Testing Bevacizumab with Chemotherapy and Immunotherapy for Endometrial Cancer
This study is looking at whether adding bevacizumab (an antiangiogenic drug that stops blood vessel formation to tumors) to a standard treatment improves outcomes for women with advanced or recurrent endometrial cancer. The standard treatment includes carboplatin and paclitaxel (chemotherapy) with or without pembrolizumab (immunotherapy). To join, you must have stage III, IVA, or IVB advanced or recurrent endometrial cancer that has specific biomarkers (pMMR and TP53 mutated). Researchers want to see if adding bevacizumab helps you live longer without the cancer growing or spreading. The study plans to enroll 255 women, but its current status is unclear.
- Study design
- This is a Phase III interventional study comparing different treatment combinations. It plans to enroll 255 women.
- What's involved
- You would undergo biospecimen collection (urine and blood samples), CT scans, and MRI scans. Medications (bevacizumab, carboplatin, paclitaxel) would be given intravenously (IV).
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progression-free survival will be assessed for up to 5 years from study entry.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07198074
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Recruiting
PHASE3Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~255 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:BevacizumabBiospecimen CollectionCarboplatinComputed TomographyMagnetic Resonance ImagingPaclitaxel
At a glance
Recruiting sites
252 of 255 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS)
Measured over From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 5 years
Conditions
Where it's being run
255 sites across 41 statesMichigan28
New York23
Illinois22
Ohio22
Minnesota14
Iowa13
California11
Pennsylvania10
Study leadership
- Amanda N Fader · PRINCIPAL_INVESTIGATOR · NRG Oncology
Who to contact
Site Public Contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Documentation of disease:
Stage III and stage IVA endometrial cancers (with measurable disease),
Stage IVB endometrial cancer (with or without measurable disease), or
Recurrent endometrial cancer (with or without measurable disease)
In patients with measurable disease, lesions will be defined and monitored by RECIST 1.1. Measurable disease (RECIST 1.1) is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be ≥ 10 mm when measured by CT or MRI. Lymph nodes must be ≥ 15 mm in short axis when measured by CT or MRI
Histologic confirmation of the original primary tumor is required (submission of pathology report\[s\] is required). Patients with the following histologic types are eligible: endometrioid, serous, dedifferentiated/undifferentiated, clear cell, mixed epithelial, carcinosarcoma, adenocarcinoma not otherwise specified (N.O.S.)
Patients must have:
Tumoral mismatch repair proficient (pMMR) disease as assessed by immunohistochemistry (IHC) AND
P53 IHC with aberrant staining pattern (aberrant p53 expression is consistent with mutant TP53). TP53 mutation by next-generation sequencing will also be accepted
A pathology report demonstrating results of institutional MMR IHC and p53 IHC and/or TP53 by next-generation sequencing
Patients may have received:
NO prior chemotherapy for treatment of endometrial cancer OR
Prior adjuvant chemotherapy (e.g., paclitaxel/carboplatin alone or as a component of concurrent chemotherapy and radiation therapy \[with or without cisplatin\]) provided adjuvant chemotherapy was completed ≥ 12 months prior to registration
Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para-aortic radiation therapy, intravaginal brachytherapy, and/or palliative radiation therapy. All radiation therapy must be completed at least 4 weeks prior to registration. For patients with recent radiation, they must have RECIST-evaluable disease outside of the radiation field and have recovered their marrow function
Patients may have received prior hormonal (endocrine) therapy. All hormonal (endocrine) therapy must have been completed at least 1 week prior to registration
NO prior pembrolizumab (or other anti-PD1, anti-PDL1 or anti-CTLA4 therapy) or bevacizumab (or other antiangiogenic therapy)
Interval or cytoreductive surgery, after start of treatment on this trial, and prior to documentation of disease progression, is NOT permitted
Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of disease progression. Patients with brain metastases must have follow up imaging demonstrating no evidence of disease progression and that the disease is stable off of steroids
Age ≥ 18
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Not pregnant and not nursing
Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
Platelets ≥ 100,000 cells/mm\^3
Hemoglobin ≥ 8 g/dl
Creatinine clearance (CrCl) of ≥ 30 mL/min by the Cockcroft-Gault formula
Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better
No active infection requiring parenteral antibiotics
No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube
No clinically significant bleeding within 28 days prior to registration
No uncontrolled hypertension, defined as systolic ≥ 160 mm Hg or diastolic ≥ 100 mm Hg
No major surgery within 28 days of initiation of bevacizumab
No active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including corticosteroids. This includes, but is not limited to, patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease
Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible
Topical or inhaled steroids are allowed
Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), and anti-thyroid antibodies should be evaluated with the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
No history of (non-infectious) pneumonitis that required steroids, or current pneumonitis
No history of stem cell or solid organ transplant
No history of allergic reaction to the study agent(s) or compounds of similar chemical or biologic composition to the study agent(s) (or any of its excipients)
What this trial measures
- Progression-free survival (PFS)From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 5 years
Will be defined using Response Evaluation Criteria in Solid Tumors version (v) 1.1. Will be tested using one-sided log-rank tests with α-levels stratified by factors used in the randomization. Patients will be grouped by their randomized treatment assignment for intention-to-treat (ITT) analyses, supported by patients in ITT population. Treatment hazard ratios and their 95% confidence intervals will be estimated using a Cox proportional hazards models specified with a main effect for the randomized treatment assignment and stratified using the stratification factors applied at randomization.