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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05419388




Registration number
NCT05419388
Ethics application status
Date submitted
13/06/2022
Date registered
15/06/2022

Titles & IDs
Public title
A Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma
Scientific title
A Randomized, Open-Label, Multicenter, Phase II Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma
Secondary ID [1] 0 0
BP43963
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RO7247669

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.

Experimental: High dose Q3W - Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months.


Treatment: Drugs: RO7247669
Participants will receive intravenous (IV) RO7247669 Q3W
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS)
Timepoint [1] 0 0
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 outcome [1] 0 0
Percentage of Participants with Adverse Events
Timepoint [1] 0 0
Up to 25 months
Secondary outcome [2] 0 0
Objective response rate (ORR)
Timepoint [2] 0 0
Up to 25 months
Secondary outcome [3] 0 0
Disease control rate (DCR)
Timepoint [3] 0 0
Up to 25 months
Secondary outcome [4] 0 0
Duration of response (DOR)
Timepoint [4] 0 0
From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 25 months)
Secondary outcome [5] 0 0
Serum concentration of RO7247669
Timepoint [5] 0 0
Up to 25 months
Secondary outcome [6] 0 0
Percentage of participants with anti-drug antibodies (ADAs)
Timepoint [6] 0 0
Baseline up to 25 months
Secondary outcome [7] 0 0
Change from baseline in the number and activation status of peripheral blood immune cells
Timepoint [7] 0 0
Baseline up to 25 months
Secondary outcome [8] 0 0
Change from baseline in the number and activation of immune cells in the tumor microenvironment
Timepoint [8] 0 0
Baseline to Cycle 2 Day 9 (cycle = 21 days)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/10/2025
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Coffs Harbour Health Campus - Coffs Harbour
Recruitment hospital [2] 0 0
Melanoma Institute Australia - North Sydney
Recruitment hospital [3] 0 0
Princess Alexandra Hospital; Cancer Trials Unit - Woolloongabba
Recruitment hospital [4] 0 0
One Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2060 - North Sydney
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
RS
Country [2] 0 0
Brazil
State/province [2] 0 0
SP
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Czechia
State/province [4] 0 0
Brno
Country [5] 0 0
Czechia
State/province [5] 0 0
Olomouc
Country [6] 0 0
Czechia
State/province [6] 0 0
Prague 2
Country [7] 0 0
Greece
State/province [7] 0 0
Athens
Country [8] 0 0
Greece
State/province [8] 0 0
Thessaloniki
Country [9] 0 0
New Zealand
State/province [9] 0 0
Auckland
Country [10] 0 0
New Zealand
State/province [10] 0 0
Wellington
Country [11] 0 0
Poland
State/province [11] 0 0
Gda?sk
Country [12] 0 0
Poland
State/province [12] 0 0
Pozna?
Country [13] 0 0
Poland
State/province [13] 0 0
Warszawa
Country [14] 0 0
Slovakia
State/province [14] 0 0
Bratislava
Country [15] 0 0
Slovakia
State/province [15] 0 0
Poprad
Country [16] 0 0
Spain
State/province [16] 0 0
Barcelona
Country [17] 0 0
Spain
State/province [17] 0 0
Madrid
Country [18] 0 0
Turkey
State/province [18] 0 0
Adana
Country [19] 0 0
Turkey
State/province [19] 0 0
Ankara
Country [20] 0 0
Turkey
State/province [20] 0 0
Edirne
Country [21] 0 0
Turkey
State/province [21] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: BP43963 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
1-888-662-6728
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05419388