Ovarian cancer metastatic – Trials in Disease

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Ongoing Clinical Trials for Ovarian Cancer Metastatic

There are currently 5 ongoing clinical trials testing new treatments for metastatic ovarian cancer. These studies are evaluating various investigational drugs, including antibody-drug conjugates, immunotherapies, and targeted therapies, often in combination with standard chemotherapy or lifestyle interventions like exercise. Trials are being conducted across several European countries, offering patients opportunities to access experimental treatments that may improve outcomes for advanced disease.

Clinical trial locations

Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors

This trial is testing DS-3939a, a new investigational drug given through an intravenous infusion. The study is divided into two parts: the first focuses on safety and tolerability, while the second evaluates how well the treatment works at shrinking tumors.

Main inclusion criteria: Participants must provide informed consent and have adequate heart function with a left ventricular ejection fraction of at least 50%. They should have measurable disease according to RECIST V1.1 criteria and an ECOG performance status of 0 or 1, meaning they are fully active or able to carry out light work. For Part 1, patients need a confirmed diagnosis of locally advanced, metastatic, or unresectable cancer in specific organs including the ovary. For Part 2, patients must show disease progression after their most recent cancer treatment and provide a tumor sample for analysis.

Main exclusion criteria: Patients with metastatic or advanced solid tumors who do not meet the age requirements or belong to vulnerable populations cannot participate. Those who do not meet the safety and tolerability requirements for DS-3939a are also excluded.

Focus and goal: The trial aims to evaluate the safety and effectiveness of DS-3939a in treating advanced cancers that have spread beyond their original location. The study will closely monitor participants through regular check-ups, laboratory tests, and imaging studies to track treatment progress and side effects.

Investigational drug: DS-3939a is designed to target specific pathways that cancer cells use to grow and spread. It is delivered directly into the bloodstream and is being evaluated for its potential to control tumor growth in advanced solid tumors.

Study on the Impact of Exercise and Atorvastatin on Advanced Breast, Ovarian, Prostate, and Kidney Cancer Patients

This unique trial explores whether supervised exercise combined with atorvastatin, a cholesterol-lowering medication, can improve treatment outcomes for patients with metastatic cancer, including ovarian cancer.

Main inclusion criteria: Patients must have confirmed metastatic cancer, including ovarian cancer, verified through tissue samples and imaging tests. They should be starting their first line of cancer treatment and must be at least 18 years old. Women participating must use reliable contraception during the trial.

Main exclusion criteria: Individuals not diagnosed with advanced stages of the specified cancers, those outside the defined age range, or those unable to participate in supervised group exercise are excluded. Patients who cannot take atorvastatin or belong to vulnerable populations are also not eligible.

Focus and goal: The study investigates whether combining supervised aerobic and resistance training with atorvastatin can enhance the effectiveness of cancer therapy. Researchers will monitor cancer progression and compare outcomes between supervised exercise groups and those managing their own exercise routines.

Investigational approach: This trial tests atorvastatin alongside structured exercise programs. The medication is taken orally as a tablet, while the exercise component includes both aerobic activities that strengthen the heart and resistance training that builds muscle strength.

Study on Mirvetuximab Soravtansine and Carboplatin for Patients with Recurrent Ovarian Cancer Eligible for Platinum-Based Chemotherapy

This trial specifically targets recurrent ovarian cancer, testing a combination of mirvetuximab soravtansine with carboplatin chemotherapy. The study focuses on patients whose cancer expresses high levels of folate receptor alpha.

Main inclusion criteria: Patients must be female, at least 18 years old, with confirmed epithelial cancer of the ovary, fallopian tube, or peritoneum. They need an ECOG performance status of 0 or 1 and must have relapsed disease with a platinum-free interval of more than 3 months. Patients must have received at least one previous chemotherapy regimen including at least 4 cycles of platinum-based treatment that resulted in a partial or complete response. They must provide tumor tissue samples to confirm high levels of folate receptor alpha. Women of childbearing potential must use effective birth control during the study and for 8 months after treatment ends.

Main exclusion criteria: Male patients cannot participate. Those not eligible for platinum-based chemotherapy, without recurrent ovarian cancer, or without high levels of folate receptor alpha protein are excluded. Vulnerable populations requiring special care are also not eligible.

Focus and goal: The study evaluates how long patients live without their cancer progressing when treated with this combination therapy. It will monitor progression-free survival, overall survival, and how well the cancer responds to treatment through regular assessments and imaging studies.

Investigational drug: Mirvetuximab soravtansine is an antibody-drug conjugate that targets folate receptor alpha, a protein found in high amounts on some ovarian cancer cells. By binding to this protein, it delivers a toxic substance directly to cancer cells, potentially killing them while minimizing damage to healthy tissue.

Study on the Safety and Effects of ICT01, Aldesleukin, and Pembrolizumab for Patients with Advanced Solid Tumors

This immunotherapy trial tests ICT01 combined with low-dose interleukin-2 and, in some cases, pembrolizumab. The study includes patients with metastatic ovarian cancer among other advanced solid tumors.

Main inclusion criteria: Patients must be 18 years or older and have signed informed consent. They need confirmed metastatic ovarian cancer that is resistant to platinum-based chemotherapy and have received at least one treatment line after becoming resistant. Participants must have at least one measurable tumor lesion and be willing to provide tumor biopsies. They need an ECOG performance status of 0 or 1, a life expectancy of more than 3 months, and adequate organ function including acceptable blood counts, liver enzymes, and kidney function. Participants must agree to use contraception, and women must not be breastfeeding.

Main exclusion criteria: Patients outside the specified age range, those not meeting gender requirements, or belonging to vulnerable populations are excluded. The study specifically targets those with metastatic disease who have progressed on standard therapies.

Focus and goal: The trial has two parts. Part I focuses on understanding the safety and tolerability of the treatment combinations. Part II evaluates preliminary anti-tumor activity and disease control, which includes stable disease, partial response, or complete response. Regular monitoring includes physical exams, blood tests, and imaging studies.

Investigational drugs: ICT01 is given through intravenous infusion and aims to activate the immune system against cancer cells. Interleukin-2 is a protein that boosts immune response and is injected under the skin at low doses. In certain cases, pembrolizumab, an established immunotherapy drug, is also included to help the immune system recognize and attack cancer cells.

Study on the Safety and Effects of LY2880070 and Gemcitabine in Patients with Advanced or Metastatic Cancer, Focusing on Ovarian Cancer

This trial evaluates LY2880070, a new experimental medication, both alone and in combination with gemcitabine, a standard chemotherapy drug. The study particularly focuses on patients with a specific type of ovarian cancer called BRCA1/2 wild-type high-grade serous ovarian carcinoma.

Main inclusion criteria: Patients must be 18 years or older and able to swallow capsules. They need adequate organ function including sufficient blood cell counts, acceptable liver and kidney function. Participants must have stopped previous cancer treatments at least 21 days before joining and recovered from most side effects. They should have received 2 to 4 previous treatments for advanced or metastatic disease, with at least one being platinum-based. Patients must have progressive disease after their last treatment with measurable tumor lesions. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 6 months after.

Main exclusion criteria: Only female patients with advanced or metastatic cancer can participate. Male patients and those from vulnerable populations are not eligible.

Focus and goal: The study aims to assess the safety and tolerability of LY2880070 when used alone or with gemcitabine. Researchers will monitor how well patients tolerate the combination and evaluate any side effects through regular visits, blood tests, and imaging studies.

Investigational drugs: LY2880070 is an experimental capsule medication that targets certain pathways cancer cells use to grow and survive. Gemcitabine is an established chemotherapy drug given through intravenous infusion that slows or stops cancer cell growth. The trial explores whether combining these two medications can be more effective than using them separately.

Summary

The five ongoing clinical trials for metastatic ovarian cancer reflect diverse therapeutic approaches being investigated across Europe. A notable concentration of studies is taking place in France and Germany, each hosting two trials, while Belgium, Spain, Finland, Croatia, and Poland each host one trial.

The trials encompass various treatment strategies, from novel targeted therapies like DS-3939a and antibody-drug conjugates such as mirvetuximab soravtansine, to immunotherapy combinations involving ICT01 and pembrolizumab. One unique study explores the potential benefits of lifestyle interventions, combining supervised exercise with atorvastatin to enhance cancer treatment outcomes.

Most trials focus on patients who have already received multiple lines of treatment, reflecting the need for new options in recurrent or treatment-resistant disease. Several studies specifically require platinum-based chemotherapy history, highlighting the importance of this standard treatment in ovarian cancer management. The emphasis on biomarker testing, particularly folate receptor alpha expression and BRCA status, demonstrates the growing importance of personalized medicine in cancer treatment.

These trials offer hope for patients with advanced disease by testing innovative approaches that may improve survival and quality of life beyond currently available treatments.

Ongoing Clinical Trials on Ovarian cancer metastatic

  • Phase 3 Study of LY4170156 (Sofetabart Mipitecan) with drug combination in platinum‑resistant and platinum‑sensitive ovarian cancer patients

    Recruiting

    1 1 1 1
    Austria Belgium Czechia Denmark France Germany +9
  • Study on the Impact of Exercise and Atorvastatin on Advanced Breast, Ovarian, Prostate, and Kidney Cancer Patients

    Recruiting

    1 1 1 1
    Investigated drugs:
    Finland
  • Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors

    Recruiting

    1 1
    Investigated drugs:
    Belgium France Spain
  • Study on Mirvetuximab Soravtansine and Carboplatin for Patients with Recurrent Ovarian Cancer Eligible for Platinum-Based Chemotherapy

    Not recruiting

    1 1 1
    Germany
  • Study on the Safety and Effects of ICT01, Aldesleukin, and Pembrolizumab for Patients with Advanced Solid Tumors

    Not recruiting

    1 1 1
    Investigated diseases:
    France Germany
  • Study on the Safety and Effects of LY2880070 and Gemcitabine in Patients with Advanced or Metastatic Cancer, Focusing on Ovarian Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Croatia Poland