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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04802759




Registration number
NCT04802759
Ethics application status
Date submitted
15/03/2021
Date registered
17/03/2021
Date last updated
3/05/2024

Titles & IDs
Public title
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer
Scientific title
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Breast Cancer (MORPHEUS- BREAST CANCER)
Secondary ID [1] 0 0
2020-004889-19
Secondary ID [2] 0 0
CO42867
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Giredestrant
Treatment: Drugs - Abemaciclib
Treatment: Drugs - Ipatasertib
Treatment: Drugs - Inavolisib
Treatment: Drugs - Ribociclib
Treatment: Drugs - Everolimus
Treatment: Drugs - Samuraciclib
Treatment: Drugs - PH FDC SC
Treatment: Drugs - Palbociclib
Treatment: Drugs - Atezolizumab

Active Comparator: Cohort 1: Giredestrant Monotherapy -

Experimental: Cohort 1: Giredestrant + Abemaciclib -

Experimental: Cohort 1: Giredestrant + Ipatasertib -

Experimental: Cohort 1: Giredestrant + Inavolisib -

Experimental: Cohort 1: Giredestrant + Ribociclib -

Experimental: Cohort 1: Giredestrant + Everolimus -

Experimental: Cohort 1: Giredestrant + Samuraciclib -

Experimental: Cohort 1: Giredestrant + Atezolizumab -

Experimental: Cohort 1: Giredestrant + Abemaciclib + Atezolizumab -

Active Comparator: Cohort 2: Giredestrant + PH FDC SC -

Experimental: Cohort 2: Giredestrant + PH FDC SC + Abemaciclib -

Experimental: Cohort 2: Giredestrant + PH FDC SC + Palbociclib -


Treatment: Drugs: Giredestrant
30 milligrams (mg) orally once a day (during each 28-day cycle or 21-day cycle, depending on the regimen) until unacceptable toxicity or disease progression

Treatment: Drugs: Abemaciclib
150 mg orally twice a day (during each 28-day cycle or 21-day cycle, depending on the regimen) until unacceptable toxicity or disease progression

Treatment: Drugs: Ipatasertib
400 mg orally once a day on Days 1-21 of each 28-day cycle until unacceptable toxicity or disease progression

Treatment: Drugs: Inavolisib
9 mg orally once a day during each 28-day cycle until unacceptable toxicity or disease progression

Treatment: Drugs: Ribociclib
600 mg orally once a day on Days 1-21 of each 28-day cycle until unacceptable toxicity or disease progression

Treatment: Drugs: Everolimus
10 mg orally once a day during each 28-day cycle until unacceptable toxicity or disease progression

Treatment: Drugs: Samuraciclib
360 mg orally once a day during each 28-day cycle until unacceptable toxicity or disease progression

Treatment: Drugs: PH FDC SC
On Day 1 of Cycle 1 (1 cycle is 21 days), pertuzumab and trastuzumab fixed-dose combination for subcutaneous use (PH FDC SC) will be administered SC as a fixed dose formulation of 1200 mg pertuzumab, 600 mg trastuzumab, and 30,000 units hyaluronidase. On Day 1 of Cycles 2 and beyond, PH FDC SC will be administered SC once every 21 days as a fixed dose of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase.

Treatment: Drugs: Palbociclib
125 mg orally once a day on Days 1-21 during each 28-day cycle until unacceptable toxicity or disease progression

Treatment: Drugs: Atezolizumab
840 mg by intravenous (IV) infusion on Days 1 and 15 each 28-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with Objective Response, Defined as a Complete or Partial Response, as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
Timepoint [1] 0 0
From Baseline until disease progression (up to 6 years)
Primary outcome [2] 0 0
Number of Participants with Adverse Events, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0)
Timepoint [2] 0 0
From Baseline until 30 days after the last dose of study drug (up to 6 years)
Primary outcome [3] 0 0
Plasma Concentration of Giredestrant at Specified Timepoints
Timepoint [3] 0 0
Days 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 8, and 16 (each cycle is 28 days), and at treatment discontinuation visit (within 30 days after last dose)
Primary outcome [4] 0 0
Plasma Concentration of Abemaciclib at Specified Timepoints
Timepoint [4] 0 0
Days 1 and 15 of Cycle 1; Day 1 of Cycles 2 and 3 (each cycle is 28 days), and at treatment discontinuation visit (within 30 days after last dose)
Primary outcome [5] 0 0
Plasma Concentration of Ipatasertib at Specified Timepoints
Timepoint [5] 0 0
Days 1 and 15 of Cycle 1; Day 1 of Cycles 2 and 3 (each cycle is 28 days)
Primary outcome [6] 0 0
Plasma Concentration of Inavolisib at Specified Timepoints
Timepoint [6] 0 0
Days 1 and 15 of Cycle 1; Day 1 of Cycles 2 and 3 (each cycle is 28 days)
Primary outcome [7] 0 0
Plasma Concentration of Ribociclib at Specified Timepoints
Timepoint [7] 0 0
Days 1 and 15 of Cycle 1; Day 1 of Cycle 2 (each cycle is 28 days)
Primary outcome [8] 0 0
Blood Concentration of Everolimus at Specified Timepoints
Timepoint [8] 0 0
Days 1 and 15 of Cycle 1; Day 1 of Cycle 2 (each cycle is 28 days)
Primary outcome [9] 0 0
Plasma Concentration of Samuraciclib at Specified Timepoints
Timepoint [9] 0 0
Days 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 8, and 16 (each cycle is 28 days), and at treatment discontinuation visit (within 30 days after last dose)
Primary outcome [10] 0 0
Serum Concentration of Pertuzumab in PH FDC SC Treatment Arms at Specified Timepoints
Timepoint [10] 0 0
Day 1 of Cycles 1 and 4 (each cycle is 21 days), and at treatment discontinuation visit (within 30 days after last dose)
Primary outcome [11] 0 0
Serum Concentration of Trastuzumab in PH FDC SC Treatment Arms at Specified Timepoints
Timepoint [11] 0 0
Day 1 of Cycles 1 and 4 (each cycle is 21 days), and at treatment discontinuation visit (within 30 days after last dose)
Primary outcome [12] 0 0
Plasma Concentration of Palbociclib at Specified Timepoints
Timepoint [12] 0 0
Days 1 and 15 of Cycle 1; Day 1 of Cycles 2 and 3 (each cycle is 28 days), and at treatment discontinuation visit (within 30 days after last dose)
Primary outcome [13] 0 0
Serum Concentration of Atezolizumab at Specified Timepoints
Timepoint [13] 0 0
Days 1 of Cycles 1, 2, 3, 4, 8, 12, and 16 (each cycle is 28 days), and at treatment discontinuation visit (within 30 days after last dose)
Secondary outcome [1] 0 0
Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1
Timepoint [1] 0 0
From randomization to the date of the first recorded occurrence of disease progression or death from any cause, whichever occurs first (up to 6 years)
Secondary outcome [2] 0 0
Disease Control Rate, Defined as the Percentage of Participants with Stable Disease for =12 Weeks or a Complete or Partial Response, as Determined by the Investigator According to RECIST v1.1
Timepoint [2] 0 0
From Baseline until disease progression (up to 6 years)
Secondary outcome [3] 0 0
Clinical Benefit Rate, Defined as the Percentage of Participants with Stable Disease for =24 Weeks or with Confirmed Complete or Partial Response, as Determined by the Investigator According to RECIST v1.1
Timepoint [3] 0 0
From Baseline until disease progression (up to 6 years)
Secondary outcome [4] 0 0
Overall Survival
Timepoint [4] 0 0
From randomization to death from any cause (up to 6 years)
Secondary outcome [5] 0 0
Duration of Response, as Determined by the Investigator According to RECIST v1.1
Timepoint [5] 0 0
From first occurrence of a document objective response to the first date of recorded disease progression or death from any cause, whichever occurs first (up to 6 years)

Eligibility
Key inclusion criteria
Inclusion Criteria for Cohort 1 (Stage 1 [and Stage 2, only where indicated]):

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Documented estrogen receptor-positive (ER+) tumor

- Patients for whom endocrine therapy is recommended and treatment with cytotoxic
chemotherapy is not indicated at time of entry into the study, as per national or
local treatment guidelines

- Radiologic/objective evidence of recurrence or progression after the most recent
systemic therapy for breast cancer

- Disease progression during or after first- or second-line hormonal therapy for locally
advanced or metastatic disease (note: at least one line of therapy must have contained
a CDK4/6i administered for a minimum of 8 weeks prior to disease progression.)

- Postmenopausal status for women

- Life expectancy =3 months

- Availability of a representative tumor specimen that is suitable for biomarker
evaluation via central testing

- Prior fulvestrant therapy is allowed

- Stages 1 and 2: Measurable disease (at least one target lesion) according to RECIST
v1.1

- Stages 1 and 2: Adequate hematologic and end-organ function

- Stages 1 and 2: Stable anticoagulant regimen for patients receiving therapeutic
anticoagulation

Inclusion Criteria for Cohort 2 (Stage 1 [and Stage 2, only where indicated]):

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Histologically or cytologically confirmed and documented adenocarcinoma of the breast
with metastatic or locally advanced disease not amenable to curative resection

- ER-positive, HER2-positive breast cancer

- Postmenopausal status for women

- Life expectancy =3 months

- Willingness to have a representative tumor specimen that is suitable for biomarker
evaluation via central testing submitted, if available

- Prior endocrine therapy in the advanced setting allowed, including fulvestrant if
given more than 28 days prior to randomization, but excluding other selective estrogen
receptor degraders (SERDs)

- Stages 1 and 2: Measurable disease (at least one target lesion) according to RECIST
v1.1

- Stages 1 and 2: Baseline left ventricular ejection fraction (LVEF) =50% as measured by
ECHO or MUGA scans

- Stages 1 and 2: Adequate hematologic and end-organ function

- Stages 1 and 2: Stable anticoagulant regimen for patients receiving therapeutic
anticoagulation

Inclusion Criteria for Cohorts 1 and 2 (Stage 2):

- Ability to initiate Stage 2 treatment within 3 months after experiencing unacceptable
toxicity, disease progression as determined by the investigator according to RECIST
v1.1, or loss of clinical benefit as determined by the investigator, provided that a
Stage 2 slot is available and patient meets eligibility criteria for Stage 2

- Availability of a tumor specimen from a biopsy performed upon discontinuation of Stage
1 because of unacceptable toxicity to drugs, disease progression as determined by the
investigator according to RECIST v1.1, or loss of clinical benefit as determined by
the investigator
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
General Exclusion Criteria for all Treatment Arms in Stage 1, Cohorts 1 and 2 (unless only
applicable to one cohort, as indicated):

- Prior treatment with any of the protocol-specified study treatments

- Treatment with investigational therapy within 28 days prior to initiation of study
treatment

- Systemic treatment for breast cancer within 2 weeks of Cycle 1, Day 1 or 5 half-lives
of the drug prior to Cycle 1, Day 1

- Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug
elimination half-lives (whichever is longer) prior to randomization

- Adverse events from prior anti-cancer therapy that have not resolved to Grade =1 or
better, with the exception of alopecia of any grade and Grade =2 peripheral neuropathy

- Eligible only for the control arm

- Prior allogeneic stem cell or solid organ transplantation

- Major surgical procedure other than for diagnosis within 4 weeks prior to initiation
of study treatment or anticipation of need for a major surgical procedure during the
course of the study

- History of malignancy other than breast cancer within 2 years prior to screening, with
the exception of those with a negligible risk of metastasis or death

- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
drainage procedures

- Uncontrolled tumor-related pain

- Uncontrolled or symptomatic hypercalcemia

- Symptomatic, untreated, or actively progressing central nervous system (CNS)
metastases

- History of leptomeningeal disease

- Active tuberculosis

- Severe infection within 4 weeks prior to initiation of study treatment

- Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation
of study treatment

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest computed tomography scan

- Active cardiac disease or history of cardiac dysfunction

- Positive HIV test at screening or at any time prior to screening

- Active Hepatitis B or Hepatitis C virus infection

- Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, or major
upper gastrointestinal (GI) surgery, including gastric resection, potentially
affecting enteral absorption

- Known allergy or hypersensitivity to any of the study drugs or any of their excipients
applicable to one cohort, as indicated):

- Cohort 1 only: Known HER2-positive breast cancer

- Cohort 1 only: Concurrent hormone replacement therapy

- Cohort 1 only: Prior treatment with cytotoxic chemotherapy for metastatic breast
cancer (with the exception of single agent capecitabine, which will count as a single
line of therapy)

- Cohort 2 only: Dyspnea at rest due to complications of advanced malignancy, or other
disease requiring continuous oxygen therapy

- Cohort 2 only: Current chronic daily treatment (continuous for >3 months) with
corticosteroids (dose of 10 mg/day methylprednisolone equivalent), excluding inhaled
steroids

Additional Exclusion Criteria for Giredestrant + Abemaciclib Arm and Giredestrant +
Abemaciclib + Atezolizumab Arm (Cohort 1, Stage 1):

- Interstitial lung disease or severe dyspnea at rest or requiring oxygen therapy

- History of major surgical resection involving the stomach or small bowel, or a
preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea

- History of syncope of cardiovascular etiology, ventricular arrhythmia, or sudden
cardiac arrest

Additional Exclusion Criteria for Giredestrant + Ipatasertib Arm (Cohort 1, Stage 1):

- Prior treatment with an Akt inhibitor

- Inability to swallow medication or malabsorption condition that would alter the
absorption of orally administered medications

- Grade =2 uncontrolled or untreated hypercholesterolemia or hypertriglyceremia

- History of Type 1 or Type 2 diabetes mellitus requiring insulin

- History or presence of an abnormal electrocardiogram (ECG) that is clinically
significant in the investigator's opinion

Additional Exclusion Criteria for Giredestrant + Inavolisib Arm (Cohort 1, Stage 1):

- Prior treatment with any PI3K, Akt, or mTOR inhibitor, or any agent whose mechanism of
action is to inhibit the PI3K/Akt/mTOR pathway

- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or
any history of Type 1 diabetes

- Fasting glucose =126 mg/dL or =7.0 mmol/L and HbA1c =5.7%

- Any concurrent ocular or intraocular condition that, in the opinion of the
investigator, would require medical or surgical intervention during the study period
to prevent or treat vision loss that might result from that condition

- Active inflammatory or infectious conditions in either eye or history of idiopathic or
autoimmune-associated uveitis in either eye

- Symptomatic active lung disease, including pneumonitis

- Inability to confirm biomarker eligibility based on valid results from either central
testing of blood or local testing of blood or tumor tissue that documents one of the
protocol-defined PIK3CA mutations

Additional Exclusion Criteria for Giredestrant + Ribociclib Arm (Cohort 1, Stage 1):

- Currently receiving or has received systemic corticosteroids =2 weeks prior to
starting trial treatment

- Impairment of GI function or GI disease that may significantly alter the absorption of
the oral trial treatments

Additional Exclusion Criteria for Giredestrant + Samuraciclib Arm (Cohort 1, Stage 1):

- Prior treatment with mTOR inhibitor

- Receipt of systemic corticosteroids (at a dose >10 mg prednisone/day or equivalent)
within 14 days before the first dose of samuraciclib

- Active bleeding diatheses

- History of hemolytic anemia or marrow aplasia

- Receipt of a live-virus vaccination within 28 days or less of planned treatment start

Additional Exclusion Criteria for Giredestrant + Atezolizumab-Containing Arms (Cohort 1,
Stage 1):

- Active or history of autoimmune disease or immune deficiency

- Significant cardiovascular disease (such as New York Heart Association Class II or
greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3
months prior to initiation of study treatment, unstable arrhythmia, or unstable angina

- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study
treatment, or anticipation of need for such a vaccine during atezolizumab treatment or
within 5 months after the final dose of atezolizumab

- Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination
half-lives (whichever is longer) prior to initiation of study treatment

- Treatment with systemic immunosuppressive medication within 2 weeks prior to
initiation of study treatment, or anticipation of need for systemic immunosuppressive
medication during study treatment

- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies
or fusion proteins

- Known hypersensitivity to Chinese hamster ovary cell products or recombinant human
antibodies

- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including
anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies

- Pregnant or breastfeeding, or intending to become pregnant during study treatment or
within 5 months for atezolizumab

Additional Exclusion Criteria for Giredestrant + PH FDC SC + Abemaciclib Arm (Cohort 2,
Stage 1):

- Interstitial lung disease or severe dyspnea

- History of major surgical resection involving the stomach or small bowel, preexisting
chronic condition resulting in baseline Grade 2 or higher diarrhea, or a condition
that may significantly alter the absorption of the oral trial treatments

- History of syncope of cardiovascular etiology, ventricular arrhythmia, or sudden
cardiac arrest

Additional Exclusion Criteria for Giredestrant + PH FDC SC + Palbociclib Arm (Cohort 2,
Stage 1):

- History of major surgical resection involving the stomach or small bowel, preexisting
chronic condition resulting in baseline Grade 2 or higher diarrhea, or a condition
that may significantly alter the absorption of the oral trial treatments

- Interstitial lung disease or severe dyspnea

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2026
Actual
Sample size
Target
510
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Peninsula Health-Frankston Hospital - Frankston
Recruitment hospital [3] 0 0
Peter Maccallum Cancer Centre - Melbourne
Recruitment hospital [4] 0 0
Linear Clinical Research Limited - Nedlands
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
Israel
State/province [7] 0 0
Jerusalem
Country [8] 0 0
Israel
State/province [8] 0 0
Petach Tikva
Country [9] 0 0
Israel
State/province [9] 0 0
Ramat Gan
Country [10] 0 0
Israel
State/province [10] 0 0
Tel Aviv
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Goyang-si
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Seoul
Country [13] 0 0
Spain
State/province [13] 0 0
Barcelona
Country [14] 0 0
Spain
State/province [14] 0 0
Madrid
Country [15] 0 0
Spain
State/province [15] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants
with breast cancer. Cohort 1 will focus on participants with inoperable, locally advanced or
metastatic, estrogen receptor (ER)-positive, HER2-negative breast cancer who had disease
progression during or following treatment with a cyclin-dependent kinase 4/6 inhibitor
(CDK4/6i; e.g., palbociclib, ribociclib, abemaciclib) in the first- or second-line setting.
Cohort 2 will focus on inoperable, locally advanced or metastatic, ER-positive, HER2-positive
breast cancer with previous progression to standard-of-care anti-HER2 therapies, of which one
was a trastuzumab-and-taxane-based systemic therapy (including in the early setting if
recurrence occurred within 6 months of finishing adjuvant therapy) and one was a
HER2-targeting antibody-drug conjugate (ADC; e.g., ado-trastuzumab emtansine or
trastuzumab-deruxtecan) or a HER2-targeting tyrosine kinase inhibitor (TKI; e.g., tucatinib,
lapatinib, pyrotinib or neratinib). The study is designed with the flexibility to open new
treatment arms as new treatments become available, close existing treatment arms that
demonstrate minimal clinical activity or unacceptable toxicity, or modify the patient
population. During Stage 1, participants in each cohort will be randomly assigned to
treatment arms. Participants in the control or experimental arms who experience unacceptable
toxicity, disease progression as determined by the investigator according to RECIST v1.1, or
loss of clinical benefit as determined by the investigator during Stage 1 will be given the
option of receiving a different treatment combination during Stage 2, provided they meet
eligibility criteria and a treatment arm is open for enrollment. No Stage 2 treatment is
currently available.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04802759
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: CO42867 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. Only)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04802759