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New treatment option 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?
Bevacizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced endometrial carcinoma.
Also referred to as ABP 215, ABP-215.
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 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.
- 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
- 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...
See the full eligibility 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...
- 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...
- 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...
- 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. Patients with brain metastases must have...
- 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. This includes, but is not limited...
- 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's taking place
- Birmingham, Alabama, United States
- Anchorage, Alaska, United States
- Phoenix, Arizona, United States
- Fayetteville, Arkansas, United States
- Little Rock, Arkansas, United States
- Rogers, Arkansas, United States
- Springdale, Arkansas, United States
- Carmichael, California, United States
- Elk Grove, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Rancho Mirage, California, United States
- Rocklin, California, United States
- Sacramento, California, United States
- Woodland, California, United States
- Colorado Springs, Colorado, United States
- Fort Collins, Colorado, United States
- Greeley, Colorado, United States
- Loveland, Colorado, United States
- Hartford, Connecticut, United States
+ 166 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 - 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?
Study sites include Birmingham, Alabama, United States; Anchorage, Alaska, United States; Phoenix, Arizona, United States; Fayetteville, Arkansas, United States; Little Rock, Arkansas, United States; Rogers, Arkansas, United States and 180 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.