Stage III or IV MelanomaPhase 1PD-L1NCT01455103
Phase 1 Biomarker Study of Anti-PDL-1 in Advanced Melanoma
A Phase 1 study testing BMS-936559 (Anti-PD-L1) in people with Stage III or IV Melanoma, run by Bristol-Myers Squibb.
Trial summary
The purpose of this study is to evaluate pharmacodynamic changes of BMS-936559 treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with unresectable Stage III or IV Melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage III or IV Melanoma
- What is being tested?
- BMS-936559 (Anti-PD-L1)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Nov 2013
- 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
- Men and women ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) status = 0 to 1
- Subjects with unresectable Stage III or IV Melanoma who are either refractory or intolerant to, or have refused standard therapy for treatment of metastatic Melanoma
- Subject must have histologic or cytologic confirmation of advanced Melanoma
- Subjects must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- Subjects must have at least 1 tumor site that can be biopsied at acceptable clinical risk and must consent to pre- and post-treatment biopsies
Who cannot join
- Active or progressing brain metastases
- Other concomitant malignancies (with some exceptions per protocol)
- Active or history of autoimmune disease
- Positive test for human immunodeficiency virus (HIV) 1\&2 or known acquired immunodeficiency syndrome (AIDS)
- History of any hepatitis
- Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti Programmed cell death 1 (PD-1), anti Programmed cell death ligand 1 (anti-PD-L1), anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40 or anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibodies
About this study
Official title: A Phase I Study of the Biologic Effects of BMS-936559 Treatment in Subjects With Unresectable Stage III or IV Melanoma
The purpose of this study is to evaluate pharmacodynamic changes of BMS-936559 treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with unresectable Stage III or IV Melanoma.
- Conditions
- Stage III or IV Melanoma
- Being tested
- BMS-936559 (Anti-PD-L1)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-936559 (Anti-PD-L1)Biological
Also called MDX1105
Solution, Intravenous infusion, 1 mg/kg, Every 2 weeks, Up to 2 years, depending on response
BMS-936559 (Anti-PD-L1)Biological
Also called MDX1105
Solution, Intravenous infusion, 3 mg/kg, Every 2 weeks, Up to 2 years, depending on response
BMS-936559 (Anti-PD-L1)Biological
Also called MDX1105
Solution, Intravenous infusion, 10 mg/kg, Every 2 weeks, Up to 2 years, depending on response
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: BMS-936559 (1mg/kg) | Experimental | Not described Receives: Biological: BMS-936559 (Anti-PD-L1) |
| Arm 2: BMS-936559 (3mg/kg) | Experimental | Not described Receives: Biological: BMS-936559 (Anti-PD-L1) |
| Arm 3: BMS-936559 (10mg/kg) | Experimental | Not described Receives: Biological: BMS-936559 (Anti-PD-L1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of immunomodulatory effects of BMS-936559 as measured by changes from baseline in biomarkers assessed 1) peripheral blood assays including flow cytometry and soluble factors and 2) tumor based assays including immunohistochemistry
Measured: Baseline and within the first 24 weeks of study participation
Secondary outcomes (4)
Safety and tolerability of BMS-936559 as measured by the incidence of adverse events (AEs), serious AEs, laboratory test abnormalities, and changes in vital signs
Measured: Every 2 weeks until 70 days after last treatment
Antitumor Activity of BMS-936559 as measured by the objective response rate, disease control rate, duration of response, and progression free survival
Measured: Every 6 weeks for 1 year, every 12 weeks thereafter until confirmed disease progression
Immunogenicity of BMS-936559 as measured by the frequency of subjects with an increase in anti-drug antibody levels from baseline
Measured: Baseline, Week 6, Week 12, and then every 12 weeks until follow-up
Pharmacodynamic activity of BMS-936559 as measured by changes from baseline of the tetramer assay in HLA-A*0210 positive subject only
Measured: Predose (screening) and Cycle 3 Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III or IV 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
- 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
- NCT01455103
- Sponsor's protocol ID
- CA210-002
- Acronym
- PD-L1
- Status last verified
- Oct 2011
- First submitted
- 18 Oct 2011
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Biologic Effects of BMS-936559 Treatment in Subjects With Unresectable Stage III or IV Melanoma
- ClinicalTrials.gov ID
- NCT01455103
- Acronym / sponsor ID
- PD-L1 / CA210-002
- Conditions
- Stage III or IV Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 19 Oct 2011 (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 evaluate pharmacodynamic changes of BMS-936559 treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with unresectable Stage III or IV Melanoma.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: BMS-936559 (1mg/kg) | Experimental | Biological: BMS-936559 (Anti-PD-L1) |
| Arm 2: BMS-936559 (3mg/kg) | Experimental | Biological: BMS-936559 (Anti-PD-L1) |
| Arm 3: BMS-936559 (10mg/kg) | Experimental | Biological: BMS-936559 (Anti-PD-L1) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) status = 0 to 1
- Subjects with unresectable Stage III or IV Melanoma who are either refractory or intolerant to, or have refused standard therapy for treatment of metastatic Melanoma
- Subject must have histologic or cytologic confirmation of advanced Melanoma
- Subjects must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Key exclusion criteria (6 listed)
- Active or progressing brain metastases
- Other concomitant malignancies (with some exceptions per protocol)
- Active or history of autoimmune disease
- Positive test for human immunodeficiency virus (HIV) 1\&2 or known acquired immunodeficiency syndrome (AIDS)
- History of any hepatitis
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 |
|---|---|---|
| BMS-936559 (Anti-PD-L1)Also: MDX1105Solution, Intravenous infusion, 1 mg/kg, Every 2 weeks, Up to 2 years, depending on response | Biological | Arm 1: BMS-936559 (1mg/kg) |
| BMS-936559 (Anti-PD-L1)Also: MDX1105Solution, Intravenous infusion, 3 mg/kg, Every 2 weeks, Up to 2 years, depending on response | Biological | Arm 2: BMS-936559 (3mg/kg) |
| BMS-936559 (Anti-PD-L1)Also: MDX1105Solution, Intravenous infusion, 10 mg/kg, Every 2 weeks, Up to 2 years, depending on response | Biological | Arm 3: BMS-936559 (10mg/kg) |
Primary outcome
Evidence of immunomodulatory effects of BMS-936559 as measured by changes from baseline in biomarkers assessed 1) peripheral blood assays including flow cytometry and soluble factors and 2) tumor based assays including immunohistochemistry
Time frame: Baseline and within the first 24 weeks of study participation
4 secondary outcomes
Safety and tolerability of BMS-936559 as measured by the incidence of adverse events (AEs), serious AEs, laboratory test abnormalities, and changes in vital signs
Time frame: Every 2 weeks until 70 days after last treatment
Antitumor Activity of BMS-936559 as measured by the objective response rate, disease control rate, duration of response, and progression free survival
Time frame: Every 6 weeks for 1 year, every 12 weeks thereafter until confirmed disease progression
Immunogenicity of BMS-936559 as measured by the frequency of subjects with an increase in anti-drug antibody levels from baseline
Time frame: Baseline, Week 6, Week 12, and then every 12 weeks until follow-up
Pharmacodynamic activity of BMS-936559 as measured by changes from baseline of the tetramer assay in HLA-A*0210 positive subject only
Time frame: Predose (screening) and Cycle 3 Day 1
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 13 Dec 2011.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-936559 (Anti-PD-L1) in people with Stage III or IV Melanoma, run by Bristol-Myers Squibb.
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 6 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: withdrawn, as of the sponsor's last update on 13 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Evidence of immunomodulatory effects of BMS-936559 as measured by changes from baseline in biomarkers assessed 1) peripheral blood assays including flow cytometry and soluble factors and 2) tumor based assays including immunohistochemistry (time frame: Baseline and within the first 24 weeks of study participation). 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 13 Dec 2011.