Phase II Study of Atezolizumab + Bevacizumab in Endometrial Cancer

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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

Brief Summary

      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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Number of patients who experience complete or partial tumor response

Secondary Outcome

 Progression-free Survival

Condition

Endometrial Cancer

Intervention

Bevacizumab

Study Arms / Comparison Groups

 Bevacizumab + Atezolizumab
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

55

Start Date

August 8, 2018

Completion Date

May 25, 2023

Primary Completion Date

May 25, 2021

Eligibility Criteria

        Inclusion Criteria:

          1. Histologic or cytologic diagnosis of endometrial carcinoma (including endometrioid,
             serous, mixed adenocarcinoma, clear-cell carcinoma, or carcinosarcoma).

          2. Evidence that the endometrial cancer is advanced, recurrent, or persistent and has
             relapsed or is refractory to curative therapy or established treatments.

          3. At least 1 prior platinum-based chemotherapeutic regimen, but not more than 2 prior
             chemotherapeutic regimens, for management of endometrial carcinoma. Prior treatment
             may include chemotherapy, and/or consolidation/maintenance therapy.

          4. 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). Each lesion must
             be ≥ 10 mm in long axis when measured by CT, MRI, or caliper measurement by clinical
             exam. Lymph nodes must be ≥ 15 mm in short axis when measured by CT or MRI.

          5. Female patients 18 years or older.

          6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

          7. For women of childbearing potential: agreement to remain abstinent (refrain from
             heterosexual intercourse) or use contraceptive methods as defined in study protocol.

          8. Clinical laboratory values as specified in study protocol within 4 weeks before the
             first dose of study drug.

          9. Able to understand and willing to sign the Informed Consent Form and the written
             consent must be given before performance of any study-related procedure not part of
             standard medical care, with the understanding that consent may be withdrawn by the
             patient at any time without prejudice to future medical care.

         10. Must have ability to comply with the study protocol, in the investigator's judgment.

         11. Patients MSI status must be known (via immunohistochemistry)

         12. 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.

         13. Life expectancy of greater than 12 weeks.

        Exclusion Criteria:

          1. 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.

          2. Previous treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody.

          3. History of auto-immune disorders (SLE, sarcoidosis, RA, Crohn's).

          4. 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

          5. Sensory or motor neuropathy ≥ Grade 2.

          6. Patients with symptomatic, untreated Central nervous system (CNS) metastasis; Patients
             with a history of treated CNS lesions are eligible if all criteria provided per study
             protocol are met.

          7. 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.

          8. Diagnosed or treated for another malignancy within 2 years before administration of
             the first dose of study drug or previously diagnosed with another malignancy and have
             any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma
             in situ of any type are not excluded if they have undergone complete resection.

          9. Patients with prior allogeneic bone marrow transplantation or prior solid organ
             transplantation

         10. 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; however, some therapies are allowed per study
             protocol.

         11. 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

         12. History of severe allergic, anaphylactic, or other hypersensitivity reactions to
             chimeric or humanized antibodies or fusion proteins, compounds similar to bevacizumab
             or atezolizumab, or Chinese hamster ovary products.

         13. 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

         14. History of abdominal/pelvic fistula, gastrointestinal perforation and/or
             intraabdominal abscess within 6 months prior to day 1. Serious or non-healing wound,
             active ulcer or bone fracture

         15. Immunocompromised patients and subjects known to be HIV positive and currently
             receiving antiretroviral therapy. NOTE: Subjects known to be HIV positive, but without
             clinical evidence of an immunocompromised state, are eligible for this trial.
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Camille Gunderson, MD, 405 271-8777, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03526432

Organization ID

OU-SCC-GEN-001


Responsible Party

Sponsor

Study Sponsor

University of Oklahoma

Collaborators

 Genentech, Inc.

Study Sponsor

Camille Gunderson, MD, Principal Investigator, Obstetrics and Gynecology


Verification Date

June 2020