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
Official title: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Multiple Indications Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-05-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of subjects who report on-study Adverse Events(AEs)
timeFrame: approximately 24 months
measure: incidence of subjects who report on-study Serious Adverse Events(SAEs)
timeFrame: approximately 24 months
Secondary outcomes:
measure: Distribution of on-study AEs
timeFrame: approximately 24 months
measure: Distribution of on-study SAEs
timeFrame: approximately 24 months
measure: Distribution of drug-related AEs
timeFrame: approximately 24 months
measure: Distribution of drug-related SAEs
timeFrame: approximately 24 months
measure: Distribution of AEs leading to discontinuation
timeFrame: approximately 24 months
measure: Distribution of SAEs leading to discontinuation
timeFrame: approximately 24 months
measure: Distribution of age in patients
timeFrame: At Baseline
measure: Distribution of gender in patients
timeFrame: At Baseline
measure: Distribution of tumor history in patients
timeFrame: At Baseline
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: