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PD-L1 Inhibitor
Targeted Therapy + Atezolizumab for Endometrial Cancer (EndoMAP Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Alliance Foundation Trials, LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights
EndoMAP Trial Summary
This trial is testing targeted cancer drugs plus atezolizumab, an immune checkpoint therapy, to see if it is effective and safe for patients with endometrial cancer that has come back or does not go away.
Who is the study for?
This trial is for individuals with recurrent or persistent endometrial cancer who have undergone no more than two prior treatments (excluding certain hormonal therapies and radiosensitizers). Participants must have a life expectancy over 12 weeks, measurable disease per RECIST 1.1, and a suitable tumor specimen for biomarker testing. Those with autoimmune diseases, severe infections recently, significant cardiovascular disease, other recent malignancies except certain skin cancers and localized breast cancer treated over 5 years ago are excluded.Check my eligibility
What is being tested?
The study evaluates the effectiveness of targeted agents like Abemaciclib, Giredestrant, Talazoparib among others in combination with or without Atezolizumab—an immune checkpoint therapy—in treating endometrial cancer. It's designed to match participants to treatment based on specific biomarkers identified through genomic screening.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation in various organs due to atezolizumab; organ-specific toxicity from targeted agents; increased risk of infection; fatigue; digestive issues; blood disorders; and possible infusion-related reactions.
EndoMAP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Investigator-assessed overall response rate (ORR) of each biomarker cohort
The proportion of participants in each biomarker cohort who remain alive and progression-free for at least 6 months
Secondary outcome measures
Duration of response for participants in each biomarker cohort who achieve a complete or partial response.
Duration of response for participants in each biomarker cohort who achieve a confirmed response (complete or partial)
Investigator assessed disease-control rate of each biomarker cohort
+3 moreOther outcome measures
Assess exploratory biomarkers in tumor tissue and peripheral blood, and their association with other molecular characteristics, disease status and/or participant response to study treatment
Safety of each biomarker cohort: adverse events
The safety of each biomarker cohort: Adverse Events
EndoMAP Trial Design
7Treatment groups
Experimental Treatment
Group I: Inavolisib and Letrozole CohortExperimental Treatment2 Interventions
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.
Group II: Giredestrant and AbemaciclibExperimental Treatment2 Interventions
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.
Group III: Atezolizumab and Trastuzumab emtansine (TDM-1) CohortExperimental Treatment2 Interventions
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.
Group IV: Atezolizumab and Tiragolumab CohortExperimental Treatment2 Interventions
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.
Group V: Atezolizumab and Talazoparib CohortExperimental Treatment2 Interventions
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.
Group VI: Atezolizumab and Ipatasertib CohortExperimental Treatment2 Interventions
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.
Group VII: Atezolizumab and Bevacizumab CohortExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tiragolumab
2020
Completed Phase 2
~350
Talazoparib
2021
Completed Phase 2
~2770
Trastuzumab emtansine
2010
Completed Phase 4
~2220
Inavolisib
2021
Completed Phase 2
~260
Letrozole
2002
Completed Phase 4
~3240
Abemaciclib
2019
Completed Phase 2
~1710
Giredestrant
2019
Completed Phase 2
~300
Bevacizumab
2013
Completed Phase 4
~5280
Ipatasertib
2011
Completed Phase 3
~2320
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
567,995 Total Patients Enrolled
6 Trials studying Endometrial Cancer
318 Patients Enrolled for Endometrial Cancer
Foundation MedicineIndustry Sponsor
32 Previous Clinical Trials
16,044 Total Patients Enrolled
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,915,863 Total Patients Enrolled
2 Trials studying Endometrial Cancer
100 Patients Enrolled for Endometrial Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for at least 12 more weeks.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.My endometrial cancer has returned or worsened after 1 or 2 treatments.I have not had severe infections in the last 4 weeks.I haven't taken strong immune-weakening medicines in the last 2 weeks, except for my asthma or low blood pressure.You currently have or have had a condition where your immune system attacks your own body or your immune system is not working properly.I have had a bone marrow or organ transplant in the past.I haven't taken any immune-boosting drugs in the last 4 weeks or longer.I can provide a recent tumor sample for testing or have a suitable test report from after September 1, 2019.I have recovered from recent cancer treatments.I have a history of lung scarring or inflammation not caused by infections.I have not had a stroke, mini-stroke, or severe brain bleed in the last 6 months.I have not taken antibiotics in the last 2 weeks, except for prevention.I have been diagnosed with ovarian or cervical cancer at the same time.I haven't had cancer in the last 5 years, except for non-melanoma skin cancer or treated breast cancer.I have active tuberculosis.I have a serious heart condition.My endometrial cancer is either squamous carcinoma or sarcoma.I have previously received treatments that boost the immune system to fight cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Inavolisib and Letrozole Cohort
- Group 2: Atezolizumab and Ipatasertib Cohort
- Group 3: Atezolizumab and Tiragolumab Cohort
- Group 4: Giredestrant and Abemaciclib
- Group 5: Atezolizumab and Talazoparib Cohort
- Group 6: Atezolizumab and Trastuzumab emtansine (TDM-1) Cohort
- Group 7: Atezolizumab and Bevacizumab Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What preceding investigations have been completed using Atezolizumab?
"Presently, there are 686 active trials concerning Atezolizumab with 149 of them in the late-stage Phase 3. With its epicentre located in Duarte California, 35388 medical sites around the world have been devoted to exploring this treatment's efficacy."
Answered by AI
What illnesses has Atezolizumab been found to be efficacious in treating?
"Atezolizumab is frequently used to combat recurrent platinum-resistant epithelial ovarian cancer, as well as a selection of other diseases like malignant neoplasms, localized advanced nonsquamous non-small cell lung cancer and recurrent primary peritoneal cancer with platinum sensitivity."
Answered by AI
How many healthcare facilities are currently hosting this experiment?
"This clinical trial is held in various locations, particularly at Roswell Park located in Buffalo, New york; Providence Portland Cancer Institute situated in Portland, Oregon; and University of Pittsburgh Medical Center set up in Pittsburgh Pennsylvania. There are also 16 other sites hosting this experiment."
Answered by AI
Has recruitment opened for this experiment yet?
"Affirmative. Documents posted on clinicaltrials.gov demonstrate that this medical research, which was originally shared on October 20th 2021, is actively recruiting volunteers. A total of 100 participants are needed and these will be enrolled at 16 different sites."
Answered by AI
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