Ferrand	France
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
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
HELIOS Klinikum Krefeld GmbH	Krefeld	Germany
Institut Godinot	Reims	France
Istituto Di Ricerche Farmacologiche Mario Negri	Ranica	Italy
Hopital Prive Jean Mermoz	Lyon	France
Ospedale San Raffaele S.r.l.	Milan	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Fakultni Nemocnice Brno	Brno	Czechia
Centre Hospitalier De La Cote Basque	Bayonne	France
Azienda USL Toscana Centro	Prato	Italy
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Groupe Hospitalier Diaconesses Croix Saint Simon	Paris	France
Azienda Sanitaria Locale Della Provincia Di Biella	Ponderano	Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Universita Degli Studi Di Brescia	Brescia	Italy
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
University Hospital Ostrava	Ostrava	Czechia
Hhuyrvggm Mhjcvbzi Scyigk	Milan	Italy
Uqozhtswxr Mhialjn Cohjrs Herurmqzimrwykaxs	Hamburg	Germany
Iqkxsq Isrzjvad Fvyrjlddivtib Otskxzdtpcg	Rome	Italy
Iwrddfif Myjnnwkesl Mkkgfieulx	Paris	France
Cfkbzt Hosbvnywjvr Ei Utilnjidzuqwy Dd Lgxaqfq	Limoges	France
Iujxkjyc Rabtolulk Pju Li Slkrdq Daf Tsmaoc Dunq Abocrpa Idxn Smbuyh	Meldola	Italy
Aacxnze Obqkvbfgvci Pdm Lncxscoboxvbwhbwh Cupdvzxdxn	Catania	Italy
Ajjrzmv Ohjxkxwckke Uzptmcfhalikk Cpinpggbtihb Djmgz Seqkvz E Dcmxl Sieqare Dh Tygwwx	Turin	Italy
Ksnqorxf ddv Uwdvvcapjdqi Mwblmcuv Ayn	Munich	Germany
Iyfxujhf Pqepccpujjrcdhf Clnmtq Ccexjt	Marseille	France

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	16.12.2020
France	Recruiting	16.12.2020
Germany	Recruiting	16.12.2020
Italy	Recruiting	16.12.2020

Trial locations

Investigated drugs:

Niraparib is a medication used in this trial to treat patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. It works by blocking certain enzymes in cancer cells, which can help stop the cancer from growing and spreading.

Dostarlimab is another medication used in the trial. It is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. This can help slow down or stop the growth of cancer.

Chemotherapy refers to the use of drugs to kill or slow the growth of cancer cells. In this trial, the specific chemotherapy drugs are chosen by the physician based on the patient’s condition and needs. Chemotherapy can be used to shrink tumors and improve symptoms in patients with cancer.

Investigated diseases:

Recurrent ovarian cancer – This type of cancer occurs when ovarian cancer returns after treatment. It typically involves the growth of cancerous cells in the ovaries, which are the reproductive glands where eggs are produced. The disease may spread to nearby tissues and organs, causing symptoms such as abdominal pain, bloating, and changes in bowel habits. Over time, the cancer can become more aggressive and resistant to treatment. The progression of the disease can vary, with some patients experiencing slow growth and others facing rapid advancement. Monitoring and management are crucial to address the symptoms and complications associated with the recurrence.

Recurrent fallopian tube cancer – This cancer reappears in the fallopian tubes after initial treatment. The fallopian tubes are part of the female reproductive system, connecting the ovaries to the uterus. Recurrent cancer in this area can lead to symptoms like pelvic pain, abnormal bleeding, and swelling. The disease may spread to other parts of the body, complicating the clinical picture. As the cancer progresses, it can become more challenging to manage due to potential resistance to therapies. Regular follow-up is essential to monitor the disease’s behavior and address any arising issues.

Recurrent primary peritoneal cancer – This cancer recurs in the peritoneum, the lining of the abdominal cavity, after previous treatment. It shares similarities with ovarian cancer in terms of symptoms and progression. Patients may experience abdominal discomfort, bloating, and digestive disturbances. The cancer can spread within the abdominal cavity and potentially to other organs. Over time, the disease may become more difficult to control, requiring ongoing assessment and management. Understanding the pattern of recurrence is important for addressing the challenges associated with this condition.

Trial ID:

2024-516649-38-00

Protocol code:

MITO 33

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Niraparib and Dostarlimab for Patients with Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Not Suitable for Platinum Treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?