TerminatedNCT05170009Updated Feb 26, 2025Results posted

Baloxavir in Combination With Oseltamivir in Allogenic Bone Marrow Transplant Recipients With Influenza

A Phase 2/3 interventional study of Baloxavir Marboxil and Placebo in Influenza, sponsored by Weill Medical College of Cornell University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-26.

Sponsored by Weill Medical College of Cornell University · Phase 2/3, Interventional, and Treatment

Why this study was terminated

Slow enrollment rate

Phase: Phase 2/3
Study type: Interventional
Enrollment: 2
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

This is a randomized, double-blind, placebo-controlled pilot study of the efficacy and safety of baloxavir in combination with oseltamivir (standard of care) for the treatment of influenza in allogeneic stem cell transplant patients. Although there are no data about this treatment option currently available, the investigator hypothesizes that combination therapy may be more effective in clearing influenza virus infection and decreasing the rate of emergence of resistant influenza in immunocompromised human hosts.

Read the detailed description

This is a randomized double-blind placebo-controlled pilot study of the efficacy and safety of baloxavir in combination with oseltamivir (standard of care) for the treatment of influenza in allogeneic stem cell transplant patients. 30 SCT recipients will take part in the study. Participants with be randomly assigned (1:1) to either baloxavir + oseltamivir or baloxavir-matched placebo +oseltamivir. Before randomization, patients will be stratified by hospitalization status and influenza type A (yes/no).

Patients in the baloxavir combination arm will receive weight-adjusted baloxavir (40 mg for patients weighing \<80 kg and 80 mg for those weighing ≥80 kg) at baseline and at day 4 and day 7. They will also receive oseltamivir 75 mg twice daily for 10 days. Patients in the baloxavir-matched placebo + oseltamivir arm will receive baloxavir-matched placebo at baseline and at day 3 and day 7and oseltamivir 75 mg twice daily for 10 days.

Conditions studied

Influenza

Browse trials for

Influenza, Human 2,264

Keywords

Influenza
Bone marrow transplant
Flu
Baloxavir Marboxil
Xofluza
Oseltamivir

In context

Influenza, Human

2,264 studies on the registry are indexed under Influenza, Human; 173 are open to participants now.

This study's enrollment of 2 is below the median of 240 across 1,894 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 890 studies on the registry; 164 are open to participants now.

Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.

Browse Weill Medical College of Cornell University studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Adult patients: Signed informed consent by any patient capable of giving consent, or, where the patient is not capable of giving consent, by his or her legal/authorized representative
Age greater than or equal to 18 years at the time of signing the Informed Consent Form/Assent Form
Ability to comply with the study protocol, in the investigator's judgment
Have received allogeneic bone marrow transplant
Tested positive for influenza infection after the onset of symptoms using a polymerase chain reaction (PCR)-based diagnostic assay.
Presence of (a) fever (≥38.0 °C per tympanic or rectal thermometer; ≥ 37.5 °C per axillary, oral or forehead/temporal thermometer) or (b) any influenza symptoms (cough, sore throat, nasal congestion, headache, feverishness or chills, muscle or joint pain, fatigue).
The time interval between the diagnosis of influenza and the pre-dose examinations is 48 hours or less.
For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse):
Women must remain abstinent or use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for 28 days after the last dose of study treatment. Hormonal contraceptive methods must be supplemented by a barrier method. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state greater than or equal to 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.

Exclusion criteria

Exclusion Criteria:

Patients who have received more than 48 hours of antiviral treatment for the current influenza infection prior to screening
Patients who have received Baloxavir for the current influenza infection
Known contraindication to neuraminidase inhibitors
Patients weighing \< 40 kg
Patients unable to swallow tablets
Patients with known severe renal impairment (estimated glomerular filtration rate \< 30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis
Patients with any of the following laboratory abnormalities detected within 24 hours prior to or during screening (according to local laboratory reference ranges: ALT or AST level > 5 times the upper limit of normal (ULN) OR ALT or AST > 3 times the ULN and total bilirubin level > 2 times the ULN
Pregnant or breastfeeding, or positive pregnancy test in a predose examination, or intending to become pregnant during the study or within 28 days after the last dose of study treatment
Exposure to an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization
Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
Known hypersensitivity to baloxavir marboxil or the drug product excipients
Known COVID-19 coinfection
Unwilling to undergo nasopharyngeal (NP) swabs as per study schedule

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 2 participants (actual)

Study arms

Active comparator
Active and standard of care
Active Baloxavir Marboxil and standard of care Oseltamivir
Drug: Baloxavir Marboxil · Drug: Oseltamivir
Placebo comparator
Placebo and standard of care
Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir
Drug: Placebo · Drug: Oseltamivir

Interventions

DrugBaloxavir Marboxil
Weight-adjusted Baloxavir Marboxil (40 mg for patients weighing \<80 kg and 80 mg for those weighing ≥80 kg) at baseline, day 4, and day 7.
Also known as: Xofluza
DrugPlacebo
Placebo at baseline, day 4, and day 7.
DrugOseltamivir
Oseltamivir 75 mg twice daily for 10 days.
Also known as: Tamiflu

What researchers measure

Primary outcomes

Change of Influenza Viral RNA Loads From Baseline at the End of Treatment as Measured by Quantitative Real Time Polymerase Chain Reaction.
Influenza viral RNA loads will be measured by quantitative real time polymerase chain reaction.
Time frame: Baseline; Day 10
Between-treatment-arm Difference in the Change of Influenza Viral RNA Loads From Baseline at the End of Treatment as Measured by Quantitative Real Time Polymerase Chain Reaction.
Influenza viral load will be measured by the quantitative real time polymerase chain reaction.
Time frame: Baseline; Day 10
Between-treatment-arm Difference in the Change of Influenza Viral RNA Loads From Baseline at the End of Treatment as Measured by Influenza Plaque Assay (Replicating Virus).
Influenza viral load will be measured by the influenza plaque assay.
Time frame: Baseline; Day 10

Secondary outcomes

Change of Influenza Viral RNA Load From Baseline at Day 4 and Day 7 and 10 in Each Treatment Arm
Influenza viral RNA load will be measured by quantitative real time polymerase chain reaction.
Time frame: Baseline; Day 4; Day 7; Day 10
Difference in Change of Influenza Viral Loads From Baseline at Day 4, 7 and 10 Between the Two Treatment Arms as Measured by Quantitative Real Time Polymerase Chain Reaction
Influenza viral RNA load will be measured by quantitative real time polymerase chain reaction.
Time frame: Baseline; Day 4; Day 7; Day 10
Change of Influenza Viral Loads From Baseline at Day 4, 7 and 10 as Measured by Influenza Plaque Assay (Replicating Virus) in Each Treatment Arm
Influenza viral load will be measured by the influenza plaque assay (replicating virus).
Time frame: Baseline; Day 4; Day 7; Day 10
Difference in Change of Influenza Viral Loads From Baseline at Day 4, 7 and 10 Between the Two Treatment Arms as Measured by Influenza Plaque Assay (Replicating Virus)
Influenza viral load will be measured by the influenza plaque assay (replicating virus).
Time frame: Baseline; Day 4; Day 7; Day 10
Time to Improvement of Individual Influenza Symptoms as Assessed by Patient-reported Outcome Measures on a Single Scale
Patients will self-assess the severity of 7 influenza-associated symptoms on a 4-point single scale with 0 indicating no symptoms and higher scores indicating mild, moderate, and severe symptoms. Time to improvement of individual influenza symptoms are defined as the time from the start of treatment to the time when each of the influenza symptoms are alleviated, maintained, or improved for a duration of at least 21.5 hours. These are defined as: pre-existing symptoms (cough, fatigue, or muscle/join pain that existed prior to influenza) that were worse at baseline and had improved at least 1 point from baseline; pre-existing symptoms not worse at baseline that maintained baseline severity; and new symptoms that were alleviated, defined as a symptom score of non (0) or mild (1).
Time frame: Baseline to Day 30
Percentage of Patients Who Experience Each Influenza-related Complications: Hospitalization, Death, Sinusitis, Otitis Media, Bronchitis, and Radiologically-confirmed Pneumonia as an Adverse Event After the Initiation of Study Treatment
A composite score of multiple measures will be used and calculated by count of patients who experience each influenza-related complications. Adverse events will only include those that are determined to be related to the study drug.
Time frame: Day 1 to Day 30
Time to Return to Preinfluenza Health Status
Preinfluenza health status will be measured on a score from 0 (worst possible health) to 10 (normal health \[for someone your age and condition\]).
Time frame: Day 1 to Day 30
Time to Viral Clearance, as Assessed by Difference in Percentage of Participants Positive by Influenza Plaque Assay at Each Time-point (in Each Treatment Group)
Time to viral clearance will be assessed by percentage of participants positive by influenza plaque assay at each time-point.
Time frame: Baseline to Day 30
Time to Viral Clearance, as Assessed by Difference in Percentage of Participants Positive by Quantitative Real Time Polymerase Chain Reaction
Time to viral clearance will be assessed by percentage of participants positive by qPCR at each time-point.
Time frame: Baseline to Day 30
Change of Treatment-emergent Variants of Neuraminidase and Polymerase Known to Confer Antiviral Resistance to Oseltamivir in Each Arm by Direct Next-generation Sequencing Symptoms
Treatment-emergent variants will be identified using direct next-generation sequencing of a comprehensive panel of genes.
Time frame: Baseline to Day 30
Percentage of Participants With Adverse Events (AEs)
Adverse events will only include those that are determined to be related to the study drug and will assess the safety and tolerability of Baloxavir in Combination with SOC treatment.
Time frame: Day 1 to Day 15

Results

Posted Feb 26, 2025

Limitations and caveats

Due to change in patterns of respiratory viruses, and low or no flu circulating, we were unable to enroll the target number of participants. The only participants enrolled were the 2 in the placebo arm, 1 of whom withdrew early on. No comparison is possible with only 1 placebo participant.

Participant flow

Recruitment for this study was challenging because of changed flu seasonality and low flu cases following covid-19

Participant flow — Overall Study
Milestone	Active and Standard of Care	Placebo and Standard of Care
Started	0	2
Completed	0	1
Not completed	0	1
Withdrew: Physician decision	0	1

Outcome measures

PrimaryChange of Influenza Viral RNA Loads From Baseline at the End of Treatment as Measured by Quantitative Real Time Polymerase Chain Reaction.

Influenza viral RNA loads will be measured by quantitative real time polymerase chain reaction.

Time frame:: Baseline; Day 10
Reported as:: Number · copies per mL

Change of Influenza Viral RNA Loads From Baseline at the End of Treatment as Measured by Quantitative Real Time Polymerase Chain Reaction.
copies per mL	Active and Standard of Care	Placebo and Standard of Care
Baseline	—	2300000
Day 10	—	0

PrimaryBetween-treatment-arm Difference in the Change of Influenza Viral RNA Loads From Baseline at the End of Treatment as Measured by Quantitative Real Time Polymerase Chain Reaction.

Influenza viral load will be measured by the quantitative real time polymerase chain reaction.

Time frame:: Baseline; Day 10
Reported as:: Number · copies per mL

Between-treatment-arm Difference in the Change of Influenza Viral RNA Loads From Baseline at the End of Treatment as Measured by Quantitative Real Time Polymerase Chain Reaction.
copies per mL	Active and Standard of Care	Placebo and Standard of Care
Baseline	—	2300000
Day 10	—	0

PrimaryBetween-treatment-arm Difference in the Change of Influenza Viral RNA Loads From Baseline at the End of Treatment as Measured by Influenza Plaque Assay (Replicating Virus).

Influenza viral load will be measured by the influenza plaque assay.

Time frame:: Baseline; Day 10
Reported as:: Number · PFU per mL

Between-treatment-arm Difference in the Change of Influenza Viral RNA Loads From Baseline at the End of Treatment as Measured by Influenza Plaque Assay (Replicating Virus).
PFU per mL	Active and Standard of Care	Placebo and Standard of Care
Baseline	—	2300000
Day 10	—	0

SecondaryChange of Influenza Viral RNA Load From Baseline at Day 4 and Day 7 and 10 in Each Treatment Arm

Influenza viral RNA load will be measured by quantitative real time polymerase chain reaction.

Time frame:: Baseline; Day 4; Day 7; Day 10
Reported as:: Number · copies per mL

Change of Influenza Viral RNA Load From Baseline at Day 4 and Day 7 and 10 in Each Treatment Arm
copies per mL	Active and Standard of Care	Placebo and Standard of Care
Baseline	—	2300000
Day 4	—	800
Day 7	—	1300
Day 10	—	0

SecondaryDifference in Change of Influenza Viral Loads From Baseline at Day 4, 7 and 10 Between the Two Treatment Arms as Measured by Quantitative Real Time Polymerase Chain Reaction

Influenza viral RNA load will be measured by quantitative real time polymerase chain reaction.

Time frame:: Baseline; Day 4; Day 7; Day 10
Reported as:: Number · copies per mL

Difference in Change of Influenza Viral Loads From Baseline at Day 4, 7 and 10 Between the Two Treatment Arms as Measured by Quantitative Real Time Polymerase Chain Reaction
copies per mL	Active and Standard of Care	Placebo and Standard of Care
Baseline	—	2300000
Day 4	—	800
Day 7	—	1300
Day 10	—	0

SecondaryChange of Influenza Viral Loads From Baseline at Day 4, 7 and 10 as Measured by Influenza Plaque Assay (Replicating Virus) in Each Treatment Arm

Influenza viral load will be measured by the influenza plaque assay (replicating virus).

Time frame:: Baseline; Day 4; Day 7; Day 10
Reported as:: Number · PFU per mL

Change of Influenza Viral Loads From Baseline at Day 4, 7 and 10 as Measured by Influenza Plaque Assay (Replicating Virus) in Each Treatment Arm
PFU per mL	Active and Standard of Care	Placebo and Standard of Care
Baseline	—	2300000
Day 4	—	800
Day 7	—	1300
Day 10	—	0

SecondaryDifference in Change of Influenza Viral Loads From Baseline at Day 4, 7 and 10 Between the Two Treatment Arms as Measured by Influenza Plaque Assay (Replicating Virus)

Influenza viral load will be measured by the influenza plaque assay (replicating virus).

Time frame:: Baseline; Day 4; Day 7; Day 10
Reported as:: Number · PFU per mL

Difference in Change of Influenza Viral Loads From Baseline at Day 4, 7 and 10 Between the Two Treatment Arms as Measured by Influenza Plaque Assay (Replicating Virus)
PFU per mL	Active and Standard of Care	Placebo and Standard of Care
Baseline	—	2300000
Day 4	—	800
Day 7	—	1300
Day 10	—	0

SecondaryTime to Improvement of Individual Influenza Symptoms as Assessed by Patient-reported Outcome Measures on a Single Scale

Patients will self-assess the severity of 7 influenza-associated symptoms on a 4-point single scale with 0 indicating no symptoms and higher scores indicating mild, moderate, and severe symptoms. Time to improvement of individual influenza symptoms are defined as the time from the start of treatment to the time when each of the influenza symptoms are alleviated, maintained, or improved for a duration of at least 21.5 hours. These are defined as: pre-existing symptoms (cough, fatigue, or muscle/join pain that existed prior to influenza) that were worse at baseline and had improved at least 1 point from baseline; pre-existing symptoms not worse at baseline that maintained baseline severity; and new symptoms that were alleviated, defined as a symptom score of non (0) or mild (1).

Time frame:: Baseline to Day 30
Reported as:: Number · Days to recovery

Time to Improvement of Individual Influenza Symptoms as Assessed by Patient-reported Outcome Measures on a Single Scale
Days to recovery	Active and Standard of Care	Placebo and Standard of Care
Time to Improvement of Individual Influenza Symptoms as Assessed by Patient-reported Outcome Measures on a Single Scale	—	8

SecondaryPercentage of Patients Who Experience Each Influenza-related Complications: Hospitalization, Death, Sinusitis, Otitis Media, Bronchitis, and Radiologically-confirmed Pneumonia as an Adverse Event After the Initiation of Study Treatment

A composite score of multiple measures will be used and calculated by count of patients who experience each influenza-related complications. Adverse events will only include those that are determined to be related to the study drug.

Time frame:: Day 1 to Day 30
Reported as:: Number · Number of patients with complications.

Percentage of Patients Who Experience Each Influenza-related Complications: Hospitalization, Death, Sinusitis, Otitis Media, Bronchitis, and Radiologically-confirmed Pneumonia as an Adverse Event After the Initiation of Study Treatment
Number of patients with complications.	Active and Standard of Care	Placebo and Standard of Care
Percentage of Patients Who Experience Each Influenza-related Complications: Hospitalization, Death, Sinusitis, Otitis Media, Bronchitis, and Radiologically-confirmed Pneumonia as an Adverse Event After the Initiation of Study Treatment	—	0

SecondaryTime to Return to Preinfluenza Health Status

Preinfluenza health status will be measured on a score from 0 (worst possible health) to 10 (normal health \[for someone your age and condition\]).

Time frame:: Day 1 to Day 30
Reported as:: Number · Days

Time to Return to Preinfluenza Health Status
Days	Active and Standard of Care	Placebo and Standard of Care
Time to Return to Preinfluenza Health Status	—	8

SecondaryTime to Viral Clearance, as Assessed by Difference in Percentage of Participants Positive by Influenza Plaque Assay at Each Time-point (in Each Treatment Group)

Time to viral clearance will be assessed by percentage of participants positive by influenza plaque assay at each time-point.

Time frame:: Baseline to Day 30
Reported as:: Number · Days

Time to Viral Clearance, as Assessed by Difference in Percentage of Participants Positive by Influenza Plaque Assay at Each Time-point (in Each Treatment Group)
Days	Active and Standard of Care	Placebo and Standard of Care
Time to Viral Clearance, as Assessed by Difference in Percentage of Participants Positive by Influenza Plaque Assay at Each Time-point (in Each Treatment Group)	—	8

SecondaryTime to Viral Clearance, as Assessed by Difference in Percentage of Participants Positive by Quantitative Real Time Polymerase Chain Reaction

Time to viral clearance will be assessed by percentage of participants positive by qPCR at each time-point.

Time frame:: Baseline to Day 30
Reported as:: Number · Days

Time to Viral Clearance, as Assessed by Difference in Percentage of Participants Positive by Quantitative Real Time Polymerase Chain Reaction
Days	Active and Standard of Care	Placebo and Standard of Care
Time to Viral Clearance, as Assessed by Difference in Percentage of Participants Positive by Quantitative Real Time Polymerase Chain Reaction	—	8

SecondaryChange of Treatment-emergent Variants of Neuraminidase and Polymerase Known to Confer Antiviral Resistance to Oseltamivir in Each Arm by Direct Next-generation Sequencing Symptoms

Treatment-emergent variants will be identified using direct next-generation sequencing of a comprehensive panel of genes.

Time frame:: Baseline to Day 30
Reported as:: Number · Resistant variant

Change of Treatment-emergent Variants of Neuraminidase and Polymerase Known to Confer Antiviral Resistance to Oseltamivir in Each Arm by Direct Next-generation Sequencing Symptoms
Resistant variant	Active and Standard of Care	Placebo and Standard of Care
Change of Treatment-emergent Variants of Neuraminidase and Polymerase Known to Confer Antiviral Resistance to Oseltamivir in Each Arm by Direct Next-generation Sequencing Symptoms	—	0

SecondaryPercentage of Participants With Adverse Events (AEs)

Adverse events will only include those that are determined to be related to the study drug and will assess the safety and tolerability of Baloxavir in Combination with SOC treatment.

Time frame:: Day 1 to Day 15
Reported as:: Count of participants · Participants

Percentage of Participants With Adverse Events (AEs)
Participants	Active and Standard of Care	Placebo and Standard of Care
Percentage of Participants With Adverse Events (AEs)	—	1

Adverse events

Collected over 1 month. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Active and Standard of Care	—	—	—
Placebo and Standard of Care	1/2 (50%)	1/2 (50%)	1/2 (50%)

Most frequent serious events

Most frequent serious events
Event	Active and Standard of Care	Placebo and Standard of Care
renal insufficiencyRenal and urinary disorders	—	1/2

Most frequent other events

Most frequent other events
Event	Active and Standard of Care	Placebo and Standard of Care
alopeciaSkin and subcutaneous tissue disorders	—	1/2

Baseline characteristics

Participants were not analyzed in the Active and Standard of Care arm because 0 participants were enrolled in that arm.

Age, Continuous
Age, Continuous(years)	Active and Standard of Care	Placebo and Standard of Care	Total
Mean	—	45 ± 30	45 ± 30

Sex: Female, Male
Sex: Female, Male(Participants)	Active and Standard of Care	Placebo and Standard of Care	Total
Female	0	1	1
Male	0	1	1

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Active and Standard of Care	Placebo and Standard of Care	Total
Hispanic or Latino	—	1	1
Not Hispanic or Latino	—	1	1
Unknown or Not Reported	—	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Active and Standard of Care	Placebo and Standard of Care	Total
American Indian or Alaska Native	—	0	0
Asian	—	0	0
Native Hawaiian or Other Pacific Islander	—	0	0
Black or African American	—	1	1
White	—	1	1
More than one race	—	0	0
Unknown or Not Reported	—	0	0

Study locations

1 site

Weill Cornell Medicine
New York, New York 10065, United States

References and documents

Publications

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Marty FM, Vidal-Puigserver J, Clark C, Gupta SK, Merino E, Garot D, Chapman MJ, Jacobs F, Rodriguez-Noriega E, Husa P, Shortino D, Watson HA, Yates PJ, Peppercorn AF. Intravenous zanamivir or oral oseltamivir for hospitalised patients with influenza: an international, randomised, double-blind, double-dummy, phase 3 trial. Lancet Respir Med. 2017 Feb;5(2):135-146. doi: 10.1016/S2213-2600(16)30435-0. Epub 2017 Jan 14. PubMed 28094141 ↗
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Study documents

Protocol and statistical analysis plan · Oct 5, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2022 to primary completion in Jan 2024, 20 months.

Results were first posted in Feb 2025, 1 year 1 month after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Dec 9, 2021
First posted: Dec 27, 2021
StartActual: Apr 22, 2022
Primary completionActual: Jan 17, 2024
CompletionActual: Feb 7, 2024
Results first posted: Feb 26, 2025
Last update: Feb 26, 2025

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Feb 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05170009
Lead sponsor: Weill Medical College of Cornell University
Collaborators: Genentech, Inc.
Responsible party: Sponsor
First posted: Dec 27, 2021
Start date: Apr 22, 2022
Primary completion: Jan 17, 2024
Completion: Feb 7, 2024
Results posted: Feb 26, 2025
Last update: Feb 26, 2025

Study contacts

Mirella Salvatore, MD

principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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