Study of Cabozantinib Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
1 other identifier
interventional
914
9 countries
124
Brief Summary
This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in subjects with multiple tumor types, including advanced urothelial carcinoma (UC) (including bladder, renal pelvis, ureter, urethra), renal cell carcinoma (RCC), castration-resistant prostate cancer (CRPC), non-small-cell lung cancer (NSCLC), triple negative breast cancer (TNBC), ovarian cancer (OC), endometrial cancer (EC), hepatocellular cancer (HCC), gastric cancer/gastroesophageal junction cancer/lower esophageal cancer (GC/GEJC/LEC), colorectal cancer (CRC), head and neck (H\&N) cancer, and differentiated thyroid cancer (DTC). The study consists of two stages: in the Dose Escalation Stage, an appropriate recommended cabozantinib dose for the combination with standard dosing regimen of atezolizumab will be established; in the Expansion Stage, tumor-specific cohorts will be enrolled in order to further evaluate the safety and efficacy of the combination treatment in these tumor indications. Three exploratory single-agent cabozantinib (SAC) cohorts may also be enrolled with UC, NSCLC, or CRPC subjects. One exploratory single-agent atezolizumab (SAA) cohort may also be enrolled with CRPC subjects. Subjects enrolled in the SAC cohorts and SAA cohort may receive combination treatment with both cabozantinib and atezolizumab after they experience radiographic progressive disease per the Investigator per RECIST 1.1. Due to the nature of this study design, some tumor cohorts may complete enrollment earlier than others.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2017
Longer than P75 for phase_1
124 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2017
CompletedFirst Posted
Study publicly available on registry
May 31, 2017
CompletedStudy Start
First participant enrolled
September 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
ExpectedAugust 17, 2025
August 1, 2025
5.5 years
May 23, 2017
August 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Dose Escalation: MTD/Recommended Dose
To determine the maximum tolerated dose (MTD) and/or recommended dose and schedule for the subsequent Expansion Stage of daily oral administration of cabozantinib in subjects with solid tumors when taken in combination with atezolizumab.
Up to Day 21
Dose Expansion: ORR
To evaluate preliminary efficacy by estimating the Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1.
Up to a maximum of 59 months
Secondary Outcomes (1)
Incidence and severity of nonserious AEs and SAEs (Safety)
From first dose to 30 days following last dose (up to a maximum of 59 months)
Study Arms (25)
Dose Escalation
EXPERIMENTALSubjects will accrue in cohorts of 3-6 subjects for evaluation of cabozantinib tablet dose of either 20 mg, 40 mg, and 60 mg orally qd in combination with standard dosing regimen of atezolizumab (1200 mg infusion q3w). A standard "3 plus 3" design will be utilized to determine a recommended combination dosing regimen for the Expansion Stage.
Expansion Cohort 1
EXPERIMENTALRCC subjects with clear cell histology who have not received prior systemic anticancer therapy.
Expansion Cohort 2
EXPERIMENTALUC subjects (including bladder, renal pelvis, ureter, urethra) who have progressed on or after platinum-containing chemotherapy.
Expansion Cohort 3
EXPERIMENTALUC subjects (including bladder, renal pelvis, ureter, urethra) who are ineligible for cisplatin-based chemotherapy and have not received prior systemic chemotherapy.
Expansion Cohort 4
EXPERIMENTALUC subjects (including bladder, renal pelvis, ureter, urethra) eligible for cisplatin-based chemotherapy and have not received prior systemic chemotherapy.
Expansion Cohort 5
EXPERIMENTALUC subjects (including renal pelvis, ureter, urinary bladder, urethra) who have radiographically progressed on or after one prior immune check-point inhibitor (ICI) (anti-PD1 or anti-PD-L1) therapy.
Expansion Cohort 6
EXPERIMENTALCRPC subjects who have radiographically progressed in soft tissue on or after enzalutamide and/or abiraterone acetate for metastatic disease.
Expansion Cohort 7
EXPERIMENTALStage IV non-squamous NSCLC subjects who have radiographically progressed on or after treatment with one prior immune checkpoint inhibitor (ICI) (anti-PD-1 or anti-PD-L1) therapy.
Expansion Cohort 8
EXPERIMENTALStage IV non-squamous NSCLC subjects with positive PD-L1 expression and without prior systemic anticancer therapy.
Expansion Cohort 9
EXPERIMENTALStage IV nonsquamous NSCLC subjects with sensitizing EGFR mutation who have radiographically progressed during or following prior treatment with an EGFR-targeting TKI. Prior treatment with ICIs (anti-PD1 or anti-PD-L1) is allowed if given in combination with chemotherapy.
Expansion Cohort 10
EXPERIMENTALRCC subjects with non-clear cell histology who have had up to one prior VEGFR-targeting TKI therapy.
Expansion Cohort 11
EXPERIMENTALTNBC subjects who have radiographically progressed during or following treatment with at least one prior systemic anticancer therapy. Prior treatment with ICIs (anti-PD1 or anti-PD-L1) is allowed if given in combination with chemotherapy.
Expansion Cohort 12
EXPERIMENTALOC subjects (including primary peritoneal cancer and fallopian tube cancer) who have platinum-resistant or refractory disease who have had up to two lines of prior systemic anticancer therapy.
Expansion Cohort 13
EXPERIMENTALEC subjects (serous or endometrioid histology) who have radiographically progressed during or following treatment with at least one prior systemic anticancer therapy.
Expansion Cohort 14
EXPERIMENTALHCC subjects (Child-Pugh score A) who have not received prior systemic anticancer therapy.
Expansion Cohort 15
EXPERIMENTALGC/GEJC/LEC subjects who have radiographically progressed during or following platinum-containing or fluoropyrimidine-containing chemotherapy.
Expansion Cohort 16
EXPERIMENTALCRC subjects who have radiographically progressed during or following systemic chemotherapy that contained fluoropyrimidine in combination with oxaliplatin or irinotecan.
Expansion Cohort 17
EXPERIMENTALH\&N cancer subjects who have radiographically progressed during or following prior platinum-containing chemotherapy. Prior treatment with ICIs (anti-PD1 or anti-PD-L1) is allowed if given in combination with chemotherapy.
Expansion Cohort 18
EXPERIMENTALDTC subjects (follicular, papillary, and poorly differentiated histologies) who are radioactive iodine (RAI) refractory or deemed ineligible for treatment with RAI.
Expansion Cohort 19 (SAC)
EXPERIMENTALUC subjects (including renal pelvis, ureter, urinary bladder, urethra) who have radiographically progressed on or after one prior ICI (anti-PD-1 or anti-PD-L1). Subjects may be allowed to receive combination therapy at the Cohort Review Committee recommended dose following radiographic disease progression.
Expansion Cohort 20 (SAC)
EXPERIMENTALStage IV non-squamous NSCLC subjects who have radiographically progressed on or after treatment with one prior ICI (anti-PD-1 or anti-PD-L1). Subjects may be allowed to receive combination therapy at the Cohort Review Committee recommended dose following radiographic disease progression.
Expansion Cohort 21 (SAC)
EXPERIMENTALMetastatic CRPC (mCRPC) subjects who have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features who have had prior treatment with one, and only one, novel hormonal therapy (NHT) (eg, abiraterone, enzalutamide, apalutamide, daralutamide) for CSPC, mCRPC, or non-metastatic CRPC. Subjects may be allowed to receive combination therapy at the Cohort Review Committee recommended dose following radiographic disease progression.
Expansion Cohort 22 (SAA)
EXPERIMENTALMetastatic CRPC (mCRPC) subjects who have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features who have had prior treatment with one, and only one, novel hormonal therapy (NHT) (eg, abiraterone, enzalutamide, apalutamide, daralutamide) for CSPC, mCRPC, or non-metastatic CRPC. Subjects may be allowed to receive combination therapy at the Cohort Review Committee recommended dose following radiographic disease progression.
Expansion Cohort 23
EXPERIMENTALMetastatic CRPC (mCRPC) subjects who have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features who have had prior treatment with one, and only one, novel hormonal therapy (NHT) (eg, abiraterone, enzalutamide, apalutamide, daralutamide) for CSPC, mCRPC, or non-metastatic CRPC
Expansion Cohort 24
EXPERIMENTALMetastatic CRPC (mCRPC) subjects who have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features who have had prior treatment with at least one NHT and have received docetaxel for mCRPC
Interventions
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
Eligibility Criteria
You may qualify if:
- Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent:
- Dose-Escalation Stage:
- Subjects with UC (including renal pelvis, ureter, bladder, urethra) after prior platinum-based therapy, or
- Subjects with RCC (clear cell, non-clear cell histology) with or without prior systemic anticancer therapy
- Expansion Stage:
- Inoperable locally advanced or metastatic solid tumor (UC, RCC, CRPC, NSCLC, TNBC, OC, EC, HCC, GC/GEJC/LEC, CRC, H\&N cancer, and DTC as outlined above)
- Measurable disease per RECIST 1.1 as determined by the investigator.
- Tumor tissue material available (archival or recent tumor biopsy)
- Recovery to baseline or ≤ Grade 1 CTCAE v4 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
- Age eighteen years or older on the day of consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Adequate organ and marrow function.
- Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception.
- Female subjects of childbearing potential must not be pregnant at screening.
You may not qualify if:
- Prior treatment with cabozantinib or immune checkpoint inhibitors including anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy except in Expansion Cohorts 5, 7, 9, 11, 17, 19 and 20. Other restrictions regarding prior therapy may apply.
- Known brain metastases or cranial epidural disease unless adequately treated and stable for at least 4 weeks before first dose of study treatment.
- Concomitant anticoagulation with oral anticoagulants.
- Subject is receiving systemic steroid therapy (\>10 mg daily prednisone equivalent) or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment.
- Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.
- The subject has uncontrolled, significant intercurrent or recent illness, including, but not limited to, an active or history of autoimmune disease or immune deficiency; idiopathic pulmonary fibrosis, organizing pneumonia, pneumonitis; active infection requiring systemic treatment, infection with human immunodeficiency virus (HIV), AIDS-related illness, acute or chronic hepatitis B or C infection, positive test for tuberculosis, moderate to severe hepatic impairment (Child-Pugh B or C).
- Pregnant or lactating females.
- Previously identified allergy or hypersensitivity to components of the study treatment formulations.
- Diagnosis of another malignancy within 2 years before first dose of study treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Exelixislead
Study Sites (124)
Exelixis Clinical Site #53
Gilbert, Arizona, 85234, United States
Exelixis Clinical Site #18
Phoenix, Arizona, 85054, United States
Exelixis Clinical Site #1
Duarte, California, 91010, United States
Exelixis Clinical Site #20
La Jolla, California, 92090, United States
Exelixis Clinical Site #46
Los Angeles, California, 90025, United States
Exelixis Clinical Site #51
Newport Beach, California, 92663, United States
Exelixis Clinical Site #62
Santa Monica, California, 90404, United States
Exelixis Clinical Site #21
Stanford, California, 94305, United States
Exelixis Clinical Site #34
Denver, Colorado, 80218, United States
Exelixis Clinical Site #50
Denver, Colorado, 80218, United States
Exelixis Clinical Site #42
New Haven, Connecticut, 06511, United States
Exelixis Clinical Site #48
Washington D.C., District of Columbia, 20007, United States
Exelixis Clinical Site #16
Jacksonville, Florida, 32224, United States
Exelixis Clinical Site #76
Tampa, Florida, 33612, United States
Exelixis Clinical Site #60
Atlanta, Georgia, 30318, United States
Exelixis Clinical Site #79
Atlanta, Georgia, 30341, United States
Exelixis Clinical Site #32
Harvey, Illinois, 60426, United States
Exelixis Clinical Site #23
Fairway, Kansas, 66205, United States
Exelixis Clinical Site #57
Lexington, Kentucky, 40536, United States
Exelixis Clinical Site #24
New Orleans, Louisiana, 70112, United States
Exelixis Clinical Site #10
Boston, Massachusetts, 02215, United States
Exelixis Clinical Site #3
Detroit, Michigan, 48201, United States
Exelixis Clinical Site #17
Rochester, Minnesota, 55905, United States
Exelixis Clinical Site #65
Bolivar, Missouri, 65613, United States
Exelixis Clinical Site #43
Kansas City, Missouri, 64111, United States
Exelixis Clinical Site #35
Omaha, Nebraska, 68130, United States
Exelixis Clinical Site #59
Omaha, Nebraska, 68130, United States
Exelixis Clinical Site #61
Las Vegas, Nevada, 89169, United States
Exelixis Clinical Site #38
Camden, New Jersey, 08103, United States
Exelixis Clinical Site #27
East Brunswick, New Jersey, 08816, United States
Exelixis Clinical Site #31
New Brunswick, New Jersey, 08903, United States
Exelixis Clinical Site #40
East Setauket, New York, 11733, United States
Exelixis Clinical Site #11
New York, New York, 10029, United States
Exelixis Clinical Site #37
The Bronx, New York, 10461, United States
Exelixis Clinical Site #67
Cleveland, Ohio, 44195, United States
Exelixis Clinical Site #49
Columbus, Ohio, 43210, United States
Exelixis Clinical Site #64
Kettering, Ohio, 45409, United States
Exelixis Clinical Site #71
Oklahoma City, Oklahoma, 73104, United States
Exelixis Clinical Site #6
Oklahoma City, Oklahoma, 73120, United States
Exelixis Clinical Site #102
Portland, Oregon, 97213, United States
Exelixis Clinical Site #45
Portland, Oregon, 97239, United States
Exelixis Clinical Site #41
Bethlehem, Pennsylvania, 18015, United States
Exelixis Clinical Site #15
Philadelphia, Pennsylvania, 19107, United States
Exelixis Clinical Site #55
Philadelphia, Pennsylvania, 19111, United States
Exelixis Clinical Site #66
Pittsburgh, Pennsylvania, 15232, United States
Exelixis Clinical Site #95
Charleston, South Carolina, 29414, United States
Exelixis Clinical Site #13
Dallas, Texas, 75246, United States
Exelixis Clinical Site #26
Dallas, Texas, 75390, United States
Exelixis Clinical Site #114
Fort Worth, Texas, 76104, United States
Exelixis Clinical Site #29
Houston, Texas, 77030, United States
Exelixis Clinical Site #39
Houston, Texas, 77030, United States
Exelixis Clinical Site #44
Houston, Texas, 77030, United States
Exelixis Clinical Site #33
Lubbock, Texas, 79410, United States
Exelixis Clinical Site #63
San Antonio, Texas, 78229, United States
Exelixis Clinical Site #2
Salt Lake City, Utah, 84112, United States
Exelixis Clinical Site #30
Blacksburg, Virginia, 24060, United States
Exelixis Clinical Site #14
Charlottesville, Virginia, 22908, United States
Exelixis Clinical Site #98
Albury, New South Wales, 2640, Australia
Exelixis Clinical Site #101
Camperdown, New South Wales, 2050, Australia
Exelixis Clinical Site #115
Gosford, New South Wales, 2250, Australia
Exelixis Clinical Site #112
North Ryde, New South Wales, 2109, Australia
Exelixis Clinical Site #123
Randwick, New South Wales, 2031, Australia
Exelixis Clinical Site #99
St Albans, Victoria, 3021, Australia
Exelixis Clinical Site #52
Ghent, 9000, Belgium
Exelixis Clinical Site #54
Leuven, 3000, Belgium
Exelixis Clinical Site #88
La Roche-sur-Yon, Cedex 9, 85925, France
Exelixis Clinical Site #8
Villejuif, Cedex, 94805, France
Exelixis Clinical Site #92
Bordeaux, 33076, France
Exelixis Clinical Site #93
Brest, 29229, France
Exelixis Clinical Site #87
Caen, 14076, France
Exelixis Clinical Site #69
Le Mans, 72000, France
Exelixis Clinical Site #97
Lille, 59000, France
Exelixis Clinical Site #89
Lyon, 69373, France
Exelixis Clinical Site #109
Marseille, 13273, France
Exelixis Clinical Site #104
Nice, 06189, France
Exelixis Clinical Site #80
Nîmes, 30029, France
Exelixis Clinical Site #78
Paris, 75005, France
Exelixis Clinical Site #7
Paris, 75010, France
Exelixis Clinical Site #68
Paris, 75013, France
Exelixis Clinical Site #72
Paris, 75015, France
Exelixis Clinical Site #82
Saint-Grégoire, 35760, France
Exelixis Clinical Site #119
Strasbourg, 67000, France
Exelixis Clinical Site #107
Suresnes, 92150, France
Exelixis Clinical Site #105
Vandœuvre-lès-Nancy, 54519, France
Exelixis Clinical Site #56
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Exelixis Clinical Site #36
Tübingen, 72076, Germany
Exelixis Clinical Site #84
Meldola, FC, 47014, Italy
Exelixis Clinical Site #47
Rozzano, Milano, 20089, Italy
Exelixis Clinical Site #108
Milan, 20132, Italy
Exelixis Clinical Site #103
Milan, 20133, Italy
Exelixis Clinical Site #25
Milan, 20133, Italy
Exelixis Clinical Site #4
Milan, 20133, Italy
Exelixis Clinical Site #85
Napoli, 80131, Italy
Exelixis Clinical Site #121
Pavia, 27100, Italy
Exelixis Clinical Site #110
Roma, 00168, Italy
Exelixis Clinical Site #12
Nijmegen, Gelderland, 6525 GA, Netherlands
Exelixis Clinical Site #74
Santiago de Compostela, A Coruña, 15706, Spain
Exelixis Clinical Site #91
Elche, Alicante, 03203, Spain
Exelixis Clinical Site #70
Palma de Mallorca, Balearic Islands, 07120 / 07010, Spain
Exelixis Clinical Site #113
Badalona, Barcelona, 08916, Spain
Exelixis Clinical Site #116
Sabadell, Barcelona, 08208, Spain
Exelixis Clinical Site #96
Jeréz de La Frontera, Cádiz, 11407, Spain
Exelixis Clinical Site #90
Pamplona, Navarre, 31008, Spain
Exelixis Clinical Site #94
Oviedo, Principality of Asturias, 33011, Spain
Exelixis Clinical Site #117
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain
Exelixis Clinical Site #75
Barcelona, 08003, Spain
Exelixis Clinical Site #58
Barcelona, 08022, Spain
Exelixis Clinical Site #83
Barcelona, 08023, Spain
Exelixis Clinical Site #86
Barcelona, 08025, Spain
Exelixis Clinical Site #28
Barcelona, 08035, Spain
Exelixis Clinical Site #9
Barcelona, 08035, Spain
Exelixis Clinical Site #73
Barcelona, 08036, Spain
Exelixis Clinical Site #118
Girona, 17007, Spain
Exelixis Clinical Site #77
Madrid, 28034, Spain
Exelixis Clinical Site #106
Madrid, 28040, Spain
Exelixis Clinical Site #111
Madrid, 28040, Spain
Exelixis Clinical Site #22
Madrid, 28041, Spain
Exelixis Clinical Site #5
Madrid, 28041, Spain
Exelixis Clinical Site #81
Madrid, 28046, Spain
Exelixis Clinical Site #100
Málaga, 29010, Spain
Exelixis Clinical Site #122
Middlesex, England, HA6 2RN, United Kingdom
Exelixis Clinical Site #120
Preston, England, PR2 9HT, United Kingdom
Exelixis Clinical Site #124
Cardiff, Wales, CF14 2TL, United Kingdom
Exelixis Clinical Site #19
London, EC1M 6BQ, United Kingdom
Related Publications (4)
Pal SK, Loriot Y, Necchi A, Singh P, Castellano D, Pagliaro L, Suarez C, McGregor BA, Vaishampayan UN, Hauke RJ, Powles T, Van Herpen CML, Courtney KD, Dreicer R, Sudhagoni R, Schwickart M, Andrianova S, Agarwal N. COSMIC-021 Phase Ib Study of Cabozantinib Plus Atezolizumab: Results from the Locally Advanced or Metastatic Urothelial Carcinoma Cohorts. J Clin Oncol. 2025 May 10;43(14):1650-1662. doi: 10.1200/JCO-24-01675. Epub 2025 Feb 18.
PMID: 39965176DERIVEDLi D, Loriot Y, Burgoyne AM, Cleary JM, Santoro A, Lin D, Aix SP, Garrido-Laguna I, Sudhagoni R, Guo X, Andrianova S, Paulson S. Cabozantinib plus atezolizumab in previously untreated advanced hepatocellular carcinoma and previously treated gastric cancer and gastroesophageal junction adenocarcinoma: results from two expansion cohorts of a multicentre, open-label, phase 1b trial (COSMIC-021). EClinicalMedicine. 2023 Dec 21;67:102376. doi: 10.1016/j.eclinm.2023.102376. eCollection 2024 Jan.
PMID: 38204489DERIVEDAgarwal N, McGregor B, Maughan BL, Dorff TB, Kelly W, Fang B, McKay RR, Singh P, Pagliaro L, Dreicer R, Srinivas S, Loriot Y, Vaishampayan U, Goel S, Curran D, Panneerselvam A, Schwickart M, Choueiri TK, Pal S. Cabozantinib in combination with atezolizumab in patients with metastatic castration-resistant prostate cancer: results from an expansion cohort of a multicentre, open-label, phase 1b trial (COSMIC-021). Lancet Oncol. 2022 Jul;23(7):899-909. doi: 10.1016/S1470-2045(22)00278-9. Epub 2022 Jun 9.
PMID: 35690072DERIVEDPal SK, McGregor B, Suarez C, Tsao CK, Kelly W, Vaishampayan U, Pagliaro L, Maughan BL, Loriot Y, Castellano D, Srinivas S, McKay RR, Dreicer R, Hutson T, Dubey S, Werneke S, Panneerselvam A, Curran D, Scheffold C, Choueiri TK, Agarwal N. Cabozantinib in Combination With Atezolizumab for Advanced Renal Cell Carcinoma: Results From the COSMIC-021 Study. J Clin Oncol. 2021 Nov 20;39(33):3725-3736. doi: 10.1200/JCO.21.00939. Epub 2021 Sep 7.
PMID: 34491815DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2017
First Posted
May 31, 2017
Study Start
September 5, 2017
Primary Completion
February 21, 2023
Study Completion (Estimated)
September 30, 2027
Last Updated
August 17, 2025
Record last verified: 2025-08