West Cancer Center

MOLECULARY TARGETED: BRAF II Mutant or Fusion/BRAF III Tumors (TAPISTRY ARM I/J)

Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational For You (TAPISTRY) Phase 2 Platform Trial: Cohorts I/J: Belvarafenib in patients with BRAF class II mutant/fusion-positive tumors (I) BRAF class III mutant positive tumors (J)

Title

ROCHE BO41932: TAPISTRY ARMS I and J

Study Title

Site Link

Malignancy

Solid Tumors

Stage

Stage 4

Disease Setting

metastatic or advanced

Line Of Therapy

any

Investigational Agent

Belvarafenib

Drug Class

Type II pan-RAF kinase inhibitor

Daniel Vaena, MD

Sponsor

Hoffmann-La Roche

Phase

Phase 2

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

Inclusion Criteria:

Patients with advanced or solid malignancy with BRAF class II mutation or fusion (ARM I)
Patients with advanced or solid malignancy with BRAF class III mutation (ARM J)
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

Objective

Overall Response Rate

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Dosing Frequency

Control Agents

Study Protocol

Randomized