Multiple Indications CancerNCT03161613
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
An observational study of Multiple Indications Cancer, run by Bristol-Myers Squibb at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Indications Cancer
- What is being tested?
- Non-Interventional
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- 17 Jul 2017to 1 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
- 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
- Patients who present with brain metastases are allowed, if asymptomatic, do not have edema, and are not receiving corticosteroids or radiation
- Patients have received at least 1 dose of nivolumab
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Multiple Indications Cancer
- Being tested
- Non-Interventional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
Non-Interventional
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients in Mexico | 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 Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of subjects who report on-study Adverse Events(AEs)
Measured: approximately 24 months
incidence of subjects who report on-study Serious Adverse Events(SAEs)
Measured: approximately 24 months
Secondary outcomes (9)
Distribution of on-study AEs
Measured: approximately 24 months
Distribution of on-study SAEs
Measured: approximately 24 months
Distribution of drug-related AEs
Measured: approximately 24 months
Distribution of drug-related SAEs
Measured: approximately 24 months
Distribution of AEs leading to discontinuation
Measured: approximately 24 months
Distribution of SAEs leading to discontinuation
Measured: approximately 24 months
Distribution of age in patients
Measured: At Baseline
Distribution of gender in patients
Measured: At Baseline
Distribution of tumor history in patients
Measured: At Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start17 Jul 2017
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Apr 2019 (estimated)
Why it stopped: Business objectives have changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Indications CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161613
- Sponsor's protocol ID
- CA209-869
- Status last verified
- May 2022
- First submitted
- 18 May 2017
- Last updated
- 27 May 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03161613
- Acronym / sponsor ID
- CA209-869
- Conditions
- Multiple Indications Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Business objectives have changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients in Mexico | – | Other: Non-Interventionallung 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
- 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
- Patients who present with brain metastases are allowed, if asymptomatic, do not have edema, and are not receiving corticosteroids or radiation
- Patients have received at least 1 dose of nivolumab
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-InterventionalNon-Interventional | Other | Cancer patients in Mexico |
Primary outcome
Incidence of subjects who report on-study Adverse Events(AEs)
Time frame: approximately 24 months
incidence of subjects who report on-study Serious Adverse Events(SAEs)
Time frame: approximately 24 months
9 secondary outcomes
Distribution of on-study AEs
Time frame: approximately 24 months
Distribution of on-study SAEs
Time frame: approximately 24 months
Distribution of drug-related AEs
Time frame: approximately 24 months
Distribution of drug-related SAEs
Time frame: approximately 24 months
Distribution of AEs leading to discontinuation
Time frame: approximately 24 months
Distribution of SAEs leading to discontinuation
Time frame: approximately 24 months
Distribution of age in patients
Time frame: At Baseline
Distribution of gender in patients
Time frame: At Baseline
Distribution of tumor history in patients
Time frame: At Baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
Related trials for Multiple Indications Cancer
Not yet recruitingObservational study
Outcomes for IR and High Risk (HR) Non-muscle Invasive Bladder Cancer (NMIBC) and ctDNA-based Biomarkers for Response and Recurrence in Muscle Invasive Bladder Cancer (MIBC)
NMIBC, MIBC
Active, not recruiting
HELP Study - Towards High Throughput and Efficient Long-axial PET With Oral [18F]FDG
Multiple Cancers, Multiple Indications Cancer
Not yet recruitingPhase 4
A Trial of Pembrolizumab With Chemotherapy or Chemoradiotherapy in Participants From India With Different Types of Cancer (MK-3475-G44/KEYNOTE-G44)
Neoplasm Malignant, Gastric Neoplasms
RecruitingPhase 2/3
DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage/Young Adult Patients With BRAF V600 Mutation-Positive Cancers.
Haematological Malignancy, Malignant Neoplasm
RecruitingObservational study
A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
Hematologic Malignancies, Inherited Disorders of Metabolism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Indications Cancer, run by Bristol-Myers Squibb at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of subjects who report on-study Adverse Events(AEs) (time frame: approximately 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.