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

Withdrawn

• Conditions: Multiple Indications Cancer
• Interventions: Other: Non-Interventional

• Registration Number: NCT03161613
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-18
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-22
• Study Start: 2017-07-17
• Primary Completion: 2019-04-01
• Study Completion: 2019-04-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-25
• Last Update Posted: 2022-05-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cancer patients in Mexico	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Local Institution; 🇲🇽 Mexico, Distrito Federal, Mexico