Clinical trial for Advanced Endometrial Carcinoma
Official title Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
ClinicalTrials.gov ID: NCT07198074
What this study is testing
What is Bevacizumab?
An investigational IV medicine being studied as a potential treatment for advanced or recurrent endometrial carcinoma. It is designed to block vascular endothelial growth factor (VEGF) and inhibit new blood‑vessel formation that feeds tumors.
Also referred to as Avastin.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether adding bevacizumab to the usual chemotherapy and immunotherapy improves treatment for advanced or recurrent pMMR, TP53‑mutated endometrial cancer.
- Who it's for
- You may be able to join if you have stage III, IVA or IVB endometrial cancer that is pMMR and TP53 mutated, and it has spread or returned after treatment.
- What's involved
- You would receive the drug bevacizumab together with carboplatin, paclitaxel and pembrolizumab. You will have regular clinic visits for injections and blood tests, and you will be monitored for side effects.
- Time commitment
- The study lasts about 6 to 12 months, with visits every 3 weeks for treatment and follow‑up checks.
- Phase 3: a large, late-stage study
- Time commitment: about 3 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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.
- Histologic confirmation of the original primary tumor is required (submission of pathology report(s) is required).
See the full eligibility criteria
- 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...
- Histologic confirmation of the original primary tumor is required (submission of pathology report(s) is required).
- 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
- 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...
- 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...
- 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.
- 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...
- 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.
- 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...
- 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)
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Anchorage, Alaska, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Fayetteville, Arkansas, United States
- Little Rock, Arkansas, United States
- Rogers, Arkansas, United States
- Springdale, Arkansas, United States
- Carmichael, California, United States
- Dublin, California, United States
- Elk Grove, California, United States
- Fremont, California, United States
- Fresno, California, United States
- Los Angeles, California, United States
- Modesto, California, United States
- Oakland, California, United States
- Palo Alto, California, United States
- Rancho Mirage, California, United States
- Rocklin, California, United States
- Roseville, California, United States
+ 212 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Anchorage, Alaska, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Fayetteville, Arkansas, United States; Little Rock, Arkansas, United States and 226 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.