MelanomaPhase 2NCT06101134

A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations

A Phase 2 study testing relatlimab+nivolumab, relatlimab+nivolumab+rHuPH20 and nivolumab in people with Melanoma, run by Bristol-Myers Squibb at 31 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Melanoma
What is being tested?: relatlimab+nivolumab, relatlimab+nivolumab+rHuPH20 and nivolumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 31 sitesin 5 countries
Study dates: 6 Nov 2023to 21 Dec 2026
Phase: Phase 2
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

Must have either metastatic melanoma and have not had previous treatment for their cancer, or resected melanoma and have had the cancer removed fully with surgery no later than 12 weeks before the start of treatment and confirmed free of disease
Must have a low level of disability and cancer that is considered advanced for metastatic melanoma and at risk for becoming advanced (intermediate) or advanced for resected melanoma

Who cannot join

Must not have any brain cancer/disease treated with radiation, any cancer in the eyes or mucous membranes (cells that cover inside surface of parts of the body and keep it moist), any autoimmune disease, or any condition that is being treated with steroids for inflammation (corticosteroids) or medication to decrease the body's immune system response (immunosuppressive drugs)
Other protocol-defined inclusion/exclusion criteria apply.

Trial locations and contacts

31 sites in 5 countries.

Country

City, postcode or hospital

31 sites in 5 countries

United States9 sites

Local Institution - 0028
Albuquerque, New Mexico, 87106
Local Institution - 0007
Anchorage, Alaska, 99508-2974
Local Institution - 0034
Atlanta, Georgia, 30342
Local Institution - 0032
Edgewood, Kentucky, 41017
Local Institution - 0037
Edmonds, Washington, 98026-8032
Local Institution - 0036
Issaquah, Washington, 98026
Local Institution - 0013
Phoenix, Arizona, 85054-4502
Local Institution - 0010
San Francisco, California, 94115-3010
Local Institution - 0030
Seattle, Washington, 98104

Other trials in United States

Italy7 sites

Local Institution - 0017
Bergamo, BG, 24127
Local Institution - 0035
Meldola, FC, 47014
Local Institution - 0018
Milan, MI, 20141
Local Institution - 0026
Naples, 80131
Local Institution - 0012
Padova, PD, 35128
Local Institution - 0021
Roma, RM, 00144
Local Institution - 0004
Torino, TO, 10126

Other trials in Italy

Spain7 sites

Local Institution - 0020
Badalona, 08916
Local Institution - 0011
Barcelona, B, 08025
Local Institution - 0022
Barcelona, B, 08908
Local Institution - 0027
Cantabria, 39008
Local Institution - 0009
Cartagena, MU, 30120
Local Institution - 0003
San Pedro Alcántara, Málaga, 10002
Local Institution - 0006
Seville, 41013

Other trials in Spain

Greece6 sites

Local Institution - 0014
Athens, I, 115 27
Local Institution - 0023
Holargos, Athens, 155 62
Local Institution - 0029
Marousi, I, 151 25
Local Institution - 0008
Piraeus, 185 47
Local Institution - 0019
Thessaloniki, B, 546 22
Local Institution - 0033
Thessaloniki, 564 29

Other trials in Greece

Chile2 sites

Local Institution - 0005
Concepción, 4070196
Local Institution - 0015
Las Condes, Santiago Metropolitan, 8331010

Other trials in Chile

About this study

Official title: A Phase 2 Open-label, Two-cohort Study to Evaluate Patient Preference for Nivolumab + Relatlimab Fixed-dose Combination Subcutaneous Versus Nivolumab + Relatlimab Fixed-dose Combination Intravenous and Nivolumab Subcutaneous Versus Nivolumab Intravenous in Participants With Melanoma

The purpose of this study is to assess the patient's preference for nivolumab subcutaneous (SC) or nivolumab + relatlimab fixed-dose combination (FDC) SC and provide patient experience data by route of administration. This study will also generate safety data which will further characterize the safety profile of patients switching the route of administration from intravenous (IV) to SC.

Conditions: Melanoma
Being tested: relatlimab+nivolumab, relatlimab+nivolumab+rHuPH20, nivolumab, nivolumab+rHuPH20
Keywords: Patient preference, Nivolumab Relatlimab IV, Nivolumab Relatimab SC, Melanoma, rHuPH20, FDC IV, FDC SC, Adjuvant, Metastatic, Switch, Nivolumab, Relatlimab
Medical subject headings: Melanoma, Patient Preference, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

relatlimab+nivolumabDrug
Also called BMS-986213, Opdualag
Specified dose on specified days
relatlimab+nivolumab+rHuPH20Drug
Specified dose on specified days
nivolumabDrug
Also called BMS-936558, Opdivo
Specified dose on specified days
nivolumab+rHuPH20Drug
Also called BMS-986298
Specified dose on specified days

Study groups in NCT06101134
Study group	Role	What they receive
Cohort 1: Metastatic Melanoma	Experimental	Not described Receives: Drug: relatlimab+nivolumab; Drug: relatlimab+nivolumab+rHuPH20
Cohort 2: Resected Melanoma	Experimental	Not described Receives: Drug: nivolumab; Drug: nivolumab+rHuPH20

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Evaluable Participants That Prefer SC Route of Administration Using the Patient Experience and Preference Questionnaire (PEPQ) (Question 7) After Cycle 4 Day 1 Dose
PEPQ included 7 items 1. Pain or Discomfort (rated on 1 to 10 scale), 2. Length of time related to administration 3. Length of time related to administration impact amount of time to speak to doctor or nurse about illness or concern 4. Length of time for administration impact time to interact or socialize with other individuals 5. Convenience 6. Satisfaction 7. Choice of which route of administration would be preferred. 95% CI exact confidence interval was reported.
Measured: Cycle 4 Day 1 (each cycle consist of 4 weeks)

Secondary outcomes (2)

Number of Participants With Adverse Events and Deaths
An adverse event is any untoward medical occurrence that begins or worsens after the first dose of study treatment, including any unfavorable sign, symptom, disease, or abnormal lab finding, whether or not related to the product, and may include worsening of pre-existing conditions. A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect, or is considered an important medical event requiring intervention to prevent these outcomes.
Measured: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 16 months)
Number of Participants With Laboratory Abnormalities and Immune Mediate Adverse Event
Measured: From first dose (Day 1) and up to study completion (up to approximately 45 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Nov 202321 Dec 2026

First posted26 Oct 2023
Study start6 Nov 2023
Primary completion10 Apr 2025
Study completion21 Dec 2026 (estimated)

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 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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06101134
Sponsor's protocol ID: CA224-1044
Other IDs: U1111-1289-5947, 2023-504515-33-00, 2023
Status last verified: Aug 2026
First submitted: 20 Oct 2023
Last updated: 14 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Community Based Strategies for Early Detection of Melanoma
Melanoma
Active, not recruitingPhase 3
Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
Active, not recruitingPhase 2
A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma
Acral Lentiginous Melanoma, Clinical Stage III Cutaneous Melanoma AJCC v8
RecruitingObservational study
Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma
Melanoma, Dysplastic Nevus Syndrome
RecruitingPhase 1
A Phase 1 Study to Evaluate OPB-201 in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.
Endometrial Cancer Recurrent, Endometrial Cancer

All Melanoma trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Open-label, Two-cohort Study to Evaluate Patient Preference for Nivolumab + Relatlimab Fixed-dose Combination Subcutaneous Versus Nivolumab + Relatlimab Fixed-dose Combination Intravenous and Nivolumab Subcutaneous Versus Nivolumab Intravenous in Participants With Melanoma
ClinicalTrials.gov ID: NCT06101134
Acronym / sponsor ID: CA224-1044
Conditions: Melanoma
Keywords: Patient preference, Nivolumab Relatlimab IV, Nivolumab Relatimab SC, Melanoma, rHuPH20, FDC IV, FDC SC, Adjuvant
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 100 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 6 Nov 2023 (actual)
Primary completion: 10 Apr 2025 (actual)
Study completion: 21 Dec 2026 (estimated)
First posted: 26 Oct 2023 (actual)
Results: Posted 9 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort 1: Metastatic Melanoma	Experimental	Drug: relatlimab+nivolumab, Drug: relatlimab+nivolumab+rHuPH20
Cohort 2: Resected Melanoma	Experimental	Drug: nivolumab, Drug: nivolumab+rHuPH20

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Must have either metastatic melanoma and have not had previous treatment for their cancer, or resected melanoma and have had the cancer removed fully with surgery no later than 12 weeks before the start of treatment and confirmed free of disease
Must have a low level of disability and cancer that is considered advanced for metastatic melanoma and at risk for becoming advanced (intermediate) or advanced for resected melanoma

Key exclusion criteria (2 listed)

Must not have any brain cancer/disease treated with radiation, any cancer in the eyes or mucous membranes (cells that cover inside surface of parts of the body and keep it moist), any autoimmune disease, or any condition that is being treated with steroids for inflammation (corticosteroids) or medication to decrease the body's immune system response (immunosuppressive drugs)
Other protocol-defined inclusion/exclusion criteria apply.

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
relatlimab+nivolumabAlso: BMS-986213, OpdualagSpecified dose on specified days	Drug	Cohort 1: Metastatic Melanoma
relatlimab+nivolumab+rHuPH20Specified dose on specified days	Drug	Cohort 1: Metastatic Melanoma
nivolumabAlso: BMS-936558, OpdivoSpecified dose on specified days	Drug	Cohort 2: Resected Melanoma
nivolumab+rHuPH20Also: BMS-986298Specified dose on specified days	Drug	Cohort 2: Resected Melanoma

Primary outcome

Percentage of Evaluable Participants That Prefer SC Route of Administration Using the Patient Experience and Preference Questionnaire (PEPQ) (Question 7) After Cycle 4 Day 1 Dose
Time frame: Cycle 4 Day 1 (each cycle consist of 4 weeks)
PEPQ included 7 items 1. Pain or Discomfort (rated on 1 to 10 scale), 2. Length of time related to administration 3. Length of time related to administration impact amount of time to speak to doctor or nurse about illness or concern 4. Length of time for administration impact time to interact or socialize with other individuals 5. Convenience 6. Satisfaction 7. Choice of which route of administration would be preferred. 95% CI exact confidence interval was reported.

2 secondary outcomes

Number of Participants With Adverse Events and Deaths
Time frame: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 16 months)
Number of Participants With Laboratory Abnormalities and Immune Mediate Adverse Event
Time frame: From first dose (Day 1) and up to study completion (up to approximately 45 months)

Results and safety

Results posted to the registry on 9 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: Metastatic Melanoma	50	0
Cohort 2: Resected Melanoma	50	4

Primary outcome: Percentage of Evaluable Participants That Prefer SC Route of Administration Using the Patient Experience and Preference Questionnaire (PEPQ) (Question 7) After Cycle 4 Day 1 Dose

Time frame: Cycle 4 Day 1 (each cycle consist of 4 weeks). Number (95% Confidence Interval). Unit: percentage of partcipants

Measure	Cohort 1: Metastatic Melanoma n = 41	Cohort 2: Resected Melanoma n = 48
Value	78.0 (62.4 to 89.4)	70.8 (55.9 to 83.0)

Population analysed: PEPQ Evaluable population is defined as all enrolled participants who have received two doses of nivolumab + relatlimab FDC IV, two doses of nivolumab + relatlimab FDC SC and have answered Question 7 of the PEPQ

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: Metastatic Melanoma	21 of 50 (42%)	44 of 50 (88%)	8 of 50
Cohort 2: Resected Melanoma	6 of 50 (12%)	41 of 50 (82%)	2 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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.
Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Related trials for Melanoma

Enrolling by invitationObservational study
Community Based Strategies for Early Detection of Melanoma
Melanoma
Active, not recruitingPhase 3
Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
Active, not recruitingPhase 2
A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma
Acral Lentiginous Melanoma, Clinical Stage III Cutaneous Melanoma AJCC v8
RecruitingObservational study
Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma
Melanoma, Dysplastic Nevus Syndrome
RecruitingPhase 1
A Phase 1 Study to Evaluate OPB-201 in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.
Endometrial Cancer Recurrent, Endometrial Cancer

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

31 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing relatlimab+nivolumab, relatlimab+nivolumab+rHuPH20 and nivolumab in people with Melanoma, run by Bristol-Myers Squibb at 31 sites in 5 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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Italy, Spain, Greece, Chile. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 9 Apr 2026). 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?

Percentage of Evaluable Participants That Prefer SC Route of Administration Using the Patient Experience and Preference Questionnaire (PEPQ) (Question 7) After Cycle 4 Day 1 Dose (time frame: Cycle 4 Day 1 (each cycle consist of 4 weeks)). 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 NCT06101134.

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 14 Sep 2026.