The EndoBARR Trial (Endometrial Bevacizumab, Atezolizumab, Rucaparib) (EndoBARR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03694262|
Recruitment Status : Not yet recruiting
First Posted : October 3, 2018
Last Update Posted : May 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Drug: Rucaparib Drug: Bevacizumab Drug: Atezolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||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|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Non-Randomized Multisite Phase II Trial Combining Bevacizumab, Atezolizumab and Rucaparib for the Treatment of Previously Treated Recurrent and Progressive Endometrial Carcinoma|
|Estimated Study Start Date :||June 15, 2019|
|Estimated Primary Completion Date :||June 28, 2021|
|Estimated Study Completion Date :||June 28, 2026|
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 600mg orally twice daily by continuous dosing
Other Name: Rubraca
15mg/kg IV on day 1 of every cycle
Other Name: Avastin
1,200mg IV on day 1 of every cycle
Other Name: Tecentriq
- Overall Response Rate [ Time Frame: 30-36 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.
- Progression Free Survival [ Time Frame: 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.
- Number of participants with treatment-related adverse events as assessed by CTCAE V5.0 [ Time Frame: 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.
- Overall Survival [ Time Frame: 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.
- Microsatellite instability (MSI) — both genetic and epigenetic [ Time Frame: 48-60 months ]Measurement of tumor MicroSatellite Instablility (MSI) via both qtPCR (quantitative polymerase chain reaction) and IHC (immunohistochemistry).
- Homologus recombination deficiency gene alterations [ Time Frame: 48-60 months ]Tumor samples will assess for the genes that lead to homologus recombination deficiency.
- PD-L1 expression in the tumor [ Time Frame: 48-60 months ]Tumor samples (from initial diagnosis) will have PD-L1 assessed by IHC (immunohistochemistry).
- Tumor mutational burden [ Time Frame: 48-60 months ]This level will be assessed in primary patient specimens using formalin fixed, paraffin-embedded samples.
- Loss of Heterozygosity [ Time Frame: 48-60 months ]Tumor sample will be assessed for loss of heterozygosity
- Circulating tumor DNA [ Time Frame: 48-60 months ]Peripheral blood draw will be assessed for circulating tumor DNA
- Stool Microbiome [ Time Frame: 48-60 months ]Samples collected prior to therapy, after the third cycle, and after conclusion will allow longitudinal assessments of variations of the microbiome from patient to patient, and changes within a single patient.
- Cardiac toxicity [ Time Frame: 48-60 months ]Measure for cardiac strain and assess the ability of this technique to predict development of toxicity for subjects under treatment via echocardiogram derived measurements. The average strain per segment will be determined and reported on a polar map, using a 17-segment model. The global longitudinal strain (GLS) will be reported as the average strain of all 17 segments. A GLS of < -18% will be reported to be abnormal.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694262
|Contact: William Bradley, MDemail@example.com|
|Contact: Suki Skandarajah, B. Scfirstname.lastname@example.org|
|United States, Wisconsin|
|Froedtert Lutheran Memorial Hospital||Not yet recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: William Bradley, MD 414-805-6634 email@example.com|
|Contact: Suki Skandarajah, BSc 414-805-5337 firstname.lastname@example.org|
|Principal Investigator: William Bradley, MD|
|Principal Investigator:||William Bradley, MD||Medical College of Wisconsin|