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Clinical Trials in Mexico / NCT07198074
Recruiting Phase 3

Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer

NCT07198074 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 3
Started
2026-01-27
Last updated
2026-09-25

Condition(s) studied

Advanced Endometrial CarcinomaRecurrent Endometrial Carcinoma

Investigational drug(s) / intervention(s)

Bevacizumab →Biospecimen CollectionCarboplatin →Computed TomographyMagnetic Resonance ImagingPaclitaxel →Pembrolizumab →

Bevacizumab: Given IV

Biospecimen Collection: Undergo urine and blood sample collection

Carboplatin: Given IV

Computed Tomography: Undergo CT

Magnetic Resonance Imaging: Undergo MRI

Paclitaxel: Given IV

Pembrolizumab: Given IV

Study summary

This phase III trial compares the effect of bevacizumab in combination with carboplatin, paclitaxel and pembrolizumab to the usual treatments of carboplatin and paclitaxel with or without pembrolizumab in treating patients with stage III, IVA or IVB mismatch repair protein proficient (pMMR) and TP53 mutated endometrial cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has come back after a period of improvement (recurrent). Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Adding bevacizumab to the combination of carboplatin, paclitaxel and pembrolizumab may be more effective than the usual treatment combinations of carboplatin and paclitaxel with or without pembrolizumab in treating patients with advanced or recurrent pMMR and TP53 mutated endometrial cancer.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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)

Primary outcome measure(s)

Trial sites (294)

FacilityCityRegionStatus
University of Alabama at Birmingham Cancer Center Birmingham Alabama Recruiting
Alaska Women's Cancer Care Anchorage Alaska Recruiting
Cancer Center at Saint Joseph's Phoenix Arizona Recruiting
Banner University Medical Center - Tucson Tucson Arizona Recruiting
University of Arizona Cancer Center-North Campus Tucson Arizona Recruiting
Highlands Oncology Group - Fayetteville Fayetteville Arkansas Recruiting
University of Arkansas for Medical Sciences Little Rock Arkansas Recruiting
Highlands Oncology Group - Rogers Rogers Arkansas Recruiting
Highlands Oncology Group Springdale Arkansas Recruiting
Mercy Cancer Center - Carmichael Carmichael California Recruiting
Mercy San Juan Medical Center Carmichael California Recruiting
Kaiser Permanente Dublin Dublin California Recruiting
Mercy Cancer Center - Elk Grove Elk Grove California Recruiting
Kaiser Permanente-Fremont Fremont California Recruiting
Kaiser Permanente Fresno Orchard Plaza Fresno California Recruiting
Los Angeles General Medical Center Los Angeles California Recruiting
USC / Norris Comprehensive Cancer Center Los Angeles California Recruiting
Cedars-Sinai Medical Center Los Angeles California Recruiting
Kaiser Permanente- Modesto MOB II Modesto California Recruiting
Kaiser Permanente-Oakland Oakland California Recruiting
Stanford Cancer Institute Palo Alto Palo Alto California Recruiting
Eisenhower Medical Center Rancho Mirage California Recruiting
Mercy Cancer Center - Rocklin Rocklin California Recruiting
Kaiser Permanente-Roseville Roseville California Recruiting
Kaiser Permanente Downtown Commons Sacramento California Recruiting
Mercy Cancer Center - Sacramento Sacramento California Recruiting
University of California Davis Comprehensive Cancer Center Sacramento California Recruiting
Kaiser Permanente-South Sacramento Sacramento California Recruiting
Kaiser Permanente-San Francisco San Francisco California Recruiting
Kaiser Permanente-Santa Teresa-San Jose San Jose California Recruiting
Kaiser Permanente San Leandro San Leandro California Recruiting
Kaiser San Rafael-Gallinas San Rafael California Recruiting
Kaiser Permanente Medical Center - Santa Clara Santa Clara California Recruiting
Kaiser Permanente-Santa Rosa Santa Rosa California Recruiting
Kaiser Permanente-South San Francisco South San Francisco California Recruiting
Kaiser Permanente-Vallejo Vallejo California Recruiting
Kaiser Permanente-Walnut Creek Walnut Creek California Recruiting
Woodland Memorial Hospital Woodland California Recruiting
UCHealth University of Colorado Hospital Aurora Colorado Recruiting
UCHealth Memorial Hospital Central Colorado Springs Colorado Recruiting

+ 254 more sites — see the full list on the official registry below.

On this site

📄 Avastin (bevacizumab) drug profile → 📄 Keytruda (pembrolizumab) drug profile →

More National Cancer Institute (NCI) trials in Mexico

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07198074 on ClinicalTrials.gov ↗ ← All trials in Mexico