Clinical trial NCT05419388: A Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma
Official title: A Randomized, Open-Label, Multicenter, Phase II Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Melanoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2022-06-15
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 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:
measure: Percentage of Participants with Adverse Events
timeFrame: Up to 25 months
measure: Objective response rate (ORR)
timeFrame: Up to 25 months
measure: Disease control rate (DCR)
timeFrame: Up to 25 months
measure: Duration of response (DOR)
timeFrame: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 25 months)
measure: Serum concentration of RO7247669
timeFrame: Up to 25 months
measure: Percentage of participants with anti-drug antibodies (ADAs)
timeFrame: Baseline up to 25 months
measure: Change from baseline in the number and activation status of peripheral blood immune cells
timeFrame: Baseline up to 25 months
measure: Change from baseline in the number and activation of immune cells in the tumor microenvironment
timeFrame: Baseline to Cycle 2 Day 9 (cycle = 21 days)
Other outcomes:
Locations:
city: Coffs Harbour
country: Australia
facility: Coffs Harbour Health Campus
state: New South Wales
city: North Sydney
country: Australia
facility: Melanoma Institute Australia
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Nedlands
country: Australia
facility: One Clinical Research
state: Western Australia
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre X
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Hospital de Cancer de Barretos
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Sírio-Libanês
state: São Paulo
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Prague 2
country: Czechia
facility: Všeobecná fakultní nemocnice v Praze
city: Athens
country: Greece
facility: District General Hospital of Athens Laiko
city: Auckland
country: New Zealand
facility: Auckland City Hospital, Cancer and Blood Research
city: Wellington
country: New Zealand
facility: Wellington Hospital
city: Gda?sk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie
city: Bratislava
country: Slovakia
facility: Narodny Onkologicky Ustav
city: Poprad
country: Slovakia
facility: POKO Poprad
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial
city: Adana
country: Turkey
facility: Adana Baskent University Hospital
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi
city: Istanbul
country: Turkey
facility: Medipol Mega Üniversite Hastanesi Göztepe
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: