NCT04985604 · REGISTRY CONDITION SEARCH

Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: TERMINATED
Registry last update: 2025-10-02

This is a Phase 2, multi-center, open-label to evaluate the efficacy and safety of tovorafenib (DAY101) in participants ≥12 years of age with recurrent or progressive melanoma or solid tumors with BRAF fusion or CRAF/RAF1 fusions or amplification.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Response Rate (ORR) by the Investigator

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outcome · POSTED

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

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outcome · POSTED

Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-baseline Relative to Baseline

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outcome · POSTED

Number of Participants With Worst Case Chemistry Results by Maximum Grade Increase Post-baseline Relative to Baseline

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outcome · POSTED

Duration of Response (DOR) in Participants With Best Overall Response

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outcome · POSTED

Duration of Progression Free Survival

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outcome · POSTED

Duration of Overall Survival

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outcome · POSTED

Time to Response

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Signed informed consent by participants ≥ 12 years of age either a Consent or an Assent Form will be provided to the patient based on their capacity, local regulations, and guidelines. * Participants must have a histologically confirmed diagnosis of melanoma or other solid tumor and a BRAF fusion, CRAF/RAF1 fusion, or CRAF/RAF1 amplifications obtained through a tumor or liquid biopsy as assessed by genomic sequencing, polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), or another clinically accepted molecular diagnostic method recognized by local laboratory or regulatory agency. * Participants must have radiographically-recurrent or radiographically-progressive disease that is measurable using the appropriate tumor response criteria (e.g. RECIST version 1.1 or RANO). * Archival tumor tissue (preferably less than 3 years old) or fresh tumor tissue for correlative studies is required * If brain metastases are present, they must have been previously treated and be stable as assessed by radiographic imaging Exclusion Criteria: * Prior therapy of any RAS-, RAF-, MEK-, or ERK-directed inhibitor therapy * Known presence of concurrent activating mutation * Participants with current evidence or a history of central serous retinopathy (CSR), retinal vein occlusion (RVO)
healthy Volunteers: false
minimum Age: 12 Years
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Tovorafenib monotherapy
intervention Names
Drug: Tovorafenib
label
Melanoma Cohort
type
EXPERIMENTAL
description
Tovorafenib monotherapy
intervention Names
Drug: Tovorafenib
label
Tissue Agnostic Cohort
type
EXPERIMENTAL

interventions

arm Group Labels
Melanoma Cohort
Tissue Agnostic Cohort
description
Tovorafenib tablet for oral use.
name
Tovorafenib
other Names
DAY101
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 23
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
ORR was defined as the percentage of participants with the best overall confirmed response of complete response (CR) or partial response (PR) according to the appropriate response assessment criteria including Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) for the disease setting as assessed by the Investigator. CR or PR was confirmed at a subsequent scan (\>=4 weeks) if the criteria for each are met . The exact 95% confidence intervals (CIs) were calculated using Clopper-Pearson method.
measure
Overall Response Rate (ORR) by the Investigator
time Frame
Up to 23 months

secondary Outcomes

description
An adverse event (AE) is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. An AE is considered to be treatment-emergent if it has a start date/time on or after the first administration of study drug until 30 days after the last dose of study drug and before the start of subsequent therapy, whichever comes earlier. The distribution of AEs was analyzed by the type, frequency and severity for TEAEs.
measure
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
time Frame
Up to 23 months
description
Blood samples were collected for the analysis of following hematology parameters: anemia, neutrophil count decreased and white blood cell decreased. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G2, G3, and G4 are presented. The laboratory parameters were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.
measure
Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-baseline Relative to Baseline
time Frame
Baseline and up to 23 months
description
Blood samples were collected for the analysis of following chemistry parameters: creatine phosphokinase (CPK) increased, hypokalemia, hypoalbuminemia, hypercalcemia, hypocalcemia and hyponatremia. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G2, G3, and G4 are presented. The laboratory parameters were graded according to CTCAE version 5.
measure
Number of Participants With Worst Case Chemistry Results by Maximum Grade Increase Post-baseline Relative to Baseline
time Frame
Baseline and up to 23 months
description
Duration of response was defined as the interval from the date of the first documentation of tumor response (CR or PR) that was subsequently confirmed by investigator assessment to the date of first occurrence of radiographic disease progression based on RECIST 1.1 or RANO criteria or death due to any cause, whichever occurs earlier. DOR was estimated using Kaplan-Meier method.
measure
Duration of Response (DOR) in Participants With Best Overall Response
time Frame
Up to 23 months
description
Progression free survival was defined as the interval from the date of the first dose to the first occurrence of radiographic disease progression based on RECIST 1.1 or RANO criteria or death due to any cause, whichever occurs earlier. Progression free survival was estimated using Kaplan-Meier method.
measure
Duration of Progression Free Survival
time Frame
Up to 23 months
description
Overall survival is defined as the interval from the date of the first dose until the recorded date of death due to any cause. Overall survival was estimated using Kaplan-Meier method.
measure
Duration of Overall Survival
time Frame
Up to 23 months
description
Time to Response was defined in participants with best overall response of complete response or partial response as determined by Investigator. It is the interval from the date of the first dose to date of first documentation of tumor response that was subsequently confirmed by investigator assessment.
measure
Time to Response
time Frame
Up to 23 months

Full study description

brief Summary: This is a Phase 2, multi-center, open-label to evaluate the efficacy and safety of tovorafenib (DAY101) in participants ≥12 years of age with recurrent or progressive melanoma or solid tumors with BRAF fusion or CRAF/RAF1 fusions or amplification.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice