Clinical Research Directory

A Clinical Trial to Evaluate the Safety and Efficacy of COM701 in Relapsed Platinum Sensitive Ovarian Cancer

The goal of this clinical trial is to learn if the experimental antibody COM701 delays the progression of ovarian cancer in participants with Relapsed Platinum Sensitive Ovarian Cancer. It will also learn about the safety of COM701. The main questions the trial aims to answer are: * Does COM701, when used as a maintenance treatment, stop or slow the progression of ovarian cancer? * Does COM701 delay the time to needing a new anti-cancer treatment? * What side effects do participants have when taking COM701? Participants will: * Visit the clinic once every 3 weeks during which the study treatment will be administered intravenously * Undergo various tests and procedures to monitor general health throughout the trial including physical examinations, vital sign measurements (heart rate, blood pressure, breathing, and body temperature), weight measurements, electrocardiography (ECG), blood and urine tests and pregnancy tests if relevant. * Undergo various tests and procedures to assess disease response throughout the trial including tumor imaging by CT scans or MRI to assess the tumor, its location, and size, and the testing of a sample of tumor tissue (from a prior biopsy or a fresh biopsy if feasible, to evaluate tumor response to treatment and to measure levels of tumor markers,

A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003)

Researchers are looking for other ways to treat relapsed high-grade serous ovarian cancer. Relapsed means the cancer came back after treatment. High-grade means the cancer cells grow and spread quickly. Serous means the cancer started in the cells that cover the ovaries, the lining of the belly, or in the fallopian tubes. Standard treatment (usual treatment) for people with relapsed high-grade serous ovarian cancer may include: * Chemotherapy, which is a treatment that uses medicine to destroy cancer cells or stop them from growing * Targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread Raludotatug deruxtecan (R-DXd) is a study treatment that is an antibody drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. Researchers want to know if R-DXd is safe to take with other treatments and if people tolerate them together. They also want to learn how many people have the cancer respond (gets smaller or goes away) to the treatments.

Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer

This is a phase II single arm efficacy/safety trial that will evaluate the effectiveness of combining intensive locoregional intraperitoneal (IP) chemoimmunotherapy of cisplatin with IP rintatolimod (TLR-3 agonist) and IV infusion of the checkpoint inhibitor pembrolizumab (IVP) for patients with recurrent platinum-sensitive ovarian cancer (OC).

RESCUE Study (REcurrent Ovarian Cancer Secondary Cytoreduction Using Chemotherapy rEsponse)

This is a multicenter, prospective, randomized, open-label Phase III clinical trial (RESCUE study) evaluating the efficacy of secondary cytoreductive surgery (SCS) in patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have shown a favorable response to 3-4 cycles of platinum-based neoadjuvant chemotherapy and are assessed as highly likely to achieve complete tumor resection based on selection models. Eligible patients will be randomly assigned to either the experimental arm, receiving SCS followed by chemotherapy (with or without maintenance), or the active comparator arm, receiving chemotherapy only (with or without maintenance), with the primary objective being to compare the Progression-Free Survival (PFS) between the two groups to determine the additional clinical benefit of SCS in this carefully selected patient population.

A Study to Evaluate the Safety and Efficacy of OPB-101 in Platinum-resistant Ovarian Cancer

The goal of this clinical trial is to learn if OPB-101 is safe in platinum resistant ovarian cancer participants and also to find the optimal dose of OPB-101. Participants will have their own T cells modified in a laboratory and given back to them as OPB-101 in this one-time treatment. Participants will be in the hospital when they receive OPB-101 and then be checked at the clinical site frequently for the first few months.

A Study to Explore Personalized Treatment for Patients With Recurrent Gynecological Malignancies Based on MTB

This is a non-interventional, real-world study divided into two parts: a retrospective study and a prospective study. The main question it aims to answer is: Will genomic sequencing and molecular tumor boards lead to clinical responses in patients with recurrent ovarian, cervical, or endometrial cancer? The retrospective arm will analyze data from patients with recurrent gynecological malignancies (ovarian, cervical, or endometrial) who underwent multidisciplinary consultations at our institution from January 2022 onward. Data collected will include tumor tissue genomic sequencing results, medical histories, multidisciplinary consultation recommendations, and subsequent treatment courses. This analysis will examine the implementation and clinical efficacy of personalized targeted therapies guided by molecular tumor profiling and multidisciplinary consultation. The prospective arm will enroll 200 patients with recurrent gynecological malignancies (ovarian, cervical, or endometrial) referred for multidisciplinary consultation. Tumor tissue and blood samples will undergo next-generation sequencing (NGS) to determine molecular tumor profiles. A multidisciplinary expert panel will formulate individualized treatment strategies based on these profiles, patient clinical data, and treatment history. Attending physicians will determine the final treatment plan, integrating multidisciplinary recommendations with patient preferences, comorbidity considerations, drug toxicity assessments, insurance coverage for off-label medications, and the availability of investigational drug trials. This arm aims to observe and evaluate the clinical efficacy of personalized treatment plans developed through molecular tumor profiling and multidisciplinary consultation.

IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer

This is a multicenter, randomized, double-blind, phase II clinical study to evaluate the efficacy and safety of IN10018 in combination with PLD vs. placebo in combination with PLD in subjects with platinum-resistant recurrent ovarian cancer (including fallopian tube and primary peritoneal cancers).

SBRT Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARPi Therapy

SOPRANO is a multi-centre, randomised phase II trial which aims to assess the impact of Stereotactic radiotherapy (SBRT) and continuing treatment with a PARP inhibitor (PARPi) for patients with oligometastatic or oligoprogressive ovarian, fallopian tube and primary peritoneal carcinoma. SOPRANO will also establish the feasibility and acceptability of delivering SBRT in this setting.

Pegylated Liposomal Doxorubicin Plus Adebrelimab With or Without Mirabegron in Relapsed Ovarian Cancer

The goal of this clinical trial is to learn if drug regimen pegylated liposomal doxorubicin and adebrelimab with or without mirabegron works to treat relapsed ovarian cancer in adults. It will also learn about the safety of drug regimen pegylated liposomal doxorubicin and adebrelimab with or without mirabegron. The main questions it aims to answer are: Does drug pegylated liposomal doxorubicin and adebrelimab with or without mirabegron reduce tumor volume? What medical problems do participants have when taking drug pegylated liposomal doxorubicin and adebrelimab with or without mirabegron? Researchers will compare drug regimen pegylated liposomal doxorubicin and adebrelimab with mirabegron to a drug regimen pegylated liposomal doxorubicin and adebrelimab without mirabegron to see which drug regimen works better to treat relapsed ovarian cancer. Participants will: Take drug pegylated liposomal doxorubicin and adebrelimab every 21 days with or without everyday mirabegron Visit the clinic once every 2 months for checkups and tests Keep a diary of their symptoms

Exploratory Study on the Safety and Efficacy of Disitamab Vedotin in Combination with Anlotinib Hydrochloride for the Treatment of HER-2-expressing Recurrent Platinum-resistant Ovarian Cancer.

Ovarian cancer is one of the three major malignant tumors of the female reproductive system. Even if newly diagnosed ovarian cancer patients undergo ideal tumor cell reduction surgery and postoperative chemotherapy, 70% to 80% of ovarian cancer patients still experience recurrence. According to the length of PFI (platinum free interval), recurrent ovarian cancer (ROC) can be classified into platinum resistant ROC (\<6 months) and platinum sensitive ROC (\>6 months). There is currently no optimal treatment plan for platinum resistant ovarian cancer (PROC), and the prognosis for patients is poor. The guidelines recommend non platinum monotherapy chemotherapy for patients with PROC, but non platinum monotherapy has a low objective response rate (ORR) (\<20%), progression free survival (PFS) (\<4 months), and overall survival (OS,\<12 months), with significant adverse reactions and affecting quality of life. Therefore, PROC patients urgently need new and better treatment options. Antibody conjugated drugs (ADCs) have made breakthrough therapeutic progress in multiple tumor types, and currently ADCs have been approved by the FDA for the treatment of cervical cancer and ovarian cancer. HER2 (Human Epidermal Growth Factor Receptor 2) is a member of the epidermal growth factor receptor (EGFR) family, also known as the tyrosine protein kinase receptor. Research has shown that HER2 expression is associated with poor prognosis in ovarian cancer, and patients with HER2 positive expression have a worse prognosis. Vidiximab (RC48) is a novel HER2 antibody conjugate drug that received Breakthrough Therapy Design from the US Food and Drug Administration (FDA) in April 2020. Preclinical studies of ovarian cancer have shown that vediximab exhibits effective cytotoxicity against HER2 expressing ovarian tumor cell lines. Meanwhile, the registration study of RC48 for gynecological tumors is underway, and its latest data was reported at the 2024 European Congress of Gynecological Oncology (ESGO), which showed that in patients with recurrent or metastatic cervical cancer, the ORR of RC48 monotherapy was 36.4%, the median PFS was 4.37 months, and the 1-year OS was 66%. Compared to other chemotherapy drugs, it also has significant advantages in terms of toxic side effects, with severity mostly ranging from grade 1-2. Symptomatic treatment can achieve complete recovery or relief. Anti angiogenic drugs, including anti vascular endothelial growth factor (VEGF) antibodies and multi-target tyrosine kinase inhibitors (TKIs), are considered potential targets for treating platinum resistant/refractory ovarian diseases . Anlotinib is a novel oral multi-target tyrosine kinase inhibitor (TKIs) . Monotherapy for PROC has achieved initial efficacy, with an ORR of 31.2%, a median PFS of 5.3 months, and a 12-month OS rate of 90.9%. In terms of safety, most of the toxic side effects are grade 1-2. Good progress has been made in preclinical and clinical trials of ADC in combination with other anti-cancer drugs, including chemotherapy, molecular targeted drugs, anti angiogenic drugs, and immunotherapy. Among them, anti angiogenic drugs may promote the penetration and exposure of ADC to tumor cells, playing a mutually reinforcing role. Research on the combination of RC48 and anlotinib is also actively underway in other tumor types. In summary, this study creatively conducted exploratory research in clinical PROC patients based on the different expression levels of the molecular target HER2, and adopted targeted medication according to the molecular target. At the same time, in terms of combination therapy, low toxicity and high efficiency, different toxic side reaction spectra, different mechanisms of action, and synergistic effects of dual anti-tumor drugs were selected for combination therapy. Based on the above evidence, an exploratory study was conducted on the safety and efficacy of vediximab combined with anlotinib in the treatment of HER-2 expressing recurrent platinum resistant ovarian cancer, aiming to explore the efficacy of vediximab combined with anlotinib in PROC patients, in order to further improve the remission rate and quality of life of patients while prolonging their survival.

The Efficacy and Safety of Fluzopril Combined With Apatinib in Maintenance Treatment of Platinum Resistant Recurrent Ovarian Cancer Patients

Ovarian cancer is the most lethal gynecological malignancy, posing a serious threat to women's health worldwide.Platinum resistant ovarian cancer is the biggest challenge faced by gynecological oncologists.Exploring more effective treatment options and how to delay the recurrence of platinum resistant recurrent ovarian cancer remains a challenging issue in clinical treatment.The main goal of this trial is to evaluate the effectiveness and safety of fluzopril combined with apatinib in maintenance treatment of platinum resistant recurrent ovarian cancer patients by evaluating progression free survival (PFS).Fifty patients with advanced ovarian cancer who underwent platinum resistant recurrent chemotherapy and assessed no disease progression were enrolled in the study, and maintenance treatment was performed with fluzopril combined with apatinib.

Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)

This is a Phase II, open-label, multicenter, randomized umbrella study to evaluate the efficacy of cytoreductive surgery and Niraparib maintenance in participants with platinum-sensitive secondary recurrent ovarian cancer. Cohort 1 will focus on participants without prior use of PARP inhibitor, and without prior secondary cytoreduction (SCR) when first recurrence. Cohort 2 will focus on participants with prior use of PARP inhibitor, but without prior SCR when first recurrence. Cohort 3 will focus on participants with SCR when first recurrence, but without prior use of PARP inhibitor.