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A Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma

Primary Purpose

Melanoma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
RO7247669
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Coffs Harbour Health CampusRecruiting
  • Melanoma Institute Australia
  • Princess Alexandra Hospital; Cancer Trials UnitRecruiting
  • One Clinical ResearchRecruiting
  • Hospital de Clínicas de Porto Alegre X
  • Hospital de Cancer de Barretos
  • Instituto do Cancer do Estado de Sao Paulo - ICESPRecruiting
  • Hospital Sírio-Libanês
  • Princess Margaret Cancer Centre
  • Masarykuv onkologicky ustav
  • Fakultni nemocnice Olomouc; Onkologicka klinika
  • Všeobecná fakultní nemocnice v Praze; Dermatovenerologická klinikaRecruiting
  • District General Hospital of Athens Laiko; 1st Internal Medicine ClinicRecruiting
  • Theageneio Hospital
  • Auckland City Hospital, Cancer and Blood ResearchRecruiting
  • Wellington Hospital; Regional Oncology Unit
  • Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz
  • Uniwersytecki Szpital Kliniczny w Poznaniu
  • Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Now. Tkanek Miekkich,Kosci i Czer.
  • Narodny Onkologicky Ustav; Oddelenie klinickej onkologie E
  • POKO Poprad; Department of Oncology
  • Hospital Universitari Vall d'Hebron; Oncology
  • Hospital Clínic i Provincial; Servicio de OncologíaRecruiting
  • Clinica Universidad de Navarra Madrid; Servicio de OncologíaRecruiting
  • Hospital Ramon y Cajal; Servicio de Oncologia
  • Adana Baskent University Hospital; Medical Oncology
  • Memorial Ankara Hastanesi
  • Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
  • Istanbul University Cerrahpasa Medical Faculty
  • Medipol Mega Üniversite Hastanesi Göztepe

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low dose every three weeks (Q3W)

High dose Q3W

Arm Description

Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months.

Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months.

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)

Secondary Outcome Measures

Percentage of Participants with Adverse Events
Objective response rate (ORR)
Disease control rate (DCR)
Duration of response (DOR)
Serum concentration of RO7247669
Percentage of participants with anti-drug antibodies (ADAs)
Change from baseline in the number and activation status of peripheral blood immune cells
Change from baseline in the number and activation of immune cells in the tumor microenvironment

Full Information

First Posted
June 13, 2022
Last Updated
October 4, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT05419388
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
October 15, 2025 (Anticipated)
Study Completion Date
October 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low dose every three weeks (Q3W)
Arm Type
Experimental
Arm Description
Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months.
Arm Title
High dose Q3W
Arm Type
Experimental
Arm Description
Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months.
Intervention Type
Drug
Intervention Name(s)
RO7247669
Intervention Description
Participants will receive intravenous (IV) RO7247669 Q3W
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
Percentage of Participants with Adverse Events
Time Frame
Up to 25 months
Title
Objective response rate (ORR)
Time Frame
Up to 25 months
Title
Disease control rate (DCR)
Time Frame
Up to 25 months
Title
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)
Title
Serum concentration of RO7247669
Time Frame
Up to 25 months
Title
Percentage of participants with anti-drug antibodies (ADAs)
Time Frame
Baseline up to 25 months
Title
Change from baseline in the number and activation status of peripheral blood immune cells
Time Frame
Baseline up to 25 months
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: BP43963 https://forpatients.roche.com/
Phone
1-888-662-6728
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Coffs Harbour Health Campus
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
Individual Site Status
Recruiting
Facility Name
Melanoma Institute Australia
City
North Sydney
State/Province
New South Wales
ZIP/Postal Code
2060
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Princess Alexandra Hospital; Cancer Trials Unit
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Name
One Clinical Research
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Name
Hospital de Clínicas de Porto Alegre X
City
Porto Alegre
State/Province
RS
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital de Cancer de Barretos
City
Barretos
State/Province
SP
ZIP/Postal Code
14784-400
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Sírio-Libanês
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01308-050
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Masarykuv onkologicky ustav
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Individual Site Status
Withdrawn
Facility Name
Fakultni nemocnice Olomouc; Onkologicka klinika
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Individual Site Status
Withdrawn
Facility Name
Všeobecná fakultní nemocnice v Praze; Dermatovenerologická klinika
City
Prague 2
ZIP/Postal Code
128 08
Country
Czechia
Individual Site Status
Recruiting
Facility Name
District General Hospital of Athens Laiko; 1st Internal Medicine Clinic
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Individual Site Status
Recruiting
Facility Name
Theageneio Hospital
City
Thessaloniki
ZIP/Postal Code
546 39
Country
Greece
Individual Site Status
Active, not recruiting
Facility Name
Auckland City Hospital, Cancer and Blood Research
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Wellington Hospital; Regional Oncology Unit
City
Wellington
ZIP/Postal Code
6002
Country
New Zealand
Individual Site Status
Active, not recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz
City
Gda?sk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Uniwersytecki Szpital Kliniczny w Poznaniu
City
Pozna?
ZIP/Postal Code
60-780
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Now. Tkanek Miekkich,Kosci i Czer.
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Narodny Onkologicky Ustav; Oddelenie klinickej onkologie E
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
Individual Site Status
Active, not recruiting
Facility Name
POKO Poprad; Department of Oncology
City
Poprad
ZIP/Postal Code
058 01
Country
Slovakia
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitari Vall d'Hebron; Oncology
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Clínic i Provincial; Servicio de Oncología
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Universidad de Navarra Madrid; Servicio de Oncología
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Ramon y Cajal; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Adana Baskent University Hospital; Medical Oncology
City
Adana
ZIP/Postal Code
01120
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Memorial Ankara Hastanesi
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Istanbul University Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Medipol Mega Üniversite Hastanesi Göztepe
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).

Learn more about this trial

A Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma

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