A study to look at the effects of different treatments on rare types of previously treated epithelial ovarian, fallopian tube or primary peritoneal cancers with different molecular changes

A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors

  • Cancer
  • Ovarian Cancer
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Active, not recruiting

This trial runs in
Countries
  • Australia
  • Canada
  • Czechia
  • France
  • Germany
  • Italy
  • Russia
  • South Korea
  • Spain
  • Switzerland
  • Türkiye
  • United Kingdom
  • United States
Trial Identifier:

NCT04931342 GOG-3051, ENGOT-GYN2 WO42178

      Show trial locations

      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      This study will evaluate the efficacy and safety of multiple biomarker-selected treatments in patients with persistent or recurrent rare epithelial ovarian, fallopian tube, or primary peritoneal tumors. Enrollment will take place in two phases: a preliminary phase followed by a potential expansion phase.

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT04931342,WO42178,GOG-3051, ENGOT-GYN2 Trial Identifier
      Female Gender
      ≥18 Years Age
      No Healthy Volunteers

      1. Why is this study needed?

      Cancer is a health condition where the body's cells start growing and multiplying in an uncontrolled and abnormal way. These cells don’t follow the usual pattern of cell division and growth. Instead they form a lump or mass called a tumour. Some cancers have certain changes in their genes. Genes are a sections of DNA that has instructions for making the body. These changes help the cancer grow and survive. New treatments may work better than current ones by targeting changes in cancer.

      This study is testing different anti-cancer medicines. They are being developed to treat rare epithelial ovarian, fallopian tube or primary peritoneal cancers (rare EOC). Some of the anti-cancer medicines in this study are approved by authorities (like the U.S. Food and Drug Administration and European Medicines Agency). They are approved on their own or with other medicines for treating certain cancers in some countries. In this study, the anti-cancer medicines or medicine combinations are experimental. This means health authorities have not approved them for treating rare EOC. This study aims to test the effects of different anti-cancer medicines in people with rare EOC with certain changes in the genes.

      2. Who can take part in the study?

      Females of 18 years of age or older with certain types of rare EOC can take part in the study. But only if they have previously received treatment, including at least one platinum-based treatment. They must also meet other criteria for the group they join.

      People may not be able to take part in this study if they have fast-growing (high-grade serous or high-grade endometrioid) EOC. Neither can people who have previously received certain medications or have certain medical conditions. People who are pregnant, or currently breastfeeding cannot take part in the study.

      3. How does this study work?

      Participants will be screened to check if they are able to participate in the study. The screening period will take place from 1 day to 1 month before the start of treatment. Study medicines will be given in ‘cycles’. A treatment cycle is the period of treatment and recovery time before the next set of treatment is given.

      Everyone in this study will join 1 of 11 groups. The group a participant is put into will depend on the type of cancer they have AND if they meet the criteria to join that group. Participants will be given either:

      • Group A: ipatasertib, given as a pill to be swallowed on Days 1 to 21 of each 4-week cycle AND paclitaxel as a drip into a vein on Days 1, 8 and 15 of each 4-week cycle
      • Group B: cobimetinib, given as a pill to be swallowed on Days 1 to 21 of each 4-week cycle
      • Group C: trastuzumab emtansine, given as a drip into a vein every 3 weeks
      • Group D: atezolizumab AND bevacizumab, given as drips into a vein every 3 weeks
      • Group E: giredestrant, given as a pill to be swallowed once a day AND abemaciclib given as a pill to be swallowed twice a day
      • Group F: inavolisib, given as a pill to be swallowed once a day AND palbociclib, given as a pill to be swallowed on Days 1 to 21 of each 4-week cycle
      • Group G: inavolisib AND letrozole, given as pills to be swallowed once a day, AND palbociclib, given as a pill to be swallowed on Days 1 to 21 of each 4-week cycle
      • Group H: inavolisib, given as a pill to be swallowed once a day, AND olaparib given as a pill to be swallowed twice a day
      • Group I: inavolisib AND giredestrant, given as pills to be swallowed once a day
      • Group J: inavolisib, given as a pill to be swallowed once a day AND bevacizumab, given as a drip into a vein every 3 weeks
      • Group K: atezolizumab AND bevacizumab, given as drips into a vein every 3 weeks, AND cyclophosphamide given as a pill to be swallowed once a day

      This is an open-label study. This means everyone involved, including the participant and the study doctor, will know the study treatment the participant has been given.

      During this study, the study doctor will see participants regularly. They will see how well the treatment is working and any unwanted effects participants may have. Participants will have follow-up visits either at a clinic or by telephone calls around every 3 months after completing the study treatment, for as long as they agree to it. The follow-up visits are done to check on the participant’s wellbeing and to see if they have received any other treatments since completing study treatment. Total time of participation in the study could be more than 2 years, depending on how the participant responds to the study treatment. Participants have the right to stop study treatment and leave the study at any time, if they wish to do so.

      4. What are the main results measured in this study?

      The main result measured in the study to assess if the medicines have worked is how many participants have a specific level of reduction in the size of their tumour. Other key results measured in the study include:

      • How much time is there between the participant’s cancer first responding to treatment and the cancer getting worse
      • The time between when a participant has no signs of cancer and when the cancer worsens
      • How long participants live without their cancer getting worse
      • The number of participants who are alive and whose cancer has not gotten worse 6 months after starting treatment
      • How long participants live
      • The number and seriousness of unwanted effects

      5. Are there any risks or benefits in taking part in this study?

      Taking part in the study may or may not make participants feel better. But the information collected in the study can help other people with similar health conditions in the future.

      It may not be fully known at the time of the study how safe and how well the study treatment works. The study involves some risks to the participant. But these risks are generally not greater than those related to routine medical care or the natural progression of the health condition. People interested in taking part will be informed about the risks and benefits, as well as any additional procedures or tests they may need to undergo. All details of the study will be described in an informed consent document. This includes information about possible effects and other options of treatment.

      Risks associated with the study medicines

      Participants may have unwanted effects of the medicines used in this study. These unwanted effects can be mild to severe, even life-threatening, and vary from person to person. During this study, participants will have regular check-ups to see if there are any unwanted effects.

      Participants will be told about the known unwanted effects of the study medicines, and possible unwanted effects based on human and laboratory studies or knowledge of similar medicines. Known unwanted effects include cough, rash, fever, frequent watery stools, throwing up or wanting to throw up, feeling tired or weak, and pain or discomfort in the head. The study medicines ipatasertib, cobimetinib, giredestrant, abemaciclib, inavolisib, palbociclib, letrozole, olaparib and cyclophosphamide will be given as a pill to be swallowed. The study medicines paclitaxel, trastuzumab emtansine, bevacizumab, atezolizumab will be given as drips into a vein. Known unwanted effects of a drip into a vein include itching, feeling or being sick, a feeling of coldness that makes the body shiver, low blood pressure, fever, reddening of the skin, pain or discomfort in the head, a rapid heart rate, breathing problems, throat irritation, pain or swelling.

      The study medicine(s) may be harmful to an unborn baby. Women and men must take precautions to avoid exposing an unborn baby to the study treatment.

      For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov

      Trial-identifier: NCT04931342

      Trial Summary

      This study will evaluate the efficacy and safety of multiple biomarker-selected treatments in patients with persistent or recurrent rare epithelial ovarian, fallopian tube, or primary peritoneal tumors. Enrollment will take place in two phases: a preliminary phase followed by a potential expansion phase.

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT04931342,WO42178,GOG-3051, ENGOT-GYN2 Trial Identifier
      Ipatasertib, Cobimetinib, Trastuzumab Emtansine, Atezolizumab, Bevacizumab, Paclitaxel, Giredestrant, Abemaciclib, Inavolisib, Palbociclib, Letrozole, Olaparib, Luteinizing Hormone-Releasing Hormone (LHRH) Agonists, Cyclophosphamide, Inavolisib Treatments
      Ovarian Cancer Condition
      Official Title

      A phase II, open-label, multicenter, platform study evaluating the efficacy and safety of biomarker-driven therapies in patients with persistent or recurrent rare epithelial ovarian tumors

      Eligibility Criteria

      Female Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Persistent or recurrent EOC that meets the following criteria: Histologically confirmed non-high-grade serous, non-high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer, including but not limited to low-grade serous ovarian carcinoma, clear cell carcinoma, mucinous carcinoma, carcinosarcoma, undifferentiated carcinoma, seromucinous carcinoma, malignant Brenner tumors, Grades 1 or 2 endometrioid carcinoma, mesonephric-like adenocarcinoma and small cell carcinoma of the ovary, hypercalcemic type (SCCOHT). Disease that is not amenable to curative surgery
      • Measurable disease (at least one target lesion) according to RECIST v1.1
      • Previous treatment with one to four lines of therapy, at least one of which was platinum-based. Hormonal therapy does not count as a line of therapy.
      • Platinum-resistant disease, defined as disease progression during or within 6 months of last platinum therapy, with the following exception: Participants with primary platinum-refractory disease are excluded.
      • Submission of a representative tumor specimen that is suitable for next-generation sequencing (NGS) testing and estrogen receptor immunohistochemistry (ER IHC) to determine treatment arm assignment and for central pathology review.
      • Submission of the local pathology report and, if available, any associated stained slides that supported the local diagnosis of the histology (to be used for central pathology review)
      • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
      • Adequate hematologic and end-organ function
      • For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs (if applicable)
      • In addition to the general inclusion criteria above, participants must meet all of the arm-specific inclusion criteria for the respective arm
      Exclusion Criteria

      General Exclusion Criteria:

      • Pregnant or breastfeeding, or intending to become pregnant or breastfeed during the study
      • Primary platinum-refractory disease, defined as progression during or within 4 weeks after the last dose of the first-line platinum treatment
      • Histologic diagnosis of high-grade serous or high-grade endometrioid ovarian, fallopian tube, or primary peritoneal cancer
      • Current diagnosis of solely borderline epithelial ovarian tumor
      • Current diagnosis of non-epithelial ovarian tumors
      • Current diagnosis of synchronous primary endometrial cancer
      • Prior history of primary endometrial cancer, with the following exception: a prior diagnosis of primary endometrial cancer is permitted if it meets all of the following conditions: Stage IA, no lymphovascular invasion, International Federation of Gynecology and Obstetrics Grade 1 or 2, not a high-grade subtype.
      • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
      • Symptomatic, untreated, or actively progressing CNS metastases
      • Severe infection within 4 weeks prior to initiation of study treatment
      • Treatment with chemotherapy, radiotherapy, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, or investigational therapy within 28 days prior to initiation of study treatment
      • Treatment with hormonal therapy within 14 days prior to initiation of study treatment
      • In addition to the general exclusion criteria above, participants can not meet any of the arm-specific exclusion criteria for the respective arm

      Clinical Research Explained

      Information about what clinical trials and observational studies are. Understand why you might want to take part in clinical research and why diversity in clinical research is important.

      Find out now