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Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04589845
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : January 17, 2023
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE October 11, 2020
First Posted Date  ICMJE October 19, 2020
Last Update Posted Date January 17, 2023
Actual Study Start Date  ICMJE January 18, 2021
Estimated Primary Completion Date September 25, 2032   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2020)
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) [ Time Frame: Approximately up to 12 years ]
Confirmed objective response indicates >/= 4 weeks after initial documentation of response
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2021)
  • All Cohorts: IRC-assessed duration of response (DOR) per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: IRC-assessed clinical benefit rate (CBR) per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: IRC-assessed progression free survival (PFS) per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: Investigator (INV)-assessed ORR per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: INV-assessed DOR per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: INV-assessed CBR per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: INV-assessed PFS per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: IRC- and INV-assessed time to central nervous system (CNS) progression per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: Overall Survival (OS) [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-ORR per Response Assessment in Neuro-Oncology (RANO) [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-DOR per RANO [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-CBR per RANO [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-PFS per RANO [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D, I, J, K: INV-assessed CNS-ORR per RANO [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D, I, J, K: INV-assessed CNS-DOR per RANO [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D, I, J, K: INV-assessed CNS-CBR per RANO [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D, I, J, K: INV-assessed CNS-PFS per RANO [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, D, E, F, H, I, J, K: IRC-assessed ORR per International Neuroblastoma Response Criteria (INRC) [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, D, E, F, H, I, J, KIRC-assessed DOR per INRC [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, D, E, F, H, I, J, K: IRC-assessed CBR per INRC [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, D, E, F, H, I, J, K: IRC-assessed PFS per INRC [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, D, E, F, H, I, J, K: INV-assessed ORR per INRC [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, D, E, F, H, I, J, K: INV-assessed DOR per INRC [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, D, E, F, H, I, J, K: INV-assessed CBR per INRC [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, D, E, F, H, I, J, K: INV-assessed PFS per INRC [ Time Frame: Approximately up to 12 years ]
  • 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 [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: IRC-assessed DOR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: IRC-assessed CBR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: IRC-assessed PFS per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: INV-assessed ORR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: INV-assessed DOR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: INV-assessed CBR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: INV-assessed PFS per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D, I, J, K: IRC-assessed intracranial (IC)-ORR per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D, I, J, K: IRC-assessed IC-DOR per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D, I, J, K: IRC-assessed IC-CBR per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D, I, J, K: IRC-assessed IC-PFS rate per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D, I, J, K: INV-assessed IC-ORR per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D, I, J, K: INV-assessed IC-DOR per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D, I, J, K: INV-assessed IC-CBR per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D, I, J, K: INV-assessed IC-PFS rate per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • 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) [ Time Frame: Approximately up to 12 years ]
    The EORTC QLQ-C30 is a validated, reliable self-report measure. It consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), eight symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea) and global health/quality of life, with a recall period of the previous week. Scale scores can be obtained for the multi-item scales using rating scales of 4 or 7 points.
  • All Cohorts: Change from Baseline in the EORTC-QLQ-C30 total score [ Time Frame: Approximately up to 12 years ]
  • 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 [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: Time to confirmed symptom onset or worsening from tumor-related symptom scores from the EORTC QLQ-C30 and EORTC Item Library [ Time Frame: Approximately up to 12 years ]
    The EORTC Item library includes stand-alone symptoms scales and an overall assessment of treatment bother to provide additional information not currently captured in the EORTC QLQ-C30. The scales use the same rating scale and recall period of previous week as the symptom scales in the EORTC QLQ-C30.
  • All Cohorts: Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Approximately up to 12 years ]
    Adverse event severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5 (NCI CTCAE v5.0.)
  • Cohorts A, B: Plasma concentration of entrectinib at specified timepoints [ Time Frame: Day 1 of Cycle 1-6 and Day 1 of every other Cycle going forward (one Cycle=28 days) ]
  • Cohort C: Plasma concentration of alectinib at specified timepoints [ Time Frame: 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) ]
  • Cohort D: Plasma concentration of atezolizumab at specified timepoints [ Time Frame: 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 E: Plasma concentration of ipatasertib at specified timepoints [ Time Frame: 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) ]
  • Cohort F: Serum concentration of trastuzumab emtansine at specified timepoints [ Time Frame: 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) ]
  • Cohort G: Plasma concentration of idasanutlin at specified timepoint [ Time Frame: 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) ]
  • Cohort H: Plasma concentration of GDC-0077 at specified timepoints [ Time Frame: 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) ]
  • Cohorts D, F: Percentage of participants with anti-drug antibodies (ADA) [ Time Frame: 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2020)
  • All Cohorts: IRC-assessed duration of response (DOR) per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: IRC-assessed clinical benefit rate (CBR) per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: IRC-assessed progression free survival (PFS) per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: Investigator (INV)-assessed ORR per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: INV-assessed DOR per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: INV-assessed CBR per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: INV-assessed PFS per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: IRC- and INV-assessed time to central nervous system (CNS) progression per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: Overall Survival (OS) [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D: IRC-assessed CNS-ORR per Response Assessment in Neuro-Oncology (RANO) [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D: IRC-assessed CNS-DOR per RANO [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D: IRC-assessed CNS-CBR per RANO [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D: IRC-assessed CNS-PFS per RANO [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D: INV-assessed CNS-ORR per RANO [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D: INV-assessed CNS-DOR per RANO [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D: INV-assessed CNS-CBR per RANO [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D: INV-assessed CNS-PFS per RANO [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, D, E, F, G, H: IRC-assessed ORR per International Neuroblastoma Response Criteria (INRC) [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, D, E, F, G, H: IRC-assessed DOR per INRC [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, D, E, F, G, H: IRC-assessed CBR per INRC [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, D, E, F, G, H: IRC-assessed PFS per INRC [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, D, E, F, G, H: INV-assessed ORR per INRC [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, D, E, F, G, H: INV-assessed DOR per INRC [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, D, E, F, G, H: INV-assessed CBR per INRC [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, D, E, F, G, H: INV-assessed PFS per INRC [ Time Frame: Approximately up to 12 years ]
  • 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 [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: IRC-assessed DOR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: IRC-assessed CBR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: IRC-assessed PFS per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: INV-assessed ORR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: INV-assessed DOR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: INV-assessed CBR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: INV-assessed PFS per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D: IRC-assessed intracranial (IC)-ORR per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D: IRC-assessed IC-DOR per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D: IRC-assessed IC-CBR per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D: IRC-assessed IC-PFS rate per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D: INV-assessed IC-ORR per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D: INV-assessed IC-DOR per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D: INV-assessed IC-CBR per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • Cohorts A, B, C, D: INV-assessed IC-PFS rate per RECIST v1.1 [ Time Frame: Approximately up to 12 years ]
  • 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) [ Time Frame: Approximately up to 12 years ]
    The EORTC QLQ-C30 is a validated, reliable self-report measure. It consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), eight symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea) and global health/quality of life, with a recall period of the previous week. Scale scores can be obtained for the multi-item scales using rating scales of 4 or 7 points.
  • All Cohorts: Change from Baseline in the EORTC-QLQ-C30 total score [ Time Frame: Approximately up to 12 years ]
  • 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 [ Time Frame: Approximately up to 12 years ]
  • All Cohorts: Time to confirmed symptom onset or worsening from tumor-related symptom scores from the EORTC QLQ-C30 and EORTC Item Library [ Time Frame: Approximately up to 12 years ]
    The EORTC Item library includes stand-alone symptoms scales and an overall assessment of treatment bother to provide additional information not currently captured in the EORTC QLQ-C30. The scales use the same rating scale and recall period of previous week as the symptom scales in the EORTC QLQ-C30.
  • All Cohorts: Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Approximately up to 12 years ]
    Adverse event severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5 (NCI CTCAE v5.0.)
  • Cohorts A, B: Plasma concentration of entrectinib at specified timepoints [ Time Frame: Day 1 of Cycle 1-6 and Day 1 of every other Cycle going forward (one Cycle=28 days) ]
  • Cohort C: Plasma concentration of alectinib at specified timepoints [ Time Frame: 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) ]
  • Cohort D: Plasma concentration of atezolizumab at specified timepoints [ Time Frame: 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 E: Plasma concentration of ipatasertib at specified timepoints [ Time Frame: 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) ]
  • Cohort F: Serum concentration of trastuzumab emtansine at specified timepoints [ Time Frame: 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) ]
  • Cohort G: Plasma concentration of idasanutlin at specified timepoint [ Time Frame: 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) ]
  • Cohort H: Plasma concentration of GDC-0077 at specified timepoints [ Time Frame: 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) ]
  • Cohorts D, F: Percentage of participants with anti-drug antibodies (ADA) [ Time Frame: 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) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study
Official Title  ICMJE Tumor-Agnostic Precision Immunooncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial
Brief Summary TAPISTRY is a Phase II, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in rational, specified combinations in participants with unresectable, locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are tumor mutational burden (TMB)-high as identified by a validated next-generation sequencing (NGS) assay. Participants with solid tumors will be treated with a drug or drug regimen tailored to their NGS assay results at screening. Participants will be assigned to the appropriate cohort based on their genetic alteration(s). Treatment will be assigned on the basis of relevant oncogenotype, will have cohort-specific inclusion/exclusion criteria, and, unless otherwise specified, will continue until disease progression, loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death, whichever occurs first.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumors
Intervention  ICMJE
  • Drug: 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).
    Other Name: Rozlytrek
  • Drug: Alectinib
    Alectinib will be administered orally BID (twice a day) with food at a dosage of 600 mg (four 150-mg capsules).
    Other Name: Alecensa
  • Drug: 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.
    Other Name: Tecentriq
  • Drug: 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.
  • Drug: 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.
    Other Name: Kadcyla
  • Drug: 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.

  • Drug: 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.
    Other Name: GDC-0077
  • Drug: 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.
  • Drug: 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).
    Other Name: Gavreto (US)
Study Arms  ICMJE
  • Experimental: Cohort A: ROS1 fusion-positive tumors
    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.
    Intervention: Drug: Entrectinib
  • 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.
    Intervention: Drug: Entrectinib
  • Experimental: Cohort C: ALK fusion-positive tumors
    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.
    Intervention: Drug: Alectinib
  • 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.
    Intervention: Drug: Atezolizumab
  • 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.
    Intervention: Drug: Ipatasertib
  • 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.
    Intervention: Drug: Trastuzumab emtansine
  • 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

    Intervention: Drug: Idasanutlin
  • 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.
    Intervention: Drug: Inavolisib
  • 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.
    Intervention: Drug: Belvarafenib
  • 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.
    Intervention: Drug: Belvarafenib
  • Experimental: Cohort K: RET fusion-positive tumors
    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).
    Intervention: Drug: Pralsetinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 6, 2021)
770
Original Estimated Enrollment  ICMJE
 (submitted: October 11, 2020)
650
Estimated Study Completion Date  ICMJE September 25, 2032
Estimated Primary Completion Date September 25, 2032   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reference Study ID Number: BO41932 https://forpatients.roche.com/ 888-662-6728 (U.S. and Canada) Global-Roche-Genentech-Trials@gene.com
Listed Location Countries  ICMJE Australia,   Belgium,   Brazil,   Canada,   China,   Denmark,   France,   Germany,   Hong Kong,   Israel,   Italy,   Japan,   Korea, Republic of,   Netherlands,   New Zealand,   Poland,   Portugal,   Puerto Rico,   Singapore,   Spain,   Swaziland,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04589845
Other Study ID Numbers  ICMJE BO41932
2020-001847-16 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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).
Current Responsible Party Hoffmann-La Roche
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hoffmann-La Roche
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP