Non-Small Cell Lung Cancer (NSCLC)Phase 4NCT03444766
Study of Nivolumab for Advanced Cancers in India
A Phase 4 study testing Nivolumab in people with Non-Small Cell Lung Cancer (NSCLC) and Non-Small-Cell Lung Carcinoma, run by Bristol-Myers Squibb at 9 sites in India.
Trial summary
This is a study of nivolumab in participants with advanced Non-Small Cell Lung Cancer or Kidney Cancer in India. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer (NSCLC), Non-Small-Cell Lung Carcinoma, Nonsmall Cell Lung Cancer
- What is being tested?
- Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 9 sitesIndia
- Study dates
- 6 Mar 2018to 17 Jul 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy OR advanced renal cell carcinoma (RCC) after prior therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to randomization
Who cannot join
- Participants with untreated, symptomatic central nervous system (CNS) metastases
- Participants with carcinomatous meningitis
- Participants with active, known or suspected autoimmune disease
- Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
- Other active malignancy requiring concurrent intervention
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
India9 sites
Local Institution
Bangalore, 560027
Local Institution
Bangalore, 560072
Local Institution
Bengaluru, 560054
Local Institution
Hyderabad, 500034
Local Institution
Jaipur, 302004
Local Institution
Kolkata, 700156
Local Institution
Mumbai, 400012
Local Institution
New Delhi, 110029
Local Institution
Vellore, 632004
About this study
Official title: Safety Study of Nivolumab for Selected Advanced Malignancies in India
This is a study of nivolumab in participants with advanced Non-Small Cell Lung Cancer or Kidney Cancer in India.
- Conditions
- Non-Small Cell Lung Cancer (NSCLC), Non-Small-Cell Lung Carcinoma, Nonsmall Cell Lung Cancer, Kidney Cancer, Kidney Neoplasms, Renal Cancer
- Being tested
- Nivolumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called Opdivo
specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy | Experimental | administering nivolumab only Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-related Adverse Events
Number of participants with treatment-related Adverse Events based on worst ctc grade
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
Measured: 26 Weeks
Secondary outcomes (3)
Number of Participants With Treatment-related Select Adverse Events
Number of participants with treatment-related Select Adverse Events based on worst ctc grade for the following categories:
Pulmonary, Gastrointestinal, Endocrinopathies, Hepatic, Renal, Skin, Neurological and Hypersensitivity/Infusion reactions
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
Measured: 26 Weeks
Number of Participants With Treatment-related Serious Adverse Events
Number of participants with treatment-related Serious Adverse Events based on worst CTC grade
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
Measured: 26 Weeks
Number of Participants With Adverse Events Leading to Discontinuation
Number of participants with Adverse events leading to discontinuation of treatment based on worst CTC grade
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
Measured: 26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start6 Mar 2018
- Primary completion17 Jul 2019
- Study completion17 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Small Cell Lung Cancer (NSCLC)Studies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT03444766
- Sponsor's protocol ID
- CA209-887
- Status last verified
- Dec 2020
- First submitted
- 20 Feb 2018
- Last updated
- 4 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of Nivolumab for Selected Advanced Malignancies in India
- ClinicalTrials.gov ID
- NCT03444766
- Acronym / sponsor ID
- CA209-887
- Conditions
- Non-Small Cell Lung Cancer (NSCLC), Non-Small-Cell Lung Carcinoma, Nonsmall Cell Lung Cancer, Kidney Cancer, Kidney Neoplasms, Renal Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 17 Jul 2019 (actual)
- Study completion
- 17 Jul 2019 (actual)
- First posted
- 23 Feb 2018 (actual)
- Results
- Posted 4 Dec 2020
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 study of nivolumab in participants with advanced Non-Small Cell Lung Cancer or Kidney Cancer in India.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monotherapy | Experimental | Drug: Nivolumabadministering nivolumab only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy OR advanced renal cell carcinoma (RCC) after prior therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to randomization
Key exclusion criteria (6 listed)
- Participants with untreated, symptomatic central nervous system (CNS) metastases
- Participants with carcinomatous meningitis
- Participants with active, known or suspected autoimmune disease
- Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
- Other active malignancy requiring concurrent intervention
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 |
|---|---|---|
| NivolumabAlso: Opdivospecified dose on specified days | Drug | Monotherapy |
Primary outcome
Number of Participants With Treatment-related Adverse Events
Time frame: 26 Weeks
Number of participants with treatment-related Adverse Events based on worst ctc grade Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
3 secondary outcomes
Number of Participants With Treatment-related Select Adverse Events
Time frame: 26 Weeks
Number of Participants With Treatment-related Serious Adverse Events
Time frame: 26 Weeks
Number of Participants With Adverse Events Leading to Discontinuation
Time frame: 26 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nivolumab in people with Non-Small Cell Lung Cancer (NSCLC) and Non-Small-Cell Lung Carcinoma, run by Bristol-Myers Squibb at 9 sites in India.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in India. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment-related Adverse Events (time frame: 26 Weeks). 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 4 Dec 2020.