← Back to Search

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
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests drugs that target cancer cells, sometimes combined with an immune-boosting drug called atezolizumab. It focuses on patients with endometrial cancer that has returned or is persistent. The drugs are chosen based on the genetic profile of the patient's tumor to improve effectiveness.

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not received a live vaccine in the last 4 weeks and do not plan to during the study.
Select...
I have had a bone marrow or organ transplant in the past.
Select...
I have a history of lung scarring or inflammation not caused by infections.
Select...
I have been diagnosed with ovarian or cervical cancer at the same time.
Select...
I have active tuberculosis.
Select...
I have a serious heart condition.
Select...
My endometrial cancer is either squamous carcinoma or sarcoma.
Select...
I have previously received treatments that boost the immune system to fight cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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 more
Other study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Talazoparib
2021
Completed Phase 2
~2820
Trastuzumab emtansine
2010
Completed Phase 4
~2290
Giredestrant
2019
Completed Phase 2
~300
Tiragolumab
2019
Completed Phase 3
~1390
Inavolisib
2021
Completed Phase 2
~260
Letrozole
2002
Completed Phase 4
~3590
Abemaciclib
2019
Completed Phase 2
~1990
Bevacizumab
2013
Completed Phase 4
~5540
Ipatasertib
2017
Completed Phase 3
~3490

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Immune checkpoint inhibitors like Atezolizumab enhance the immune system's ability to recognize and attack endometrial cancer cells by blocking proteins that inhibit immune responses. This is particularly effective for tumors with high mutational burdens, such as those that are mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H). Additionally, targeted therapies focus on specific genetic mutations, and endocrine therapies modulate hormone levels to slow cancer growth. These treatments are vital for providing personalized and potentially more effective options for patients with recurrent or persistent endometrial cancer, especially when traditional chemotherapy fails.
Immuno-Oncology for Gynecologic Malignancies.Optimizing immunotherapy for gynecologic cancers.Immunotherapy in endometrial cancer: new scenarios on the horizon.

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,555 Previous Clinical Trials
569,152 Total Patients Enrolled
6 Trials studying Endometrial Cancer
318 Patients Enrolled for Endometrial Cancer
Foundation MedicineIndustry Sponsor
32 Previous Clinical Trials
16,090 Total Patients Enrolled
PfizerIndustry Sponsor
4,640 Previous Clinical Trials
17,740,993 Total Patients Enrolled
2 Trials studying Endometrial Cancer
100 Patients Enrolled for Endometrial Cancer

Media Library

Atezolizumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04486352 — Phase 1 & 2
Endometrial Cancer Research Study Groups: Inavolisib and Letrozole Cohort, Atezolizumab and Ipatasertib Cohort, Atezolizumab and Tiragolumab Cohort, Giredestrant and Abemaciclib, Atezolizumab and Talazoparib Cohort, Atezolizumab and Trastuzumab emtansine (TDM-1) Cohort, Atezolizumab and Bevacizumab Cohort
Endometrial Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04486352 — Phase 1 & 2
Atezolizumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04486352 — Phase 1 & 2
~35 spots leftby Oct 2025