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AzTrials

Endometrial CancerPhase 1/2EndoMAPNCT04486352

A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer

A Phase 1/2 study testing Atezolizumab - 28 Day Cycle, Bevacizumab and Ipatasertib in people with Endometrial Cancer, run by Alliance Foundation Trials, LLC. at 21 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
Atezolizumab - 28 Day Cycle, Bevacizumab and Ipatasertib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
21 sitesUnited States
Study dates
20 Oct 2021to Oct 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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 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
  • AFT-50A Specific Exclusion Criteria:
  • ● 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 cohort specific inclusion and exclusion criteria may apply based on cohort assignment.

Trial locations and contacts

21 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Quality Management and Compliance contact

617-732-8727

ClinicalTrials.Queries@alliancefoundationtrials.org

21 sites in 1 country

United States21 sites, 1 recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02125

    Active, not recruiting

  • Roswell Park

    Buffalo, New York, 14263

    Active, not recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Active, not recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

    Active, not recruiting

  • Duke University Cancer Center

    Durham, North Carolina, 27710

    Active, not recruiting

  • Englewood Health

    Englewood, New Jersey, 07631

    Active, not recruiting

  • Baptist Memorial Hospital

    Memphis, Tennessee, 38120

    Withdrawn

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

    Active, not recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Active, not recruiting

  • Atlantic Health Systems/Morristown Medical Center

    Morristown, New Jersey, 07960

    Active, not recruiting

  • Weill Cornell Medicine

    New York, New York, 10065

    Active, not recruiting

  • University of Oklahoma Health Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

    Debra Richardson, MD

    Debra Richardson, MD

    Recruiting

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

    Active, not recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15261

    Active, not recruiting

  • Providence Portland Cancer Institute

    Portland, Oregon, 97213

    Active, not recruiting

  • Lifespan - Rhode Island Hospital

    Providence, Rhode Island, 02903

    Active, not recruiting

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94143

    Active, not recruiting

  • Maine Medical Center

    Scarborough, Maine, 04074

    Active, not recruiting

  • Washington University School of Medicine Siteman Cancer Center

    St Louis, Missouri, 63110

    Withdrawn

  • Medstar Georgetown Cancer Institute

    Washington D.C., District of Columbia, 20007

    Active, not recruiting

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

    Active, not recruiting

Other trials in United States

About this study

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

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.

Read the detailed 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 participants with recurrent and/or persistent endometrial cancer.

This biomarker-driven study provides a platform whereby participants with persistent/recurrent endometrial cancer will be placed into study cohorts evaluating targeted agents selected on the basis of the tumor's specific genomic profile. Prospective participants with persistent and/or recurrent endometrial cancer will be prescreened within 60 days of treatment assignment to have a tumor tissue sample submitted for next-generation sequencing (NGS) using FoundationOne® companion diagnostic (CDx) testing prior to entering screening. If a participant has FoundationOne® CDx testing within five years of enrollment, the previous tumor tissue may be re-analyzed for use in the study. Non-FMI NGS testing may be submitted if approved.

Depending on the cohort assignment per the tumor's biomarker profile, participants will be assigned to the AFT-50A Protocol (atezolizumab+targeted agent) or the AFT-50B Protocol (non-atezolizumab targeted agents). The current study cohorts are as follows:

AFT-50A Cohorts

  • Atezolizumab + Bevacizumab doublet - Closed to Accrual
  • Atezolizumab + Ipatasertib doublet - Closed to Accrual
  • Atezolizumab + Talazoparib doublet
  • Atezolizumab + Trastuzumab emtansine (TDM-1) doublet - Closed to Accrual
  • Atezolizumab + Tiragolumab doublet - Closed to Accrual

AFT-50B Cohorts

  • Inavolisib + Letrozole doublet
  • Giredestrant + Abemaciclib doublet

It is anticipated that approximately 20 participants will be enrolled in each study cohort in AFT-50A and 24 participants in each study cohort in AFT-50B, unless otherwise specified for a given cohort due to statistical considerations. Each study cohort will open/close independently of other study cohorts. Once a study cohort reaches the prespecified number of participants, it will be closed to further enrollment, unless an expansion phase is planned.

The study is structured to allow for additional cohorts to be added as the study progresses. These additional study cohorts may be proposed by investigators, but requires approval by the Steering Committee in order to be added to the protocol.

Being tested
Atezolizumab - 28 Day Cycle, Bevacizumab, Ipatasertib, Talazoparib, Trastuzumab emtansine
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atezolizumab - 28 Day CycleDrug

    Also called Tecentriq, L01XC32

    Atezolizumab will be given to participants intravenously at a dosage of 1680 mg on day 1 of each 28-day cycle.

  • BevacizumabDrug

    Also called Avastin, L01XC07

    Bevacizumab will be given to participants intravenously at a dosage of 10mg per participant kilogram every 2 weeks of the 28-day cycle.

  • IpatasertibDrug

    Also called RG7440, GDC-0068

    Ipatasertib will be given as an orally at a dosage of 400 mg once daily for 21 days of each 28-day cycle.

  • TalazoparibDrug

    Also called Talzenna, L01XX60

    Talazoparib will be given in an orally at a dosage of 1 mg once daily for each day of the 28-day cycle.

  • Trastuzumab emtansineDrug

    Also called T-DM1, Kadcyla

    Trastuzumab emtansine be given to participants intravenously at a dosage of 3.6 mg per participant kilogram, on day 1 of each 21-day cycle.

  • TiragolumabDrug

    Tiragolumab will be given to participants intravenously at a dosage of 840 mg on day 1 of each 28-day cycle.

  • Atezolizumab - 21 Day CycleDrug

    Also called Tecentriq, L01XC32

    Atezolizumab will be given to participants intravenously at a dosage of 1200 mg on day 1 of each 21-day cycle.

  • InavolisibDrug

    Also called GDC-0077

    Inavolisib will be given in an orally at a dosage of 9 mg once daily for each day of the 28-day cycle.

  • LetrozoleDrug

    Also called Femara

    Letrozole will be given orally at a dosage of 2.5 mg once daily for each day of the 28-day cycle.

  • GiredestrantDrug

    Also called GDC-9545

    Giredestrant will be given orally at a dosage of 30 mg once daily for each day of the 28-day cycle.

  • AbemaciclibDrug

    Also called Verzenio

    Giredestrant will be given orally at a dosage of 150 mg twice daily for each day of the 28-day cycle.

Study groups in NCT04486352
Study groupRoleWhat they receive
Atezolizumab and Bevacizumab Cohort - Closed to AccrualExperimentalFollowing 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.
Receives: Drug: Atezolizumab - 28 Day Cycle; Drug: Bevacizumab
Atezolizumab and Ipatasertib Cohort - Closed to AccrualExperimentalFollowing 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.
Receives: Drug: Atezolizumab - 28 Day Cycle; Drug: Ipatasertib
Atezolizumab and Talazoparib CohortExperimentalFollowing 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.
Receives: Drug: Atezolizumab - 28 Day Cycle; Drug: Talazoparib
Atezolizumab and Trastuzumab emtansine (TDM-1) Cohort - Closed to AccrualExperimentalFollowing 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.
Receives: Drug: Trastuzumab emtansine; Drug: Atezolizumab - 21 Day Cycle
Atezolizumab and Tiragolumab Cohort - Closed to AccrualExperimentalFollowing 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.
Receives: Drug: Atezolizumab - 28 Day Cycle; Drug: Tiragolumab
Inavolisib and Letrozole CohortExperimentalFollowing 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.
Receives: Drug: Inavolisib; Drug: Letrozole
Giredestrant and AbemaciclibExperimentalFollowing 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.
Receives: Drug: Giredestrant; Drug: Abemaciclib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Investigator-assessed overall response rate (ORR) of each biomarker cohort

    AFT-50A Protocol: Overall response rate for each biomarker cohort is defined as the proportion of participants achieving a complete (CR) or partial (PR) response on two consecutive occasions at least 4 weeks apart, as determined by the investigator from AFT50A Protocol: Tumor assessments per RECIST v1.1.

    Measured: 48 Months

  2. The proportion of participants in each biomarker cohort who remain alive and progression-free for at least 6 months

    AFT-50B Protocol: Progression free survival rate at 6 months is defined as the proportion of participants who have not experienced disease progression or death from any cause at 6 months, as determined by the investigator according to RECIST v1.1

    Measured: 6 Months

Secondary outcomes (7)

  1. Relative proportion of participants in each biomarker cohort who remain progression-free for at least 6 months compared to that from historical control studies

    AFT-50A Protocol: PFS rate at 6 months is defined as the proportion of participants who have not experienced disease progression or death from any cause at 6 months, as determined by the investigator according to RECIST v1.1

    Measured: 6 Months per cohort

  2. Investigator assessed disease-control rate of each biomarker cohort

    AFT-50A Protocol: Disease-control rate is defined as the proportion of participants achieving either stable disease, complete response, or partial response.

    Measured: 48 Months

  3. Duration of response for participants in each biomarker cohort who achieve a complete or partial response.

    AFT-50A Protocol: Duration of response is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.

    Measured: 48 Months

  4. Overall survival (OS) rates of participants in each biomarker cohort after 24 months

    AFT-50A Protocol: 24-month overall survival rate is defined as the proportion of participants who have not experienced death from any cause at 24 months.

    Measured: 24 Months per cohort

  5. Investigator assessed disease-control rate of each biomarker cohort

    AFT-50B Protocol: Disease control rate is defined as the proportion of participants achieving either stable disease, complete response, or partial response at any time.

    Measured: 48 Months

  6. Duration of response for participants in each biomarker cohort who achieve a confirmed response (complete or partial)

    AFT-50B Protocol: Duration of response is defined as the time from the first occurrence of a documented objective response (complete or partial) to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1

    Measured: 48 Months

  7. Overall survival rates of participants in each biomarker cohort

    AFT-50B Protocol: 24-month overall survival rate is defined as the proportion of participants who have not experienced death from any cause at 24 months.

    Measured: 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2020
  2. Study start20 Oct 2021
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
148 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04486352
Sponsor's protocol ID
AFT-50
Acronym
EndoMAP
Status last verified
Jul 2025
First submitted
22 Jul 2020
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Aghajanian C, Sill MW, Darcy KM, Greer B, McMeekin DS, Rose PG, Rotmensch J, Barnes MN, Hanjani P, Leslie KK. Phase II trial of bevacizumab in recurrent or persistent endometrial cancer: a Gynecologic Oncology Group study. J Clin Oncol. 2011 Jun 1;29(16):2259-65. doi: 10.1200/JCO.2010.32.6397. Epub 2011 May 2.

    PubMed 21537039

  • Le DT, Uram JN, Wang H, Bartlett BR, Kemberling H, Eyring AD, Skora AD, Luber BS, Azad NS, Laheru D, Biedrzycki B, Donehower RC, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Duffy SM, Goldberg RM, de la Chapelle A, Koshiji M, Bhaijee F, Huebner T, Hruban RH, Wood LD, Cuka N, Pardoll DM, Papadopoulos N, Kinzler KW, Zhou S, Cornish TC, Taube JM, Anders RA, Eshleman JR, Vogelstein B, Diaz LA Jr. PD-1 Blockade in Tumors with Mismatch-Repair Deficiency. N Engl J Med. 2015 Jun 25;372(26):2509-20. doi: 10.1056/NEJMoa1500596. Epub 2015 May 30.

    PubMed 26028255

  • Rous J, Rems J, Cermak Z. [Extraction of peripherally located bronchial foreign bodies using a x-ray picture amplifier with a television loop]. Cesk Otolaryngol. 1975 Dec;24(6):335-41. No abstract available. Czech.

    PubMed 1204078

  • Rosenberg JE, Hoffman-Censits J, Powles T, van der Heijden MS, Balar AV, Necchi A, Dawson N, O'Donnell PH, Balmanoukian A, Loriot Y, Srinivas S, Retz MM, Grivas P, Joseph RW, Galsky MD, Fleming MT, Petrylak DP, Perez-Gracia JL, Burris HA, Castellano D, Canil C, Bellmunt J, Bajorin D, Nickles D, Bourgon R, Frampton GM, Cui N, Mariathasan S, Abidoye O, Fine GD, Dreicer R. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial. Lancet. 2016 May 7;387(10031):1909-20. doi: 10.1016/S0140-6736(16)00561-4. Epub 2016 Mar 4.

    PubMed 26952546

  • Schwartz LH, Seymour L, Litiere S, Ford R, Gwyther S, Mandrekar S, Shankar L, Bogaerts J, Chen A, Dancey J, Hayes W, Hodi FS, Hoekstra OS, Huang EP, Lin N, Liu Y, Therasse P, Wolchok JD, de Vries E. RECIST 1.1 - Standardisation and disease-specific adaptations: Perspectives from the RECIST Working Group. Eur J Cancer. 2016 Jul;62:138-45. doi: 10.1016/j.ejca.2016.03.082. Epub 2016 May 26.

    PubMed 27237360

  • Rini BI, Powles T, Atkins MB, Escudier B, McDermott DF, Suarez C, Bracarda S, Stadler WM, Donskov F, Lee JL, Hawkins R, Ravaud A, Alekseev B, Staehler M, Uemura M, De Giorgi U, Mellado B, Porta C, Melichar B, Gurney H, Bedke J, Choueiri TK, Parnis F, Khaznadar T, Thobhani A, Li S, Piault-Louis E, Frantz G, Huseni M, Schiff C, Green MC, Motzer RJ; IMmotion151 Study Group. Atezolizumab plus bevacizumab versus sunitinib in patients with previously untreated metastatic renal cell carcinoma (IMmotion151): a multicentre, open-label, phase 3, randomised controlled trial. Lancet. 2019 Jun 15;393(10189):2404-2415. doi: 10.1016/S0140-6736(19)30723-8. Epub 2019 May 9.

    PubMed 31079938

  • Colle R, Cohen R, Cochereau D, Duval A, Lascols O, Lopez-Trabada D, Afchain P, Trouilloud I, Parc Y, Lefevre JH, Flejou JF, Svrcek M, Andre T. Immunotherapy and patients treated for cancer with microsatellite instability. Bull Cancer. 2017 Jan;104(1):42-51. doi: 10.1016/j.bulcan.2016.11.006. Epub 2016 Dec 13.

    PubMed 27979364

  • Westin SN, Sill MW, Coleman RL, Waggoner S, Moore KN, Mathews CA, Martin LP, Modesitt SC, Lee S, Ju Z, Mills GB, Schilder RJ, Fracasso PM, Birrer MJ, Aghajanian C. Safety lead-in of the MEK inhibitor trametinib in combination with GSK2141795, an AKT inhibitor, in patients with recurrent endometrial cancer: An NRG Oncology/GOG study. Gynecol Oncol. 2019 Dec;155(3):420-428. doi: 10.1016/j.ygyno.2019.09.024. Epub 2019 Oct 15.

    PubMed 31623857

  • LoRusso PM. Inhibition of the PI3K/AKT/mTOR Pathway in Solid Tumors. J Clin Oncol. 2016 Nov 1;34(31):3803-3815. doi: 10.1200/JCO.2014.59.0018. Epub 2016 Sep 30.

    PubMed 27621407

  • Correction: A First-in-Human Phase I Study of the ATP-Competitive AKT Inhibitor Ipatasertib Demonstrates Robust and Safe Targeting of AKT in Patients with Solid Tumors. Cancer Discov. 2018 Nov;8(11):1490. doi: 10.1158/2159-8290.CD-18-1114. No abstract available.

    PubMed 30385525

  • Xue G, Zippelius A, Wicki A, Mandala M, Tang F, Massi D, Hemmings BA. Integrated Akt/PKB signaling in immunomodulation and its potential role in cancer immunotherapy. J Natl Cancer Inst. 2015 Jun 11;107(7):djv171. doi: 10.1093/jnci/djv171. Print 2015 Jul.

    PubMed 26071042

  • Cancer Genome Atlas Research Network; Kandoth C, Schultz N, Cherniack AD, Akbani R, Liu Y, Shen H, Robertson AG, Pashtan I, Shen R, Benz CC, Yau C, Laird PW, Ding L, Zhang W, Mills GB, Kucherlapati R, Mardis ER, Levine DA. Integrated genomic characterization of endometrial carcinoma. Nature. 2013 May 2;497(7447):67-73. doi: 10.1038/nature12113.

    PubMed 23636398

  • Miyasaka A, Oda K, Ikeda Y, Wada-Hiraike O, Kashiyama T, Enomoto A, Hosoya N, Koso T, Fukuda T, Inaba K, Sone K, Uehara Y, Kurikawa R, Nagasaka K, Matsumoto Y, Arimoto T, Nakagawa S, Kuramoto H, Miyagawa K, Yano T, Kawana K, Osuga Y, Fujii T. Anti-tumor activity of olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, in cultured endometrial carcinoma cells. BMC Cancer. 2014 Mar 13;14:179. doi: 10.1186/1471-2407-14-179.

    PubMed 24625059

  • Gockley AA, Kolin DL, Awtrey CS, Lindeman NI, Matulonis UA, Konstantinopoulos PA. Durable response in a woman with recurrent low-grade endometrioid endometrial cancer and a germline BRCA2 mutation treated with a PARP inhibitor. Gynecol Oncol. 2018 Aug;150(2):219-226. doi: 10.1016/j.ygyno.2018.05.028. Epub 2018 Jun 22.

    PubMed 29937315

  • Jiao S, Xia W, Yamaguchi H, Wei Y, Chen MK, Hsu JM, Hsu JL, Yu WH, Du Y, Lee HH, Li CW, Chou CK, Lim SO, Chang SS, Litton J, Arun B, Hortobagyi GN, Hung MC. PARP Inhibitor Upregulates PD-L1 Expression and Enhances Cancer-Associated Immunosuppression. Clin Cancer Res. 2017 Jul 15;23(14):3711-3720. doi: 10.1158/1078-0432.CCR-16-3215. Epub 2017 Feb 6.

    PubMed 28167507

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Atezolizumab - 28 Day Cycle, Bevacizumab and Ipatasertib in people with Endometrial Cancer, run by Alliance Foundation Trials, LLC. at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Quality Management and Compliance (617-732-8727, ClinicalTrials.Queries@alliancefoundationtrials.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Investigator-assessed overall response rate (ORR) of each biomarker cohort (time frame: 48 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04486352, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.

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