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Endometrial CancerPhase 2EndoBARRNCT03694262

The EndoBARR Trial (Endometrial Bevacizumab, Atezolizumab, Rucaparib)

A Phase 2 study testing Rucaparib, Bevacizumab and Atezolizumab in people with Endometrial Cancer and Uterine Carcinosarcoma, run by Medical College of Wisconsin at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To demonstrate the efficacy and safety of the combination of rucaparib, bevacizumab and atezolizumab in recurrent, progressive endometrial carcinoma. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer, Uterine Carcinosarcoma
What is being tested?
Rucaparib, Bevacizumab and Atezolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesUnited States
Study dates
19 Jul 2019to 10 Mar 2026
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Patients must meet pre-entry requirements, as specified in section 5.
  • Patients of childbearing potential must agree to use an accepted and effective nonhormonal method of contraception i.e., double-barrier method (e.g., condom plus diaphragm) from the time of signing the informed consent through six months after last dose of study drug.
  • Patients 18 years of age or greater.
  • Be willing to provide tissue from the primary surgical resection (paraffin block).
  • Must have laboratory values in the below ranges:
  • System Laboratory Value Endocrine Thyroid function testing (TSH) 0.350 - 5.500 ulU/mL (Or within institutional labarotory range).
  • Free T4/Total T3 If TSH is outside of laboratory range and subject is clinically euthyroid, enrollment may occur if Free T4/Total T3 are in normal range by local lab values Hematological
  • System Laboratory Value Absolute neutrophil count (ANC) ≥1,500 /mcL Platelets ≥100,000 / mcL Hemoglobin ≥9 g/dL or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment) Renal Serum creatinine OR Measured or calculateda creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 X upper limit of normal (ULN) OR
  • ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN Hepatic Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR
  • ≤ 5 X ULN for subjects with liver metastases Albumin >2.5 mg/dL Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT)
  • Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  • ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants aCreatinine clearance should be calculated per institutional standard.
  • 4.2 Exclusion Criteria
  • 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.
  • History of arterial ischemia or thrombus.
  • Patients with uncontrolled hypertension defined as systolic > 150 mm Hg or diastolic > 90 mm Hg. The use of antihypertensive medications to control hypertension is permitted.
  • Patients who have undergone major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of study treatment or who have a major surgical procedure anticipated during the course of the study. Laparoscopic biopsy is acceptable and will not require a delay in study treatment.
  • Patients with serious nonhealing wound, ulcer (including gastrointestinal) or bone fracture.
  • Patients with any condition, which in the investigator's opinion, makes the patient unsuitable for study participation.
  • Patients not available for follow-up assessments.
  • Patients with known sensitivity to any of the products to be administered during dosing.

Who cannot join

None listed.

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • St. Luke's Hospital and Health Network

    Bethlehem, Pennsylvania, 18015

  • Froedtert Lutheran Memorial Hospital

    Milwaukee, Wisconsin, 53226

  • Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

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

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

Read the detailed description

The combination of the three proposed agents offers the opportunity to explore synergistic relationships between antiangiogenic and immunotherapy and antiangiogenic and PARPi. Increasing genetic instability by PARPi and double-strand breaks may lead to a proinflammatory state that would enhance the activity of immunotherapy, leading to synergistic response in a category of solid tumors that lack active therapy. It is expected that increased double-strand breaks may lead to increased expression of immunogenic antigens, increasing the effect of anti-PD-L1 therapy. Phase I data combining the PD-L1 inhibitor durvalamab with either olaparib or cediranib showed good tolerability and evidence of response.

Being tested
Rucaparib, Bevacizumab, Atezolizumab
Keywords
recurrent endometrial cancer, Bevacizumab, Atezolizumab, Rucaparib
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RucaparibDrug

    Also called Rubraca

    Rucaparib 600mg orally twice daily by continuous dosing

  • BevacizumabDrug

    Also called Avastin

    15mg/kg IV on day 1 of every cycle

  • AtezolizumabDrug

    Also called Tecentriq

    1,200mg IV on day 1 of every cycle

Study groups in NCT03694262
Study groupRoleWhat they receive
TreatmentExperimentalCycle 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
Receives: Drug: Rucaparib; Drug: Bevacizumab; Drug: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 44 months

  2. 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

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

Secondary outcomes (3)
  1. Progression Free Survival

    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.

    Measured: 48-60 months

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

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

    Measured: 30-36 months

  3. Overall Survival

    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.

    Measured: 48-60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2018
  2. Study start19 Jul 2019
  3. Primary completion30 Mar 2023
  4. Study completion10 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03694262
Sponsor's protocol ID
EndoBARR
Acronym
EndoBARR
Status last verified
Mar 2026
First submitted
26 Sep 2018
Last updated
13 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Aghajanian, C., Filiaci, V.L., Dizon, D.S., Carlson, J., Powell, M.A., Secord, A.A., Tewari, K.S., Bender, D., O'Malley, D.M., Stuckey, A., et al. (2015). A randomized phase II study of paclitaxel/carboplatin/bevacizumab, paclitaxel/carboplatin/temsirolimus and ixabepilone/carboplatin/bevacizumab as initial therapy for measurable stage III or IVA, stage IVB or recurrent endometrial cancer, GOG-86P. Journal of Clinical Oncology 33, 5500-5500.

  • Aghajanian C, Sill MW, Darcy KM, Greer B, McMeekin DS, Rose PG, Rotmensch J, Barnes MN, Hanjani P, Leslie KK. Phase II trial of bevacizumab in recurrent or persistent endometrial cancer: a Gynecologic Oncology Group study. J Clin Oncol. 2011 Jun 1;29(16):2259-65. doi: 10.1200/JCO.2010.32.6397. Epub 2011 May 2.

    PubMed 21537039
  • Arielle Lutterman Heeke, T.B., Filipa Lynce, Michael J. Pishvaian, Claudine Isaacs (2017). Prevalence of homologous recombination deficiency among all tumor types. Journal of Clinical Oncology 35.

  • Bhattacharya S, Fyfe G, Gray RJ, Sargent DJ. Role of sensitivity analyses in assessing progression-free survival in late-stage oncology trials. J Clin Oncol. 2009 Dec 10;27(35):5958-64. doi: 10.1200/JCO.2009.22.4329. Epub 2009 Oct 13.

    PubMed 19826121
  • Cancer Genome Atlas Research Network; Kandoth C, Schultz N, Cherniack AD, Akbani R, Liu Y, Shen H, Robertson AG, Pashtan I, Shen R, Benz CC, Yau C, Laird PW, Ding L, Zhang W, Mills GB, Kucherlapati R, Mardis ER, Levine DA. Integrated genomic characterization of endometrial carcinoma. Nature. 2013 May 2;497(7447):67-73. doi: 10.1038/nature12113.

    PubMed 23636398
  • Carlson MJ, Thiel KW, Leslie KK. Past, present, and future of hormonal therapy in recurrent endometrial cancer. Int J Womens Health. 2014 May 2;6:429-35. doi: 10.2147/IJWH.S40942. eCollection 2014.

    PubMed 24833920
  • Castonguay V, Lheureux S, Welch S, Mackay HJ, Hirte H, Fleming G, Morgan R, Wang L, Blattler C, Ivy PS, Oza AM. A phase II trial of sunitinib in women with metastatic or recurrent endometrial carcinoma: a study of the Princess Margaret, Chicago and California Consortia. Gynecol Oncol. 2014 Aug;134(2):274-80. doi: 10.1016/j.ygyno.2014.05.016. Epub 2014 May 29.

    PubMed 24882554
  • Choueiri TK, Mayer EL, Je Y, Rosenberg JE, Nguyen PL, Azzi GR, Bellmunt J, Burstein HJ, Schutz FA. Congestive heart failure risk in patients with breast cancer treated with bevacizumab. J Clin Oncol. 2011 Feb 20;29(6):632-8. doi: 10.1200/JCO.2010.31.9129. Epub 2011 Jan 4.

    PubMed 21205755
  • Coleman RL, Sill MW, Lankes HA, Fader AN, Finkler NJ, Hoffman JS, Rose PG, Sutton GP, Drescher CW, McMeekin DS, Hu W, Deavers M, Godwin AK, Alpaugh RK, Sood AK. A phase II evaluation of aflibercept in the treatment of recurrent or persistent endometrial cancer: a Gynecologic Oncology Group study. Gynecol Oncol. 2012 Dec;127(3):538-43. doi: 10.1016/j.ygyno.2012.08.020. Epub 2012 Aug 23.

    PubMed 22922531
  • Cosgrove CM, Cohn DE, Hampel H, Frankel WL, Jones D, McElroy JP, Suarez AA, Zhao W, Chen W, Salani R, Copeland LJ, O'Malley DM, Fowler JM, Yilmaz A, Chassen AS, Pearlman R, Goodfellow PJ, Backes FJ. Epigenetic silencing of MLH1 in endometrial cancers is associated with larger tumor volume, increased rate of lymph node positivity and reduced recurrence-free survival. Gynecol Oncol. 2017 Sep;146(3):588-595. doi: 10.1016/j.ygyno.2017.07.003. Epub 2017 Jul 11.

    PubMed 28709704
  • Fleming GF. Second-Line Therapy for Endometrial Cancer: The Need for Better Options. J Clin Oncol. 2015 Nov 1;33(31):3535-40. doi: 10.1200/JCO.2015.61.7225. Epub 2015 Jul 20. No abstract available.

    PubMed 26195695
  • Fleming GF, Brunetto VL, Cella D, Look KY, Reid GC, Munkarah AR, Kline R, Burger RA, Goodman A, Burks RT. Phase III trial of doxorubicin plus cisplatin with or without paclitaxel plus filgrastim in advanced endometrial carcinoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2004 Jun 1;22(11):2159-66. doi: 10.1200/JCO.2004.07.184.

    PubMed 15169803
  • Gabrilovich DI, Chen HL, Girgis KR, Cunningham HT, Meny GM, Nadaf S, Kavanaugh D, Carbone DP. Production of vascular endothelial growth factor by human tumors inhibits the functional maturation of dendritic cells. Nat Med. 1996 Oct;2(10):1096-103. doi: 10.1038/nm1096-1096.

    PubMed 8837607
  • Goldberg SB, Narayan A, Kole AJ, Decker RH, Teysir J, Carriero NJ, Lee A, Nemati R, Nath SK, Mane SM, Deng Y, Sukumar N, Zelterman D, Boffa DJ, Politi K, Gettinger SN, Wilson LD, Herbst RS, Patel AA. Early Assessment of Lung Cancer Immunotherapy Response via Circulating Tumor DNA. Clin Cancer Res. 2018 Apr 15;24(8):1872-1880. doi: 10.1158/1078-0432.CCR-17-1341. Epub 2018 Jan 12.

    PubMed 29330207
  • Goodfellow PJ, Billingsley CC, Lankes HA, Ali S, Cohn DE, Broaddus RJ, Ramirez N, Pritchard CC, Hampel H, Chassen AS, Simmons LV, Schmidt AP, Gao F, Brinton LA, Backes F, Landrum LM, Geller MA, DiSilvestro PA, Pearl ML, Lele SB, Powell MA, Zaino RJ, Mutch D. Combined Microsatellite Instability, MLH1 Methylation Analysis, and Immunohistochemistry for Lynch Syndrome Screening in Endometrial Cancers From GOG210: An NRG Oncology and Gynecologic Oncology Group Study. J Clin Oncol. 2015 Dec 20;33(36):4301-8. doi: 10.1200/JCO.2015.63.9518. Epub 2015 Nov 9.

    PubMed 26552419

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rucaparib, Bevacizumab and Atezolizumab in people with Endometrial Cancer and Uterine Carcinosarcoma, run by Medical College of Wisconsin at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 50 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Related Overall Response Rate (time frame: 44 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03694262, which also lists 38 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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