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New treatment option for Endometrial Cancer
Official title A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer
ClinicalTrials.gov ID: NCT04486352
What this study is testing
What is Atezolizumab - 28 Day Cycle?
Atezolizumab - 28 Day Cycle is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for endometrial cancer.
Also referred to as Tecentriq, L01XC32.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Recurrent or persistent endometrial carcinoma which has progressed or recurred after at least 1, but no more than 2, prior lines of therapy. Prior...
- 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...
- Life expectancy \> 12 weeks
- Recovery from effects of recent radiotherapy, surgery, or chemotherapy Key
You likely can't join if
- 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...
- 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...
- Active tuberculosis
See the full eligibility 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...
- 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...
- Life expectancy \> 12 weeks
- Recovery from effects of recent radiotherapy, surgery, or chemotherapy Key
- 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...
- 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
- 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...
- 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...
- 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...
- 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 Note: Additional study...
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- San Francisco, California, United States
- Washington D.C., District of Columbia, United States
- Miami Beach, Florida, United States
- Chicago, Illinois, United States
- Westwood, Kansas, United States
- Scarborough, Maine, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Englewood, New Jersey, United States
- Morristown, New Jersey, United States
- Buffalo, New York, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Oklahoma City, Oklahoma, United States
- Portland, Oregon, United States
- Pittsburgh, Pennsylvania, United States
- Providence, Rhode Island, United States
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; San Francisco, California, United States; Washington D.C., District of Columbia, United States; Miami Beach, Florida, United States; Chicago, Illinois, United States; Westwood, Kansas, United States and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.