Clinical Trials Logo
  1. Home
  2. Melanoma
  3. NCT02717364
  4. Details
NCT02717364 Clinical Trial

Yervoy® Postmarketing Surveillance for Patients in Japan With Unresectable, Malignant Melanoma

Melanoma Clinical Trial

Official title:
Yervoy® Postmarketing Surveillance for Patients in Japan With Unresectable, Malignant Melanoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02717364
Other study ID # CA184-438
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 27, 2015
Est. completion date March 7, 2018

Study information
Verified date January 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is a local, prospective, non-interventional, non-controlled, multicenter, observational study (regulatory postmarketing surveillance). Each physician will enroll patients who have received at least 1 dose of Yervoy, and each patient will be followed for up to 12 months. All patients will be evaluated for safety and effectiveness during Yervoy use (4 doses) and for 12 months from the first dose of Yervoy to confirm the safety profile of Yervoy under routine, daily practice

Recruitment information / eligibility
Status Completed
Enrollment 556
Est. completion date March 7, 2018
Est. primary completion date March 7, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All patients who are initiating treatment with Yervoy Exclusion Criteria: - Not Applicable Other protocol defined inclusion/exclusion criteria could apply

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Local Institution Chiyoda-ku Tokyo
Japan Local Institution Tokyo

Sponsors (2)
Lead Sponsor Collaborator
Bristol-Myers Squibb Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of adverse events (AEs) by types among the analysis population 12 months
Primary The Overall Survival (OS) Rate 12 months
Primary The factors that potentially affect safety or effectiveness Stratified analysis on the incidence of adverse events (AEs) and effectiveness by patient background 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT03979872 - Risk Information and Skin-cancer Education for Undergraduate Prevention N/A
Recruiting NCT04986748 - Using QPOP to Predict Treatment for Sarcomas and Melanomas
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Recruiting NCT05707286 - Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
Active, not recruiting NCT05470283 - Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma Phase 1
Recruiting NCT05077137 - A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy Phase 1
Active, not recruiting NCT02721459 - XL888 + Vemurafenib + Cobimetinib for Unresectable BRAF Mutated Stage III/IV Melanoma Phase 1
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Recruiting NCT05839912 - Excision of Lymph Node Trial (EXCILYNT) (Mel69) N/A
Recruiting NCT04971499 - A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma Phase 1/Phase 2
Recruiting NCT05263453 - HL-085+Vemurafenib to Treat Advanced Melanoma Patients With BRAF V600E/K Mutation Phase 2
Active, not recruiting NCT05060432 - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors Phase 1/Phase 2
Not yet recruiting NCT06413680 - A First-In Human (FIH) Trial to Find Out if REGN10597 is Safe and How Well it Works for Adult Participants With Advanced Solid Organ Malignancies Phase 1/Phase 2
Completed NCT03348891 - TNF in Melanoma Patients Treated With Immunotherapy N/A
Terminated NCT03399448 - NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells) Phase 1
Completed NCT03171064 - Exercise as a Supportive Measure for Patients Undergoing Checkpoint-inhibitor Treatment Phase 2
Not yet recruiting NCT05539118 - Interferon-α1b Combined With Toripalimab and Anlotinib Hydrochloride in Advanced Unresectable Melanoma Phase 1/Phase 2
Recruiting NCT05171374 - pRospective Evaluation of Clinical Outcomes in Patients With metAsTatIс melanOma Treated With dabrafeNib and trAmetinib in reaL practicE
Withdrawn NCT02854488 - Yervoy Pregnancy Surveillance Study

External Links