Gynecologic Cancer Clinical Trials
When appropriate, we also offer our patients the option to participate in clinical trials to try a promising new medical drug or other treatment. New treatments through clinical trials are expected to be at least as effective as — or possibly more effective than — current treatments.
Clinical trials test new treatment options only after they have first been researched in the laboratory, where they are carefully studied in the test tube and in laboratory animals. Only the treatments most likely to work are further evaluated in humans during clinical trials. For any new drug or treatment to receive approval by the U.S. Food and Drug Administration (FDA) and become available to the public, it must pass through three phases of clinical trials to show that it is safe and effective in treating the disease. If the FDA approves the drug, it will continue to be monitored for safety and effectiveness in what is known as a Phase 4 study.
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A Prospective Low-Interventional Phase 4 Single Arm Study of Ocular Assessments in Patients Treated with Tivdak in Recurrent or Metastatic Cervical Cancer +
A Prospective Low-Interventional Phase 4 Single Arm Study of Ocular Assessments in Patients Treated with Tivdak in Recurrent or Metastatic Cervical Cancer
Protocol No: C5721005
Age Group: Adult
Disease Sites: Cervix
NCT Id: NCT06952660
Phase: IV
Principal Investigators: Shelly Seward, MD
Eligibility Document -
Attachment Id: 15612
File Name: C5721005_ Subject Eligibility _Screening Checklist Version 01Oct2024.docx
URL:
Objective
This study is being done to learn more about how tisotumab vedotin affects the eyes. Doctors want to understand how safe the medicine is for vision, what types of eye side effects may happen, and how to best manage them. By carefully monitoring eye health during treatments, researchers hope to improve the safety and comfort of patients receiving tisotumab vedotin.
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A Phase III, Randomized, Open-Label, Multicenter, Global Study of Puxitatug Samrotecan (AZD8205) Monotherapy versus Physician's Choice of Chemotherapy in Participants with B7-H4-Selected Advanced/Metastatic Endometrial Cancer Who Progressed on or After Platinum-Based Chemotherapy and Anti-PD-1/Anti-PD-L1 Therapy (BLUESTAR-Endometrial01) +
A Phase III, Randomized, Open-Label, Multicenter, Global Study of Puxitatug Samrotecan (AZD8205) Monotherapy versus Physician's Choice of Chemotherapy in Participants with B7-H4-Selected Advanced/Metastatic Endometrial Cancer Who Progressed on or After Platinum-Based Chemotherapy and Anti-PD-1/Anti-PD-L1 Therapy (BLUESTAR-Endometrial01)
Protocol No: D6900C00003
Age Group: Adult
Disease Sites: Corpus Uteri
NCT Id: NCT07044336
Phase: III
Principal Investigators: Shelly Seward, MD
Eligibility Document -
Attachment Id: 23693
File Name: Subject Eligibility _Screening Checklist_D6900C00003_V1.0 dated 05Feb2025.docx
URL:
Objective
The purpose of this study is to assess the efficacy and safety of puxitatug samrotecan monotherapy against physician's choice of chemotherapy in participants with advanced/metastatic B7-H4-selected (tumor cell greater than or equal to 25%) endometrial cancer who have progressed on or after platinum-based chemotherapy and anti-PD-1/anti-PD-L1 therapy, either separately or in combination.
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Phase 2, Open-Label, Randomized, Master Dose Optimization Protocol Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations with Mirvetuximab Soravtansine in Subjects with Ovarian Cancer +
Phase 2, Open-Label, Randomized, Master Dose Optimization Protocol Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations with Mirvetuximab Soravtansine in Subjects with Ovarian Cancer
Protocol No: M25-709
Age Group: Adult
Disease Sites: Ovary
NCT Id: NCT07059845
Phase: II
Principal Investigators: Shelly Seward, MD
Eligibility Document -
Attachment Id: 24315
File Name: Subject Eligibility _Screening Checklist_M25-709_Substudy2_Protocol Version 3.0 dated 22Aug2025.docx
URL:
Objective
This study is being sone to learn more about a medicine called mirvetuximab soravtansine (MIRV) and how it works in women with ovarian cancer that shows folate receptor alpha. The study will test MIRV in combination with other treatments to find out what dose is safest, how well it controls the cancer and how the body processes the drug. Researchers will also look at blood and tumor samples to better understand who may benefit most from this treatment.
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A Phase III Trial of One vs. Two Years of Maintenance Olaparib, with or Without Bevacizumab, in Patients with BRCA1/2 Mutated or Homologous Recombination Deficient (HRD+) Ovarian Cancer Following Response to First Line Platinum-Based Chemotherapy +
A Phase III Trial of One vs. Two Years of Maintenance Olaparib, with or Without Bevacizumab, in Patients with BRCA1/2 Mutated or Homologous Recombination Deficient (HRD+) Ovarian Cancer Following Response to First Line Platinum-Based Chemotherapy
Protocol No: NRG-GY036
Age Group: Adult
Disease Sites: Ovary
NCT Id: NCT06580314
Phase: III
Principal Investigators: Shelly Seward, MD
Eligibility Document -
Attachment Id: 19673
File Name: Subject Eligibility _Screening Checklist_NRG_GY036_ Version 02 08JAN2026.docx
URL:
Objective
This study is comparing one year versus two years of a maintenance treatment called Olaparib, with or without bevacizumab, in patients with advanced ovarian cancer who have a BRCA mutation or similar DNA repair defect. The goal is to find out which approach better helps prevent the cancer from coming back after initial treatments.
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A Phase III Study of Induction Pembrolizumab and Chemotherapy Followed by Chemoradiation and Pembrolizumab vs Chemoradiation and Pembrolizumab Both Followed by Pembrolizumab for High Risk Locally Advanced Cervical Cancer +
A Phase III Study of Induction Pembrolizumab and Chemotherapy Followed by Chemoradiation and Pembrolizumab vs Chemoradiation and Pembrolizumab Both Followed by Pembrolizumab for High Risk Locally Advanced Cervical Cancer
Protocol No: NRG-GY037
Age Group: Adult
Disease Sites: Cervix
NCT Id: NCT07061977
Phase: III
Principal Investigators: Shelly Seward, MD
Eligibility Document -
Attachment Id: 22033
File Name: Subject Eligibility _Screening Checklist NRG-GY037_Version_13Aug2025.docx
URL:
Objective
This study is looking at how different treatments help people with cancer stay healthier longer. Researchers are comparing two treatment groups to see which one helps patients live longer without their cancer getting worse. They re also checking how many people are still doing well after two years, and looking at other health factors like side effects, treatment timing, and lab results to better understand how each treatment works.
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