EndoMAP: A Phase IB/II Multi-Cohort Study of Targeted Agents and/or Immunotherapy with Atezolizumab for Patients with Recurrent or Persistent Endometrial Cancer

ENROLLING
Protocol # :
21-702
Conditions
Endometrial Cancer
Phase
I/II
Disease Sites
Corpus Uteri
Other Female Genital
Principal Investigator
Liu, Joyce, F
Site Research Nurses
Belavusava, Vera
Bowes, Brittany, N.
Doherty, Kelsie
Hindenach, Sarah
Hurley-Whalen, Christin
Morrissey, Stephanie, C.
Neals, Allison

Trial Description

This is a Phase IB/II multi-cohort study designed to evaluate the efficacy and safety of
targeted agents with or without cancer immune checkpoint therapy with atezolizumab in
participant with recurrent and/or persistent endometrial cancer. The main protocol provides a
platform for genomic screening with homogeneous basic eligibility criteria in order to direct
study participants into biomarker-matched study cohorts consisting of testing targeted
agents.

Eligibility Requirements

Key Inclusion Criteria:

- Recurrent or persistent endometrial carcinoma which has progressed or recurred after
at least 1, but no more than 2, prior lines of therapy. Prior hormonal therapies
(e.g., tamoxifen, aromatase inhibitors) will not count toward the prior regimen limit.
Chemotherapy given in conjunction with radiotherapy as a radiosensitizer will be
counted as a systemic therapeutic regimen.

- Measurable disease per RECIST 1.1

- Availability of a representative tumor specimen that is suitable for determination of
biomarker status via central testing (F1CDx) OR If a patient has a prior F1CDx report
from 1 September 2019 or later, those NGS results can be used to determine biomarker
status as long as the tumor tissue used in the report was obtained within 5 years
prior to prescreening and appropriate signed consent is obtained from the patient.

- Life expectancy > 12 weeks

- Recovery from effects of recent radiotherapy, surgery, or chemotherapy

Key Exclusion Criteria:

- Endometrial tumors with the following histologies: squamous carcinomas, sarcomas

- Other invasive malignancies within the last 5 years, except for non-melanoma skin
cancer with no evidence of disease within the past 5 years AND localized breast cancer
with previous adjuvant chemotherapy treatment for breast cancer completed > 5 years
ago

- Synchronous primary invasive ovarian or cervical cancer

- Have an active or history of autoimmune disease or immune deficiency

- Have a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis based on a
screening chest computed tomography (CT) scan

- Active tuberculosis

- Severe infections within 4 weeks

- Have received therapeutic oral or IV antibiotic medication within 2 weeks, except
prophylactic antibiotic medication

- Have significant cardiovascular disease

- Are administered treatment with a live attenuated vaccine within 4 weeks, or
anticipation of need for such a vaccine during the course of the study

- Have prior allogeneic bone marrow transplantation or solid organ transplant

- Prior treatment with T-cell costimulating or immune checkpoint blockade therapies
including, but not limited to, CD137 agonists, anti-PD-1, anti-PD-L1, and anti-CTLA-4
therapeutic antibodies

- History of treatment with systemic immunostimulatory agents (including but not limited
to interferons, interleukin-2) within 4 weeks or 5 half-lives of the drug, whichever
is longer, prior to initiation of study treatment

- History of treatment with systemic immunosuppressive medications within 2 weeks except
acute, low-dose, systemic immunosuppressant medications, corticosteroids for chronic
obstructive pulmonary disease and asthma, or mineralocorticoids and low-dose
corticosteroids for participants with orthostatic hypotension or adrenocortical
insufficiency

- Have a history or clinical evidence of any untreated CNS disease, seizures not
controlled with standard medical therapy, or history of cerebrovascular accident
(stroke), transient ischemic attack or subarachnoid hemorrhage within 6 months

Note: Additional study cohort specific inclusion and exclusion criteria may apply based on
cohort assignment.

21-702