The EndoBARR Trial (Endometrial Bevacizumab, Atezolizumab, Rucaparib)

NCT03694262 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: EndoBARR
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

To demonstrate the efficacy and safety of the combination of rucaparib, bevacizumab and atezolizumab in recurrent, progressive endometrial carcinoma.

Conditions

Uterine Carcinosarcoma; Endometrial Cancer

Keywords

recurrent endometrial cancer; Bevacizumab; Atezolizumab; Rucaparib

Outcome Measures

Primary Outcomes (2)

• Treatment Related Overall Response Rate

  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.

  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.

  overall response rate

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

Secondary Outcomes (3)

• Progression Free Survival

  48-60 months

• Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE V5.0

  30-36 months

• Overall Survival

  48-60 months

Other Outcomes (6)

• Microsatellite Instability (MSI) - Both Genetic and Epigenetic

  48-60 months

• Homologus Recombination Deficiency Gene Alterations

  48-60 months

• PD-L1 Expression in the Tumor

  48-60 months

Study Arms (1)

Treatment

EXPERIMENTAL

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

Drug: Rucaparib; Drug: Bevacizumab; Drug: Atezolizumab

Interventions

Rucaparib DRUG

Rucaparib 600mg orally twice daily by continuous dosing

Also known as: Rubraca

Treatment

Bevacizumab DRUG

15mg/kg IV on day 1 of every cycle

Also known as: Avastin

Treatment

Atezolizumab DRUG

1,200mg IV on day 1 of every cycle

Also known as: Tecentriq

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have recurrent or persistent/progressive endometrial carcinoma, which is refractory to curative therapy or established treatments. Histologic confirmation of the original primary tumor is required. Stained slides of either the primary or recurrent tumor are required. If primary FFPE samples are not available, a biopsy demonstrating recurrent disease must be obtained. Pathologic Slides/Blocks will be reviewed at the primary site for confirmation.
• Patients with the following histologic epithelial cell types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, transitional cell carcinoma and uterine carcinosarcoma (MMT).
• Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma. Chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a chemotherapy regimen. Patients may have had, but are not required to have received, a second chemotherapeutic regimen for recurrent disease.
• All patients must have measurable disease, as defined by RECIST 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each target lesion must be ≥ 10 mm when measured by
• CT or MRI. Lymph nodes must be \> 15 mm in short axis when measured by CT or MRI.
• Patients may be enrolled if they do not have a target lesion (\>= 10 mm lesion or \>=15 mm lymph node), if they have measurable disease. This is defined by RECIST 1.1 as a suspicious lesion \<10mm or a lymph node \>=10mm but \<15mm.
• Patients must have an EGOG Performance Status of 0, 1.
• Recovery from effects of recent surgery, radiotherapy, or chemotherapy
• Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated UTI).
• Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration.
• Any other prior therapy directed at the malignant tumor, including chemotherapy and immunologic agents, must be discontinued at least three weeks prior to first cycle of treatment.
• Any prior radiation therapy must be completed at least four weeks prior to first cycle of treatment.
• Prior hormonal therapy is allowed. There is no limit on the number of prior hormonal therapies allowed. Hormonal therapy will not be counted as a line of therapy for purposes of this trial.
• Patients must have a urine protein of 2+ on dipstick. If dipstick is \>2+, 24-hour urine protein must be obtained and should be \< 1g for patient to be eligible.
• Patients must have signed an approved informed consent and authorization permitting release of personal health information for study purposes.

You may not qualify if:

• Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of the other malignancy being present within the last two years. Patients with Ductal Carcinoma in situ (DCIS) of the breast in the prior two years may be enrolled on study if the treatment required no chemotherapy or radiation. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
• Patients must not have had exposure to Bevacizumab, PARPi, or immunotherapy. Patients may have had exposure to anti-angiogentic therapy provided it was not Bevacizumab.
• Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of endometrial cancer within the last three years are excluded. Prior radiation for localized cancer of the breast, head and neck or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.
• Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of endometrial cancer within the last three years are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than two years prior to registration, and that the patient remains free of recurrent or metastatic disease.
• Inability to tolerate an oral medication or keep pills down.
• Patients who are pregnant or nursing.
• Patients with a complete bowel obstruction; recent (within six months) history of fistula, intraabdominal abscess or bowel perforation; subjects requiring total parenteral nutrition or parenteral hydration.
• Has a current diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within seven days prior to the first dose of trial treatment.
• Patients with history or evidence upon physical examination of CNS disease, including brain tumor, seizures not controlled with standard medical therapy or any brain metastases.
• Patients with clinically significant cardiovascular disease. This includes:
• Myocardial infarction or unstable angina within 12 months of the first date of study treatment.
• New York Heart Association (NYHA) Class II or greater congestive heart failure (Appendix I).
• History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) or cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication).
• Grade 2 or greater peripheral vascular disease.
• Cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of study treatment.

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Genentech, Inc.: collaborator
• Clovis Oncology, Inc.: collaborator

Study Sites (3)

Mount Sinai

New York, New York, 10029, United States

Location

St. Luke's Hospital and Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

Froedtert Lutheran Memorial Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (38)

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MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

rucaparib; Bevacizumab; atezolizumab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: William Bradley, MD
• Organization: Medical College of Wisconsin

wbradley@mcw.edu

414-805-6606

Study Officials

• William Bradley, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: October 3, 2018
• Study Start: July 19, 2019
• Primary Completion: March 30, 2023
• Study Completion: March 10, 2026
• Last Updated: April 13, 2026
• Results First Posted: May 30, 2025

Record last verified: 2026-03

Locations

US (3)