Ongoing Clinical Trials for Peritoneal Cancer Index
Currently, there are 5 ongoing clinical trials investigating treatments for conditions related to the peritoneal cancer index, including peritoneal cancer, ovarian cancer, and fallopian tube cancer. These trials are testing various combinations of immunotherapy drugs, chemotherapy approaches, and novel treatment methods across multiple countries in Europe.
Clinical trial locations
- Austria
- Belgium
- Study on the Safety and Effectiveness of REGN5668 with Cemiplimab or Ubamatamab for Patients with Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- Study of Nemvaleukin Alfa and Pembrolizumab for Patients with Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.
- Study of Pembrolizumab, MK-4830, and Chemotherapy for Patients with High-Grade Serous Ovarian Cancer
- Czechia
- Denmark
- France
- Germany
- Italy
- Lithuania
- Netherlands
- Norway
- Poland
- Spain
- Study on the Safety and Effectiveness of REGN5668 with Cemiplimab or Ubamatamab for Patients with Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- Study of Nemvaleukin Alfa and Pembrolizumab for Patients with Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.
- Study of Pembrolizumab, MK-4830, and Chemotherapy for Patients with High-Grade Serous Ovarian Cancer
Study of Pembrolizumab and Chemotherapy for Patients with Recurrent Platinum-Sensitive Low-Grade Serous Ovarian Cancer
This trial is investigating the effectiveness of pembrolizumab combined with chemotherapy for women with recurrent low-grade serous ovarian cancer, including cancer affecting the fallopian tubes and peritoneum. The study focuses on patients whose cancer has returned but still responds to platinum-based treatments.
Main inclusion criteria: Participants must be female and at least 18 years old with a confirmed diagnosis of low-grade serous ovarian, fallopian tube, or primary peritoneal cancer. They must have completed at least one previous platinum-containing therapy and have platinum-sensitive disease, meaning the cancer returned or worsened no sooner than 6 months after the last platinum treatment. An ECOG performance status of 0 or 1 is required, indicating the ability to perform daily activities with minimal restriction. Participants must provide a tumor tissue sample and have adequate organ and bone marrow function.
Main exclusion criteria: The study excludes patients who do not have recurrent platinum-sensitive low-grade serous ovarian cancer. Only female participants are eligible, and those outside the specified age range or belonging to vulnerable populations cannot participate.
Trial focus: The primary goal is to determine whether pembrolizumab, when combined with chemotherapy, can help patients live longer without disease progression. The study monitors progression-free survival at 6, 12, 18, and 24 months, with the 12-month progression-free survival rate as the primary endpoint. Secondary endpoints include overall response rate, overall survival, and quality of life assessments.
Investigational drugs: Pembrolizumab is an immunotherapy drug that helps the immune system fight cancer cells by blocking a specific protein, allowing immune cells to better detect and attack cancer. It is given through intravenous infusion in combination with standard chemotherapy to potentially improve treatment outcomes.
Study on the Safety and Effectiveness of REGN5668 with Cemiplimab or Ubamatamab for Patients with Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This trial is studying new treatment combinations for advanced ovarian, fallopian tube, and primary peritoneal cancers. The study tests REGN5668, a bispecific antibody, in combination with either cemiplimab or REGN4018, both of which are immunotherapy medications designed to help the immune system recognize and attack cancer cells.
Main inclusion criteria: Participants must have a confirmed diagnosis of advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer and have received at least one previous platinum-based therapy. Blood tests must show a serum CA-125 level at least twice the normal limit. Adequate organ and bone marrow function is required, along with an ECOG performance status of 0 or 1 and a life expectancy of at least 3 months. Some study groups require at least one measurable tumor according to RECIST 1.1 criteria.
Main exclusion criteria: Only female patients are eligible. Those with medical conditions other than the specified cancers or those considered part of vulnerable populations cannot participate.
Trial focus: The study is divided into two phases: Dose Escalation and Dose Expansion. The first phase identifies the safest and most effective dose of the medications, while the second evaluates how well the treatment works in a larger group. Participants receive treatments through intravenous infusion with regular monitoring for side effects and cancer response.
Investigational drugs: REGN5668 is a bispecific antibody that connects two proteins on cancer and immune cells to enhance immune response. Cemiplimab blocks the PD-1 protein to allow immune cells to better attack cancer. REGN4018 connects MUC16 and CD3 proteins to direct immune cells against cancer cells.
Study of Nemvaleukin Alfa and Pembrolizumab for Patients with Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.
This trial is testing a new treatment combination for platinum-resistant cancers, meaning cancers that no longer respond to platinum-based chemotherapy. The study compares nemvaleukin alfa and pembrolizumab against standard chemotherapy options.
Main inclusion criteria: Participants must be female and at least 18 years old with confirmed platinum-resistant or refractory epithelial ovarian, fallopian tube, or primary peritoneal cancer. The cancer must be high-grade serous, endometrioid of any grade, or clear cell type. The disease must have progressed within 180 days after the last platinum therapy dose. Patients must have received at least one but no more than five prior lines of systemic anticancer therapy, including at least one with bevacizumab. At least one measurable tumor lesion is required, and patients must be willing to provide a tumor tissue sample. Good general health with an ECOG status of 0 or 1 and life expectancy of at least three months is necessary, along with adequate organ and bone marrow function.
Main exclusion criteria: Only female patients within the specified age range are eligible. Those with medical conditions other than the specified cancers or those in vulnerable populations cannot participate.
Trial focus: The study evaluates whether the combination of nemvaleukin alfa and pembrolizumab improves survival compared to standard chemotherapy. Participants are randomly assigned to receive either the combination therapy or chemotherapy through intravenous infusion. Regular assessments monitor treatment effectiveness, safety, and cancer response.
Investigational drugs: Nemvaleukin alfa helps stimulate the immune system to attack cancer cells. Pembrolizumab is an immunotherapy drug that helps the immune system recognize and destroy cancer cells by blocking the PD-1 protein. The study compares this combination to standard chemotherapy options including topotecan, gemcitabine, paclitaxel, and doxorubicin.
Study of Pembrolizumab, MK-4830, and Chemotherapy for Patients with High-Grade Serous Ovarian Cancer
This trial investigates whether adding an experimental medication called MK-4830 to pembrolizumab and standard chemotherapy can improve treatment outcomes for high-grade serous ovarian cancer and related conditions.
Main inclusion criteria: Participants must have a confirmed diagnosis of Stage III or Stage IV high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. They must be candidates for carboplatin and paclitaxel chemotherapy and interval debulking surgery. A tumor tissue sample must be provided, adequate organ function is required, and only female patients are eligible.
Main exclusion criteria: Patients with a history of cancer types other than the specified conditions cannot participate. Only female patients within the specified age range are eligible, and those in vulnerable populations may not be included.
Trial focus: The primary goal is to evaluate whether adding MK-4830 to pembrolizumab and chemotherapy leads to greater reduction in circulating tumor DNA in the blood. Participants receive treatment through intravenous infusion in cycles, with some receiving a placebo instead of MK-4830. Regular assessments track changes in cancer-related DNA levels and overall treatment response.
Investigational drugs: Pembrolizumab is an immunotherapy that helps the immune system recognize and attack cancer cells. MK-4830 is an experimental medication being tested to see if it can enhance the effects of pembrolizumab and chemotherapy by targeting specific immune system pathways. Standard chemotherapy drugs including carboplatin, paclitaxel, bevacizumab, and docetaxel are also used in the study.
Study on Dosing Methods of Cisplatin for Women with Advanced Ovarian Cancer
This trial compares two different methods of determining the cisplatin dose for hyperthermic intraperitoneal chemotherapy, a treatment where heated chemotherapy is delivered directly into the abdominal cavity.
Main inclusion criteria: Participants must be female and at least 18 years old with confirmed FIGO stage III high-grade serous ovarian, peritoneal, or fallopian tube cancer. They must have adequate kidney, bone marrow, and liver function and be fit for major surgery with a WHO performance status of 0-2. Patients must have received at least three courses of neo-adjuvant chemotherapy with carboplatin and paclitaxel, with no disease progression after two cycles. They must be eligible for interval cytoreductive surgery and have peritoneal disease present at surgery. The surgery must have achieved optimal or complete tumor removal.
Main exclusion criteria: Only female patients within the specified age range are eligible. Those without the specified cancer types or those in vulnerable populations cannot participate.
Trial focus: The study aims to determine which dosing method for cisplatin is more effective: one based on body surface area or one based on drug concentration. During surgery, cisplatin is delivered directly into the abdominal cavity using hyperthermic intraperitoneal chemotherapy. The primary focus is measuring platinum concentration in tumor tissue, with secondary evaluations including toxicity, concentration in normal tissue, and survival rates.
Investigational drugs: Cisplatin is a platinum-based chemotherapy drug that works by binding to DNA and interfering with cancer cell division and growth. In this trial, it is delivered as heated chemotherapy directly into the abdominal cavity to target cancer cells more effectively.
Summary
The five ongoing clinical trials for conditions related to the peritoneal cancer index demonstrate a strong focus on immunotherapy approaches combined with chemotherapy. Three trials are testing pembrolizumab, an immune checkpoint inhibitor, in various combinations, reflecting the growing interest in harnessing the immune system to fight these cancers.
The trials span multiple European countries, with the largest geographical distribution seen in the platinum-resistant cancer trial, which operates across 10 countries including Italy, Belgium, Czechia, France, Austria, Germany, Spain, Norway, Lithuania, and Denmark. This suggests significant international collaboration in researching treatment options for difficult-to-treat platinum-resistant cases.
The studies address different stages and types of disease progression, from platinum-sensitive to platinum-resistant cancers, and from low-grade to high-grade serous cancers. Notably, several trials are investigating novel bispecific antibodies like REGN5668 and experimental agents like MK-4830 and nemvaleukin alfa, indicating active research into new therapeutic mechanisms beyond traditional chemotherapy.
One trial takes a different approach by comparing dosing methods of cisplatin in hyperthermic intraperitoneal chemotherapy, focusing on optimizing existing treatment delivery rather than testing new drugs. This trial is uniquely conducted in the Netherlands and represents an important effort to refine current treatment protocols.
