MelanomaPhase 1NCT03978611
A Study to Assess Safety of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-Programmed Cell Death Protein 1 (Anti-PD-1) Treatment
A Phase 1 study testing Relatlimab and Ipilimumab in people with Melanoma, run by Bristol-Myers Squibb at 28 sites in 6 countries.
Trial summary
The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) of relatlimab in combination with ipilimumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Relatlimab and Ipilimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 28 sitesin 6 countries
- Study dates
- 9 Dec 2021to 26 Jul 2023
- 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
- Must have documented progression while on a prior anti-programmed cell death protein 1 (PD-1) containing regimen limited to Nivolumab or Pembrolizumab
- Must have histologically confirmed advanced unresectable (Stage III) or metastatic (Stage IV) melanoma, as per (AJCC) staging system
- Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses
- Eastern Cooperative Oncology Group (ECOG) 0-1
Who cannot join
- History of uveal melanoma
- Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome
- Prior treatment with ipilimumab, relatlimab, or any other cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) or lymphocyte-activation gene 3 (LAG-3) targeted agents
Trial locations and contacts
28 sites in 6 countries.
28 sites in 6 countries
United States8 sites
Local Institution - 0003
Ann Arbor, Michigan, 48109
Local Institution - 0004
Chicago, Illinois, 60611
Local Institution - 0002
Los Angeles, California, 90033
Local Institution - 0005
Los Angeles, California, 90033
Local Institution - 0015
Miami, Florida, 33136
Local Institution - 0008
Morristown, New Jersey, 07960
Local Institution - 0001
Santa Monica, California, 90404
Local Institution - 0023
Tucson, Arizona, 85724
Germany7 sites
Local Institution - 0037
Erlangen, 91054
Local Institution - 0034
Essen, 45147
Local Institution - 0036
Gera, 07548
Local Institution - 0035
Hanover, 30625
Local Institution - 0033
Heidelberg, 69120
Local Institution - 0032
Lübeck, 23562
Local Institution - 0040
Nuremberg, 90419
Spain6 sites
Local Institution - 0026
Barcelona, 08035
Local Institution - 0030
Córdoba, 14004
Local Institution - 0031
Donostia / San Sebastian, 20014
Local Institution - 0027
Hospitalet de Llobregat - Barcelona, 08908
Local Institution - 0029
Madrid, 28034
Local Institution - 0028
Valencia, 46009
Belgium4 sites
Local Institution - 0017
Antwerp, 2020
Local Institution - 0018
Brussels, Brussels Capital, 1000
Local Institution - 0016
Brussels, 1090
Local Institution - 0038
Brussels, 1200
Italy2 sites
Local Institution - 0053
Padova, 35128
Local Institution - 0055
Siena, 53100
About this study
Official title: A Phase 1/2a Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab Administered in Combination With Ipilimumab or Ipilimumab Alone in Participants With Unresectable or Metastatic Melanoma Who Have Progressed on Anti-PD-1 Therapy
The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) of relatlimab in combination with ipilimumab.
- Conditions
- Melanoma
- Being tested
- Relatlimab, Ipilimumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RelatlimabDrug
Also called BMS-986016
Specified dose on specified days
IpilimumabDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Escalation Phase | Experimental | Not described Receives: Drug: Relatlimab; Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs)
Measured: Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])
Number of Participants with Serious Adverse Events (SAEs)
Measured: Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])
Number of Participants With Adverse Events Including Dose Limiting Toxicity
Measured: Up to 28 days after last study drug dose (approximately up to 2 years)
Number of Participants with AEs resulting in Discontinuation
Measured: Up to end of study (approximately 2.4 years)
Number of Participants with AEs resulting in Death
Measured: Up to end of study (approximately 2.4 years)
Number of Participants with AEs resulting in Laboratory Abnormalities
Measured: Up to end of study (approximately 2.4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start9 Dec 2021
- Primary completion26 Jul 2023
- Study completion26 Jul 2023
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 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 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
- NCT03978611
- Sponsor's protocol ID
- CA224-083
- Other IDs
- 2019-000132-25, 2019
- Status last verified
- Jul 2024
- First submitted
- 5 Jun 2019
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab Administered in Combination With Ipilimumab or Ipilimumab Alone in Participants With Unresectable or Metastatic Melanoma Who Have Progressed on Anti-PD-1 Therapy
- ClinicalTrials.gov ID
- NCT03978611
- Acronym / sponsor ID
- CA224-083
- Conditions
- Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business objectives have changed.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 26 Jul 2023 (actual)
- First posted
- 7 Jun 2019 (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.
The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) of relatlimab in combination with ipilimumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Escalation Phase | Experimental | Drug: Relatlimab, Drug: Ipilimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must have documented progression while on a prior anti-programmed cell death protein 1 (PD-1) containing regimen limited to Nivolumab or Pembrolizumab
- Must have histologically confirmed advanced unresectable (Stage III) or metastatic (Stage IV) melanoma, as per (AJCC) staging system
- Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses
- Eastern Cooperative Oncology Group (ECOG) 0-1
Key exclusion criteria (3 listed)
- History of uveal melanoma
- Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome
- Prior treatment with ipilimumab, relatlimab, or any other cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) or lymphocyte-activation gene 3 (LAG-3) targeted agents
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 |
|---|---|---|
| RelatlimabAlso: BMS-986016Specified dose on specified days | Drug | Part 1: Dose Escalation Phase |
| IpilimumabSpecified dose on specified days | Drug | Part 1: Dose Escalation Phase |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])
Number of Participants With Adverse Events Including Dose Limiting Toxicity
Time frame: Up to 28 days after last study drug dose (approximately up to 2 years)
Number of Participants with AEs resulting in Discontinuation
Time frame: Up to end of study (approximately 2.4 years)
Number of Participants with AEs resulting in Death
Time frame: Up to end of study (approximately 2.4 years)
Number of Participants with AEs resulting in Laboratory Abnormalities
Time frame: Up to end of study (approximately 2.4 years)
Results and safety
The study was stopped early (reason given: Business objectives have changed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink 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
28 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Relatlimab and Ipilimumab in people with Melanoma, run by Bristol-Myers Squibb at 28 sites in 6 countries.
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 3 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: stopped early, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Germany, Spain, Belgium, Italy and 1 more country. 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 was stopped early (reason given: Business objectives have changed.). Results are not available in the source record.
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 Adverse Events (AEs) (time frame: Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])). The study lists 6 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 24 Jul 2024.