A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer (EndoMAP)
Endometrial Cancer
About this trial
This is an interventional treatment trial for Endometrial Cancer
Eligibility Criteria
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
- Formalin-fixed, paraffin-embedded tumor tissue, a specimen as proximal to the current recurrence as possible, must be submitted to the Central Lab for molecular testing (FoundationOne CDxTM)
- 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 patients 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
Sites / Locations
- City of Hope Comprehensive Cancer CenterRecruiting
- UCSF Helen Diller Family Comprehensive Cancer CenterRecruiting
- Medstar Georgetown Cancer InstituteRecruiting
- Mount Sinai Comprehensive Cancer CenterRecruiting
- University of ChicagoRecruiting
- Dana Farber Cancer InstituteRecruiting
- University of MinnesotaRecruiting
- Washington University School of Medicine Siteman Cancer CenterRecruiting
- Nebraska Methodist HospitalRecruiting
- Englewood HealthRecruiting
- Atlantic Health Systems/Morristown Medical CenterRecruiting
- Roswell ParkRecruiting
- Weill Cornell MedicineRecruiting
- Duke University Cancer CenterRecruiting
- University of Oklahoma Health Stephenson Cancer CenterRecruiting
- Providence Portland Cancer InstituteRecruiting
- University of Pittsburgh Medical CenterRecruiting
- Baptist Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Atezolizumab and Bevacizumab Cohort
Atezolizumab and Ipatasertib Cohort
Atezolizumab and Talazoparib Cohort
Atezolizumab and Trastuzumab emtansine (TDM-1) Cohort
Atezolizumab and Tiragolumab Cohort
Inavolisib and Letrozole Cohort
Giredestrant and Abemaciclib
Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with no specified gene signatures will be enrolled in this cohort. Twenty participants will be enrolled. Once twenty participants are enrolled, the cohort will be closed to further enrollment. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle.
Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with PIK3CA/AKT1/PTEN-altered tumors will be enrolled in this cohort. Twenty participants will be enrolled. Once twenty participants are enrolled, the cohort will be closed to further enrollment. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle.
Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with tumors that have a ≥16%genomic loss of heterozygosity (LOH) will be assigned to this cohort. Twenty participants will be enrolled. Once twenty participants are enrolled, the cohort will be closed to further enrollment. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle.
Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with tumors that with an amplification of ERBB2/HER2 will be assigned to this cohort. Twenty participants will be enrolled. Once twenty participants are enrolled, the cohort will be closed to further enrollment. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle.
Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with tumor type MSI-H and/or tTMB >=10 mut/mb will be assigned to this cohort. Twenty participants will be enrolled initially. Once twenty participants are enrolled, the cohort may be expanded if a positive signal is shown. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle.
Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with tumors that with PIK3CA activating mutations in the absence of PTEN loss-of-function alterations or AKT1 activating mutations will be assigned to this cohort. Twenty-four participants will be enrolled. Once twenty-four participants are enrolled, the cohort will be closed to further enrollment. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle.
Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with tumors that are RB1 intact with a local grade 1-2 estrogne receptor positive (ER+) are assigned to this cohort. Twenty-four participants will be enrolled. Once twenty-four participants are enrolled, the cohort will be closed to further enrollment. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle.