The following clinical trials represent a selection of key studies currently recruiting patients with gynecologic cancers for inclusion in investigations of new therapies and new regimens of existing treatments for the disease. Each clinical trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. This information can help oncology practice managers and providers direct eligible patients to one of these trials.

The purpose of this open-label, randomized, phase 3 study is to evaluate the progression-free survival (PFS) in patients with advanced, platinum-resistant, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer treated with an intermittent regimen of relacorilant (CORT-125134) plus nab-paclitaxel (Abraxane) versus nab-paclitaxel alone. Patients aged ≥18 years with histologically confirmed diagnosis of grade 3, platinum-resistant disease per RECIST version 1.1; who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; and who have received at least 1 but ≤3 lines of previous systemic anticancer therapy, at least 1 previous line of platinum therapy, and previous treatment with bevacizumab (Avastin) may be eligible if other criteria are met. Eligible patients will be randomized to receive nab-paclitaxel 80 mg/m² intravenously (IV) on days 1, 8, and 15 of each 28-day cycle plus relacorilant 150 mg orally (PO) once daily, or nab-paclitaxel 100 mg/m² IV.

The primary outcome measure is PFS as assessed by blinded independent central review from time of randomization until time of first documented progressive disease or death due to any cause, whichever occurs first. Secondary outcome measures include overall survival (OS); objective response rate (ORR); duration of response (DOR); cancer antigen (CA)-125 response as defined by the Gynecologic Cancer InterGroup (GCIG); and the proportion of patients who attain complete response (CR), partial response (PR), or stable disease per RECIST version 1.1. The study plans to enroll approximately 360 participants throughout the United States and worldwide. For more information, contact B. Qureshi, MD, at 1-650-409-1642 or This email address is being protected from spambots. You need JavaScript enabled to view it., or L. Dreiling, MD, at 1-650-327-3270 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT05257408.

The purpose of this open-label, active comparator, randomized, phase 3 study is to assess the safety and efficacy of pembrolizumab (Keytruda) versus carboplatin (Paraplatin) plus paclitaxel (Taxol) in the first-line treatment of patients with mismatch repair deficient (dMMR), advanced or recurrent endometrial carcinoma who have not received previous systemic chemotherapy. Patients aged ≥18 years with histologically confirmed diagnosis of inoperable, stage III or IV or recurrent endometrial carcinoma that is centrally confirmed as dMMR; who have not received previous systemic therapy, except for previous radiation and hormonal therapy that was discontinued ≥1 week prior to randomization; and who have an ECOG performance status of 0 or 1 within 7 days before randomization may be eligible if other criteria are met. Eligible patients will be randomized to receive pembrolizumab 400 mg IV on day 1 of each 6-week cycle for up to 18 cycles, or a combination of paclitaxel 175 mg/m² on day 1 of each 3-week cycle and carboplatin area under the curve 5 or 6 on day 1 every 3 weeks for 6 cycles.

The primary outcome measures are PFS from date of randomization to the first documented disease progression or death due to any cause, whichever occurs first, and OS, from time of randomization to death due to any cause. Secondary outcome measures include ORR, disease control rate (DCR), DOR, the number of patients who have at least 1 adverse event (AE) or who discontinue study treatment due to an AE, and change in baseline European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core 30. The study plans to enroll approximately 350 participants throughout the United States and worldwide. For more information, contact Merck Sharp & Dohme at 1-888-577-8839 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT05173987.

The purpose of this multicenter, open-label, randomized, phase 3 study is to evaluate the efficacy of the combination of nemvaleukin alfa (ALKS 4230) plus pembrolizumab versus protocol-specific investigator’s choice of chemotherapy in the treatment of patients with platinum-resistant, epithelial ovarian, fallopian tube, or primary peritoneal cancer. Patients aged ≥18 years with histologically confirmed diagnosis whose disease progressed within 180 days following the last administered dose of platinum therapy beyond the first-line setting or lack of response or disease progression while receiving the most recent platinum-based therapy; who have at least 1 measurable lesion that qualifies as a target lesion based on RECIST version 1.1; and who have received 1 to 5 previous lines of systemic platinum anticancer therapy and at least 1 line of therapy containing bevacizumab may be eligible if other criteria are met. Eligible patients will be randomized (3:1:1:3) to receive either nemvaleukin alfa 6 µg/kg/day IV plus pembrolizumab 200 mg IV; pembrolizumab monotherapy; nemvaleukin alfa monotherapy; or investigator’s choice chemotherapy of pegylated liposomal doxorubicin, paclitaxel, topotecan, or gemcitabine.

The primary outcome measure is PFS as assessed by the investigator for up to 1 year. Secondary outcome measures include ORR, OS, DCR, DOR, time to response, CA-125 response per GCIG, and incidence of treatment-emergent AEs. The study plans to enroll approximately 376 participants throughout the United States and worldwide. For more information, contact Alkermes Global Clinical Services at 1-888-235-8008 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT05092360.

The purpose of this 2-arm, open-label, randomized, phase 3 study is to evaluate the efficacy of letrozole (Femara) with or without paclitaxel and carboplatin in the treatment of patients with stage II-IV, low-grade, serous carcinoma of the ovary, fallopian tube, or peritoneum. Patients aged ≥18 years with newly diagnosed, stage II-IV disease; who have had a bilateral salpingo-oophorectomy; who have an ECOG performance status of 0 to 2 within 14 days before registration; who are within ≤8 weeks of primary cytoreductive surgery at time of randomization; and who have attempted maximal upfront cytoreductive surgery with either optimal or suboptimal residual disease may be eligible if other criteria are met. Eligible patients will be randomized to receive paclitaxel IV and carboplatin IV on day 1 every 21 days for up to 6 cycles, then letrozole PO once daily, or letrozole alone in the absence of disease progression or unacceptable toxicity.

The primary outcome measure is PFS from time of randomization to documentation of disease progression or death from any cause, whichever comes first, assessed up to 8 years. Secondary outcome measures include the incidence of AEs, ORR, DOR, OS, and adherence to letrozole maintenance therapy. The study plans to enroll 450 participants throughout the United States and worldwide. For more information, contact the recruiting sites directly. The NLM identifier is NCT04095364.

The purpose of this multicenter, double-blind, placebo-controlled, randomized, phase 3 study is to evaluate the efficacy and safety of selinexor (Xpovio) as maintenance therapy in patients with p53 wild-type, advanced, or recurrent endometrial carcinoma who have achieved PR or CR after completing at least 12 weeks of platinum-based therapy. Patients aged ≥18 years with histologically confirmed TP53 wild-type endometrial carcinoma assessed by next-generation sequencing; who did not receive adjuvant chemotherapy at initial diagnosis and relapsed later for stage I-III disease at diagnosis or have received initial chemotherapy with or without surgery and relapsed later for stage IV disease at diagnosis; who have an ECOG performance status of 0 or 1; and who have received previous treatment with anti–PD-1 or anti–PD-L1 monoclonal antibody and concomitant biologic agents may be eligible if other criteria are met. Eligible patients will be randomized to receive selinexor 60 mg or placebo PO once weekly on days 1, 8, 15, and 22 of each 28-day cycle.

The primary outcome measure is PFS from time of randomization until disease progression or death, whichever occurs first, up to 34 months. Secondary outcome measures include OS, the number of participants with TEAEs and serious TEAEs, time to first and second subsequent therapies, PFS after consecutive treatment, and EORTC QLQ EuroQol-5 Dimensions-5 Levels. The study plans to enroll approximately 220 participants throughout the United States and worldwide. For more information, contact Karyopharm Medical Information at 1-888-209-9326 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT05611931.

The purpose of this multicenter, open-label, randomized, phase 3 study is to evaluate the safety and efficacy of mirvetuximab soravtansine (Elahere) plus bevacizumab versus bevacizumab alone as maintenance therapy in patients with FRα-high, recurrent platinum-sensitive ovarian, fallopian tube, or peritoneal cancer whose disease has not progressed after second-line platinum-based chemotherapy plus bevacizumab. Patients aged ≥18 years with an ECOG performance status of 0 or 1; with confirmation of high FRα expression as defined by the Ventana FOLR1 Assay; who have had previous BRCA testing or germline testing; whose disease has relapsed after first-line platinum-based chemotherapy and is platinum-sensitive; and who are appropriate for, currently receiving, or have completed platinum-based triplet therapy in the second-line setting may be eligible if other criteria are met. Eligible patients will be randomized to receive mirvetuximab soravtansine 6 mg/kg adjusted ideal body weight plus bevacizumab 15 mg/kg every 3 weeks, or bevacizumab alone 15 mg/kg every 3 weeks.

The primary outcome measure is PFS assessed for up to 4 years. Secondary outcome measures include OS, safety and tolerability per AEs as evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, second disease progression, ORR, DOR, disease-free survival (DFS), CA-125 response, and patient-reported outcome of health-related quality of life of disease-related symptoms using the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (FACT) Ovarian Symptom Index. The study plans to enroll approximately 418 participants throughout the United States and worldwide. For more information, contact ImmunoGen at 1-781-895-0600 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT05445778.

The purpose of this randomized, phase 3 study is to compare minimally invasive surgery to laparotomy in treating patients with stage IIIC-IV ovarian, primary peritoneal, or fallopian tube cancer who are receiving neoadjuvant chemotherapy. Patients aged ≥18 years with stage IIIC or IV, high-grade, invasive disease; who received a CR or PR to 3 or 4 cycles of neoadjuvant chemotherapy; who have a normalization of CA-125 according to individual participating center reference range; who have a time frame of <6 weeks from the last cycle of neoadjuvant chemotherapy to interval debulking surgery; and who have an ECOG performance status of 0 to 2 may be eligible if other criteria are met. Eligible patients will be randomized to receive minimally invasive surgery within 6 weeks after the last cycle of standard-of-care neoadjuvant chemotherapy or laparotomy within 6 weeks after the last cycle of standard-of-care neoadjuvant chemotherapy. Patients in both arms will receive standard-of-care chemotherapy within 6 weeks of surgery.

The primary outcome measure is DFS between randomization and physical or radiographic evidence of recurrence or death, assessed up to 5 years. Secondary outcome measures include health-related quality of life per EORTC and FACT, optimal and complete cytoreduction rates, OS, surgical morbidity rates, mortality rates, and cost of the procedure. The study plans to enroll approximately 580 participants throughout the United States. For more information, contact Jose A. Rauh-Hain, MD, MPH, at 1-713-794-1759 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT04575935.