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.
Brief Title
Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study
Central Contacts
Central Contact Role
Contact
Central Contact Phone
888-662-6728 (U.S. and Canada)
Central Contact Email
global-roche-genentech-trials@gene.com
Completion Date
Completion Date Type
Estimated
Conditions
Solid Tumors
Eligibility Criteria
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
* Measurable disease as defined by RECIST v1.1, RANO, or INRC
* Performance status as follows: Participants aged ≥ 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participants 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
* Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
* Measurable disease as defined by RECIST v1.1, RANO, or INRC
* Performance status as follows: Participants aged ≥ 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participants 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
Inclusion Criteria
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
* Measurable disease as defined by RECIST v1.1, RANO, or INRC
* Performance status as follows: Participants aged ≥ 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participants 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
* Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
* Measurable disease as defined by RECIST v1.1, RANO, or INRC
* Performance status as follows: Participants aged ≥ 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participants 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
NCT Id
NCT04589845
Org Class
Industry
Org Full Name
Hoffmann-La Roche
Org Study Id
BO41932
Overall Status
Recruiting
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial
Primary Outcomes
Outcome Description
Confirmed objective response indicates ≥4 weeks after initial documentation of response.
Outcome Measure
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)
Outcome Time Frame
Approximately up to 12 years
Secondary Ids
Secondary Id
2020-001847-16
Secondary Id
2023-507418-28-00
Secondary Outcomes
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
All Cohorts: IRC-assessed Duration of Response (DOR) per RECIST v1.1
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
All Cohorts: IRC-assessed Clinical Benefit Rate (CBR) per RECIST v1.1
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
All Cohorts: IRC-assessed Progression-free Survival (PFS) per RECIST v1.1
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
All Cohorts: Investigator (INV)-assessed ORR per RECIST v1.1
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
All Cohorts: INV-assessed DOR per RECIST v1.1
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
All Cohorts: INV-assessed CBR per RECIST v1.1
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
All Cohorts: INV-assessed PFS per RECIST v1.1
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
All Cohorts: IRC- and INV-assessed Time to Central Nervous System (CNS) Progression per RECIST v1.1
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
All Cohorts: Overall Survival (OS)
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-ORR per Response Assessment in Neuro-oncology (RANO)
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-DOR per RANO
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-CBR per RANO
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-PFS per RANO
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A, B, C, D, I, J, K: INV-assessed CNS-ORR per RANO
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A, B, C, D, I, J, K: INV-assessed CNS-DOR per RANO
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A, B, C, D, I, J, K: INV-assessed CNS-CBR per RANO
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A, B, C, D, I, J, K: INV-assessed CNS-PFS per RANO
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A, B, C, D, E, F, H, I, J, K, L, M, N: IRC-assessed ORR per International Neuroblastoma Response Criteria (INRC)
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A, B, C, D, E, F, H, I, J, K, L, M, N: IRC-assessed DOR per INRC
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A, B, C, D, E, F, H, I, J, K, L, M, N: IRC-assessed CBR per INRC
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A, B, C, D, E, F, H, I, J, K, L, M, N: IRC-assessed PFS per INRC
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A, B, C, D, E, F, H, I, J, K, L, M, N: INV-assessed ORR per INRC
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A, B, C, D, E, F, H, I, J, K, L, M, N: INV-assessed DOR per INRC
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A, B, C, D, E, F, H, I, J, K, L, M, N: INV-assessed CBR per INRC
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A, B, C, D, E, F, H, I, J, K, L, M, N: INV-assessed PFS per INRC
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A, B, C, D, I, J, K: IRC-assessed Intracranial (IC)-ORR per RECIST v1.1
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A, B, C, D, I, J, K: IRC-assessed IC-DOR per RECIST v1.1
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A, B, C, D, I, J, K: IRC-assessed IC-CBR per RECIST v1.1
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A, B, C, D, I, J, K: IRC-assessed IC-PFS Rate per RECIST v1.1
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A, B, C, D, I, J, K: INV-assessed IC-ORR per RECIST v1.1
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A, B, C, D, I, J, K: INV-assessed IC-DOR per RECIST v1.1
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A, B, C, D, I, J, K: INV-assessed IC-CBR per RECIST v1.1
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A, B, C, D, I, J, K: INV-assessed IC-PFS Rate per RECIST v1.1
Outcome Description
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.
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A and B: Percentage of Participants With Confirmed Deterioration as Assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Outcome Description
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.
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A and B: Change From Baseline in the EORTC-QLQ-C30 Total Score
Outcome Description
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.
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A and B: Percentage of Participants With a Clinical Meaningful Change on the Global Health Status, Physical Functioning, and Role Functioning Scores From the EORTC QLQ-C30
Outcome Description
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.
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
Cohorts A and B: Time to Confirmed Symptom Onset or Worsening From Tumor-related Symptom Scores From the EORTC QLQ-C30 and EORTC Item Library 71 (IL71)
Outcome Description
AE severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5 (NCI CTCAE v5.0.)
Outcome Time Frame
Approximately up to 12 years
Outcome Measure
All Cohorts: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Haiying Cheng
Investigator Email
HCHENG@montefiore.org
Investigator Phone
718-405-8404