Multiple Indications Cancer Clinical Trial
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
| NCT number | NCT03161613 |
| Other study ID # | CA209-869 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 17, 2017 |
| Est. completion date | April 1, 2019 |
| Verified date | May 2022 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | April 1, 2019 |
| Est. primary completion date | April 1, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Mexico | Local Institution | Mexico | Distrito Federal |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
Mexico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of subjects who report on-study Adverse Events(AEs) | approximately 24 months | ||
| Primary | incidence of subjects who report on-study Serious Adverse Events(SAEs) | approximately 24 months | ||
| Secondary | Distribution of on-study AEs | approximately 24 months | ||
| Secondary | Distribution of on-study SAEs | approximately 24 months | ||
| Secondary | Distribution of drug-related AEs | approximately 24 months | ||
| Secondary | Distribution of drug-related SAEs | approximately 24 months | ||
| Secondary | Distribution of AEs leading to discontinuation | approximately 24 months | ||
| Secondary | Distribution of SAEs leading to discontinuation | approximately 24 months | ||
| Secondary | Distribution of age in patients | At Baseline | ||
| Secondary | Distribution of gender in patients | At Baseline | ||
| Secondary | Distribution of tumor history in patients | At Baseline |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02297139 -
Continuing Treatment for Subjects Who Have Participated on a Prior Protocol Investigating Dasatinib
|
Phase 2 |