Study of Rucaparib and Nivolumab for Maintenance Treatment in Patients with Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer After Chemotherapy

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What is this study about?

This clinical trial is focused on studying treatments for ovarian cancer, specifically in patients with advanced stages of the disease, such as high-grade epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. The study is evaluating the effectiveness of two medications: Rucaparib, which is taken orally in the form of film-coated tablets, and Nivolumab (also known by its code name BMS936558), which is administered intravenously as a solution for infusion. The purpose of the study is to assess how well these treatments work as maintenance therapy after patients have responded to initial chemotherapy treatments that include platinum-based drugs.

Participants in the study will be divided into different groups to receive either the medications or a placebo. The study will compare the effects of taking Rucaparib alone, Rucaparib combined with Nivolumab, or a placebo. The trial will monitor the progression of the disease and overall survival rates among participants. The study aims to determine if these treatments can help maintain the positive effects of the initial chemotherapy and delay the progression of the cancer.

The trial will be conducted over several years, with participants receiving treatment and being monitored for any changes in their condition. The study will use specific criteria to evaluate the effectiveness of the treatments, such as the time it takes for the disease to progress or for any adverse effects to occur. The results will help determine the potential benefits of using Rucaparib and Nivolumab as part of a long-term treatment plan for patients with advanced ovarian cancer.

1 randomization

After completing front-line platinum-based chemotherapy and surgery, the patient is randomized within 8 weeks of the last chemotherapy cycle.

Randomization involves being assigned to one of the study groups, which determines the treatment received.

2 treatment initiation

The patient begins the assigned treatment regimen. This may include oral rucaparib and/or intravenous nivolumab, or placebos for these medications.

The specific treatment arm determines the combination and form of medication received.

3 medication administration

If assigned to receive rucaparib, the patient takes it orally in the form of film-coated tablets. Dosages may vary between 200 mg, 250 mg, or 300 mg tablets.

If assigned to receive nivolumab, it is administered intravenously as a solution for infusion.

4 monitoring and assessments

Throughout the trial, the patient’s health and response to treatment are monitored through regular assessments.

These assessments include imaging scans to evaluate disease progression and laboratory tests to monitor organ function and overall health.

5 progression-free survival evaluation

The primary goal is to evaluate progression-free survival, which is the time from randomization until disease progression or death.

This evaluation is based on criteria set by the Response Evaluation Criteria in Solid Tumors (RECIST).

6 completion of trial participation

The trial is estimated to conclude by June 2027, at which point the patient’s participation in the study ends.

Final assessments are conducted to gather data on the long-term effects and outcomes of the treatment.

Who Can Join the Study?

The patient must have signed an informed consent form approved by an ethics committee before any study-specific evaluation.
The patient must be at least 18 years old at the time of signing the consent form. In South Korea, Taiwan, and Japan, the patient must be at least 20 years old.
The patient must have newly diagnosed, advanced, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer.
The patient must have completed surgery to remove cancer, including the removal of both ovaries and part of the omentum, either before or after chemotherapy.
The patient must have received 4 to 8 cycles of first-line platinum-based chemotherapy, including at least 4 cycles of a platinum and taxane combination.
The patient must have completed chemotherapy and surgery with a response, meaning no evidence of disease progression as determined by the investigator.
The patient’s CA-125 levels, a marker used to assess ovarian cancer, must meet specific criteria before treatment.
The patient must be randomized within 8 weeks of the first day of the last cycle of chemotherapy.
The patient must have enough tumor tissue available for analysis, which must be received at the central laboratory at least 3 weeks before starting treatment.
The patient must have adequate organ function, confirmed by specific laboratory tests, including blood, liver, and kidney function tests.
The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, which indicates the patient’s ability to carry out daily activities.

Who Cannot Join the Study?

Patients who have not responded to initial treatment with platinum-based chemotherapy. This is a type of cancer treatment that uses drugs containing the metal platinum to kill cancer cells.
Patients with cancer that is not classified as advanced (FIGO stage III-IV). FIGO is a system used to describe how much cancer has spread. Stage III-IV means the cancer is more advanced.
Patients with cancer types other than high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer. These are specific types of cancer affecting the ovaries, fallopian tubes, or the lining of the abdomen.
Patients who are male, as the study is only for female participants.
Patients who are part of a vulnerable population, meaning they 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
Pomeranian Medical University	Szczecin	Poland
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Jerez de la Frontera	Jerez De La Frontera	Spain

Other Sites

Site Name	City	Country
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Alexandra Hospital	Athens	Greece
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Universitaetsklinikum Mannheim GmbH	Mannheim	Germany
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Hospital Son Llatzer	Palma	Spain
Aalborg University Hospital	Aalborg	Denmark
Hospital Universitario Virgen De Valme	Sevilla	Spain
Oncomed S.R.L.	Timisoara	Romania
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Mazowiecki Szpital Brodnowski Sp. z o.o.	Warsaw	Poland
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Masarykuv Onkologicky Ustav	Brno-Stred	Czechia
University Hospital Limerick	Limerick	Ireland
ARNAS Garibaldi Di Catania	Catania	Italy
Euromedica General Clinic Of Thessaloniki	Thessaloniki	Greece
Azienda Unita Locale Socio Sanitaria N 8 Berica	Vicenza	Italy
Bon Secours Hospital Cork	Cork	Ireland
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie	Poznan	Poland
Consorcio Hospitalario Provincial De Castellon	Castello De La Plana	Spain
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku	Bialystok	Poland
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Spitalul Clinic Judetean De Urgenta Bihor	Oradea	Romania
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate	Chieti	Italy
Cvlg Ufrvvrwqwf Hbulhudo	Cork	Ireland
Sfvixsip Pkywprcjf Szl z okuh	Gdynia	Poland
Umjchutqwwhnjgppsciol Dopjbdubjnu Akh	Duesseldorf	Germany
Htvaatpn Vahf dtkzfayi	Barcelona	Spain
Upcuzhrgpw Gdenwzk Hocqvbiz Apqhbvb	Athens	Greece

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	28.12.2018
Czechia	Not recruiting	28.12.2018
Denmark	Not recruiting	28.12.2018
Germany	Not recruiting	28.12.2018
Greece	Not recruiting	28.12.2018
Ireland	Not recruiting	28.12.2018
Italy	Not recruiting	28.12.2018
Poland	Not recruiting	28.12.2018
Romania	Not recruiting	28.12.2018
Spain	Not recruiting	28.12.2018
Sweden	Not recruiting	28.12.2018

Trial locations

Investigated drugs:

Rucaparib is a medication used in this trial as a maintenance treatment for ovarian cancer patients. It is taken orally and works by inhibiting a specific enzyme involved in repairing damaged DNA in cancer cells. This can help prevent the cancer cells from repairing themselves, leading to their death and potentially slowing the progression of the disease.

Nivolumab is an intravenous medication used in combination with rucaparib in this trial. It is an immunotherapy drug that helps the immune system recognize and attack cancer cells. By blocking a specific protein on the surface of immune cells, nivolumab can enhance the body’s natural defenses against cancer, potentially improving the effectiveness of the treatment.

Investigated diseases:

Advanced High-Grade Epithelial Ovarian Cancer – This is a type of cancer that originates in the cells on the surface of the ovary and is characterized by high-grade tumors, indicating aggressive growth. It is typically diagnosed at an advanced stage, specifically FIGO stage III-IV, where the cancer has spread beyond the ovaries to other parts of the pelvis or abdomen. The disease often responds initially to platinum-based chemotherapy, but recurrence is common.

Malignant Peritoneal Neoplasm – This refers to a cancerous growth occurring in the peritoneum, the thin layer of tissue lining the abdomen and covering most abdominal organs. It can originate from primary peritoneal cancer or be secondary, spreading from other abdominal cancers. The disease is often detected at an advanced stage due to its non-specific symptoms and can involve widespread peritoneal surfaces.

Ovarian Epithelial Cancer – This cancer arises from the epithelial cells covering the ovary and is the most common type of ovarian cancer. It often presents with vague symptoms, leading to diagnosis at a later stage when the cancer has spread. The disease is known for its potential to recur after initial treatment, which typically involves surgery and chemotherapy.

Fallopian Tube Cancer – A rare type of cancer that begins in the fallopian tubes, which connect the ovaries to the uterus. It shares similarities with ovarian cancer in terms of symptoms and treatment approaches. The disease is often diagnosed at an advanced stage due to its subtle early symptoms and can spread to nearby organs.

Trial ID:

2024-516662-11-00

Protocol code:

CO-338-087

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Rucaparib and Nivolumab for Maintenance Treatment in Patients with Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer After Chemotherapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?