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

NCT03161613 — Withdrawn, Bristol-Myers Squibb

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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

Registry	NCT03161613
Status	Withdrawn - Business objectives have changed
Study type	Observational
Sponsor	Bristol-Myers Squibb (Industry)
Conditions	Multiple Indications Cancer
Interventions	Non-Interventional (Other)
Dates	start 2017-07-17, primary completion 2019-04-01 (estimated), completion 2019-04-01 (estimated), first posted 2017-05-22, last updated 2022-05-27
Locations	1 site in Mexico

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Cancer patients in Mexico		Other: Non-Interventional	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 (Other): Non-Interventional

+Outcome measures

Primary outcomes

Incidence of subjects who report on-study Adverse Events(AEs) [approximately 24 months]
incidence of subjects who report on-study Serious Adverse Events(SAEs) [approximately 24 months]

Secondary outcomes

Distribution of on-study AEs [approximately 24 months]
Distribution of on-study SAEs [approximately 24 months]
Distribution of drug-related AEs [approximately 24 months]
Distribution of drug-related SAEs [approximately 24 months]
Distribution of AEs leading to discontinuation [approximately 24 months]
Distribution of SAEs leading to discontinuation [approximately 24 months]
Distribution of age in patients [At Baseline]
Distribution of gender in patients [At Baseline]
Distribution of tumor history in patients [At Baseline]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. 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
2. 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
3. Patients who present with brain metastases are allowed, if asymptomatic, do not have edema, and are not receiving corticosteroids or radiation
4. 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.

+Locations (1)

Facility	City	Country	Status
Local Institution	Mexico City, Mexico City	Mexico

+Investigators

Bristol-Myers Squibb, Study director, Bristol-Myers Squibb

My Notes

Public

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