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

Draft scope assessment: unclear. Attached because the study's own record names BRAF. The study record does not state V600E, so it may describe a different alteration of the same gene. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

Efficacy Analysis Set comprises of all participants who received at least one dose of study drug and have measurable disease as determined by the Investigator at baseline.

→

secondary · POSTED

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.

Safety Analysis Set comprises of all patients enrolled in the study who receive at least one dose of study drug.

→

secondary · POSTED

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.

Safety Analysis Set comprises of all patients enrolled in the study who receive at least one dose of study drug.

→

secondary · POSTED

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.

Safety Analysis Set comprises of all patients enrolled in the study who receive at least one dose of study drug.

→

secondary · POSTED

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.

Participants in the Efficacy Analysis Set who have a confirmed response of CR or PR.

→

secondary · POSTED

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.

Efficacy Analysis Set comprises of all participants who received at least one dose of study drug and have measurable disease as determined by the Investigator at baseline.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-non-small-cell-lung-cancer-tafinlar-24414ed0
nct id: NCT04985604
trial label: Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors
applicability: unclear
applicability note: Attached because the study's own record names BRAF. The study record does not state V600E, so it may describe a different alteration of the same gene. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-tafinlar-24414ed0
nct id
NCT04985604
outcome key
om-0000
source section id
NCT04985604-om-0000
source outcome index
0
endpoint
Overall Response Rate (ORR) by the Investigator
endpoint definition
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.
time origin
Up to 23 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Efficacy Analysis Set comprises of all participants who received at least one dose of study drug and have measurable disease as determined by the Investigator at baseline.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-tafinlar-24414ed0
nct id
NCT04985604
outcome key
om-0001
source section id
NCT04985604-om-0001
source outcome index
1
endpoint
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
endpoint definition
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.
time origin
Up to 23 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Safety Analysis Set comprises of all patients enrolled in the study who receive at least one dose of study drug.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-tafinlar-24414ed0
nct id
NCT04985604
outcome key
om-0002
source section id
NCT04985604-om-0002
source outcome index
2
endpoint
Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-baseline Relative to Baseline
endpoint definition
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.
time origin
Baseline and up to 23 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Safety Analysis Set comprises of all patients enrolled in the study who receive at least one dose of study drug.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-tafinlar-24414ed0
nct id
NCT04985604
outcome key
om-0003
source section id
NCT04985604-om-0003
source outcome index
3
endpoint
Number of Participants With Worst Case Chemistry Results by Maximum Grade Increase Post-baseline Relative to Baseline
endpoint definition
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.
time origin
Baseline and up to 23 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Safety Analysis Set comprises of all patients enrolled in the study who receive at least one dose of study drug.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-tafinlar-24414ed0
nct id
NCT04985604
outcome key
om-0004
source section id
NCT04985604-om-0004
source outcome index
4
endpoint
Duration of Response (DOR) in Participants With Best Overall Response
endpoint definition
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.
time origin
Up to 23 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants in the Efficacy Analysis Set who have a confirmed response of CR or PR.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-tafinlar-24414ed0
nct id
NCT04985604
outcome key
om-0005
source section id
NCT04985604-om-0005
source outcome index
5
endpoint
Duration of Progression Free Survival
endpoint definition
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.
time origin
Up to 23 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Efficacy Analysis Set comprises of all participants who received at least one dose of study drug and have measurable disease as determined by the Investigator at baseline.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-tafinlar-24414ed0
nct id
NCT04985604
outcome key
om-0000
arm key
OG000
arm label
Melanoma Cohort
regimen
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04985604-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-tafinlar-24414ed0
nct id
NCT04985604
outcome key
om-0000
arm key
OG001
arm label
Tissue Agnostic Cohort
regimen
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04985604-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-tafinlar-24414ed0
nct id
NCT04985604
outcome key
om-0001
arm key
OG000
arm label
Melanoma Cohort
regimen
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04985604-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-tafinlar-24414ed0
nct id
NCT04985604
outcome key
om-0001
arm key
OG001
arm label
Tissue Agnostic Cohort
regimen
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04985604-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-tafinlar-24414ed0
nct id
NCT04985604
outcome key
om-0002
arm key
OG000
arm label
Melanoma Cohort
regimen
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04985604-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-tafinlar-24414ed0
nct id
NCT04985604
outcome key
om-0002
arm key
OG001
arm label
Tissue Agnostic Cohort
regimen
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04985604-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-tafinlar-24414ed0
nct id
NCT04985604
outcome key
om-0003
arm key
OG000
arm label
Melanoma Cohort
regimen
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04985604-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-tafinlar-24414ed0
nct id
NCT04985604
outcome key
om-0003
arm key
OG001
arm label
Tissue Agnostic Cohort
regimen
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04985604-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-tafinlar-24414ed0
nct id
NCT04985604
outcome key
om-0004
arm key
OG000
arm label
Melanoma Cohort
regimen
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04985604-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-tafinlar-24414ed0
nct id
NCT04985604
outcome key
om-0004
arm key
OG001
arm label
Tissue Agnostic Cohort
regimen
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04985604-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-tafinlar-24414ed0
nct id
NCT04985604
outcome key
om-0005
arm key
OG000
arm label
Melanoma Cohort
regimen
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04985604-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-tafinlar-24414ed0
nct id
NCT04985604
outcome key
om-0005
arm key
OG001
arm label
Tissue Agnostic Cohort
regimen
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04985604-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-tafinlar-24414ed0
nct id
NCT04985604
harm key
EG000
source section id
NCT04985604-ae
event group key
EG000
event group label
Melanoma Cohort
serious affected
2
serious at risk
8
other affected
8
other at risk
8
frequency threshold
5
collection period
Up to 23 months
event definition
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-tafinlar-24414ed0
nct id
NCT04985604
harm key
EG001
source section id
NCT04985604-ae
event group key
EG001
event group label
Tissue Agnostic Cohort
serious affected
8
serious at risk
15
other affected
15
other at risk
15
frequency threshold
5
collection period
Up to 23 months
event definition
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice