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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04589845




Registration number
NCT04589845
Ethics application status
Date submitted
11/10/2020
Date registered
19/10/2020

Titles & IDs
Public title
Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study
Scientific title
Tumor-Agnostic Precision Immunooncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial
Secondary ID [1] 0 0
2020-001847-16
Secondary ID [2] 0 0
BO41932
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Entrectinib
Treatment: Drugs - Entrectinib
Treatment: Drugs - Alectinib
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Ipatasertib
Treatment: Drugs - Trastuzumab emtansine
Treatment: Drugs - Idasanutlin
Treatment: Drugs - Inavolisib
Treatment: Drugs - Belvarafenib
Treatment: Drugs - Pralsetinib
Treatment: Drugs - GDC-6036
Treatment: Drugs - Camonsertib

Experimental: Cohort A: ROS1 Fusion-positive tumors (excluding NSCLC) - Participants with metastatic or advanced solid tumors, with the exception of NSCLC will receive entrectinib once daily in repeated 28-day cycles at a dose of 600 milligram per day (mg/day) for adults and pediatric participants with a body surface area (BSA) \>/= 1.51 squaremeter (m2). The total dose of daily entrectinib administration for pediatric participants with BSA\<1.51 m2 will be lower.

Experimental: Cohort B: NTRK1/2/3 fusion-positive tumors - Participants with metastatic or advanced solid tumors will receive entrectinib once daily in repeated 28-day cycles at a dose of 600 mg/day for adults and pediatric participants with a BSA \>/= 1.51 m2. The total dose of daily entrectinib administration for pediatric participants with BSA\<1.51 m2 will be lower.

Experimental: Cohort C: ALK fusion-positive tumors (excluding NSCLC) - Participants with metastatic or advanced solid tumors, with the exception of NSCLC, will receive alectinib at a dosage of 600 mg orally twice a day (BID), taken with food, in repeated 28-day cycles.

Experimental: Cohort D: TMB-high tumors - Participants with metastatic or advanced solid tumors will receive atezolizumab intravenously (IV) at a fixed dose for participants aged \>/= 18 years, and 15 mg/kg (maximum 1200 mg) for participants aged \< 18 years on Day 1 of each 21-day cycle.

Note: Cohort D has been closed for enrollment

Experimental: Cohort E: AKT1/2/3 mutant-positive tumors - Participants with metastatic or advanced solid tumors will receive ipatasertib orally once daily (QD) at the starting dose of 400 mg in repeated 28-day cycles until the participant experiences disease progression, intolerable toxicity, or withdraws consent. For participants 12-17 years of age, ipatasertib will be administered at the starting dose of 200 mg for participants \<35 kg, 300 mg for participants \>/= 35 and \<45 kg, 400 mg for those \>/=45 kg orally QD in repeated 28-day cycles until the participant experiences disease progression, intolerable toxicity, or withdraws consent.

Note: Cohort E has been closed for enrollment

Experimental: Cohort F: HER2 mutant-positive tumors - Participants with metastatic or advanced solid tumors will receive trastuzumab emtansine IV at a dose of 3.6 mg/kg every 21 days.

Note: Cohort F has been closed for enrollment

Experimental: Cohort G: MDM2-amplified, TP53 wild-type tumors - Participants with metastatic or advanced solid tumors will receive idasanutlin at a dose of 250 mg orally QD on Days 1-5 of each 28-day cycle.

Note: Cohort G has been closed for enrollment

Experimental: Cohort H: PIK3CA multiple mutant-positive tumors - Participants with metastatic or advanced solid tumors will receive GDC-0077 QD at a starting dose of 9 mg by mouth (PO) in repeated 28-day cycles.

Note: Cohort H has been closed for enrollment

Experimental: Cohort I: BRAF class II mutant or fusion-positive tumors - Participants with BRAF class II mutant/fusion-positive tumors (adults and adolescents = 40 kg) will receive 400 mg belvarafenib by mouth (PO) BID (twice a day) with adequate water (more than 200 mL). One cycle consists of 28 days. Administration of belvarafenib should occur BID on every day of each 28-day cycle.

Note: Cohort I has been closed for enrollment

Experimental: Cohort J: BRAF class III mutant-positive tumors - Participants with BRAF class III mutant-positive tumors(adults and adolescents = 40 kg) will receive 400 mg belvarafenib by mouth (PO) BID (twice a day) with adequate water (more than 200 mL). One cycle consists of 28 days. Administration of belvarafenib should occur BID on every day of each 28-day cycle.

Note: Cohort J has been closed for enrollment

Experimental: Cohort K: RET fusion-positive tumors (excluding NSCLC) - Participants with RET fusion-positive tumors will self-administer Pralsetinib orally at home (except on clinic days) on a continuous daily dosing regimen at a dose of 400 mg/day (four 100-mg capsules per day) for adult and pediatric patients = 12 and \< 18 years of age. A treatment cycle consists of 4 weeks (28 days).

Note: Cohort K has been closed for enrollment

Experimental: Cohort L: KRAS G12C-positive tumors (excluding NSCLC and CRC) - Participants with KRAS G12C-positive tumors will self-administer GDC-6036 orally at home (except on clinic days).

Experimental: Cohort M: ATM Loss of Function tumors - Participants with ATM Loss of Function tumors will self-administer Camonsertib orally at home (except on clinic days).

Experimental: Cohort N: SETD2 Loss of Function tumors - Participants with SETD2 Loss of Function tumors will self-administer Camonsertib orally at home (except on clinic days).


Treatment: Drugs: Entrectinib
Adults and pediatric participants with a BSA \>/= 1.51 m2: entrectinib will be self-administered by participants orally at home at a dose of 600 mg/day (three 200-mg capsules per day). Pediatric participants with a BSA \< 1.51 m2: entrectinib will be administered orally at home in mini-tablet formulation at a dose of 400 mg/day (BSA=1.11-1.50 m2) or 300 mg/day (BSA=0.81-1.10 m2) or 200 mg/day (BSA=0.51-0.80 m2) or 100 mg/day (BSA=0.43-0.50 m2).

Treatment: Drugs: Entrectinib
Adults and pediatric participants with a BSA \>/= 1.51 m2: entrectinib will be self-administered by participants orally at home at a dose of 600 mg/day (three 200-mg capsules per day). Pediatric participants with a BSA \< 1.51 m2: entrectinib will be administered orally at home in mini-tablet formulation at a dose of 400 mg/day (BSA=1.11-1.50 m2) or 300 mg/day (BSA=0.81-1.10 m2) or 200 mg/day (BSA=0.51-0.80 m2) or 100 mg/day (BSA=0.43-0.50 m2).

Treatment: Drugs: Alectinib
Alectinib will be administered orally BID (twice a day) with food at a dosage of 600 mg (four 150-mg capsules).

Treatment: Drugs: Atezolizumab
Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg for participants aged \>/=18 years, and 15 mg/kg (maximum 1200 mg) for participants aged \<18 years on Day 1 of each 21-day cycle.

Treatment: Drugs: Ipatasertib
For participants 12-17 years of age, ipatasertib will be administered at the starting dose of 200 mg for participants \< 35 kg, 300 mg for participants \>/= 35 and \< 45 kg, 400 mg for those \>/= 45 kg orally QD, beginning of Cycle 1, on Days 1-21 of each 28-day cycle until the participant experiences disease progression, intolerable toxicity, or withdraws consent.

Treatment: Drugs: Trastuzumab emtansine
Trastuzumab emtansine will be administered at 3.6 mg/kg by IV infusion every 21 days until disease progression or unacceptable toxicity. The dosage and administration method also applies for pediatric participants 12-17 years of age.

Treatment: Drugs: Idasanutlin
Idasanutlin will be administered at 250 mg QD (daily) PO for Days 1-5 of each 28-day cycle. Idasanutlin may be given without regard to meals and water can be given as often as necessary or desired. The daily doses should be administered 10-14 hours apart.

Note: Cohort G has been closed for enrollment.

Treatment: Drugs: Inavolisib
GDC-077 will be administered QD at a starting dose of 9 mg PO in repeated 28-day cycles. The dosage and administration method also applies for pediatric participants 12-17 years of age.

Treatment: Drugs: Belvarafenib
Belvarafenib will be administered at a dose 400 mg (PO) BID with adequate water (more than 200 mL). One cycle consists of 28 days. Administration of belvarafenib should occur BID on every day of each 28-day cycle.

Treatment: Drugs: Pralsetinib
Pralsetinib will be self-administered by participants orally at home (except on clinic days) on a continuous daily dosing regimen at a dose of 400 mg/day (four 100-mg capsules per day) for adult and pediatric patients = 12 and \< 18 years of age. A treatment cycle consists of 4 weeks (28 days).

Treatment: Drugs: GDC-6036
GDC-6036 will be self-administered by patients orally at home (except on clinic days) on a continuous daily dosing regimen for both adult and pediatric patients. A treatment cycle consists of 3 weeks (21 days).

Treatment: Drugs: Camonsertib
Camonsertib will be self-administered by patients orally at home (except on clinic days). A treatment cycle consists of 3 weeks and will be given on days 1-3 and days 8-10 of every 21-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All Cohorts: Independent Review Committee (IRC)-assessed objective response rate (ORR) based on confirmed objective response (OR) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Timepoint [1] 0 0
Approximately up to 12 years
Secondary outcome [1] 0 0
All Cohorts: IRC-assessed duration of response (DOR) per RECIST v1.1
Timepoint [1] 0 0
Approximately up to 12 years
Secondary outcome [2] 0 0
All Cohorts: IRC-assessed clinical benefit rate (CBR) per RECIST v1.1
Timepoint [2] 0 0
Approximately up to 12 years
Secondary outcome [3] 0 0
All Cohorts: IRC-assessed progression free survival (PFS) per RECIST v1.1
Timepoint [3] 0 0
Approximately up to 12 years
Secondary outcome [4] 0 0
All Cohorts: Investigator (INV)-assessed ORR per RECIST v1.1
Timepoint [4] 0 0
Approximately up to 12 years
Secondary outcome [5] 0 0
All Cohorts: INV-assessed DOR per RECIST v1.1
Timepoint [5] 0 0
Approximately up to 12 years
Secondary outcome [6] 0 0
All Cohorts: INV-assessed CBR per RECIST v1.1
Timepoint [6] 0 0
Approximately up to 12 years
Secondary outcome [7] 0 0
All Cohorts: INV-assessed PFS per RECIST v1.1
Timepoint [7] 0 0
Approximately up to 12 years
Secondary outcome [8] 0 0
All Cohorts: IRC- and INV-assessed time to central nervous system (CNS) progression per RECIST v1.1
Timepoint [8] 0 0
Approximately up to 12 years
Secondary outcome [9] 0 0
All Cohorts: Overall Survival (OS)
Timepoint [9] 0 0
Approximately up to 12 years
Secondary outcome [10] 0 0
Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-ORR per Response Assessment in Neuro-Oncology (RANO)
Timepoint [10] 0 0
Approximately up to 12 years
Secondary outcome [11] 0 0
Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-DOR per RANO
Timepoint [11] 0 0
Approximately up to 12 years
Secondary outcome [12] 0 0
Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-CBR per RANO
Timepoint [12] 0 0
Approximately up to 12 years
Secondary outcome [13] 0 0
Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-PFS per RANO
Timepoint [13] 0 0
Approximately up to 12 years
Secondary outcome [14] 0 0
Cohorts A, B, C, D, I, J, K: INV-assessed CNS-ORR per RANO
Timepoint [14] 0 0
Approximately up to 12 years
Secondary outcome [15] 0 0
Cohorts A, B, C, D, I, J, K: INV-assessed CNS-DOR per RANO
Timepoint [15] 0 0
Approximately up to 12 years
Secondary outcome [16] 0 0
Cohorts A, B, C, D, I, J, K: INV-assessed CNS-CBR per RANO
Timepoint [16] 0 0
Approximately up to 12 years
Secondary outcome [17] 0 0
Cohorts A, B, C, D, I, J, K: INV-assessed CNS-PFS per RANO
Timepoint [17] 0 0
Approximately up to 12 years
Secondary outcome [18] 0 0
Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: IRC-assessed ORR per International Neuroblastoma Response Criteria (INRC)
Timepoint [18] 0 0
Approximately up to 12 years
Secondary outcome [19] 0 0
Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: KIRC-assessed DOR per INRC
Timepoint [19] 0 0
Approximately up to 12 years
Secondary outcome [20] 0 0
Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: IRC-assessed CBR per INRC
Timepoint [20] 0 0
Approximately up to 12 years
Secondary outcome [21] 0 0
Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: IRC-assessed PFS per INRC
Timepoint [21] 0 0
Approximately up to 12 years
Secondary outcome [22] 0 0
Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: INV-assessed ORR per INRC
Timepoint [22] 0 0
Approximately up to 12 years
Secondary outcome [23] 0 0
Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: INV-assessed DOR per INRC
Timepoint [23] 0 0
Approximately up to 12 years
Secondary outcome [24] 0 0
Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: INV-assessed CBR per INRC
Timepoint [24] 0 0
Approximately up to 12 years
Secondary outcome [25] 0 0
Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: INV-assessed PFS per INRC
Timepoint [25] 0 0
Approximately up to 12 years
Secondary outcome [26] 0 0
All Cohorts: IRC-assessed ORR per RECIST v1.1 in participants with alteration/biomarker-positive circulating tumor DNA (ctDNA) by blood-based next-generation sequencing (NGS) assay
Timepoint [26] 0 0
Approximately up to 12 years
Secondary outcome [27] 0 0
All Cohorts: IRC-assessed DOR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay
Timepoint [27] 0 0
Approximately up to 12 years
Secondary outcome [28] 0 0
All Cohorts: IRC-assessed CBR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay
Timepoint [28] 0 0
Approximately up to 12 years
Secondary outcome [29] 0 0
All Cohorts: IRC-assessed PFS per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay
Timepoint [29] 0 0
Approximately up to 12 years
Secondary outcome [30] 0 0
All Cohorts: INV-assessed ORR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay
Timepoint [30] 0 0
Approximately up to 12 years
Secondary outcome [31] 0 0
All Cohorts: INV-assessed DOR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay
Timepoint [31] 0 0
Approximately up to 12 years
Secondary outcome [32] 0 0
All Cohorts: INV-assessed CBR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay
Timepoint [32] 0 0
Approximately up to 12 years
Secondary outcome [33] 0 0
All Cohorts: INV-assessed PFS per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay
Timepoint [33] 0 0
Approximately up to 12 years
Secondary outcome [34] 0 0
Cohorts A, B, C, D, I, J, K: IRC-assessed intracranial (IC)-ORR per RECIST v1.1
Timepoint [34] 0 0
Approximately up to 12 years
Secondary outcome [35] 0 0
Cohorts A, B, C, D, I, J, K: IRC-assessed IC-DOR per RECIST v1.1
Timepoint [35] 0 0
Approximately up to 12 years
Secondary outcome [36] 0 0
Cohorts A, B, C, D, I, J, K: IRC-assessed IC-CBR per RECIST v1.1
Timepoint [36] 0 0
Approximately up to 12 years
Secondary outcome [37] 0 0
Cohorts A, B, C, D, I, J, K: IRC-assessed IC-PFS rate per RECIST v1.1
Timepoint [37] 0 0
Approximately up to 12 years
Secondary outcome [38] 0 0
Cohorts A, B, C, D, I, J, K: INV-assessed IC-ORR per RECIST v1.1
Timepoint [38] 0 0
Approximately up to 12 years
Secondary outcome [39] 0 0
Cohorts A, B, C, D, I, J, K: INV-assessed IC-DOR per RECIST v1.1
Timepoint [39] 0 0
Approximately up to 12 years
Secondary outcome [40] 0 0
Cohorts A, B, C, D, I, J, K: INV-assessed IC-CBR per RECIST v1.1
Timepoint [40] 0 0
Approximately up to 12 years
Secondary outcome [41] 0 0
Cohorts A, B, C, D, I, J, K: INV-assessed IC-PFS rate per RECIST v1.1
Timepoint [41] 0 0
Approximately up to 12 years
Secondary outcome [42] 0 0
All Cohorts: Percentage of participants with confirmed deterioration as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)
Timepoint [42] 0 0
Approximately up to 12 years
Secondary outcome [43] 0 0
All Cohorts: Change from Baseline in the EORTC-QLQ-C30 total score
Timepoint [43] 0 0
Approximately up to 12 years
Secondary outcome [44] 0 0
All Cohorts: Percentage of participants with a clinical meaningful change on the Global Health Status, Physical Functioning, and Role Functioning scores from the EORTC QLQ-C30
Timepoint [44] 0 0
Approximately up to 12 years
Secondary outcome [45] 0 0
All Cohorts: Time to confirmed symptom onset or worsening from tumor-related symptom scores from the EORTC QLQ-C30 and EORTC Item Library
Timepoint [45] 0 0
Approximately up to 12 years
Secondary outcome [46] 0 0
All Cohorts: Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [46] 0 0
Approximately up to 12 years
Secondary outcome [47] 0 0
Cohorts A, B: Plasma concentration of entrectinib at specified timepoints
Timepoint [47] 0 0
Day 1 of Cycle 1-6 and Day 1 of every other Cycle going forward (one Cycle=28 days)
Secondary outcome [48] 0 0
Cohort C: Plasma concentration of alectinib at specified timepoints
Timepoint [48] 0 0
Cycle 1, Day 1 and Day 15; Day 1 of Cycle 2-6, and Day 1 of every other Cycle going forward (one Cycle=28 days)
Secondary outcome [49] 0 0
Cohort D: Plasma concentration of atezolizumab at specified timepoints
Timepoint [49] 0 0
Day 1 of Cycle 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, and every even Cycles thereafter (one Cycle=21 days)
Secondary outcome [50] 0 0
Cohort E: Plasma concentration of ipatasertib at specified timepoints
Timepoint [50] 0 0
Cycle 1, Day 1 and 15; Cycle 2, Day 1; Cycle 3, Day 15; Cycle 4, Day 1, and every even Cycle thereafter (one Cycle=28 days)
Secondary outcome [51] 0 0
Cohort F: Serum concentration of trastuzumab emtansine at specified timepoints
Timepoint [51] 0 0
Cycle 1, Day 1; Cycle 2, Day 1; Cycle 4, Day 1; Cycle 6, Day 1, and every even Cycle thereafter (one Cycle=21 days)
Secondary outcome [52] 0 0
Cohort G: Plasma concentration of idasanutlin at specified timepoint
Timepoint [52] 0 0
Cycle 1, Day 1, 2, 5, 8; Cycle 2, Day 1, 2, 5; Cycle 3, Day 2, 5; Cycle 4, Day 1, and every other Cycle going forward (one Cycle=28 days)
Secondary outcome [53] 0 0
Cohort H: Plasma concentration of GDC-0077 at specified timepoints
Timepoint [53] 0 0
Cycle 1, Day 1, 8 (+/-1 day), 15 (+/-1 day); Cycle 2, Day 1 (+/-1 day); Day 1 of Cycle 4, and every other even Cycle going forward (one Cycle=28 days)
Secondary outcome [54] 0 0
Cohort L: Plasma concentration of GDC-6036 at specified timepoints
Timepoint [54] 0 0
Cycle 1: Day 1, 15; Cycles 2-5, Day 1, Cycle 7, Day 1 and every other cycle until post 1-year of treatment (Day of Cycles 7, 9, 11) (Cycle=21 days))
Secondary outcome [55] 0 0
Cohort M: Plasma concentration of Camonsertib at specified timepoints
Timepoint [55] 0 0
Cycle 1, Day 1, 2, 8; Cycle 2-4, Day 1; Cycle 5, Day 1, and every odd cycle until post 1-year of treatment (Cycles 7, 9, 11, and 13) (Cycle=21 days))
Secondary outcome [56] 0 0
Cohort N: Plasma concentration of Camonsertib at specified timepoints
Timepoint [56] 0 0
Cycle 1, Day 1, 2, 8; Cycle 2-4, Day 1; Cycle 5, Day 1, and every odd cycle until post 1-year of treatment (Cycles 7, 9, 11, and 13) (Cycle=21 days))
Secondary outcome [57] 0 0
Cohorts D, F: Percentage of participants with anti-drug antibodies (ADA)
Timepoint [57] 0 0
Cohort D: Day 1 of Cycle 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, and every even Cycles thereafter (one Cycle=21 days); Cohort F: Cycle 1, Day 1; Cycle 2, Day 1; Cycle 4, Day 1; Cycle 6, Day 1, and every even Cycle thereafter (one Cycle=21 days)

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), Response Assessment in Neuro-Oncology (RANO) criteria, or International Neuroblastoma Response Criteria (INRC)
* Performance status as follows: Participantss aged >= 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participantss aged 16 to < 18 years: Karnofsky score >= 50%; Participants aged < 16 years: Lansky score >= 50%
* For participants aged >= 18 and <18 years: adequate hematologic and end-organ function
* Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
* Adequate recovery from most recent systemic or local treatment for cancer
* Life expectancy >= 8 weeks
* Ability to comply with the study protocol, in the investigator's judgment
* For female participants of childbearing potential: Negative serum pregnancy test <= 14 days prior to initiating study treatment; agreement to remain abstinent or use single or combined contraception methods that result in a failure rate of < 1% per year for the period defined in the cohort-specific inclusion criteria; and agreement to refrain from donating eggs during the same period
* For male participants: Willingness to remain abstinent or use acceptable methods of contraception as defined in the cohort-specific inclusion criteria
* In addition to the general inclusion criteria above, participants must meet all of the cohort-specific inclusion criteria for the respective cohort
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current participation or enrollment in another therapeutic clinical trial
* Any anticancer treatment within 2 weeks or 5 half-lives prior to start of study treatment
* Whole brain radiotherapy within 14 days prior to start of study treatment
* Stereotactic radiosurgery within 7 days prior to start of study treatment
* Pregnant or breastfeeding, or intending to become pregnant during the study
* History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study or confounds the ability to interpret data from the study
* Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment
* Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or higher), myocardial infarction, or cerebrovascular accident within 3 months prior to enrollment, unstable arrhythmias, or unstable angina
* History of another active cancer within 5 years prior to screening that may interfere with the determination of safety or efficacy of study treatment with respect to the qualifying solid tumor malignancy
* In addition to the general exclusion criteria above, in order to be enrolled in a treatment cohort of the study, participants must not meet any of the cohort-specific exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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 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
18/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/09/2032
Actual
Sample size
Target
920
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,VIC
Recruitment hospital [1] 0 0
Kinghorn Cancer Centre; St Vincents Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [3] 0 0
Royal Darwin Hospital; Alan Walker Cancer Centre - Tiwi
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre; Medical Oncology - Melbourne
Recruitment hospital [6] 0 0
Royal Children's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
0810 - Tiwi
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment postcode(s) [6] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Delaware
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maine
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Montana
Country [17] 0 0
United States of America
State/province [17] 0 0
Nebraska
Country [18] 0 0
United States of America
State/province [18] 0 0
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Sutton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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: BO41932 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. and Canada)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04589845