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Select Ongoing Trials Currently Enrolling Patients with Gynecologic Cancers

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 clinical trials.


1 Durvalumab plus Chemoradiotherapy versus Chemoradiotherapy Alone in Locally Advanced Cervical Cancer

The purpose of this randomized, multicenter, double-blind, placebo-controlled, phase 3 clinical trial is to evaluate the efficacy and safety of durvalumab (Imfinzi) plus chemoradiotherapy versus chemoradiotherapy alone in patients with locally advanced cervical cancer. Patients aged ≥18 years with documented evidence of cervical adenocarcinoma or squamous carcinoma International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IB2-IIB node-positive or FIGO 2009 stage IIIA-IVA any node cancer who have had no previous chemotherapy or radiotherapy, who have a World Health Organization/Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and who have at least 1 lesion not previously irradiated that qualifies for Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 target lesion at baseline may be eligible if other criteria are met. Eligible patients will be randomized 1:1 to receive durvalumab intravenously (IV) every 4 weeks plus standard-of-care concurrent chemoradiotherapy followed by durvalumab monotherapy for up to 24 months or placebo plus standard-of-care concurrent chemoradiotherapy.

The primary outcome measure is the efficacy of durvalumab plus standard-of-care chemoradiotherapy compared with placebo plus standard-of-care chemoradiotherapy in terms of progression-free survival (PFS), defined as the time from randomization until date of objective disease progression. Secondary outcome measures include the efficacy of durvalumab plus standard-of-care chemoradiotherapy in terms of overall survival (OS) up to 5 years, complete response (CR) rate up to 20 weeks, objective response rate (ORR) up to 4.5 years, and duration of response (DOR) in patients with CR up to 4.5 years; the efficacy of durvalumab plus standard-of-care chemoradiotherapy PFS and OS in patients with programmed cell death-ligand 1–positive disease; and the overall safety and tolerability of the combination. This study expects to enroll 714 in the United States and worldwide. For more information, contact the AstraZeneca Clinical Study Information Center at 1-877-240-9479 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT03830866.


2 Chemotherapy plus Pelvic Radiation with or without Adjuvant Chemotherapy in Patients with High-Risk Early-Stage Cervical Carcinoma

The purpose of this randomized phase 3 clinical trial is to study the efficacy of chemotherapy plus pelvic radiation therapy when given with or without additional chemotherapy in the treatment of patients with high-risk early-stage cervical cancer after radical hysterectomy. Patients aged ≥18 years with histologically confirmed squamous, adenosquamous, or adenocarcinoma of the cervix with high-risk features after surgery; have tumor node metastasis stage IA2, IB, or IIA disease; who have had a radical hysterectomy within the past 70 days; and those who have no previous chemotherapy for current cervical cancer are eligible if other criteria are met. Eligible patients will be randomized into 2 arms. Patients in arm 1 will receive external beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) to the pelvis once daily for 5 days a week for 5 to 6 weeks with concurrent cisplatin IV for 6 weeks. Patients in arm 2 will receive EBRT or IMRT as in arm 1 followed by paclitaxel IV for 4 to 6 weeks after chemoradiotherapy every 21 days for 4 courses.

The primary outcome measure is disease-free survival, defined as the time from randomization to date of first failure or last follow-up. Secondary outcome measures include OS, chemotherapy-induced neuropathy as measured by Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG)-neurotoxicity (NTX) version 4, and quality of life as measured by FACT-cervix and Functional Assessment of Chronic Illness Therapy-diarrhea. This study plans on enrolling 400 patients throughout the United States and worldwide. For more information, contact the Radiation Therapy Oncology Group at This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT00980954.


3 Pembrolizumab plus Lenvatinib versus Chemotherapy as First-Line Therapy in Advanced or Recurrent Endometrial Cancer

The purpose of this randomized, open-label, phase 3 clinical trial is to compare the efficacy of pembrolizumab (Keytruda) plus lenvatinib (Lenvima) versus chemotherapy in patients with stage III-IV or recurrent endometrial carcinoma. Patients aged ≥18 years with histologically confirmed disease that is either measurable or nonmeasurable but radiographically apparent per RECIST version 1.1 with an ECOG performance status of 0 or 1 within 7 days of first dose of study intervention may be eligible if other criteria are met. Eligible patients will be randomized to receive lenvatinib 20 mg daily plus pembrolizumab 200 mg IV on day 1 of each 3-week cycle, or paclitaxel plus carboplatin once at the start of each 3-week cycle.

Primary outcome measures include PFS based on RECIST version 1.1, measured from the time of randomization to the first documented disease progression or death due to any cause, whichever occurs first, and OS, measured from the time of randomization up to death due to any cause. Secondary outcome measures include ORR, percentage of participants experiencing an adverse event (AE; including a serious AE or immune-related AE), and percentage of patients discontinuing treatment due to an AE. This study plans to enroll 720 patients throughout the United States and worldwide. For more information, contact Merck Sharp & Dohme Corp 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 NCT03884101.


4 Adjuvant Radiation versus Chemoradiation in Intermediate-Risk, Stage I/IIA Cervical Cancer

The purpose of this randomized phase 3 clinical trial is to assess the efficacy of chemoradiation versus radiation therapy alone in patients with stage I-IIA cervical cancer who have previously had radial hysterectomy and pelvic lymphadenectomy. Patients aged ≥18 years with pathologically proven primary cervical cancer who were initially treated with standard radical hysterectomy and pelvic lymphadenectomy between 3 and 8 weeks before randomization, who have an ECOG performance status 0-2, and who have positive capillary lymphovascular space or negative capillary-lymphatic space involvement may be eligible if other criteria are met. Eligible patients will be randomized to either pelvic EBRT or IMRT once daily 5 days a week for 5.5 weeks, or pelvic EBRT or IMRT plus cisplatin IV on day 1 every 7 days for up to 6 courses.

The primary outcome measure is recurrence-free survival, defined as time from registration to date of first documented recurrence or death up to 11 months, according to Kaplan and Meier and 1-sided log-rank test. Secondary outcome measures include OS, sites of recurrence, incidence of AEs according to the active version of the Common Terminology Criteria for Adverse Events, patient risk–benefit, treatment compliance, and quality of life as per FACT-cervix, FACT/GOG-NTX 4 subscale, and the brief pain inventory. The study plans to enroll 360 participants throughout the United States and worldwide. For more information, contact the sites directly and mention the NLM identifier. The NLM identifier is NCT01101451.


5 Dostarlimab plus Carboplatin-Paclitaxel versus Placebo plus Carboplatin-Paclitaxel for Recurrent or Primary Advanced Endometrial Cancer

The purpose of this randomized, double-blind, multicenter, phase 3 clinical trial is to evaluate the efficacy and safety of dostarlimab, an anti–PD-1 monoclonal antibody, in combination with carboplatin-paclitaxel, the standard-of-care, in the treatment of patients with recurrent or primary advanced endometrial cancer. Patients aged ≥18 years with primary stage III or IV or first recurrence of endometrial cancer with a low potential for cure by radiation therapy or surgery alone, who have an ECOG performance status of 0-1, and who can provide adequate tumor tissue sample at screening for microsatellite instability may be eligible if other criteria are met. Eligible patients will be randomized in a 1:1 ratio to receive dostarlimab 500 mg IV every 3 weeks from cycle 1 to cycle 6, then 1000 mg every 6 weeks, plus carboplatin-paclitaxel combination or placebo.

The primary outcome measure is PFS, defined as time from the date of randomization to the earliest date of assessment of disease progression or death by any cause, whichever occurs first. Secondary outcome measures include OS, ORR, DOR, disease control rate, number of participants experiencing treatment-emergent AEs, and changes from baseline in hematology, electrolytes, protein, hormone, and cardiovascular parameters. The study plans to enroll 470 patients throughout the United States and worldwide. For more information, contact the GlaxoSmithKline Clinical Trials at 1-877-379-3718 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT03981796.


6 Bintrafusp Alfa Monotherapy as Treatment for Advanced, Unresectable Cervical Cancer with Disease Progression During or After Platinum-Containing Chemotherapy

The purpose of this multicenter, open-label phase 2 clinical trial is to evaluate the clinical efficacy and safety of bintrafusp alfa in patients with advanced, unresectable cervical cancer whose disease progressed during or after platinum-containing chemotherapy. Patients aged ≥18 years with an ECOG performance status of 0-1, who have a life expectancy of ≥12 weeks, and who have adequate hematologic, hepatic, and renal function may be eligible if other criteria are met. Eligible patients will receive bintrafusp alfa 1200 mg IV once every 2 weeks until confirmed disease progression, death, unacceptable toxicity, or study withdrawal.

The primary outcome measure is ORR according to RECIST version 1.1 (time from first treatment to planned final assessment at 2 years). Secondary outcome measures include DOR, durable response at ≥6 months, PFS, occurrence of treatment-emergent and treatment-related AEs, OS, and concentration of bintrafusp alfa at end of infusion and at end of dosing interval at approximately 2 years. The study plans to enroll 135 patients throughout the United States and worldwide. For more information, contact EMD Serono Research & Development Institute’s US Medical Information at 1-888-275-7376, or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT04246489.


7 Maintenance Selinexor After Chemotherapy for Advanced or Recurrent Endometrial Cancer

The purpose of this multicenter, randomized, double-blind, phase 3 clinical trial is to evaluate the efficacy of maintenance selinexor (Xpovio) in the treatment of patients with advanced or recurrent endometrial cancer after receiving a single line of at least 12 weeks of taxane-platinum combination chemotherapy. Patients aged ≥18 years with histologically confirmed endometrial cancer of the endometrioid, serous, or undifferentiated type; who have primary stage IV disease; have had no surgery and achieved partial response or CR after chemotherapy; and who have an ECOG performance status of 0-1 may be eligible if other criteria are met. Eligible patients will be randomized to receive a fixed dose of selinexor orally on days 1, 8, 15, and 22 of each 28-day cycle, or placebo.

The primary outcome measure is PFS between the 2 treatment arms as assessed by the investigator per RECIST version 1.1. Secondary outcome measures include disease-specific survival, OS, time to first subsequent treatment and PFS after subsequent treatment, disease control rate, and health-related quality of life. The study plans to enroll 248 patients throughout the United States and worldwide. For more information, contact Jatin Shah, MD, at 1-617-658-0600 or This email address is being protected from spambots. You need JavaScript enabled to view it., or Sharon Shacham, PhD, at This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT03555422.


8 Durvalumab plus Paclitaxel/Carboplatin, Followed by Durvalumab Maintenance Therapy with or without Olaparib for Advanced or Recurrent Endometrial Cancer

The purpose of this randomized, multicenter, double-blind, placebo-controlled, phase 3 clinical trial is to assess the efficacy and safety of durvalumab (Imfinzi) in combination with paclitaxel/carboplatin followed by durvalumab maintenance therapy with or without olaparib (Lynparza) for the treatment of patients with newly diagnosed advanced or recurrent endometrial cancer. Patients aged ≥18 years with histologically confirmed epithelial endometrial carcinoma who have newly diagnosed stage III or IV disease as per RECIST version 1.1, who are naïve to first-line systemic anticancer treatment, and who have an ECOG performance status of 0-1 may be eligible if other criteria are met. Eligible patients will be randomized to receive either platinum-based chemotherapy and durvalumab placebo followed by maintenance durvalumab placebo and olaparib placebo; platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib placebo; or platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib.

The primary outcome measure is PFS, defined as time from randomization to first progression by investigator assessment using modified RECIST version 1.1 or death by any cause in the absence of progression. Secondary outcome measures include OS, ORR, DOR, time to first and second subsequent therapy, time to discontinuation or death, and the immunogenicity of durvalumab as determined by concentration of antidrug antibodies to durvalumab. The study plans to enroll 699 patients throughout the United States and worldwide. For more information, contact the AstraZeneca Clinical Study Information Center at 1-877-240-9479 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT04269022.

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