CompletedPhase 2

The EndoBARR Trial (Endometrial Bevacizumab, Atezolizumab, Rucaparib)

United States30 participantsStarted 2019-07-19

Plain-language summary

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

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. 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
✓. 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).

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.

What they're measuring

Treatment Related Overall Response Rate

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.

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

Trial details

NCT IDNCT03694262

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-30

Results submitted2024-06-06

View on ClinicalTrials.gov More Endometrial Cancer trials