- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05419388
A Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma
March 14, 2024 updated by: Hoffmann-La Roche
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.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Reference Study ID Number: BP43963 https://forpatients.roche.com/
- Phone Number: 1-888-662-6728
- Email: global-roche-genentech-trials@gene.com
Study Locations
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New South Wales
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Coffs Harbour, New South Wales, Australia, 2450
- Active, not recruiting
- Coffs Harbour Health Campus
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North Sydney, New South Wales, Australia, 2060
- Active, not recruiting
- Melanoma Institute Australia
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Queensland
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Woolloongabba, Queensland, Australia, 4102
- Active, not recruiting
- Princess Alexandra Hospital; Cancer Trials Unit
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Active, not recruiting
- One Clinical Research
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RS
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Porto Alegre, RS, Brazil
- Active, not recruiting
- Hospital de Clínicas de Porto Alegre X
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SP
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Barretos, SP, Brazil, 14784-400
- Active, not recruiting
- Hospital de Cancer de Barretos
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Sao Paulo, SP, Brazil, 01246-000
- Active, not recruiting
- Instituto do Cancer do Estado de Sao Paulo - ICESP
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Sao Paulo, SP, Brazil, 01308-050
- Active, not recruiting
- Hospital Sirio-Libanes
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Ontario
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Toronto, Ontario, Canada, M5G 1Z5
- Active, not recruiting
- Princess Margaret Cancer Centre
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Brno, Czechia, 656 53
- Withdrawn
- Masarykuv onkologicky ustav
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Olomouc, Czechia, 779 00
- Withdrawn
- Fakultni nemocnice Olomouc; Onkologicka klinika
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Prague 2, Czechia, 128 08
- Active, not recruiting
- Všeobecná fakultní nemocnice v Praze; Dermatovenerologická klinika
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Athens, Greece, 115 27
- Active, not recruiting
- District General Hospital of Athens Laiko; 1st Internal Medicine Clinic
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Thessaloniki, Greece, 546 39
- Active, not recruiting
- Theageneio Hospital
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Auckland, New Zealand, 1023
- Active, not recruiting
- Auckland City Hospital, Cancer and Blood Research
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Wellington, New Zealand, 6002
- Active, not recruiting
- Wellington Hospital; Regional Oncology Unit
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Gda?sk, Poland, 80-214
- Active, not recruiting
- Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz
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Pozna?, Poland, 60-780
- Withdrawn
- Uniwersytecki Szpital Kliniczny w Poznaniu
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Warszawa, Poland, 02-781
- Active, not recruiting
- Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Now. Tkanek Miekkich,Kosci i Czer.
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Bratislava, Slovakia, 833 10
- Active, not recruiting
- Narodny Onkologicky Ustav; Oddelenie klinickej onkologie E
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Poprad, Slovakia, 058 01
- Active, not recruiting
- POKO Poprad; Department of Oncology
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Barcelona, Spain, 08035
- Active, not recruiting
- Hospital Universitari Vall d'Hebron; Oncology
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Barcelona, Spain, 08036
- Recruiting
- Hospital Clínic i Provincial; Servicio de Oncología
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Madrid, Spain, 28034
- Withdrawn
- Hospital Ramon y Cajal; Servicio de Oncologia
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Madrid, Spain, 28027
- Withdrawn
- Clinica Universidad de Navarra Madrid; Servicio de Oncología
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Adana, Turkey, 01120
- Active, not recruiting
- Adana Baskent University Hospital; Medical Oncology
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Ankara, Turkey, 06520
- Active, not recruiting
- Memorial Ankara Hastanesi
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Edirne, Turkey, 22030
- Completed
- Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
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Istanbul, Turkey, 34000
- Active, not recruiting
- Istanbul University Cerrahpasa Medical Faculty
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Istanbul, Turkey, 34214
- Completed
- Medipol Mega Üniversite Hastanesi Göztepe
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Low dose every three weeks (Q3W)
Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months.
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Participants will receive intravenous (IV) RO7247669 Q3W
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Experimental: High dose Q3W
Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months.
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Participants will receive intravenous (IV) RO7247669 Q3W
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
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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)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Participants with Adverse Events
Time Frame: Up to 25 months
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Up to 25 months
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Objective response rate (ORR)
Time Frame: Up to 25 months
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Up to 25 months
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Disease control rate (DCR)
Time Frame: Up to 25 months
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Up to 25 months
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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)
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From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 25 months)
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Serum concentration of RO7247669
Time Frame: Up to 25 months
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Up to 25 months
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Percentage of participants with anti-drug antibodies (ADAs)
Time Frame: Baseline up to 25 months
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Baseline up to 25 months
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Change from baseline in the number and activation status of peripheral blood immune cells
Time Frame: Baseline up to 25 months
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Baseline up to 25 months
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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)
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Baseline to Cycle 2 Day 9 (cycle = 21 days)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2022
Primary Completion (Estimated)
October 15, 2025
Study Completion (Estimated)
October 15, 2025
Study Registration Dates
First Submitted
June 13, 2022
First Submitted That Met QC Criteria
June 13, 2022
First Posted (Actual)
June 15, 2022
Study Record Updates
Last Update Posted (Actual)
March 15, 2024
Last Update Submitted That Met QC Criteria
March 14, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BP43963
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org).
Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).
For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Hoffmann-La RocheRecruitingUrothelial CancerKorea, Republic of, United States, Brazil, China, France, Germany, Mexico, Poland, Denmark, Turkey, Australia, Greece, Spain, United Kingdom, Italy
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Hoffmann-La RocheRecruitingRenal Cell CarcinomaKorea, Republic of, United States, China, Germany, France, Spain, United Kingdom, Poland, Australia
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-
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