NCT07198074|RecruitingPhase 3FDA Drug

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

A Randomized Phase III Trial of Carboplatin, Paclitaxel, Pembrolizumab Versus Carboplatin, Paclitaxel, Bevacizumab Versus Carboplatin, Paclitaxel, Pembrolizumab, Bevacizumab in the Treatment of pMMR, TP53 Mutated Advanced or Recurrent Endometrial Cancer

National Cancer Institute (NCI)ClinicalTrials.gov

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3 other identifiers

NCI-2025-06974NRG-GY035U10CA180868

Study Type

interventional

Target

255

Locations

1 country

Sites

212

Timeline

RegisteredSep 2025

StartedJan 2026

CompletionJul 2028

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

255

participants targeted

Target at P50-P75 for phase_3

Timeline

25mo left

Started Jan 2026

Geographic Reach

1 country

212 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.4 years study duration

Study Progress16%

Jan 2026Jul 2028

First Submitted

Initial submission to the registry

September 27, 2025

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed

4 months until next milestone

Study Start

First participant enrolled

January 27, 2026

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

June 12, 2026

Status Verified

April 1, 2026

Enrollment Period

2.4 years

First QC Date

September 27, 2025

Last Update Submit

June 11, 2026

Conditions

Advanced Endometrial Carcinoma Recurrent Endometrial Carcinoma

Outcome Measures

Primary Outcomes (1)

Progression-free survival (PFS)
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.
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

Secondary Outcomes (5)

Overall survival (OS)
From study entry to time of death from any cause, assessed up to 5 years
Prognostic and predictive associations of type of TP53 mutation status with PFS
Up to 5 years
Prognostic and predictive associations of type of TP53 mutation status with OS
Up to 5 years
Incidence of adverse events (AEs) in treatment with bevacizumab when combined with carboplatin, paclitaxel, and pembrolizumab
Up to 90 days after last dose of study treatment
Objective response rate
Within 12 months of initiating therapy

Other Outcomes (3)

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
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
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

Study Arms (3)

Arm 1 (paclitaxel, carboplatin, pembrolizumab)

ACTIVE COMPARATOR

Patients receive paclitaxel IV over 3 hours, carboplatin IV and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 3 weeks for up to 6-10 cycles in the absence of disease progression or unacceptable toxicity. Starting 3 weeks after last combination phase cycle, patients may continue to receive maintenance pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for up to an additional 14 cycles. Additionally, patients undergo urine and blood sample collection and CT or MRI throughout the study.

Procedure: Biospecimen CollectionDrug: CarboplatinProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingDrug: PaclitaxelBiological: Pembrolizumab

Arm 2 (paclitaxel, carboplatin, bevacizumab)

EXPERIMENTAL

Patients receive paclitaxel IV over 3 hours, carboplatin IV, and bevacizumab IV or anti-VEGF antibody biosimilar on day 1 of each cycle. Cycles repeat every 3 weeks for up to 6-10 cycles in the absence of disease progression or unacceptable toxicity. Starting 3 weeks after last combination phase cycle, patients may continue to receive maintenance bevacizumab IV on day 1 of each cycle. Treatment repeats every 3 weeks for up to an additional 28 doses. Additionally, patients undergo urine and blood sample collection and CT or MRI throughout the study.

Biological: BevacizumabProcedure: Biospecimen CollectionDrug: CarboplatinProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingDrug: Paclitaxel

Arm 3 (paclitaxel, carboplatin, pembrolizumab, bevacizumab)

EXPERIMENTAL

Patients receive paclitaxel IV over 3 hours, carboplatin IV, pembrolizumab IV over 30 minutes, and bevacizumab IV or anti-VEGF antibody biosimilar on day 1 of each cycle. Cycles repeat every 3 weeks for up to 6-10 cycles in the absence of disease progression or unacceptable toxicity. Starting 3 weeks after last combination phase cycle, patients may continue to receive maintenance pembrolizumab IV over 30 minutes every 6 weeks for up to an additional 14 cycles and bevacizumab IV every 3 weeks for up to an additional 28 doses. Additionally, patients undergo urine and blood sample collection and CT or MRI throughout the study.

Biological: BevacizumabProcedure: Biospecimen CollectionDrug: CarboplatinProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingDrug: PaclitaxelBiological: Pembrolizumab

Interventions

BevacizumabBIOLOGICAL

Given IV

Also known as: ABP 215, ABP-215, ABP215, Alymsys, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF Monoclonal Antibody SIBP04, Anti-VEGF rhuMAb, Avastin, Avzivi, Aybintio, BAT 1706, BAT-1706, BAT1706, BAT1706 Biosimilar, Bevacizumab awwb, Bevacizumab Biosimilar ABP 215, Bevacizumab Biosimilar BAT1706, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar GB-222, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MB02, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar Mvasi, Bevacizumab Biosimilar MYL-1402O, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar QL1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, Bevacizumab Biosimilar Zirabev, Bevacizumab-adcd, Bevacizumab-aveg, Bevacizumab-awwb, Bevacizumab-aybi, Bevacizumab-bvzr, Bevacizumab-byva, Bevacizumab-equi, Bevacizumab-maly, Bevacizumab-nwgd, Bevacizumab-onbe, Bevacizumab-tnjn, BP102, BP102 Biosimilar, CT P16, CT-P16, CTP16, Equidacent, FKB 238, FKB-238, FKB238, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Jobevne, MB 02, MB-02, MB02, Mvasi, MYL-1402O, Onbevzi, Oyavas, PF 06439535, PF-06439535, PF06439535, QL1101, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, SIBP 04, SIBP-04, SIBP04, Vegzelma, Zirabev

Arm 2 (paclitaxel, carboplatin, bevacizumab)Arm 3 (paclitaxel, carboplatin, pembrolizumab, bevacizumab)

Biospecimen CollectionPROCEDURE

Undergo urine and blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection