Boufarik, Algeria
Special Drug Use-results Surveillance of Tafinlar/Mekinist
In the Post-Marketing Surveillance (PMS), dabrafenib and trametinib are used as the marketed drugs. Registration of the corresponding patients is to be conducted by the central registered system under current medical practice. Target number of adult patient is 65 (as the number of patients in the effectiveness analysis set). Target number of pediatric patient is not determined. Estimated number of enrolled patients is approximately 20 (as the number of patients in the enrolled set) The observation period for pediatric patients will last after the start of treatment until 8 years (planned, November 2031) after the approval of additional indications, regardless of discontinuation of the product, in order to collect long-term information from as many patients as possible during the reexamination period. The duration of observation for adult patients will be 1 year after the start of treatment with the product.
Phase
N/ASpan
412 weeksSponsor
Novartis PharmaceuticalsNagoya, Aichi
Recruiting
Nagoya, Aichi
Recruiting
A Clinical Study of KK2260 in Patients With Advanced or Metastatic Solid Tumors
Phase
1Span
339 weeksSponsor
Kyowa Kirin Co., Ltd.Nagoya, Aichi
Recruiting
Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06)
The goal of this trial is to determine the efficacy and safety of acasunlimab (an experimental antibody also known as GEN1046 or DuoBody® PDL1x4-1BB) in combination with pembrolizumab (an antibody known as KEYTRUDA®) compared to that of docetaxel (a standard of care chemotherapy). During the trial, the participant's quality of life will also be evaluated using industry-standard scales of measurement. To be eligible, participants: 1. must have lung cancer that has metastasized (spread) 2. have tumors that are positive for the PD-L1 protein (a biomarker that may be predictive of response to therapy) 3. will have been previously treated with a PD-1/PD-L1-inhibitor and a platinum-containing cancer therapy administered in combination or sequentially. Other eligibility criteria will also apply. Participants will be assigned to 1 of 2 active therapies, also known as treatment arms, as follows: - Acasunlimab (100 mg) and pembrolizumab (400 mg) once every 6 weeks (Q6W), or - Docetaxel 75 mg/m^2 once every 3 weeks (Q3W). The estimated trial duration for a participant will vary but may be up to 5 years, consisting of: - An optional 56-day pre-screening period - A 28-day screening period - Up to 2 years of treatment - A 90-day safety follow-up period - Post-treatment follow-up.
Phase
3Span
258 weeksSponsor
GenmabNagoya
Recruiting
A Study of Avutometinib + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer in Japanese Patients
This is a multi-center, open label Phase 2 study designed to evaluate safety and tolerability and confirm efficacy by BICR of avutometinib in combination with defactinib in Japanese patients with molecularly profiled recurrent LGSOC.
Phase
2Span
157 weeksSponsor
Verastem, Inc.Nagoya, Aichi
Recruiting
A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) (MK-7962-024)
Phase
2Span
87 weeksSponsor
Merck Sharp & Dohme LLCNagoya, Aichi
Recruiting
Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1
Phase
3Span
308 weeksSponsor
Gilead SciencesNagoya
Recruiting
Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1
Phase
3Span
308 weeksSponsor
Gilead SciencesNagoya
Recruiting
A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo
Phase
3Span
159 weeksSponsor
PfizerNagoya, Aichi
Recruiting
A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors
This study is designed to assess the safety and efficacy of HER3-DXd monotherapy in subjects with refractory locally advanced or metastatic solid tumors who have been previously treated with ≥1 prior line of systemic anticancer therapy. The primary objective of the study is to assess the efficacy of HER3-DXd monotherapy for each type of indicated locally advanced or metastatic tumor. Secondary objectives include the assessment of safety and tolerability, efficacy, and pharmacokinetics of HER3-DXd monotherapy for each type of indicated locally advanced or metastatic tumor. HER3 protein expression in tumor tissue and its relationship with HER3-DXd efficacy will also be evaluated.
Phase
2Span
114 weeksSponsor
Daiichi SankyoNagoya
Recruiting