Clinical Trials /

Phase II Study of Atezolizumab + Bevacizumab in Endometrial Cancer

NCT03526432

Description:

This is a single arm, Phase II study using the combination of atezolizumab and bevicacizumab in women with advanced, recurrent or persistent endometrial cancer. Safety and futility of this drug combination will be assessed to see what effect this treatment has on this patient population.

Related Conditions:
  • Endometrial Carcinoma
  • Uterine Corpus Carcinosarcoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase II Study of Atezolizumab + Bevacizumab in Endometrial Cancer
  • Official Title: A Phase II, Single Arm Study of Atezolizumab + Bevacizumab in Women With Advanced, Recurrent or Persistent Endometrial Cancer

Clinical Trial IDs

  • ORG STUDY ID: OU-SCC-GEN-001
  • NCT ID: NCT03526432

Conditions

  • Endometrial Cancer

Interventions

DrugSynonymsArms
BevacizumabBevacizumab + Atezolizumab
AtezolizumabBevacizumab + Atezolizumab

Purpose

This is a single arm, Phase II study using the combination of atezolizumab and bevicacizumab in women with advanced, recurrent or persistent endometrial cancer. Safety and futility of this drug combination will be assessed to see what effect this treatment has on this patient population.

Detailed Description

      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.
    

Trial Arms

NameTypeDescriptionInterventions
Bevacizumab + AtezolizumabExperimental
  • Bevacizumab
  • Atezolizumab

Eligibility Criteria

        Inclusion Criteria:

          -  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
             investigator discretion.

        Exclusion Criteria:

          -  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
             drug

          -  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
             transplantation

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of patients who experience complete or partial tumor response
Time Frame:3 years
Safety Issue:
Description:To estimate the objective tumor response in women of this patient population

Secondary Outcome Measures

Measure:Progression-free Survival
Time Frame:up to 3 years
Safety Issue:
Description:To estimate progression-free survival (PFS) and overall survival (OS) of patients with recurrent or persistent endometrial cancer treated with Atezolizumab and Bevacizumab.
Measure:Overall survival
Time Frame:up to 3 years
Safety Issue:
Description:To estimate overall survival (OS) of patients with recurrent or persistent endometrial cancer treated with Atezolizumab and Bevacizumab.
Measure:Number of patients who experience toxicity
Time Frame:6 months
Safety Issue:
Description:To determine the nature and degree of toxicity in combination of atezolizumab and bevacizumab.
Measure:Number of participants who experience immune related response
Time Frame:6 months
Safety Issue:
Description:To estimate response using immune related response criteria (irRC) in patients receiving Atezolizumab and Bevacizumab.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Oklahoma

Last Updated

March 3, 2020