MelanomaPhase 2NCT05419388
A Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma
A Phase 2 study testing RO7247669 in people with Melanoma, run by Hoffmann-La Roche at 22 sites in 10 countries.
Trial summary
The purpose of this study is to assess the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics of two dose levels of RO7247669 in participants with unresectable or metastatic melanoma to select the recommended dose for further development. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- RO7247669
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 22 sitesin 10 countries
- Study dates
- 15 Aug 2022to 27 Nov 2025
- Phase
- Phase 2
- 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
- Histologically confirmed unresectable or metastatic melanoma, per the American Joint Committee on Cancer (AJCC) staging system (unresectable Stage III or Stage IV)
- Radiologically measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Known v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status
- Adequate cardiovascular, hematological, hepatic and renal function
- Willingness to abide by contraceptive measures for the duration of the study
- Participants must have known PD-L1 status
Who cannot join
- Pregnancy, lactation, or breastfeeding
- Known hypersensitivity to any of the components of RO7247669
- Participants must not have ocular melanoma
- Symptomatic central nervous system (CNS) metastases
- Significant cardiovascular/cerebrovascular disease within 6 months prior to randomization
- Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic, or other infection or any major episode of infection requiring treatment with intravenous (IV) antibiotics or hospitalization within 28 days prior to randomization
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- Major surgical procedure or significant traumatic injury (excluding biopsies) within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study
- Active or history of autoimmune disease or immune deficiency with some exceptions
- Prior systemic anticancer therapy for unresectable or metastatic melanoma
- Prior anticancer therapy with any-immunomodulatory agents including CPIs (such as anti-programmed death-ligand 1[PD-L1]/PD-1 and anti-cytotoxic T lymphocyte-associated antigen [CTLA-4]) with some exceptions if used as prior adjuvant or neoadjuvant melanoma therapies
- Prior treatment with anti-LAG3 therapy
Trial locations and contacts
22 sites in 10 countries.
22 sites in 10 countries
Australia4 sites
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, 2450
One Clinical Research
Nedlands, Western Australia, 6009
Melanoma Institute Australia
North Sydney, New South Wales, 2060
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Brazil4 sites
Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400
Hospital de Clínicas de Porto Alegre X
Porto Alegre, Rio Grande do Sul, DUMMY_VALUE
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, 01246-000
Hospital Sírio-Libanês
São Paulo, São Paulo, 01308-050
Turkey (Türkiye)3 sites
Adana Baskent University Hospital
Adana, 01120
Memorial Ankara Hastanesi
Ankara, 06520
Medipol Mega Üniversite Hastanesi Göztepe
Istanbul, 34214
New Zealand2 sites
Auckland City Hospital, Cancer and Blood Research
Auckland, 1023
Wellington Hospital
Wellington, 6002
Poland2 sites
Uniwersyteckie Centrum Kliniczne
Gda?sk, 80-214
Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie
Warsaw, 02-781
Slovakia2 sites
Narodny Onkologicky Ustav
Bratislava, 833 10
POKO Poprad
Poprad, 058 01
Spain2 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Clínic i Provincial
Barcelona, 08036
About this study
Official title: A Randomized, Open-Label, Multicenter, Phase II Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma
The purpose of this study is to assess the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics of two dose levels of RO7247669 in participants with unresectable or metastatic melanoma to select the recommended dose for further development.
- Conditions
- Melanoma
- Being tested
- RO7247669
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7247669Drug
Participants will receive intravenous (IV) RO7247669 Q3W
| Study group | Role | What they receive |
|---|---|---|
| Low dose every three weeks (Q3W) | Experimental | Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months. Receives: Drug: RO7247669 |
| High dose Q3W | Experimental | Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months. Receives: Drug: RO7247669 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Measured: From randomization to the first occurrence of progression or death during the treatment period or within 60 days of the last tumor assessment after treatment discontinuation from any cause, whichever occurs first (up to 25 months)
Secondary outcomes (8)
Percentage of Participants with Adverse Events
Measured: Up to 25 months
Objective response rate (ORR)
Measured: Up to 25 months
Disease control rate (DCR)
Measured: Up to 25 months
Duration of response (DOR)
Measured: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 25 months)
Serum concentration of RO7247669
Measured: Up to 25 months
Percentage of participants with anti-drug antibodies (ADAs)
Measured: Baseline up to 25 months
Change from baseline in the number and activation status of peripheral blood immune cells
Measured: Baseline up to 25 months
Change from baseline in the number and activation of immune cells in the tumor microenvironment
Measured: Baseline to Cycle 2 Day 9 (cycle = 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start15 Aug 2022
- Primary completion1 May 2024
- Study completion27 Nov 2025
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 Hoffmann-La RocheThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419388
- Sponsor's protocol ID
- BP43963
- Other IDs
- 2023-505672-30-00, 2023
- Status last verified
- Jan 2026
- First submitted
- 13 Jun 2022
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multicenter, Phase II Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT05419388
- Acronym / sponsor ID
- BP43963
- Conditions
- Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 27 Nov 2025 (actual)
- First posted
- 15 Jun 2022 (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 purpose of this study is to assess the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics of two dose levels of RO7247669 in participants with unresectable or metastatic melanoma to select the recommended dose for further development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose every three weeks (Q3W) | Experimental | Drug: RO7247669Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months. |
| High dose Q3W | Experimental | Drug: RO7247669Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed unresectable or metastatic melanoma, per the American Joint Committee on Cancer (AJCC) staging system (unresectable Stage III or Stage IV)
- Radiologically measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Known v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status
- Adequate cardiovascular, hematological, hepatic and renal function
Key exclusion criteria (11 listed)
- Pregnancy, lactation, or breastfeeding
- Known hypersensitivity to any of the components of RO7247669
- Participants must not have ocular melanoma
- Symptomatic central nervous system (CNS) metastases
- Significant cardiovascular/cerebrovascular disease within 6 months prior to randomization
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 |
|---|---|---|
| RO7247669Participants will receive intravenous (IV) RO7247669 Q3W | Drug | High dose Q3W, Low dose every three weeks (Q3W) |
Primary outcome
Progression-free survival (PFS)
Time frame: From randomization to the first occurrence of progression or death during the treatment period or within 60 days of the last tumor assessment after treatment discontinuation from any cause, whichever occurs first (up to 25 months)
8 secondary outcomes
Percentage of Participants with Adverse Events
Time frame: Up to 25 months
Objective response rate (ORR)
Time frame: Up to 25 months
Disease control rate (DCR)
Time frame: Up to 25 months
Duration of response (DOR)
Time frame: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 25 months)
Serum concentration of RO7247669
Time frame: Up to 25 months
Percentage of participants with anti-drug antibodies (ADAs)
Time frame: Baseline up to 25 months
Change from baseline in the number and activation status of peripheral blood immune cells
Time frame: Baseline up to 25 months
Change from baseline in the number and activation of immune cells in the tumor microenvironment
Time frame: Baseline to Cycle 2 Day 9 (cycle = 21 days)
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 4 Feb 2026.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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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.
Clinical Trials study director
Hoffmann-La Roche
22 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RO7247669 in people with Melanoma, run by Hoffmann-La Roche at 22 sites in 10 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 7 inclusion and 11 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 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Australia, Brazil, Turkey (Türkiye), New Zealand, Poland and 5 more countries. 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?
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?
Progression-free survival (PFS) (time frame: From randomization to the first occurrence of progression or death during the treatment period or within 60 days of the last tumor assessment after treatment discontinuation from any cause, whichever occurs first (up to 25 months)). 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 4 Feb 2026.