- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03161613
Study to Assess the Safety of Nivolumab in the Treatment of Metastatic Melanoma, Lung Cancer, Renal Cancer, Squamous Cell Carcinoma of the Head and Neck, and Chronic Hodgkin Lymphoma in Adults in Mexico
May 25, 2022 updated by: Bristol-Myers Squibb
Postmarketing Study to Assess the Safety of Nivolumab as a First- and Second-line Treatment in Patients With Metastatic Melanoma or as a Second-line Treatment for Metastatic Lung Cancer (Squamous and Nonsquamous), Metastatic Renal Cancer, Squamous Cell Carcinoma of the Head and Neck, and Chronic Hodgkin Lymphoma in Adult Patients in Mexico
This is a post-marketing study of patients who started nivolumab as first- or second-line therapy for metastatic melanoma or as second-line therapy for metastatic squamous non-small cell lung cancer (SqNSCLC) , metastatic non-SqNSCLC, metastatic renal cell carcimona (RCC), or recurrent or metastatic squamous cell carcinoma of the head and neck cancer (SCCHN), or third-line therapy for classical Hodgkin lymphoma (cHL) in Mexico.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Distrito Federal
-
Mexico, Distrito Federal, Mexico, 14050
- Local Institution
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who started nivolumab as first- or second-line therapy for metastatic melanoma or as second-line therapy for metastatic squamous non-small cell lung cancer (SqNSCLC) , metastatic non-SqNSCLC, metastatic renal cell carcimona (RCC), or recurrent or metastatic squamous cell carcinoma of the head and neck cancer (SCCHN), or third-line therapy for classical Hodgkin lymphoma (cHL) in Mexico.
Description
Inclusion Criteria:
- Male and female adult patients > 18 years of age who have a confirmed diagnosis of advanced or metastatic melanoma and is indicated for the treatment of advanced (unresectable or metastatic) melanoma; metastatic NSCLC; metastatic RCC; recurrent or metastatic SCCHN; or cHL in Mexico
- Male and female adult patients > 18 years of age who completed the following lines of therapy: first-line platinum treatment for metastatic SqNSCLC or non-SqNSCLC; 1 first-line treatment for metastatic RCC; first-line platinum therapy for SCCHN; or bretuximab vedontin for the treatment of cHL
- Patients who present with brain metastases are allowed, if asymptomatic, do not have edema, and are not receiving corticosteroids or radiation
- Patients have received at least 1 dose of nivolumab
Exclusion Criteria:
1. The exclusion criteria are at the discretion of the physician. The physician should use his or her clinical judgement and international recommendations when determining eligibility. The patient will be excluded if he or she does not want to start or continue treatment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cancer patients in Mexico
lung cancer, melanoma cancer, renal cancer, Squamous Cell Carcinoma of the Head and Neck, and chronic Hodgkin Lymphoma patients in Mexico who have failed at least one treatment before being treated with nivolumab
|
Non-Interventional
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of subjects who report on-study Adverse Events(AEs)
Time Frame: approximately 24 months
|
approximately 24 months
|
incidence of subjects who report on-study Serious Adverse Events(SAEs)
Time Frame: approximately 24 months
|
approximately 24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Distribution of on-study AEs
Time Frame: approximately 24 months
|
approximately 24 months
|
Distribution of on-study SAEs
Time Frame: approximately 24 months
|
approximately 24 months
|
Distribution of drug-related AEs
Time Frame: approximately 24 months
|
approximately 24 months
|
Distribution of drug-related SAEs
Time Frame: approximately 24 months
|
approximately 24 months
|
Distribution of AEs leading to discontinuation
Time Frame: approximately 24 months
|
approximately 24 months
|
Distribution of SAEs leading to discontinuation
Time Frame: approximately 24 months
|
approximately 24 months
|
Distribution of age in patients
Time Frame: At Baseline
|
At Baseline
|
Distribution of gender in patients
Time Frame: At Baseline
|
At Baseline
|
Distribution of tumor history in patients
Time Frame: At Baseline
|
At Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 17, 2017
Primary Completion (Anticipated)
April 1, 2019
Study Completion (Anticipated)
April 1, 2019
Study Registration Dates
First Submitted
May 18, 2017
First Submitted That Met QC Criteria
May 18, 2017
First Posted (Actual)
May 22, 2017
Study Record Updates
Last Update Posted (Actual)
May 27, 2022
Last Update Submitted That Met QC Criteria
May 25, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Head and Neck Neoplasms
- Lymphoma
- Kidney Neoplasms
- Hodgkin Disease
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Neoplasms, Squamous Cell
Other Study ID Numbers
- CA209-869
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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