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Clinical Trial Finder

Search Results

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05419388
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hoffmann-La Roche
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Trials
Principal Investigator Affiliation Hoffmann-La Roche
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Australia, Brazil, Canada, Czechia, Greece, New Zealand, Poland, Slovakia, Spain, Turkey
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma
Arms & Interventions

Arms

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.

Interventions

Drug: - RO7247669

Participants will receive intravenous (IV) RO7247669 Q3W

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Coffs Harbour Health Campus, Coffs Harbour, New South Wales, Australia

Status

Address

Coffs Harbour Health Campus

Coffs Harbour, New South Wales, 2450

Melanoma Institute Australia, North Sydney, New South Wales, Australia

Status

Address

Melanoma Institute Australia

North Sydney, New South Wales, 2060

Princess Alexandra Hospital, Woolloongabba, Queensland, Australia

Status

Address

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102

One Clinical Research, Nedlands, Western Australia, Australia

Status

Address

One Clinical Research

Nedlands, Western Australia, 6009

Hospital de Clínicas de Porto Alegre X, Porto Alegre, Rio Grande Do Sul, Brazil

Status

Address

Hospital de Clínicas de Porto Alegre X

Porto Alegre, Rio Grande Do Sul, DUMMY_VALUE

Hospital de Cancer de Barretos, Barretos, São Paulo, Brazil

Status

Address

Hospital de Cancer de Barretos

Barretos, São Paulo, 14784-400

Sao Paulo, São Paulo, Brazil

Status

Address

Instituto do Cancer do Estado de Sao Paulo - ICESP

Sao Paulo, São Paulo, 01246-000

Hospital Sírio-Libanês, Sao Paulo, São Paulo, Brazil

Status

Address

Hospital Sírio-Libanês

Sao Paulo, São Paulo, 01308-050

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Status

Address

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9

Všeobecná fakultní nemocnice v Praze, Prague 2, Czechia

Status

Address

Všeobecná fakultní nemocnice v Praze

Prague 2, , 128 08

Athens, Greece

Status

Address

District General Hospital of Athens Laiko

Athens, , 115 27

Auckland, New Zealand

Status

Address

Auckland City Hospital, Cancer and Blood Research

Auckland, , 1023

Wellington Hospital, Wellington, New Zealand

Status

Address

Wellington Hospital

Wellington, , 6002

Uniwersyteckie Centrum Kliniczne, Gda?sk, Poland

Status

Address

Uniwersyteckie Centrum Kliniczne

Gda?sk, , 80-214

Warszawa, Poland

Status

Address

Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie

Warszawa, , 02-781

Narodny Onkologicky Ustav, Bratislava, Slovakia

Status

Address

Narodny Onkologicky Ustav

Bratislava, , 833 10

POKO Poprad, Poprad, Slovakia

Status

Address

POKO Poprad

Poprad, , 058 01

Hospital Universitari Vall d'Hebron, Barcelona, Spain

Status

Address

Hospital Universitari Vall d'Hebron

Barcelona, , 08035

Hospital Clínic i Provincial, Barcelona, Spain

Status

Address

Hospital Clínic i Provincial

Barcelona, , 08036

Adana Baskent University Hospital, Adana, Turkey

Status

Address

Adana Baskent University Hospital

Adana, , 01120

Memorial Ankara Hastanesi, Ankara, Turkey

Status

Address

Memorial Ankara Hastanesi

Ankara, , 06520

Istanbul, Turkey

Status

Address

Medipol Mega Üniversite Hastanesi Göztepe

Istanbul, , 34214

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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