MelanomaPhase 1NCT02516527
A Phase 1 Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Ipilimumab in Chinese Subjects With Select Advanced Solid Tumors
A Phase 1 study testing Ipilimumab in people with Melanoma, run by Bristol-Myers Squibb at 1 site in China.
Trial summary
The purpose of this study is to determine whether ipilimumab is effective in the treatment of select advanced (unresectable, metastatic, or recurrent) solid tumors in Chinese subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Ipilimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2015to 20 Sep 2018
- Phase
- Phase 1
- 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
Who may be able to join
- Subjects with the following advanced solid tumors; metastatic or recurrent
- Must have measurable/non-measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria.
- Subjects have ability to comply with treatment, procedures and pharmacokinetics (PK) sample collection and the required study follow-up
- Chinese women and men, ages 18 years or older
Who cannot join
- Subjects with brain metastases are excluded unless clinically stable for more than 4 weeks at the time of randomization as determined by the investigator
- Subjects with ocular melanoma are excluded
- Any other malignancy from which the subject has been free of disease for less than two years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
- History of, or currently active, autoimmune diseases, including but not limited to inflammatory bowel disease, rheumatoid arthritis, autoimmune hepatitis, systemic sclerosis (scleroderma and variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies (eg, Guillain-Barre syndrome). Vitiligo is not excluded
- Any current or history of immunodeficiency, splenectomy, or splenic radiation
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether ipilimumab is effective in the treatment of select advanced (unresectable, metastatic, or recurrent) solid tumors in Chinese subjects.
- Conditions
- Melanoma
- Being tested
- Ipilimumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Induction Phase:Ipilimumab | Experimental | Ipilimumab dose as specified Receives: Drug: Ipilimumab |
| Maintenance Phase:Ipilimumab | Experimental | Ipilimumab dose as specified Receives: Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of ipilimumab measured by the occurrence of adverse events, serious adverse events, adverse events leading to discontinuation and deaths
Measured: Up to 90 days post discontinuation of dosing
The tolerability of ipilimumab measured by the occurrence of adverse events, serious adverse events, adverse events leading to discontinuation and deaths
Measured: Up to 90 days post discontinuation of dosing
Identify dose limiting toxicities in Chinese subjects with select advanced (unresectable, metastatic, or recurrent) solid tumors measured by the occurrence of adverse events, serious adverse events, adverse events leading to discontinuation, and deaths
Measured: Up to 90 days post discontinuation of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study start16 Oct 2015
- Primary completion20 Sep 2018
- Study completion20 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT02516527
- Sponsor's protocol ID
- CA184-247
- Status last verified
- Apr 2020
- First submitted
- 3 Jul 2015
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ma Y, Fang W, Zhao H, Bathena SP, Tendolkar A, Sheng J, Zhang L. A Phase I Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Ipilimumab in Chinese Patients with Select Advanced Solid Tumors. Oncologist. 2021 Apr;26(4):e549-e566. doi: 10.1002/onco.13577. Epub 2020 Nov 11.
PubMed 33105036
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Ipilimumab in Chinese Subjects With Select Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02516527
- Acronym / sponsor ID
- CA184-247
- Conditions
- Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2015 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 20 Sep 2018 (actual)
- First posted
- 6 Aug 2015 (estimated)
- 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.
The purpose of this study is to determine whether ipilimumab is effective in the treatment of select advanced (unresectable, metastatic, or recurrent) solid tumors in Chinese subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induction Phase:Ipilimumab | Experimental | Drug: IpilimumabIpilimumab dose as specified |
| Maintenance Phase:Ipilimumab | Experimental | Drug: IpilimumabIpilimumab dose as specified |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with the following advanced solid tumors; metastatic or recurrent
- Must have measurable/non-measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria.
- Subjects have ability to comply with treatment, procedures and pharmacokinetics (PK) sample collection and the required study follow-up
- Chinese women and men, ages 18 years or older
Key exclusion criteria (6 listed)
- Subjects with brain metastases are excluded unless clinically stable for more than 4 weeks at the time of randomization as determined by the investigator
- Subjects with ocular melanoma are excluded
- Any other malignancy from which the subject has been free of disease for less than two years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
- History of, or currently active, autoimmune diseases, including but not limited to inflammatory bowel disease, rheumatoid arthritis, autoimmune hepatitis, systemic sclerosis (scleroderma and variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies (eg, Guillain-Barre syndrome). Vitiligo is not excluded
- Any current or history of immunodeficiency, splenectomy, or splenic radiation
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 |
|---|---|---|
| Ipilimumab | Drug | Induction Phase:Ipilimumab, Maintenance Phase:Ipilimumab |
Primary outcome
The safety of ipilimumab measured by the occurrence of adverse events, serious adverse events, adverse events leading to discontinuation and deaths
Time frame: Up to 90 days post discontinuation of dosing
The tolerability of ipilimumab measured by the occurrence of adverse events, serious adverse events, adverse events leading to discontinuation and deaths
Time frame: Up to 90 days post discontinuation of dosing
Identify dose limiting toxicities in Chinese subjects with select advanced (unresectable, metastatic, or recurrent) solid tumors measured by the occurrence of adverse events, serious adverse events, adverse events leading to discontinuation, and deaths
Time frame: Up to 90 days post discontinuation of dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Derived from this study: PubMed 33105036Ma Y, Fang W, Zhao H, Bathena SP, Tendolkar A, Sheng J, Zhang L. A Phase I Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Ipilimumab in Chinese Patients with Select Advanced Solid Tumors. Oncologist. 2021 Apr;26(4):e549-e566. doi: 10.1002/onco.13577. Epub 2020 Nov 11.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ipilimumab in people with Melanoma, run by Bristol-Myers Squibb at 1 site in China.
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 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 1 May 2020. 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 China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The safety of ipilimumab measured by the occurrence of adverse events, serious adverse events, adverse events leading to discontinuation and deaths (time frame: Up to 90 days post discontinuation of dosing). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02516527, which also lists 1 linked publication.
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 1 May 2020.