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

NCT04486352 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: AFT-50
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 21

Brief 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. 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.

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  48 Months

• 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

  6 Months

Secondary Outcomes (7)

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

  6 Months per cohort

• Investigator assessed disease-control rate of each biomarker cohort

  48 Months

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

  48 Months

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

  24 Months per cohort

• Investigator assessed disease-control rate of each biomarker cohort

  48 Months

Other Outcomes (3)

• Safety of each biomarker cohort: adverse events

  48 Months

• The safety of each biomarker cohort: Adverse Events

  48 Months

• 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

  48 Months

Study Arms (7)

Atezolizumab and Bevacizumab Cohort - Closed to Accrual

EXPERIMENTAL

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.

Drug: Atezolizumab - 28 Day Cycle; Drug: Bevacizumab

Atezolizumab and Ipatasertib Cohort - Closed to Accrual

EXPERIMENTAL

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.

Drug: Atezolizumab - 28 Day Cycle; Drug: Ipatasertib

Atezolizumab and Talazoparib Cohort

EXPERIMENTAL

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.

Drug: Atezolizumab - 28 Day Cycle; Drug: Talazoparib

Atezolizumab and Trastuzumab emtansine (TDM-1) Cohort - Closed to Accrual

EXPERIMENTAL

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.

Drug: Trastuzumab emtansine; Drug: Atezolizumab - 21 Day Cycle

Atezolizumab and Tiragolumab Cohort - Closed to Accrual

EXPERIMENTAL

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.

Drug: Atezolizumab - 28 Day Cycle; Drug: Tiragolumab

Inavolisib and Letrozole Cohort

EXPERIMENTAL

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.

Drug: Inavolisib; Drug: Letrozole

Giredestrant and Abemaciclib

EXPERIMENTAL

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.

Drug: Giredestrant; Drug: Abemaciclib

Interventions

Bevacizumab DRUG

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

Also known as: Avastin, L01XC07

Atezolizumab and Bevacizumab Cohort - Closed to Accrual

Atezolizumab - 28 Day Cycle DRUG

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

Also known as: Tecentriq, L01XC32

Atezolizumab and Bevacizumab Cohort - Closed to Accrual; Atezolizumab and Ipatasertib Cohort - Closed to Accrual; Atezolizumab and Talazoparib Cohort; Atezolizumab and Tiragolumab Cohort - Closed to Accrual

Ipatasertib DRUG

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

Also known as: RG7440, GDC-0068

Atezolizumab and Ipatasertib Cohort - Closed to Accrual

Talazoparib DRUG

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

Also known as: Talzenna, L01XX60

Atezolizumab and Talazoparib Cohort

Trastuzumab emtansine DRUG

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.

Also known as: T-DM1, Kadcyla

Atezolizumab and Trastuzumab emtansine (TDM-1) Cohort - Closed to Accrual

Tiragolumab DRUG

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

Atezolizumab and Tiragolumab Cohort - Closed to Accrual

Atezolizumab - 21 Day Cycle DRUG

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

Also known as: Tecentriq, L01XC32

Atezolizumab and Trastuzumab emtansine (TDM-1) Cohort - Closed to Accrual

Inavolisib DRUG

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

Also known as: GDC-0077

Inavolisib and Letrozole Cohort

Letrozole DRUG

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

Also known as: Femara

Inavolisib and Letrozole Cohort

Giredestrant DRUG

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

Also known as: GDC-9545

Giredestrant and Abemaciclib

Abemaciclib DRUG

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

Also known as: Verzenio

Giredestrant and Abemaciclib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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 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
• 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
• ● 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

Sponsors & Collaborators

• Alliance Foundation Trials, LLC.: lead
• Genentech, Inc.: collaborator
• Foundation Medicine: collaborator
• Pfizer: collaborator
• Eli Lilly and Company: collaborator

Study Sites (21)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

ACTIVE NOT RECRUITING

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94143, United States

ACTIVE NOT RECRUITING

Medstar Georgetown Cancer Institute

Washington D.C., District of Columbia, 20007, United States

ACTIVE NOT RECRUITING

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

ACTIVE NOT RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

ACTIVE NOT RECRUITING

University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

ACTIVE NOT RECRUITING

Maine Medical Center

Scarborough, Maine, 04074, United States

ACTIVE NOT RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02125, United States

ACTIVE NOT RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

ACTIVE NOT RECRUITING

Washington University School of Medicine Siteman Cancer Center

St Louis, Missouri, 63110, United States

WITHDRAWN

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

ACTIVE NOT RECRUITING

Englewood Health

Englewood, New Jersey, 07631, United States

ACTIVE NOT RECRUITING

Atlantic Health Systems/Morristown Medical Center

Morristown, New Jersey, 07960, United States

ACTIVE NOT RECRUITING

Roswell Park

Buffalo, New York, 14263, United States

ACTIVE NOT RECRUITING

Weill Cornell Medicine

New York, New York, 10065, United States

ACTIVE NOT RECRUITING

Duke University Cancer Center

Durham, North Carolina, 27710, United States

ACTIVE NOT RECRUITING

University of Oklahoma Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Providence Portland Cancer Institute

Portland, Oregon, 97213, United States

ACTIVE NOT RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15261, United States

ACTIVE NOT RECRUITING

Lifespan - Rhode Island Hospital

Providence, Rhode Island, 02903, United States

ACTIVE NOT RECRUITING

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

WITHDRAWN

Related Publications (16)

• 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.

  PMID: 21537039 BACKGROUND

• 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.

  PMID: 26028255 BACKGROUND

• 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.

  PMID: 1204078 BACKGROUND

• 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.

  PMID: 26952546 BACKGROUND

• 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.

  PMID: 27237360 BACKGROUND

• 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.

  PMID: 31079938 BACKGROUND

• 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.

  PMID: 27979364 BACKGROUND

• 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.

  PMID: 31623857 BACKGROUND

• 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.

  PMID: 27621407 BACKGROUND

• 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.

  PMID: 30385525 BACKGROUND

• 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.

  PMID: 26071042 BACKGROUND

• 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.

  PMID: 23636398 BACKGROUND

• 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.

  PMID: 24625059 BACKGROUND

• 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.

  PMID: 29937315 BACKGROUND

• 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.

  PMID: 28167507 BACKGROUND

• Strickland KC, Howitt BE, Shukla SA, Rodig S, Ritterhouse LL, Liu JF, Garber JE, Chowdhury D, Wu CJ, D'Andrea AD, Matulonis UA, Konstantinopoulos PA. Association and prognostic significance of BRCA1/2-mutation status with neoantigen load, number of tumor-infiltrating lymphocytes and expression of PD-1/PD-L1 in high grade serous ovarian cancer. Oncotarget. 2016 Mar 22;7(12):13587-98. doi: 10.18632/oncotarget.7277.

  PMID: 26871470 BACKGROUND

Related Links

• CTCAE Version 5.0

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

atezolizumab; Bevacizumab; ipatasertib; talazoparib; Ado-Trastuzumab Emtansine; Tiragolumab; inavolisib; Letrozole; giredestrant; abemaciclib

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Maytansine; Macrolides; Lactones; Organic Chemicals; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Trastuzumab; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Quality Management and Compliance

CONTACT

617-732-8727; ClinicalTrials.Queries@alliancefoundationtrials.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 24, 2020
• Study Start: October 20, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)