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Malignant peritoneal neoplasm – Trials in Disease

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Ongoing Clinical Trials for Malignant Peritoneal Neoplasm

Currently, there are 10 clinical trials investigating treatments for malignant peritoneal neoplasm. These trials are testing various approaches including chemotherapy combinations, targeted therapies, immunotherapies, and innovative surgical techniques. Studies are being conducted across multiple European countries, offering patients access to experimental treatments that may improve outcomes for this challenging condition.

Clinical trial locations

Comparison of Niraparib alone versus Niraparib with Bevacizumab in patients with newly diagnosed advanced ovarian cancer after chemotherapy with carboplatin and paclitaxel

This trial is comparing two maintenance treatment approaches for patients with newly diagnosed advanced ovarian, peritoneal, or fallopian tube cancer who have completed initial chemotherapy with carboplatin and paclitaxel. The study tests whether combining niraparib with bevacizumab provides better results than using niraparib alone.

Main inclusion criteria: Patients must be female and at least 18 years old with advanced ovarian, peritoneal, or fallopian tube cancer confirmed through tissue examination. They must have undergone cytoreductive surgery within the past 8 weeks and have good physical function with adequate blood test results showing normal liver, kidney, and blood cell counts. Patients must have normal or well-controlled blood pressure and provide tissue samples for genetic testing. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during treatment and for 6 months afterward.

Main exclusion criteria: The trial excludes patients who have received prior cancer treatment for this condition, have a history of other cancers within the past 5 years, or have brain metastases. Patients with significant cardiovascular disease including uncontrolled high blood pressure, recent heart attack, unstable chest pain, or serious heart rhythm problems cannot participate. Also excluded are those who had major surgery within 4 weeks, have active bleeding, serious infections, are pregnant or breastfeeding, or have allergies to study medications.

Focus and goal: The study aims to determine if adding bevacizumab to niraparib treatment leads to better outcomes than using niraparib alone in preventing cancer progression. Researchers will monitor how long patients remain without their cancer getting worse. The treatment period can last up to 36 months, with regular medical examinations and tests to assess response and side effects. Quality of life will also be evaluated using questionnaires.

Investigational drugs: Niraparib is a PARP inhibitor taken as an oral medication that blocks an enzyme cancer cells need to repair their DNA. Bevacizumab is a targeted therapy given through intravenous infusion that blocks the formation of new blood vessels feeding tumors. The standard chemotherapy drugs carboplatin and paclitaxel are also used initially, both given intravenously to interfere with cancer cell growth and division.

Study of Raludotatug Deruxtecan for Patients with Platinum-resistant High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

This trial tests a new treatment called Raludotatug Deruxtecan for cancers that have not responded well to platinum-based chemotherapy. The study compares this experimental antibody-drug conjugate with standard chemotherapy options to see which approach works better.

Main inclusion criteria: Participants must be at least 18 years old and sign an informed consent form. They need a confirmed diagnosis of high-grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer with platinum-resistant disease. This means the cancer did not respond well to platinum treatments. Patients must have received at least one but no more than three previous treatments and have at least one measurable lesion that can be biopsied. They must be willing to provide tissue samples before and during treatment. Women who can become pregnant must have a negative pregnancy test and use highly effective birth control during the study and for 7 months after the last dose.

Main exclusion criteria: The study excludes patients who have a different type of cancer than those specified, are not female, or are considered part of a vulnerable population requiring special protection.

Focus and goal: The study evaluates how well Raludotatug Deruxtecan works compared to other standard chemotherapy treatments such as paclitaxel, liposomal doxorubicin, gemcitabine, or topotecan. The main objectives are to assess response rates and progression-free survival between different treatment options. All treatments are administered through intravenous infusion. The study includes both Phase 2 and Phase 3 components, with regular monitoring through imaging and follow-up visits.

Investigational drugs: Raludotatug Deruxtecan is an antibody-drug conjugate that targets the CDH6 protein on cancer cells, delivering a cytotoxic agent directly to tumors. The standard chemotherapy options include paclitaxel, which stops cancer cells from dividing; pegylated liposomal doxorubicin, which uses a special coating to target cancer cells more effectively; gemcitabine, which interferes with cancer cell DNA; and topotecan, which inhibits an enzyme cancer cells need to grow.

Study on the Effectiveness of Hyperthermic Intraperitoneal Chemotherapy with Cisplatin and Sodium Thiosulfate for Ovarian Cancer Patients Undergoing Surgery

This trial studies whether adding heated chemotherapy directly into the abdominal cavity during surgery can help patients with ovarian cancer live longer without the disease returning. The treatment being tested is called hyperthermic intraperitoneal chemotherapy or HIPEC.

Main inclusion criteria: Patients must be between 18 and 76 years old with confirmed epithelial ovarian, fallopian tube, or peritoneal cancer at stage III. They must be eligible for either primary or interval debulking surgery and chemotherapy with or without targeted therapy. Patients need good general well-being with a WHO Performance Status of 2 or less and adequate bone marrow and kidney function. During surgery, there should be no visible leftover cancer or very small amounts (less than 2.5 mm), blood loss under 2.5 liters, and no more than two parts of the digestive system removed. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control.

Main exclusion criteria: The trial excludes patients who are not diagnosed with the specific types of cancer being studied, male patients, and those considered part of a vulnerable population.

Focus and goal: The study aims to determine if HIPEC can improve disease-free survival compared to standard surgical care alone. After removing as much tumor as possible through surgery, some patients receive heated chemotherapy with cisplatin directly applied to the abdominal cavity. Sodium thiosulfate is also used. Patients are monitored through regular follow-up visits to assess recovery, cancer recurrence, and quality of life. The study follows participants over time to evaluate overall health outcomes and treatment effectiveness.

Investigational drugs: The main treatment being studied is HIPEC, which involves delivering heated chemotherapy directly into the abdominal cavity during surgery. The chemotherapy drugs used are cisplatin and sodium thiosulfate, administered through intravenous or intraperitoneal routes. The heat is believed to enhance the effectiveness of the chemotherapy in killing remaining cancer cells.

Study on the Effects of ZN-c3 for Patients with High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

This trial evaluates a medication called azenosertib for patients with recurrent high-grade serous ovarian, fallopian tube, or primary peritoneal cancer. The study examines both the safety and effectiveness of this experimental treatment.

Main inclusion criteria: Participants must be at least 18 years old with a confirmed diagnosis of recurrent high-grade serous cancer affecting the ovaries, fallopian tubes, or peritoneum. They must have platinum-resistant disease, meaning the cancer has not responded well to platinum-based treatments and has returned within a specific timeframe after treatment. Patients should have had between one and four previous treatments, with some cases allowing up to five. At least one measurable lesion must be present, and patients need a Performance Status of 0 or 1, indicating good ability to carry out daily activities. Adequate blood and organ function is required.

Main exclusion criteria: The study excludes patients with different cancer types than those specified, those not within the specified age range, and those considered part of a vulnerable population.

Focus and goal: The trial is conducted in two parts. The first part focuses on determining safety and how well patients tolerate azenosertib. The second part investigates the medication’s ability to reduce or eliminate cancer. Participants receive ZN-c3 as oral film-coated tablets, and some may receive a placebo for comparison. Regular monitoring through check-ups and assessments tracks the cancer’s response to treatment and any side effects.

Investigational drugs: Azenosertib (ZN-c3) is an oral medication currently in the investigational stage. It works by inhibiting certain enzymes involved in cancer cell growth and survival, potentially slowing or stopping disease progression. The trial aims to gather information about its effectiveness and safety in treating these specific cancer types.

Study on the Safety and Effectiveness of IMGN151 for Women with Recurrent Endometrial and Ovarian Cancer

This trial tests IMGN151, an antibody-drug conjugate, for women with recurrent endometrial cancer and certain types of recurrent ovarian, primary peritoneal, or fallopian tube cancers. The study seeks to find the best dose and evaluate how well the treatment works.

Main inclusion criteria: Patients must be at least 18 years old with confirmed recurrent cancer of specific types: endometrial cancer or high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancers. They must have completed major surgery at least 4 weeks before starting the study drug and have adequate blood, liver, and kidney function. This includes sufficient white blood cells, platelets, hemoglobin, and normal kidney and liver enzyme levels. Patients need a performance status of 0 or 1 and must have tumors that can be evaluated by imaging. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for at least 28 weeks after the last dose.

Main exclusion criteria: The trial excludes male patients and those not considered part of the target population for the study.

Focus and goal: The study is conducted in two phases. The first phase tests different doses to find the safest and most effective amount. The second phase evaluates how well the chosen dose works in treating these cancers. IMGN151 is delivered intravenously, and participants also use specific eye drops to manage potential side effects. Throughout the trial, regular monitoring assesses treatment effectiveness and any adverse reactions.

Investigational drugs: IMGN151 is an experimental antibody-drug conjugate that combines an antibody with a cancer-fighting drug to specifically target and kill cancer cells. It is designed to deliver treatment directly to cancer cells while minimizing damage to healthy tissue. The study aims to determine its safety, tolerability, and optimal dosing for future research.

Study on Bevacizumab Dose Equivalence for Patients with Ovarian, Fallopian Tube, or Peritoneal Cancer Using Bevacizumab, Olaparib, Carboplatin, and Paclitaxel

This trial compares two different doses of bevacizumab to determine if a lower dose is as effective as the standard dose in treating newly diagnosed advanced ovarian, fallopian tube, or peritoneal cancer when combined with other medications.

Main inclusion criteria: Patients must be female and at least 18 years old with confirmed advanced ovarian, fallopian tube, or peritoneal cancer at stage III-IV. They must have undergone cytoreductive surgery within 8 weeks before joining the study and be able to start treatment within this timeframe. Patients need a general health status (ECOG) of 0-1 and adequate liver, kidney, and blood function. This includes specific blood test results showing sufficient platelet count, leukocyte count, neutrophil count, and hemoglobin levels. Blood pressure must be normal or well-controlled. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during treatment and for 6 months after.

Main exclusion criteria: The study excludes patients without the specified cancer types, male patients, and those considered part of a vulnerable population.

Focus and goal: The study aims to see if a lower dose of bevacizumab (7.5 mg) is as effective as the standard dose (15 mg) in preventing disease progression. All patients receive chemotherapy with carboplatin and paclitaxel, and different groups receive different combinations with bevacizumab and olaparib. Treatment can last up to 76 weeks. Researchers monitor progression-free survival, objective response rate, and overall quality of life through regular examinations and questionnaires.

Investigational drugs: Bevacizumab is a monoclonal antibody given through infusion that inhibits blood vessel growth to tumors. Olaparib is a PARP inhibitor taken orally that prevents cancer cells from repairing DNA damage. Carboplatin and paclitaxel are standard chemotherapy drugs given intravenously that interfere with cancer cell growth and division.

Study Comparing Paclitaxel, Carboplatin, and Oregovomab with Paclitaxel, Carboplatin, and Placebo for Patients with Advanced Ovarian Cancer

This trial tests whether adding oregovomab to standard chemotherapy can improve outcomes for patients with newly diagnosed advanced epithelial ovarian, fallopian tube, or peritoneal cancer who have undergone surgery to remove tumors.

Main inclusion criteria: Patients must be at least 18 years old with a new diagnosis of epithelial adenocarcinoma of the ovary, fallopian tube, or peritoneum at stage III or IV. Eligible cancer types include high-grade serous adenocarcinoma or clear cell adenocarcinoma. They must have completed debulking surgery (either primary or interval) and have CA 125 levels of at least 50 U/mL. Patients need adequate kidney and liver function with creatinine levels no more than 1.5 times the normal limit and liver enzymes within specified ranges. An ECOG Performance Status of 0 or 1 is required, along with adequate bone marrow function and hemoglobin levels of at least 8.0 g/dL. Women of childbearing potential must use effective birth control from the start of treatment until 6 months after the last dose.

Main exclusion criteria: The trial excludes patients without the specified cancer types, those who have not undergone optimal debulking surgery, those not newly diagnosed at stage III or IV, male patients, and vulnerable populations.

Focus and goal: The study aims to determine if adding oregovomab to standard chemotherapy with paclitaxel and carboplatin can improve progression-free survival compared to chemotherapy with placebo. One group receives oregovomab along with chemotherapy, while the control group receives the same chemotherapy with placebo. All treatments are given through intravenous infusion. The study monitors disease progression, overall survival, and side effects over time.

Investigational drugs: Oregovomab is a monoclonal antibody being studied for its potential to work with the immune system to target and destroy cancer cells. Paclitaxel and carboplatin are standard chemotherapy drugs that stop cancer cells from dividing and growing by damaging their DNA and preventing cell division.

Study of Farletuzumab Ecteribulin vs. Chemotherapy for Women with Platinum-resistant High-grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

This trial compares a new treatment called farletuzumab ecteribulin (MORAb-202) with standard chemotherapy options for women whose cancer has not responded to platinum-based treatments.

Main inclusion criteria: Participants must be at least 18 years old (or the age of majority in their area) when signing the consent form. They must be women with confirmed high-grade serous ovarian, primary peritoneal, or fallopian tube cancer that is platinum-resistant. This means if they had one round of platinum treatment, the cancer returned between 1 and 6 months after the last dose, or if they had two or three rounds, it returned within 6 months. Patients should have had at least one but no more than three previous treatments and be suitable for single-drug treatment next. The cancer must have progressed according to specific measurement criteria, and at least one measurable tumor must be present. A tissue sample must be available for testing. Patients need a performance status of 0 or 1, indicating good ability to perform daily activities.

Main exclusion criteria: The study excludes patients with different cancer types, male patients, those not within the specified age range, vulnerable populations, those who have had certain interfering treatments, those with serious health conditions, and those unable to follow study procedures.

Focus and goal: The study evaluates how well farletuzumab ecteribulin works compared to standard chemotherapy chosen by doctors, which may include doxorubicin, paclitaxel, or topotecan. The main focus is on objective response rate and treatment-related adverse events. Participants are randomly assigned to receive either the investigational drug or chemotherapy, all administered intravenously. Regular follow-up visits assess treatment response, duration of response, and progression-free survival.

Investigational drugs: Farletuzumab ecteribulin (MORAb-202) is an antibody-drug conjugate that targets folate receptor alpha, a protein often found on certain cancer cells. It delivers a drug directly to cancer cells to kill them while minimizing damage to healthy cells. The standard chemotherapy options work by killing rapidly dividing cells, including cancer cells, and are chosen based on individual patient needs.

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

This trial evaluates the effectiveness of rucaparib and nivolumab as maintenance treatment after initial chemotherapy for patients with advanced high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Main inclusion criteria: Patients must be at least 18 years old (20 in South Korea, Taiwan, and Japan) and have signed an informed consent form. They must have newly diagnosed, advanced, high-grade epithelial cancer at stage III-IV and have completed surgery including removal of both ovaries and part of the omentum. Patients must have received 4 to 8 cycles of first-line platinum-based chemotherapy, including at least 4 cycles of platinum and taxane combination. They must have completed chemotherapy and surgery with no evidence of disease progression and be randomized within 8 weeks of the last chemotherapy cycle. Adequate organ function is required, confirmed by specific blood, liver, and kidney function tests. An ECOG performance status of 0 to 1 is necessary. Enough tumor tissue must be available for analysis.

Main exclusion criteria: The study excludes patients who have not responded to platinum-based chemotherapy, those with cancer not classified as advanced (stage III-IV), those with cancer types other than the specified ones, male patients, and vulnerable populations.

Focus and goal: The study aims to evaluate progression-free survival, which is the time from randomization until disease progression or death. Participants are divided into groups receiving either oral rucaparib, intravenous nivolumab, a combination of both, or placebos. Regular monitoring through imaging scans and laboratory tests assesses disease progression and overall health. The trial seeks to determine if these treatments can maintain the positive effects of initial chemotherapy and delay cancer progression.

Investigational drugs: Rucaparib is a PARP inhibitor taken orally that prevents cancer cells from repairing DNA damage, potentially leading to their death. Nivolumab is an immune checkpoint inhibitor given through intravenous infusion that blocks the PD-1 protein on immune cells, enhancing the body’s immune response against cancer. Both medications are being studied for their ability to improve treatment outcomes when used as maintenance therapy.

Study on Carboplatin, Paclitaxel, Bevacizumab, and Rucaparib for Advanced Ovarian, Primary Peritoneal, and Fallopian Tube Cancer Patients

This trial examines different combinations of medications for patients with advanced stages of ovarian, primary peritoneal, and fallopian tube cancer. The study explores how well these treatments work based on specific characteristics of the cancer cells called Homologous Recombination Deficiency status.

Main inclusion criteria: Patients must be women aged 18 years or older with newly diagnosed, confirmed high-grade serous or high-grade endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer at stage III B-C or IV. Stage III patients should have had one attempt at surgery to remove as much tumor as possible, while stage IV patients must have had either a biopsy or tumor removal surgery. Previous tumor tissue samples must be available. Patients need an ECOG Performance Status of 0-1 and proper kidney, liver, and bone marrow function. This includes specific blood test requirements such as total white blood cells at least 2.5 billion per liter and adequate levels of other blood components. Women who can have children must have a negative pregnancy test within 7 days before joining the study.

Main exclusion criteria: The study excludes patients without advanced cancer at the specified stages, male patients, those not within the specified age range, and those considered part of a vulnerable population.

Focus and goal: The trial begins with a phase to determine the safest dose of combining rucaparib and bevacizumab, followed by a phase comparing progression-free survival across different treatment combinations. Participants receive one of three combinations: carboplatin, paclitaxel, and bevacizumab; carboplatin, paclitaxel, bevacizumab, and rucaparib; or carboplatin, paclitaxel, and rucaparib. Carboplatin and paclitaxel are given intravenously, while rucaparib is taken orally. Regular monitoring assesses treatment effectiveness, side effects, and overall health outcomes.

Investigational drugs: Carboplatin and paclitaxel are chemotherapy drugs given intravenously that interfere with cancer cell DNA and division. Bevacizumab is a monoclonal antibody given through infusion that blocks blood vessel formation to tumors. Rucaparib is a PARP inhibitor taken orally that prevents cancer cells from repairing DNA damage, particularly effective in patients with certain genetic characteristics.

Summary

The 10 ongoing clinical trials for malignant peritoneal neoplasm reflect a diverse range of innovative treatment approaches being investigated across Europe. Several notable patterns emerge from this collection of studies. Italy stands out as having the most trial activity, hosting seven different studies, followed by Spain with six trials, and Belgium, France, and Germany each conducting multiple investigations. This geographic concentration suggests these countries have established strong research infrastructure and clinical expertise in treating this condition.

The trials predominantly focus on advanced-stage disease, particularly stage III and IV cancers, and primarily target patients whose disease has become resistant to standard platinum-based chemotherapy. This emphasis on platinum-resistant disease highlights one of the major challenges in treating these cancers. Several trials are exploring maintenance therapy approaches, which aim to extend the period patients remain disease-free after initial treatment.

From a treatment perspective, the studies showcase a variety of therapeutic strategies. Multiple trials investigate PARP inhibitors, including rucaparib, niraparib, and olaparib, reflecting the growing importance of this drug class. Immunotherapy approaches are represented through trials testing nivolumab and oregovomab. Several antibody-drug conjugates are being evaluated, including raludotatug deruxtecan, IMGN151, and farletuzumab ecteribulin, representing a newer precision medicine approach. The anti-angiogenesis drug bevacizumab appears in multiple trials, often in combination with other agents. One study takes a unique surgical approach by testing hyperthermic intraperitoneal chemotherapy (HIPEC), which delivers heated chemotherapy directly into the abdominal cavity during surgery.

Most trials require participants to have good general health status, adequate organ function, and the ability to comply with study procedures. Common exclusion criteria include prior treatment for the current cancer, recent major surgery, and significant cardiovascular problems. The studies typically follow patients over extended periods, with some continuing until 2027 or beyond, allowing researchers to gather comprehensive data on long-term effectiveness and safety.

Ongoing Clinical Trials on Malignant peritoneal neoplasm

  • Study of Pembrolizumab for Patients with Recurrent, Platinum-Resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

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

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia Denmark Germany Greece Ireland +5

  • Study on Carboplatin, Paclitaxel, Bevacizumab, and Rucaparib for Advanced Ovarian, Primary Peritoneal, and Fallopian Tube Cancer Patients

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

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