CancerPhase 1NCT04112498
A Phase 1, Bioavailability Study of Relatlimab in Combination With Nivolumab
A Phase 1 study testing relatlimab, nivolumab and rHuPH20 in people with Cancer, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
This study will characterize the movement of drugs within the body, evaluate safety and determine to which extent the body can process relatlimab in combination with nivolumab in subjects with certain advanced tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- relatlimab, nivolumab and rHuPH20
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 27 Feb 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
- Histologic or cytologic confirmation of (unresectable and/or metastatic) advanced solid tumors
- Melanoma
- Metastatic squamous or non- squamous non-small cell lung cancer (NSCLC)
- Gastric adenocarcinoma (includes gastro-esophageal junction)
- Hepatocellular carcinoma (HCC)
- Squamous cell carcinoma of the head and neck (SCCHN)
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- Renal cell carcinoma (RCC)
- Bladder cancer
- Participants must have received available standard therapies
- Women and men must agree to follow instructions for method of contraception
- Measureable disease as per RECIST version 1.1 criteria
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Who cannot join
- Participants must not have active brain metastases or leptomeningeal metastases
- Participants with HCC must not have any history of hepatic encephalopathy, any prior (within 1 year) or current clinically significant ascites
- History of allergy or hypersensitivity to study drug components
- Participants with serious or uncontrolled cardiovascular disease
- Excluding patients with serious or uncontrolled medical disorders
- Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment
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- Participants with an active, known, or suspected autoimmune disease
- Participants must not have evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
- Other protocol defined inclusion/exclusion Criteria could apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Local Institution - 0001
Hackensack, New Jersey, 07601
About this study
Official title: A Phase 1, Multi-Tumor, Bioavailability Study of Relatlimab in Combination With Nivolumab
This study will characterize the movement of drugs within the body, evaluate safety and determine to which extent the body can process relatlimab in combination with nivolumab in subjects with certain advanced tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
relatlimabDrug
Specified dose on Specified days
nivolumabDrug
Also called Opdivo
Specified dose on Specified days
rHuPH20Drug
Also called Enhanze
Specified dose on Specified days
| Study group | Role | What they receive |
|---|---|---|
| nivolumab + relatlimab + rHuPH20 | Experimental | Not described Receives: Drug: relatlimab; Drug: nivolumab; Drug: rHuPH20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum observed serum concentration (Cmax)
Measured: approximately 60 days
time of maximum observed serum concentration (Tmax)
Measured: approximately 60 days
area under the time-concentration curve over the dosing interval AUC (TAU)
Measured: approximately 60 days
Observed concentration at the end of the dosing interval (Ctau)
Measured: approximately 60 days
Incidence of Serious Adverse Events (SAEs)
Measured: approximately 2 years
Incidence of Adverse Events (AEs)
Measured: approximately 2 years
Incidence of Adverse Events leading to discontinuation
Measured: approximately 2 years
Number of deaths
Measured: approximately 2 years
Number of laboratory abnormalities
Measured: approximately 2 years
Secondary outcomes (4)
Incidence of Adverese Events (AEs) in the broad SMQ of Anaphylactic Reaction
Measured: approximately 2 years
Number of events within the hypersensitivity/infusion reaction select AE category
Measured: approximately 2 years
Incidence of anti-relatlimab antibodies and neutralizing antibodies (if applicable)
Measured: approximately 2 years
Incidence of anti-nivolumab antibodies and neutralizing antibodies (if applicable)
Measured: approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start1 Oct 2019
- Primary completion27 Feb 2023
- Study completion27 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112498
- Sponsor's protocol ID
- CA224-087
- Status last verified
- Apr 2023
- First submitted
- 1 Oct 2019
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multi-Tumor, Bioavailability Study of Relatlimab in Combination With Nivolumab
- ClinicalTrials.gov ID
- NCT04112498
- Acronym / sponsor ID
- CA224-087
- Conditions
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 2 Oct 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.
This study will characterize the movement of drugs within the body, evaluate safety and determine to which extent the body can process relatlimab in combination with nivolumab in subjects with certain advanced tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nivolumab + relatlimab + rHuPH20 | Experimental | Drug: relatlimab, Drug: nivolumab, Drug: rHuPH20 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologic or cytologic confirmation of (unresectable and/or metastatic) advanced solid tumors
- Melanoma
- Metastatic squamous or non- squamous non-small cell lung cancer (NSCLC)
- Gastric adenocarcinoma (includes gastro-esophageal junction)
- Hepatocellular carcinoma (HCC)
Key exclusion criteria (9 listed)
- Participants must not have active brain metastases or leptomeningeal metastases
- Participants with HCC must not have any history of hepatic encephalopathy, any prior (within 1 year) or current clinically significant ascites
- History of allergy or hypersensitivity to study drug components
- Participants with serious or uncontrolled cardiovascular disease
- Excluding patients with serious or uncontrolled medical disorders
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 |
|---|---|---|
| relatlimabSpecified dose on Specified days | Drug | nivolumab + relatlimab + rHuPH20 |
| nivolumabAlso: OpdivoSpecified dose on Specified days | Drug | nivolumab + relatlimab + rHuPH20 |
| rHuPH20Also: EnhanzeSpecified dose on Specified days | Drug | nivolumab + relatlimab + rHuPH20 |
Primary outcome
maximum observed serum concentration (Cmax)
Time frame: approximately 60 days
time of maximum observed serum concentration (Tmax)
Time frame: approximately 60 days
area under the time-concentration curve over the dosing interval AUC (TAU)
Time frame: approximately 60 days
Observed concentration at the end of the dosing interval (Ctau)
Time frame: approximately 60 days
Incidence of Serious Adverse Events (SAEs)
Time frame: approximately 2 years
Incidence of Adverse Events (AEs)
Time frame: approximately 2 years
Incidence of Adverse Events leading to discontinuation
Time frame: approximately 2 years
Number of deaths
Time frame: approximately 2 years
Number of laboratory abnormalities
Time frame: approximately 2 years
4 secondary outcomes
Incidence of Adverese Events (AEs) in the broad SMQ of Anaphylactic Reaction
Time frame: approximately 2 years
Number of events within the hypersensitivity/infusion reaction select AE category
Time frame: approximately 2 years
Incidence of anti-relatlimab antibodies and neutralizing antibodies (if applicable)
Time frame: approximately 2 years
Incidence of anti-nivolumab antibodies and neutralizing antibodies (if applicable)
Time frame: approximately 2 years
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 6 Apr 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 relatlimab, nivolumab and rHuPH20 in people with Cancer, run by Bristol-Myers Squibb at 1 site in United States.
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 12 inclusion and 9 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 6 Apr 2023. 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 United States. 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?
maximum observed serum concentration (Cmax) (time frame: approximately 60 days). The study lists 9 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 6 Apr 2023.