Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (COSMIC-313)

August 22, 2025 updated by: Exelixis

A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in Combination With Nivolumab and Ipilimumab Versus Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma of Intermediate or Poor Risk

This is a multicenter, randomized, double-blinded, controlled Phase 3 trial of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in combination with matched placebo. Approximately 840 eligible subjects with intermediate- or poor-risk advanced or metastatic RCC by IMDC criteria will be randomized in a 1:1 ratio at approximately 180 sites.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a multicenter, randomized, double-blinded, controlled Phase 3 trial of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in combination with matched placebo. The primary objective of this study is to evaluate the effect of cabozantinib in combination with nivolumab and ipilimumab ("triplet") on the duration of progression-free survival (PFS) versus nivolumab and ipilimumab. A secondary objective is to evaluate the effect of triplet combination on the duration of overall survival (OS).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
855

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1125ABD
        • Exelixis Clinical Site #54
      • CABA, Argentina, C1120AAT
        • Exelixis Clinical Site #63
      • Ciudad Autonoma de Buenos Aire, Argentina, C1426ANZ
        • Exelixis Clinical Site #110
      • Córdoba, Argentina, X5004
        • Exelixis Clinical Site #120
    • Buenos Aires
      • Pilar, Buenos Aires, Argentina, B1629ODT
        • Exelixis Clinical Site #153
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000KZE
        • Exelixis Clinical Site #109
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000
        • Exelixis Clinical Site #73
  • Australia
    • New South Wales
      • Albury, New South Wales, Australia, 2640
        • Exelixis Clinical Site #32
      • Kogarah, New South Wales, Australia, 2217
        • Exelixis Clinical Site #35
      • North Ryde, New South Wales, Australia, 2109
        • Exelixis Clinical Site #27
      • Sydney, New South Wales, Australia, 2065
        • Exelixis Clinical Site #33
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Exelixis Clinical Site #17
      • Woolloongabba, Queensland, Australia, 4102
        • Exelixis Clinical Site #14
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Exelixis Clinical Site #18
      • North Adelaide, South Australia, Australia, 5006
        • Exelixis Clinical Site #11
    • Victoria
      • Ballarat, Victoria, Australia, 3350
        • Exelixis Clinical Site #9
      • Box Hill, Victoria, Australia, 3128
        • Exelixis Clinical Site #23
    • Western Australia
      • Subiaco, Western Australia, Australia, 6008
        • Exelixis Clinical Site #26
  • Austria
      • Salzburg, Austria, 5020
        • Exelixis Clinical Site #75
      • Vienna, Austria, 1090
        • Exelixis Clinical Site #126
    • Lower Austria
      • Wiener Neustadt, Lower Austria, Austria, 2700
        • Exelixis Clinical Site #98
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Exelixis Clinical Site #76
  • Belgium
      • Brussels, Belgium, 1000
        • Exelixis Clinical Site #112
      • Hasselt, Belgium, 3500
        • Exelixis Clinical Site #146
  • Brazil
      • São Paulo, Brazil, 01323-001
        • Exelixis Clinical Site #119
      • São Paulo, Brazil, 01327-001
        • Exelixis Clinical Site #141
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-090
        • Exelixis Clinical Site #154
    • Paraná
      • Curitiba, Paraná, Brazil, 80530-010
        • Exelixis Clinical Site #155
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
        • Exelixis Clinical Site #158
      • Porto Alegre, Rio Grande do Sul, Brazil, 90110-270
        • Exelixis Clinical Site #140
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Exelixis Clinical Site #163
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Exelixis Clinical Site #168
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Exelixis Clinical Site #162
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Exelixis Clinical Site #22
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Exelixis Clinical Site #105
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Exelixis Clinical Site #46
      • Toronto, Ontario, Canada, M4N 3M5
        • Exelixis Clinical Site #25
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Exelixis Clinical Site #113
  • Chile
      • Santiago, Chile, 7500921
        • Exelixis Clinical Site #91
      • Santiago, Chile, 8420383
        • Exelixis Clinical Site #100
    • Región de La Araucanía (IX)
      • Temuco, Región de La Araucanía (IX), Chile, 4810561
        • Exelixis Clinical Site #85
  • Czechia
      • Králová, Czechia, 50005
        • Exelixis Clinical Site #89
      • Prague, Czechia, 140 59
        • Exelixis Clinical Site #114
      • Prague, Czechia, 150 06
        • Exelixis Clinical Site #118
  • Finland
      • Helsinki, Finland, 00029
        • Exelixis Clinical Site #50
      • Tampere, Finland, 33520
        • Exelixis Clinical Site #56
      • Turku, Finland, 20520
        • Exelixis Clinical Site #52
  • France
      • Bordeaux, France, 33075
        • Exelixis Clinical Site #86
      • Le Mans, France, 72000
        • Exelixis Clinical Site #71
      • Lyon, France, 69373
        • Exelixis Clinical Site #78
      • Montpellier, France, 34295
        • Exelixis Clinical Site #80
      • Nice, France, 06189
        • Exelixis Clinical Site #66
      • Paris, France, 75015
        • Exelixis Clinical Site #150
      • Reims, France, 51726
        • Exelixis Clinical Site #65
      • Rennes, France, 35042
        • Exelixis Clinical Site #125
      • Strasbourg, France, 67000
        • Exelixis Clinical Site #128
      • Strasbourg, France, 67200
        • Exelixis Clinical Site #90
      • Toulouse, France, 31059
        • Exelixis Clinical Site #42
      • Vandœuvre-lès-Nancy, France, 54519
        • Exelixis Clinical Site #67
      • Villejuif, France, 94800
        • Exelixis Clinical Site #37
  • Germany
      • Dresden, Germany, 01307
        • Exelixis Clinical Site #124
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Exelixis Clinical Site #127
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Exelixis Clinical Site #115
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60596
        • Exelixis Clinical Site #117
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Exelixis Clinical Site #139
      • Münster, North Rhine-Westphalia, Germany, 90419
        • Exelixis Clinical Site #171
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Exelixis Clinical Site #164
    • Thuringia
      • Jena, Thuringia, Germany, 077477
        • Exelixis Clinical Site #137
  • Hong Kong
      • Hong Kong, Hong Kong
        • Exelixis Clinical Site #28
      • Shatin, Hong Kong
        • Exelixis Clinical Site #136
      • Tuenmen, Hong Kong
        • Exelixis Clinical Site #111
  • Hungary
      • Budapest, Hungary, 1122
        • Exelixis Clinical Site #39
      • Pécs, Hungary, 7624
        • Exelixis Clinical Site #51
  • Israel
      • Beersheba, Israel, 84101
        • Exelixis Clinical Site #88
      • Haifa, Israel, 3109601
        • Exelixis Clinical Site #81
      • Jerusalem, Israel, 9112001
        • Exelixis Clinical Site #84
      • Kfar Saba, Israel, 4428164
        • Exelixis Clinical Site #121
      • Petah Tikva, Israel, 49100
        • Exelixis Clinical Site #97
      • Ramat Gan, Israel, 5265601
        • Exelixis Clincal Site #129
  • Italy
      • Arezzo, Italy, 52100
        • Exelixis Clinical Site #47
      • Modena, Italy, 41124
        • Exelixis Clinical Site #60
      • Padua, Italy, 35128
        • Exelixis Clinical Site #61
      • Pavia, Italy, 27100
        • Exelixis Clinical Site #59
      • Perugia, Italy, 06132
        • Exelixis Clinical Site #104
      • Terni, Italy, 05100
        • Exelixis Clinical Site #68
    • Forli - Cesena
      • Meldola, Forli - Cesena, Italy, 47014
        • Exelixis Clinical Site #41
    • Ravenna
      • Faenza, Ravenna, Italy, 48018
        • Exelixis Clinical Site #70
  • Mexico
      • Mexico City, Mexico, 03100
        • Exelixis Clinical Site #160
      • Querétaro, Mexico, 76000
        • Exelixis Clinical Site #131
      • Querétaro, Mexico, 76090
        • Exelixis Clinical Site #161
    • Aguascalientes
      • Aguascalientes, Aguascalientes, Mexico, 20116
        • Exelixis Clinical Site #123
    • Guanajuato
      • León, Guanajuato, Mexico, 37000
        • Exelixis Clinical Site #167
    • Jalisco
      • Zapopan, Jalisco, Mexico, 45070
        • Exelixis Clinical Site #169
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64710
        • Exelixis Clinical Site #134
    • Oaxaca
      • Oaxaca City, Oaxaca, Mexico, 68000
        • Exelixis Clinical Site #132
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Exelixis Clinical Site #144
      • Rotterdam, Netherlands, 3015 GD
        • Exelixis Clinical Site #149
  • New Zealand
    • Waikato Region
      • Hamilton, Waikato Region, New Zealand, 3204
        • Exelixis Clinical Site #122
    • Wellington Region
      • Newtown, Wellington Region, New Zealand, 6021
        • Exelixis Clinical Site #148
  • Poland
      • Biała Podlaska, Poland, 21-500
        • Exelixis Clinical Site #31
      • Bydgoszcz, Poland, 85-796
        • Exelixis Clinical Site #62
      • Gdansk, Poland, 80-219
        • Exelixis Clinical Site #135
      • Otwock, Poland, 05-400
        • Exelixis Clinical Site #99
      • Poznan, Poland, 60-693
        • Exelixis Clinical Site #83
  • Singapore
      • Singapore, Singapore, 119074
        • Exelixis Clinical Site #77
      • Singapore, Singapore, 169610
        • Exelixis Clinical Site #40
  • South Korea
      • Seoul, South Korea, 03722
        • Exelixis Clinical Site #143
      • Seoul, South Korea, 05505
        • Exelixis Clinical Site #151
      • Seoul, South Korea, 06351
        • Exelixis Clinical Site #152
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Exelixis Clinical Site #147
  • Spain
      • Barcelona, Spain, 08035
        • Exelixis Clinical Site #43
      • Barcelona, Spain, 08036
        • Exelixis Clinical Site #36
      • Córdoba, Spain, 14004
        • Exelixis Clinical Site #49
      • Madrid, Spain, 28009
        • Exelixis Clinical Site #34
      • Madrid, Spain, 28040
        • Exelixis Clinical Site #94
      • Madrid, Spain, 28041
        • Exelixis Clinical Site #20
      • Madrid, Spain, 28050
        • Exelixis Clinical Site #55
      • Oviedo, Spain, 33011
        • Exelixis Clinical Site #96
      • Valencia, Spain, 46009
        • Exelixis Clinical Site #74
    • Coruña
      • Santiago de Compostela, Coruña, Spain, 15706
        • Exelixis Clinical Site #53
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Exelixis Clinical Site #45
  • Taiwan
      • Taichung, Taiwan, 404
        • Exelixis Clinical Site #142
      • Taipei, Taiwan, 10002
        • Exelixis Clinical Site #138
      • Taoyuan District, Taiwan, 333
        • Exelixis Clinical Site #173
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Exelixis Clinical Site #72
      • Glasgow, United Kingdom, G12 0YN
        • Exelixis Clinical Site #93
      • London, United Kingdom, EC1A 7BE
        • Exelixis Clinical Site #30
      • London, United Kingdom, W6 8RF
        • Exelixis Clinical Site #172
      • Manchester, United Kingdom, M20 4BX
        • Exelixis Clinical Site #92
  • United States
    • California
      • La Jolla, California, United States, 92093
        • Exelixis Clinical Site #116
      • Orange, California, United States, 92868-3201
        • Exelixis Clinical Site #166
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Exelixis Clinical Site #29
      • Miami, Florida, United States, 33176
        • Exelixis Clinical Site #44
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Exelixis Clinical Site #3
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Exelixis Clinical Site #95
    • Maine
      • Scarborough, Maine, United States, 04074
        • Exelixis Clinical Site #69
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Exelixis Clinical Site #58A
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Exelixis Clinical Site #7B
      • Boston, Massachusetts, United States, 02215
        • Exelixis Clinical Site #7A
      • Boston, Massachusetts, United States, 02215
        • Exelixis Clinical Site #7C
      • Burlington, Massachusetts, United States, 01805
        • Exelixis Clinical Site #6
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Exelixis Clinical Site #15
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Exelixis Clinical Site #24
      • St Louis, Missouri, United States, 63110
        • Exelixis Clinical Site #4
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Exelixis Clinical Site #2
    • New York
      • New York, New York, United States, 10032
        • Exelixis Clinical Site #159
      • New York, New York, United States, 10065
        • Exelixis Clinical Site #8
      • Syracuse, New York, United States, 13210
        • Exelixis Clinical Site #19
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Exelixis Clinical Site #101
    • Oregon
      • Portland, Oregon, United States, 97239
        • Exelixis Clinical Site #107
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Exelixis Clinical Site #12
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Exelixis Clinical Site #102
      • Myrtle Beach, South Carolina, United States, 29572
        • Exelixis Clinical Site #5
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Exelixis Clinical Site #10
      • Nashville, Tennessee, United States, 37232
        • Exelixis Clinical Site #38
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Exelixis Clinical Site #64
    • Washington
      • Seattle, Washington, United States, 98109
        • Exelixis Clinical Site #57
      • Spokane, Washington, United States, 99208
        • Exelixis Clinical Site #1
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Exelixis Clinical Site #13

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) renal cell carcinoma with a clear-cell component.
  • Intermediate- or poor-risk RCC as defined by International Metastatic RCC Database Consortium (IMDC) criteria.
  • Measurable disease per RECIST 1.1 as determined by the Investigator. Measurable disease must be outside the radiation field if radiation therapy was previously administered.
  • Karnofsky Performance Status (KPS) ≥ 70%.
  • Adequate organ and marrow function.

Exclusion Criteria:

  • Prior systemic anticancer therapy for unresectable locally advanced or metastatic RCC including investigational agents.
  • Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks prior to randomization.
  • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and stable for at least 4 weeks prior to randomization.
  • Concomitant anticoagulation with oral anticoagulants or platelet inhibitors.
  • Administration of a live, attenuated vaccine within 30 days prior to randomization.
  • Uncontrolled, significant intercurrent or recent illness including, but not limited to serious cardiovascular disorders (including uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment), GI disorders associated with high risk for perforation or fistula formation, tumors invading GI tract, bowel obstruction, intra-abdominal abscess, clinically significant bleeding events, cavitating pulmonary lesions, or lesions invading major pulmonary blood vessels.

  • Other clinically significant disorders such as:

    • Autoimmune disease that has been symptomatic or required treatment within the past two years from the date of randomization.
    • Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization.
    • Active infection requiring systemic treatment. Acute or chronic hepatitis B or C infection, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known positive test for tuberculosis infection where there is clinical or radiographic evidence of active myobacterial infection.
    • Known history of COVID-19 unless the subject has clinically recovered from the disease at least 30 days prior to randomization.
  • Major surgery (eg, nephrectomy, GI surgery, removal or biopsy of brain metastasis) within 4 weeks prior to randomization. Minor surgeries within 10 days prior to randomization. Subjects must have complete wound healing from major or minor surgery before randomization.
  • Any other active malignancy at time of randomization or diagnosis of another malignancy within 3 years prior to randomization that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Arm
Cabozantinib + nivolumab + ipilimumab (4 doses) followed by cabozantinib + nivolumab
Drug: Cabozantinib
Specified dose on specified days.
Other Names:
  • Cabometyx
  • XL184
Biological: Nivolumab
Specified dose on specified days.
Other Names:
  • BMS-936558
  • Opdivo
Biological: Ipilimumab
Specified dose on specified days.
Other Names:
  • BMS-734016
  • Yervoy
Active Comparator: Control Arm
Cabozantinib-matched placebo + nivolumab + ipilimumab (4 doses) followed by cabozantinib-matched placebo + nivolumab
Biological: Nivolumab
Specified dose on specified days.
Other Names:
  • BMS-936558
  • Opdivo
Biological: Ipilimumab
Specified dose on specified days.
Other Names:
  • BMS-734016
  • Yervoy
Drug: Cabozantinib-matched placebo
Specified dose on specified days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Duration of Progression-Free Survival (PFS) by Blinded Independent Radiology Committee (BIRC)
Time Frame: Up to 32 months
Duration of PFS was defined as the time from randomization to the earlier of either the date of radiographic progression per BIRC or the date of death due to any cause. PFS (months) = (earliest date of progression, death, censoring - date of randomization + 1)/30.4375. PFS was determined as per Response Evaluation Criteria in Solid Tumors version (RECIST) v1.1.
Up to 32 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of Overall Survival (OS)
Time Frame: Up to 58 months
Duration of OS (months) = (earliest date of death or censoring - date of randomization + 1)/30.4375.
Up to 58 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Exelixis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 25, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XL184-313
  • 2024-515616-47-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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