Ovarian and Endometrial Cancer Clinical Trials Intelligence

Monthly Update Report for Trials Started in August 2026

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1: Summary data from new trials identified for Ovarian and Endometrial Cancer.

Overview

Number of Trials: 8

These 8 trials investigate treatments for gynecologic cancers including endometrial and ovarian cancer, spanning novel cell therapies, immunotherapy, targeted agents, and supportive care devices. Approaches range from CAR T-cell and dendritic cell vaccines to repurposed drugs like losartan and tirzepatide, alongside standard chemotherapy combinations and antibody-drug conjugates.

Common Criteria Across Trials

Common Inclusion

Histologically confirmed diagnosis of endometrial or ovarian cancer
Age ≥18 years
ECOG performance status 0-2
Adequate organ function (hematologic, renal, hepatic)
Measurable disease per RECIST v1.1
Willingness to provide informed consent
Negative pregnancy test/contraception requirements for women of childbearing potential

Common Exclusion

Active or uncontrolled infections
Significant cardiac disease or uncontrolled hypertension
Pregnancy or breastfeeding
Prior therapy with specific investigational agents (e.g., anti-MUC16, VEGFR inhibitors)
Active autoimmune disease requiring systemic immunosuppression
Other active malignancies within past 2 years
CNS metastases or leptomeningeal disease

Outcomes Summary

Primary Outcomes

Safety and tolerability / incidence of adverse events (4 trials)
Objective response rate / efficacy per RECIST (4 trials)
Progression-free survival (2 trials)
Feasibility/usability of device (1 trials)
Change in biomarker/tumor tissue endpoints (1 trials)

Secondary Outcomes

Overall survival (3 trials)
Quality of life measures (2 trials)
Duration of response (2 trials)
Pharmacokinetics (1 trials)

2: Extracted Trials with New Information

Trials with Special Criteria

Genomic / Biomarker Trials

NCT07489287 — Requires MUC16-expressing tumor confirmed via biopsy; CA125 biomarker threshold for eligibility.
NCT07594015 — Requires mismatch repair (MMR) proficient status via IHC/molecular testing and prior NGS testing.
NCT07564141 — BRCA1/2 mutation or HRD-positive status determines requirement for prior PARP inhibitor maintenance.

Unique or Unusual Criteria

NCT07078838 — Repurposes a diabetes/weight-loss drug (tirzepatide) as a pre-surgical window-of-opportunity intervention in obese patients with early endometrial neoplasia.
NCT07662824 — Focuses on a non-pharmacologic medical device for post-radiation urinary incontinence rather than cancer treatment itself.
NCT07489287 — Requires mandatory pre-, on-, and end-of-treatment tumor biopsies for correlative analysis of CAR T-cell activity.
NCT07634094 — Combines autologous dendritic cell vaccines, intraperitoneal chemotherapy, and systemic immunotherapy in a complex multimodal regimen requiring leukapheresis.

Trials with Emerging Treatments

NCT07078838 — A Randomized, Window of Opportunity Trial of Tirzepatide in Women With Obesity and a Diagnosis of Endometrial Intra-epithelial Neoplasia (EIN) or Grade 1 Endometrial Cancer
Items: Tirzepatide
Note: Repurposed metabolic drug tested for oncologic biomarker effects in a novel presurgical window trial.
NCT07489287 — A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety and Tolerability of GB-5267, an IL-18 Armored CAR T Cell Product Targeting MUC16, in Patients With Platinum-Resistant Ovarian Cancer
Items: GB-5267 CAR T-cell therapy
Note: Novel IL-18 armored CAR T-cell product targeting MUC16, no FDA approval status, first-in-human dose escalation.
NCT07737795 — A Single Arm Phase 2 Trial With a Safety Lead in Evaluating the Addition of OK-1 to Weekly Paclitaxel in Patients With Recurrent Endometrial Cancer
Items: OK-1
Note: Investigational agent OK-1 combined with standard chemotherapy; no regulatory approval yet.
NCT07564141 — A Randomized, Open-label, Phase 3 Study of Rina-S ± Bevacizumab Versus Investigator's Choice of Platinum-Based Chemotherapy ± Bevacizumab as 2L Treatment in Participants With Recurrent Platinum-Sensitive Ovarian Cancer
Items: Rina-S
Note: Rina-S is an investigational antibody-drug conjugate with no FDA approval and no available description, indicating high novelty.
NCT07634094 — A Phase 2 Efficacy Trial of Intensive Locoregional Chemoimmunotherapy, Intradermal Autologous Alpha-DC1 Vaccines, and Systemic Pembrolizumab for Advanced-Stage Ovarian Cancer
Items: αDC1 Vaccine, Rintatolimod, Bioferon
Note: Combines autologous dendritic cell vaccine with experimental immunomodulators Rintatolimod and Bioferon, all lacking FDA approval.

3: Individual Trial Overviews

NCT07078838

A Randomized, Window of Opportunity Trial of Tirzepatide in Women With Obesity and a Diagnosis of Endometrial Intra-epithelial Neoplasia (EIN) or Grade 1 Endometrial Cancer

Organization/Sponsor: UNC Lineberger Comprehensive Cancer Center

Example patient: A 45-year-old obese woman (BMI 34) newly diagnosed with grade 1 endometrioid endometrial cancer, scheduled for hysterectomy, with no diabetes, pancreatitis, or thyroid cancer history.

Phase N/A

Interventions

Drug: Tirzepatide
Summary: Dual GIP and GLP-1 receptor agonist that enhances glucose-dependent insulin secretion and promotes weight loss; being evaluated for effects on endometrial neoplasia biomarkers in obese women prior to hysterectomy (Source: FDA label; Web Search Summary).

Key Inclusion

Age >18 years
ECOG ≤2 or KPS >50
Histologic confirmation of EIN or grade 1 endometrioid EC
Scheduled for standard-of-care hysterectomy and staging
Archival EC tissue available
BMI >30 kg/m2
Adequate organ function

Key Exclusion

Active infection requiring systemic therapy
Pregnant or breastfeeding
Recent use of weight-influencing medications
Known hypersensitivity to GIP/GLP-1 agonists
Type 1 diabetes or insulin-treated diabetes
History of pancreatitis or elevated lipase/amylase/triglycerides
History of gastroparesis or bariatric surgery
Personal/family history of MEN or medullary thyroid carcinoma

NCT07662824

Flyte System Transvaginal Mechanotherapy for Urinary Incontinence in Endometrial and Cervical Cancer Survivors: A Pilot Study

Organization/Sponsor: Mayo Clinic

Example patient: A 58-year-old English-speaking woman treated with pelvic radiation for endometrial cancer 6 months ago, now experiencing stress urinary incontinence, with normal cognition and smartphone access, interested in trying the Flyte device.

Phase N/A

Interventions

Referral: Referral
Summary: Process of directing patients to appropriate care services; not a therapeutic mechanism itself. Source: NCI Thesaurus.
Procedure: Questionnaire Administration
Summary: Collection of patient-reported outcomes to assess symptoms and quality of life; no biological mechanism. Source: NCI Thesaurus.
Device: Flyte Medical Device Usage and Evaluation
Summary: Non-invasive intravaginal device using mechanotherapy to stimulate pelvic floor muscle contraction, aimed at treating urinary incontinence in cancer survivors. Source: Summary of Web Search.
Procedure: Interview
Summary: Qualitative data collection method to capture patient experiences and preferences related to treatment. Source: NCI Thesaurus.
Behavioral: Educational Intervention
Summary: Educational sessions intended to inform patients and potentially alter disease course or symptom management behaviors. Source: NCI Thesaurus.

Key Inclusion

Female with prior pelvic radiation for endometrial or cervical cancer ≥3 months ago
Age ≥21 years
English speaking
Diagnosis of urinary incontinence (SUI, UUI, mixed) or OAB
Able to contract pelvic floor muscles without pain
Able to tolerate size 6 vaginal dilator
Has smartphone/tablet with internet access for Flyte app
Willing to complete follow-up

Key Exclusion

Currently receiving active cytotoxic chemotherapy post-hysterectomy
Radiation or surgery completed within 3 months of enrollment
Life expectancy <6 months
Suspected vesicovaginal or colovaginal fistula
Inability to insert intravaginal wand
Acute infection or hematuria
Inability to contract PFMs or pain with contraction
Impaired cognitive function or neurologic conditions

NCT07489287

A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety and Tolerability of GB-5267, an IL-18 Armored CAR T Cell Product Targeting MUC16, in Patients With Platinum-Resistant Ovarian Cancer

Organization/Sponsor: Roswell Park Cancer Institute

Example patient: A 55-year-old woman with platinum-resistant serous ovarian carcinoma, ECOG 1, elevated CA125, normal organ function, and no prior MUC16-targeted or cellular therapy, willing to undergo biopsies.

Phase 1

Interventions

Biological/Cellular Therapy: GB-5267 - Combined IV and IP Infusion
Summary: IL-18 armored CAR T-cell therapy targeting MUC16, administered via combined intravenous and intraperitoneal routes to directly attack MUC16-expressing ovarian cancer cells. Source: NCI Thesaurus.
Biological/Cellular Therapy: GB-5267 - IV only
Summary: CAR T-cell therapy targeting the MUC16 protein, engineered with IL-18 armoring to enhance anti-tumor activity in platinum-resistant ovarian cancer; administered intravenously. Source: Summary of Web Search.

Key Inclusion

Age ≥18 years
Epithelial ovarian, peritoneal, or fallopian tube cancer confirmed by histology/cytology
Platinum-resistant disease (progression within 6 months or intolerance to platinum therapy)
CA125 > 2x ULN
ECOG performance status 0 or 1
Measurable disease per RECIST v1.1
Adequate hematologic, renal, and liver function
Willing to undergo pre-, on-, and end-of-treatment tumor biopsies

Key Exclusion

Recent significant bleeding or coagulation abnormalities
Active CNS pathology or recent stroke/TIA
Active autoimmune disease requiring systemic immunosuppression
Active or uncontrolled infection (bacterial, viral, fungal)
Other active malignancy within 2 years
Significant cardiac disease (LVEF <40%, recent MI, arrhythmia)
Prior anti-MUC16 therapy or cellular/gene therapy
Uncontrolled hepatitis B/C or HIV infection

NCT07594015

Phase 2 Open-Label Trial Investigating the Efficacy and Safety of Pembrolizumab and Lenvatinib in Mismatch Repair Proficient Recurrent Endometrial Cancer After Failure of First-Line Therapy With Platinum-based Doublet and Immunotherapy Genomic-based

Organization/Sponsor: University of Miami

Example patient: A 62-year-old woman with recurrent MMR-proficient endometrioid endometrial carcinoma who progressed after platinum doublet plus immunotherapy, with good organ function and no cardiovascular history, seeks further treatment.

Phase 2

Interventions

Drug: Lenvatinib
Summary: Oral multi-tyrosine kinase inhibitor targeting VEGFR2 and other receptor kinases, blocking angiogenesis and tumor growth; FDA-approved with pembrolizumab for advanced endometrial carcinoma (Source: FDA label, NCI Thesaurus).
Biologic: Pembrolizumab
Summary: Humanized monoclonal antibody blocking PD-1 receptor, enhancing T-cell mediated antitumor immunity; FDA-approved for multiple cancers including endometrial carcinoma in combination with lenvatinib (Source: FDA label, NCI Thesaurus).

Key Inclusion

Recurrent endometrial carcinoma (serous, endometrioid, carcinosarcoma, clear cell)
MMR-proficient status confirmed by IHC or molecular testing
Failed first-line platinum doublet plus prior immunotherapy
Completed next-generation sequencing on tumor
ECOG performance status 0-3
Age ≥18 years
Measurable disease per RECIST 1.1
Adequate organ function (hemoglobin, ANC, platelets, GFR, bilirubin)

Key Exclusion

Uterine sarcoma
Active CNS metastases or leptomeningeal disease
Severe allergy to pembrolizumab or lenvatinib
Active autoimmune disease requiring chronic steroids
Pregnancy or breastfeeding
Prior treatment with lenvatinib or other VEGFR inhibitors
Uncontrolled hypertension (>160/110)
Recent major cardiovascular event within 12 months

NCT07265739

A Phase 2 Study of Losartan in Combination With Weekly Paclitaxel in Platinum Resistant Ovarian Cancer

Organization/Sponsor: Massachusetts General Hospital

Example patient: A 62-year-old woman with platinum-resistant high-grade serous ovarian carcinoma, ECOG 1, normal organ function, no cardiac disease, and not on antihypertensive medications, who previously received bevacizumab and a PARP inhibitor.

Phase 2

Interventions

Chemotherapy: Paclitaxel
Summary: Microtubule inhibitor that disrupts mitotic spindle function, inducing apoptosis in cancer cells; indicated for ovarian, breast, lung cancers and Kaposi's sarcoma. Administered intravenously weekly in this trial. Source: FDA label.
Angiotensin receptor blocker (repurposed): Losartan
Summary: Angiotensin II receptor blocker that normalizes tumor stroma and vasculature, potentially enhancing chemotherapy drug delivery and reducing malignant ascites in ovarian cancer. Source: Summary of Web Search.

Key Inclusion

Age ≥18 years
Histologically confirmed advanced epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (excluding mucinous and low-grade serous)
Measurable disease per RECIST
ECOG performance status 0-2
Adequate organ function (ANC, platelets, hemoglobin, bilirubin, albumin, creatinine clearance, liver enzymes)
Platinum resistant or primary platinum refractory disease
≤4 prior lines of therapy for platinum resistant ovarian cancer
Must have received bevacizumab, mirvetuximab, or PARP inhibitor if eligible

Key Exclusion

Unresolved Grade >1 AEs from prior therapy
Serious cardiac or pulmonary comorbidities
Active Hepatitis B or C infection
Pregnant or breastfeeding
History of paclitaxel hypersensitivity
Grade 2 peripheral neuropathy
Current use of antihypertensive agents (ACE/ARB, calcium channel blocker, diuretic)
Uncontrolled or unstable blood pressure (hypotension or hypertension)

NCT07737795

A Single Arm Phase 2 Trial With a Safety Lead in Evaluating the Addition of OK-1 to Weekly Paclitaxel in Patients With Recurrent Endometrial Cancer Genomic-based

Organization/Sponsor: University of Oklahoma

Example patient: A 62-year-old woman with recurrent HER2-negative endometrioid endometrial carcinoma, ECOG 1, previously treated with platinum-based chemotherapy and immunotherapy, with measurable disease and normal QTc, seeks further treatment options.

Phase 2

Interventions

Drug Combination: OK-1 & Paclitaxel
Summary: OK-1 is an investigational agent combined with weekly paclitaxel, which disrupts microtubule function to inhibit cancer cell division; being studied for efficacy and safety in recurrent endometrial cancer. Source: Summary of Web Search.

Key Inclusion

Histologically documented endometrial carcinoma, advanced/recurrent/persistent
Pre-treatment archival tissue available
Measurable disease by RECIST v1.1 (phase 2 portion)
ECOG performance status 0-2
Received ≥1 prior platinum-based therapy, ≤5 prior lines
Should have received prior immune checkpoint inhibitor unless contraindicated
HER2 3+ tumors should have received trastuzumab deruxtecan unless ineligible
QTcF < 470 msec

Key Exclusion

Prior weekly paclitaxel for recurrent endometrial cancer
Major surgery within 28 days prior to registration
Pregnant or nursing women
Bleeding diathesis or coagulopathy within past 3 months
Unresolved prior therapy-related AEs ≥ grade 1 (with exceptions)
Use of strong/moderate CYP3A4, CYP2C8, CYP2C19, CYP2C9 inhibitors/inducers
Active infection requiring parenteral antibiotics
Risk factors for torsade de pointes (e.g., EF<50%, uncorrected hypokalemia)

NCT07564141

A Randomized, Open-label, Phase 3 Study of Rina-S ± Bevacizumab Versus Investigator's Choice of Platinum-Based Chemotherapy ± Bevacizumab as 2L Treatment in Participants With Recurrent Platinum-Sensitive Ovarian Cancer Genomic-based

Organization/Sponsor: Genmab

Example patient: A 61-year-old woman with platinum-sensitive, BRCA-mutated high-grade serous ovarian cancer who relapsed 8 months after completing carboplatin-paclitaxel plus PARPi maintenance, with ECOG 1 and measurable disease, and no prior ADC or anti-angiogenic exposure beyond bevacizumab.

Phase 3

Interventions

Antibody-drug conjugate: Rina-S
Summary: Investigational folate receptor alpha (FRα)-targeting antibody-drug conjugate delivering a topoisomerase-1 inhibitor payload to induce cancer cell death; being tested as 2L therapy in platinum-sensitive ovarian cancer. Source: trial protocol.
Chemotherapy - nanoparticle: PLD
Summary: Pegylated liposomal doxorubicin nanoparticle formulation delivering chemotherapy to tumor cells with reduced systemic toxicity, used as investigator's choice comparator chemotherapy. Source: Summary of Web Search.
Chemotherapy - microtubule inhibitor: Paclitaxel
Summary: Microtubule inhibitor that disrupts mitotic spindle function, inducing apoptosis; indicated for ovarian cancer and used as investigator's choice comparator. Source: FDA label.
Chemotherapy - antimetabolite: Gemcitabine
Summary: Nucleoside analog that inhibits DNA synthesis and ribonucleotide reductase, used for relapsed ovarian cancer as part of comparator chemotherapy options. Source: FDA label.
Chemotherapy - platinum agent: Carboplatin
Summary: Platinum-based DNA-crosslinking agent used for ovarian cancer treatment, included as part of investigator's choice platinum-based chemotherapy regimen. Source: FDA label.
Monoclonal antibody - VEGF inhibitor: Bevacizumab
Summary: Recombinant humanized monoclonal antibody inhibiting VEGF-mediated angiogenesis, used in combination with chemotherapy or Rina-S in ovarian cancer treatment arms. Source: FDA label.

Key Inclusion

Histologically confirmed high-grade serous or endometrioid epithelial ovarian, peritoneal, or fallopian tube cancer
Recurrence/progression after 1L platinum-based chemotherapy
Platinum-sensitive disease (progression >183 days after last platinum dose)
Prior PARPi maintenance required if BRCA-mutated or HRD-positive
Measurable disease per RECIST v1.1
Tumor specimen must be provided
ECOG performance status 0 or 1

Key Exclusion

Clear cell, mucinous, or sarcomatous histology
Low-grade or borderline ovarian tumors
Prior anti-angiogenic therapy other than bevacizumab
Prior ADC containing topoisomerase-1 inhibitor
Prior ADC targeting folate receptor alpha

NCT07634094

A Phase 2 Efficacy Trial of Intensive Locoregional Chemoimmunotherapy, Intradermal Autologous Alpha-DC1 Vaccines, and Systemic Pembrolizumab for Advanced-Stage Ovarian Cancer

Organization/Sponsor: University of Pittsburgh

Example patient: A 58-year-old woman with newly diagnosed stage III high-grade serous ovarian carcinoma, ECOG 1, normal organ function, and no autoimmune disease, planned for neoadjuvant chemotherapy and interval debulking surgery.

Phase 2

Interventions

Procedure: Debulking Procedure
Summary: Cytoreductive surgery removes as much tumor as possible to improve chemotherapy efficacy and provides tumor tissue for vaccine loading. Source: Summary of Web Search.
Drug: Celecoxib
Summary: COX-2 inhibitor with anti-inflammatory and anti-angiogenic effects that may inhibit tumor growth in ovarian cancer. Source: Summary of Web Search.
Biologic: Pembrolizumab
Summary: Humanized anti-PD-1 monoclonal antibody that blocks PD-1/PD-L1 interaction, enhancing T-cell mediated antitumor immunity; FDA-approved across multiple solid tumors. Source: FDA label, NCI Thesaurus.
Biologic/Vaccine: αDC1 Vaccine
Summary: Autologous dendritic cell vaccine loaded with resected tumor antigens, intended to stimulate immune response against ovarian tumor cells. Source: Summary of Web Search.
Drug: Rintatolimod
Summary: TLR3 agonist immunomodulator that enhances innate immune activation, being studied to boost antitumor immune response in ovarian cancer. Source: Summary of Web Search.
Biologic: Bioferon
Summary: Interferon alfa-2a activates immune cells to promote anti-tumor effects; used locoregionally to enhance immune activity against ovarian tumor. Source: Summary of Web Search.
Drug: Cisplatin
Summary: Platinum-based alkylating-like agent causing DNA cross-links and apoptosis; used intraperitoneally in combination chemotherapy for ovarian cancer. Source: FDA label, NCI Thesaurus.
Drug: Paclitaxel
Summary: Microtubule inhibitor that disrupts mitotic spindle function, inducing apoptosis; standard chemotherapy component for advanced ovarian cancer. Source: FDA label, NCI Thesaurus.

Key Inclusion

Advanced stage III-IV epithelial ovarian, tubal, or peritoneal carcinoma or carcinosarcoma
Eligible for neoadjuvant chemotherapy, chemo-naive
ECOG performance status 0-1
Candidate for interval debulking surgery and IP chemotherapy
Tumor lesion resectable for >2g tissue for vaccine loading
Measurable disease per iRECIST
Adequate bone marrow, renal, and hepatic function
Willing to undergo leukapheresis

Key Exclusion

Sarcoma histology
Active autoimmune disease
Chronic immunosuppressive drug use
Known immunodeficiency disease
Allergy to cisplatin or taxane without alternative options
Contraindication to NSAIDs or interferon alfa-2b
History of other invasive malignancy within 5 years
Prior pelvic radiation therapy