38-501 : BRAFTOVI/MEKTOVI Combination Therapy Specified Drug Use Survey (ML)

38-501 : BRAFTOVI/MEKTOVI Combination Therapy Specified Drug Use Survey (Radically unresectable malignant melanoma with a BRAF gene mutation)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT2011210010

Enrollment

150

Registered

2021-05-25

Start date

2019-02-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

radically unresectable malignant melanoma with a BRAF gene mutation

Interventions

none

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients with radically unresectable malignant melanoma with a BRAF gene mutation for whom BRAFTOVI/MEKTOVI Combination Therapy is performed

Exclusion criteria

Exclusion criteria: patients who have not received BRAFTOVI and/or MEKTOVI

Design outcomes

Primary

Measure	Time frame
[Safety]Occurrence status of adverse drug reactions and infections, Occurrence status of adverse drug reactions corresponding to specified safety concerns, Factors that are considered to affect safety Specified safety concerns: Skin malignant tumor, palmar-plantar erythrodysaesthesia syndrome, eye disorders, cardiac dysfunction, hypertension, rhabdomyolysis, hepatic dysfunction, and haemorrhage	—

Contacts

Public ContactTakafumi Nakao

Ono Pharmaceutical Co.,LTD

pms_contact_ml@ono-pharma.com+81-662225501

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026