This phase 2 study using atezolizumab and bevacizumab aims to study the objective tumor
response in women with recurrent endometrial cancer. Drugs will be administered via IV every
21 days until disease progression, unacceptable toxicity, or loss of clinical benefit as
determined by investigator. Subjects will receive routine cancer care as well as tests and
procedures required for the purposes of this study. It is expected this combination will be
produce an anti-cancer effect with manageable toxicities in this patient population.
- Histologic or cytologic diagnosis of endometrial carcinoma (including endometrioid,
serous, mixed adenocarcinoma, clear-cell carcinoma, or carcinosarcoma).
- Evidence that the endometrial cancer is advanced, recurrent, or persistent and has
relapsed or is refractory to curative therapy or established treatments.
- At least 1 prior platinum-based chemotherapeutic regimen, but not more than 2 prior
chemotherapeutic regimens, for management of endometrial carcinoma.
- Measurable disease by RECIST 1.1, defined as at least 1 lesion that can be accurately
measured in at least 1 dimension (longest diameter to be recorded).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraceptive methods as defined in protocol
- Acceptable lab results as specified in study protocol
- MSI status must be known
- Life expectancy of greater than 12 weeks
- Patients should have archival tumor tissue available or agree to have pre-treatment
tumor biopsy if no archival tissue is available for correlative studies. If unable to
be safely biopsied and patient desires enrollment, may be enrolled per principal
- Positive serum pregnancy test during the screening period or a positive urine
pregnancy test on Day 1 before first dose of study drug. Women who are lactating and
breast feeding are not eligible.
- Previous treatment with anti−PD-1, or anti−PD-L1 therapeutic antibody or any immune
directed anti-cancer therapy.
- History of auto-immune disorders (SLE, sarcoidosis, RA, Crohn's).
- Initiation of treatment with systemic corticosteroids (either IV or oral steroids,
excluding inhalers) within 1 week before administration of the first dose of study
- Sensory or motor neuropathy ≥ Grade 2
- Patients with symptomatic, untreated Central nervous system (CNS) metastasis
- Other clinically significant co-morbidities, such as uncontrolled pulmonary disease,
active CNS disease, severe cardiac disease, bleeding diathesis, active infection, or
any other condition that could compromise participation of the patient in the study
- Patients with prior allogeneic bone marrow transplantation or prior solid organ
- Patients who have had investigational therapy, chemotherapy or radiotherapy within 4
weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those
who have not recovered from adverse events (other than alopecia) due to agents
administered more than 4 weeks earlier
- Treatment with systemic immunostimulatory agents (including, but not limited to,
interferon [IFN]-alpha or interleukin [IL]-2) within 6 weeks or five half-lives of the
drug (whichever is shorter) prior to cycle 1, day 1
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric or humanized antibodies or fusion proteins, compounds similar to bevacizumab
or atezolizumuab, or Chinese hamster ovary products.
- Major surgical procedure within 28 days prior to cycle 1, day 1 or anticipation of
need for a major surgical procedure during the course of the study
- History of abdominal/pelvic fistula, gastrointestinal perforation and/or
intraabdominal abscess within 6 months prior to day 1