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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03161613

Enrollment

Registered

2017-05-22

Start date

2017-07-17

Completion date

2019-04-01

Last updated

2022-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Indications Cancer

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.

Interventions

OTHERNon-Interventional

Non-Interventional

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 on-study AEs	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
Distribution of SAEs leading to discontinuation	approximately 24 months
Distribution of on-study SAEs	approximately 24 months

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026