Trial Outcomes & Findings for The EndoBARR Trial (Endometrial Bevacizumab, Atezolizumab, Rucaparib) (NCT NCT03694262)

Results Overview

To estimate the overall response rate (ORR) of patients with progressive/persistent or recurrent endometrial cancer on study-directed therapy, using the combination of rucaparib, bevacizumab and atezolizumab.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

44 months

Results posted on

2025-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Cycle length = 21 days Atezolizumab 1,200mg IV on day 1 Bevacizumab 15mg/kg IV on day 1 Rucaparib 600mg orally twice daily by continuous dosing Rucaparib: Rucaparib 600mg orally twice daily by continuous dosing Bevacizumab: 15mg/kg IV on day 1 of every cycle Atezolizumab: 1,200mg IV on day 1 of every cycle
Overall Study STARTED	30
Overall Study Treated	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The EndoBARR Trial (Endometrial Bevacizumab, Atezolizumab, Rucaparib)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=30 Participants Cycle length = 21 days Atezolizumab 1,200mg IV on day 1 Bevacizumab 15mg/kg IV on day 1 Rucaparib 600mg orally twice daily by continuous dosing Rucaparib: Rucaparib 600mg orally twice daily by continuous dosing Bevacizumab: 15mg/kg IV on day 1 of every cycle Atezolizumab: 1,200mg IV on day 1 of every cycle
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants
Age, Continuous	68.5 years n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: 44 months

To estimate the overall response rate (ORR) of patients with progressive/persistent or recurrent endometrial cancer on study-directed therapy, using the combination of rucaparib, bevacizumab and atezolizumab.

Outcome measures

Outcome measures
Measure	Treatment n=30 Participants Cycle length = 21 days Atezolizumab 1,200mg IV on day 1 Bevacizumab 15mg/kg IV on day 1 Rucaparib 600mg orally twice daily by continuous dosing Rucaparib: Rucaparib 600mg orally twice daily by continuous dosing Bevacizumab: 15mg/kg IV on day 1 of every cycle Atezolizumab: 1,200mg IV on day 1 of every cycle
Overall Response Rate	30 Participants

PRIMARY outcome

Timeframe: Through study completion, up to 3 years. Measured in relation to change from baseline imaging.

overall response rate

Outcome measures

Outcome measures
Measure	Treatment n=30 Participants Cycle length = 21 days Atezolizumab 1,200mg IV on day 1 Bevacizumab 15mg/kg IV on day 1 Rucaparib 600mg orally twice daily by continuous dosing Rucaparib: Rucaparib 600mg orally twice daily by continuous dosing Bevacizumab: 15mg/kg IV on day 1 of every cycle Atezolizumab: 1,200mg IV on day 1 of every cycle
To Estimate the Overall Response Rate (ORR) of Patients With Progressive/Persistent or Recurrent Endometrial Cancer on Study-directed Therapy, Using the Combination of Rucaparib, Bevacizumab and Atezolizumab.	30 Participants

SECONDARY outcome

Timeframe: 48-60 months

Progression-Free Survival (PFS) is defined as the duration of time from date of study entry to time of progression or death, whichever occurs first. The outcome is to estimate the progression free survival (PFS) of patients with progressive/persistent or recurrent endometrial cancer when treated with the combination of rucaparib, bevacizumab and atezolizumab.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30-36 months

To determine the nature and degree of toxicity of treatment using the CTCAE v5.0 with this combination in this cohort of patients.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48-60 months

Survival is defined as the duration of time from date of study entry to time of death or the date of last contact. The outcome is to estimate the overall survival of patients with persistent or recurrent endometrial cancer, when treated with the combination of rucaparib, bevacizumab and atezolizumab.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 48-60 months

Measurement of tumor MicroSatellite Instablility (MSI) via both qtPCR (quantitative polymerase chain reaction) and IHC (immunohistochemistry).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 48-60 months

Tumor samples will assess for the genes that lead to homologus recombination deficiency.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 48-60 months

Tumor samples (from initial diagnosis) will have PD-L1 assessed by IHC (immunohistochemistry).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 48-60 months

This level will be assessed in primary patient specimens using formalin fixed, paraffin-embedded samples.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 48-60 months

Tumor sample will be assessed for loss of heterozygosity

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 48-60 months

Peripheral blood draw will be assessed for circulating tumor DNA

Outcome measures

Outcome data not reported

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 15 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

William Bradley, MD

Medical College of Wisconsin

Phone: 414-805-6606

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place