This Ovarian Cancer Awareness Month 2024, we will be looking into the latest research and clinical trials focused on ovarian cancer in adults.
The following list has been carefully curated by evaluating the ongoing Phase 3 trials for ovarian cancer, specifically targeting adults in the United States. Please note that the dates provided are approximate and subject to change. This compilation primarily features studies that have released updates within the past 12 months.
This series aims to offer a glimpse into upcoming innovations in the field and how the outcomes of these studies could potentially influence clinical guidelines related to the topic.
Without further ado, let us explore the list of Ovarian Cancer Clinical Trials!
Quick View Table of Ovarian Cancer Clinical Trials
Ovarian Cancer Clinical Trials:
A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer (RAMP 301)
- Sponsor: Verastem, Inc.
- This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator’s choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.
- Interventions: DRUG: avutometinib|DRUG: Defactinib|DRUG: Pegylated liposomal doxorubicin|DRUG: Paclitaxel|DRUG: Topotecan|DRUG: Letrozole|DRUG: Anastrozole
- Primary Outcomes Measures: Progression Free Survival (PFS) per blinded independent central review (BICR), Confirmed overall response rate per RECIST 1.1 per blinded independent central review (BICR), Up to 24 months.
REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator’s Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1
- Sponsor: Sutro Biopharma, Inc.
- A Phase 2/3 study to investigate the efficacy and safety of luveltamab tazevibulin versus IC chemotherapy in women with ovarian cancer (including fallopian tube or primary peritoneal cancers) expressing FOLR1.
- Interventions: DRUG: Luveltamab tazevibulin|DRUG: Pegfilgrastim|DRUG: Gemcitabine|DRUG: Paclitaxel|DRUG: Pegylated liposomal doxorubicin|DRUG: Topotecan
- Primary Outcomes Measures: Progression Free Survival (PFS), time between the date of first dose and the first date of documented progression or death, up to 24 months|Objective Response Rate (ORR), Best response of complete response (CR) or partial response (PR) per RECIST 1.1., up to 24 months.
Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65)
- Sponsor: Merck Sharp & Dohme LLC
- The primary objective is to compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator. The hypotheses are that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score \[CPS\] ≥1) and that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for all participants.
- Interventions:BIOLOGICAL: Pembrolizumab|DRUG: Paclitaxel|DRUG: Bevacizumab|OTHER: Placebo for pembrolizumab|DRUG: Docetaxel
- Primary Outcomes Measures: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator, PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by the Investigator will be presented., Up to ~38 months.
Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected
- Sponsor: Novartis Pharmaceuticals
- The objective of this study is to assess the efficacy and safety of the combination of alpelisib and olaparib compared with single agent cytotoxic chemotherapy in patients with platinum resistant or refractory high-grade serous ovarian cancer, with no germline BRCA mutation detected.
- Interventions: DRUG: Alpelisib|DRUG: Olaparib|DRUG: Paclitaxel|DRUG: Pegylated liposomal doxorubicin (PLD)
- Primary Outcomes Measures: Progression Free Survival (PFS) based on Blinded Independent Review Committee (BIRC) assessment using RECIST 1.1 criteria, PFS is defined as the time from the date of randomization to the date of the first documented progression (based on RECIST 1.1 criteria) or death due to any cause. If a participant has not had an event, PFS will be censored at the date of the last adequate tumor assessment, From randomization until the date of the first documented progression or death due to any cause, whichever comes first, assessed up to approximately 23 months.
A Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression (SORAYA)
- Sponsor: ImmunoGen, Inc.
- This study is designed to evaluate the efficacy and safety of mirvetuximab soravtansine (MIRV) in participants with platinum-resistant high-grade serous epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of Folate Receptor-Alpha (FRα). Participants will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. All participants will receive single-agent MIRV at 6 mg/kg adjusted ideal body weight administered on Day 1 of every 3-week cycle.
- Interventions: DRUG: Mirvetuximab Soravtansine
- Primary Outcomes Measures: Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), ORR was defined as percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). PR: At least 30% decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD., Up to approximately 15 months.
A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy (ATHENA)
- Sponsor: pharmaand GmbH
- This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.
- Interventions: DRUG: Rucaparib|DRUG: Nivolumab|DRUG: Placebo Oral Tablet|DRUG: Placebo IV Infusion
- Primary Outcomes Measures: Investigator assessed Progression-free survival (PFS), From randomization until disease progression (up to approximately 7 years).
Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- Sponsor: National Cancer Institute (NCI)
- This phase II/III trial studies how well pegylated liposomal doxorubicin hydrochloride with atezolizumab and/or bevacizumab work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent). Chemotherapy drugs, such as pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. It is not yet known which combination will work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.
- Interventions: DRUG: Atezolizumab|BIOLOGICAL: Bevacizumab|PROCEDURE: Computed Tomography|DRUG: Pegylated Liposomal Doxorubicin Hydrochloride|OTHER: Quality-of-Life Assessment
- Primary Outcomes Measures: Incidence of dose limiting toxicities (DLT) of experimental regimens will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 (CTCAE version 5.0 will be used beginning April 1, 2018). DLT will be assessed., Up to 28 days|Progression free survival (PFS) (Phase II), Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria and will include estimates of the hazard ratios and the corresponding confidence intervals for the experimental regimen relative to the reference regimen, as well as Kaplan-Meier estimates of the survivorship function for each treatment group., From study enrollment to the investigator determined date of progression or death due to any cause, whichever occurs first, assessed up to 5 years|PFS (Phase III), Will be assessed by RECIST v1.1 criteria and will include estimates of the hazard ratios and the corresponding confidence intervals for the experimental regimen relative to the reference regimen, as well as Kaplan-Meier estimates of the survivorship function for each treatment group., From study enrollment to the investigator determined date of progression or death due to any cause, whichever occurs first, assessed up to 5 years|Overall survival (OS) (Phase III), OS will be evaluated., From study enrollment to the date of death regardless of the cause, assessed up to 5 years.
A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
- Sponsor: Tesaro, Inc.
- This study aims to assess efficacy of Niraparib (GSK3985771) as maintenance treatment in participants with Stage III or IV ovarian cancer. Participants must have completed front-line platinum based regimen with complete response (CR) or partial response (PR). Data collection for Secondary Outcome measures is ongoing and the approximate duration of the study will be 7 years.
- Interventions: DRUG: Niraparib|DRUG: Placebo
- Primary Outcomes Measures: Progression Free Survival, Progression free survival was defined as the time from the date of treatment randomization to the date of first documentation of disease progression or death due to any cause in the absence of documented progression, whichever occurs first. It was assessed by the blinded independent central review (BICR). Median and 95% confidence interval (CI) are presented., Up to 34 months.
Testing the Combination of Cediranib and Olaparib in Comparison to Each Drug Alone or Other Chemotherapy in Recurrent Platinum-Resistant Ovarian Cancer
- Sponsor: National Cancer Institute (NCI)
- This randomized phase II/III trial studies how well cediranib maleate and olaparib work when given together or separately, and compares them to standard chemotherapy in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has returned (recurrent) after receiving chemotherapy with drugs that contain platinum (platinum-resistant) or continued to grow while being treated with platinum-based chemotherapy drugs (platinum-refractory). Cediranib maleate and olaparib may stop the growth of tumor cells by blocking enzymes needed for cell growth. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cediranib maleate and olaparib together may cause more damage to cancer cells when compared to either drug alone or standard chemotherapy.
- Interventions: DRUG: Cediranib|DRUG: Cediranib Maleate|PROCEDURE: Computed Tomography|PROCEDURE: Magnetic Resonance Imaging|DRUG: Olaparib|DRUG: Paclitaxel|DRUG: Pegylated Liposomal Doxorubicin Hydrochloride|OTHER: Questionnaire Administration|DRUG: Topotecan|DRUG: Topotecan Hydrochloride
- Primary Outcomes Measures: Progression-free survival (PFS) (Phase II and Phase III), Progression-free survival will be assessed. The primary analysis of PFS will be assessed using a proportional hazards model with patients analyzed according to the arm to which they were randomized, regardless of whether treatment is received., Time from study enrollment to the onset of progression as determined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST) criteria, or death due to any cause, whichever occurs first, assessed up to 5 years overall survival (OS) (Phase III), Overall survival will be evaluated. To allow for better understanding of time to subsequent therapy and OS, patients on experimental study drug(s) or standard chemotherapy arm will be followed after progression, with data capture to include the date of initiation of the subsequent therapy, detailed information on the type of subsequent therapy received, and time to progression on the subsequent therapy. Time from study enrollment to death due to any cause, assessed up to 5 years.
Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy
- Sponsor: AstraZeneca
- A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (including patients with primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer with BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)) who have responded following platinum based chemotherapy.
- Interventions: DRUG: Olaparib 300mg tablets|DRUG: Placebo to match olaparib 300mg
- Primary Outcomes Measures: Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1), To determine the efficacy by progression free survival (PFS) (using investigator assessment according to modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1)) of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy., Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months.
Potential Guideline That May Be Affected Includes:
- PARP Inhibitors in the Management of Ovarian Cancer
- American Society of Clinical Oncology
- Publication: September 23, 2022
- Ovarian Masses and Treatment of Epithelial Ovarian Cancer
- American Society of Clinical Oncology
- Publication: June 23, 2021
- Germline and Somatic Tumor Testing in Epithelial Ovarian Cancer
- American Society of Clinical Oncology
- Publication: January 27, 2020
This is it – a list of Phase 3 Clinical Trials for Ovarian Cancer as of August 2024. Stay tuned, for our next Guidelines+ Trials Rundown. Sign up for alerts and stay informed on the latest published guidelines and articles.
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