A Study of Multiple Doses of RO7247669 in Participants with Previously Untreated Unresectable or Metastatic Melanoma
- Conditions
- nresectable or Metastatic MelanomaMedDRA version: 20.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2022-000631-23-ES
- Lead Sponsor
- Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 80
General
• Age >= 18 years
Type of Participants and Disease Characteristics
• Participants must have histologically confirmed unresectable or metastatic melanoma, per the American Joint Committee on Cancer (AJCC) staging system
• Radiologically measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Previously irradiated lesions should not be counted as target lesions unless clearly progressed after the radiotherapy
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
• Participants must have known v-Raf murine sarcoma viral oncogene homolog B1(BRAF) V600 mutation status
• Participants must have known programmed death-ligand 1 (PD-L1) status
• Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses.
• Participants must have at least one non-target tumor lesion accessible to biopsy per clinical judgment of the treating physician and consent undergo mandatory on treatment biopsy
Medical Conditions
• Adequate cardiovascular, hematological, liver, renal function and laboratory parameters
• Adverse events (AEs) from any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade <=1, except alopecia, vitiligo, endocrinopathy managed with replacement therapy, and Grade 2 peripheral neuropathy
Contraception
• Male and/or female participants: The contraception and abstinence requirements are intended to prevent exposure of an embryo to the study treatment. The reliability of sexual abstinence for male and/or female enrollment eligibility needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant. Periodic abstinence and withdrawal are not acceptable methods of contraception
• Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding
• Male participants: During the treatment period and for at least 4 months after the final dose of study drug
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
General
• Pregnancy, lactation, or breastfeeding
• Known hypersensitivity to any of the components of RO7247669 including but not limited to, hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
Type of Participants and Disease Characteristics
• Participants must not have ocular melanoma
Medical Conditions
• Symptomatic central nervous system (CNS) metastases. Participants with previously treated brain metastases
• Spinal cord compression not definitively treated with surgery and/or radiation or without evidence that disease has been clinically stable for >= 14 days prior to randomization
• Active or history of carcinomatous meningitis/leptomeningeal disease
• Asymptomatic CNS primary tumors or metastases if they have requirement for steroids or enzyme inducing anticonvulsants in the last 28 days prior to randomization
• Uncontrolled tumor-related pain. Participants requiring pain medication must be on a stable regimen at study entry
• Participants with an active second malignancy. Concurrent malignancy exceptions include curatively treated carcinoma in situ of the cervix, good-prognosis ductal carcinoma in situ of the breast, basal or squamous cell skin cancer, or low grade, early stage localized prostate cancer and any previously treated early-stage non-hematological malignancy that has been in remission for at least two years
• Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders, known autoimmune diseases or immune deficiency, or other diseases with ongoing fibrosis
• Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
• 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
• Known clinically significant liver disease, including alcoholic hepatitis, cirrhosis, and inherited liver disease
• Major surgical procedure or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study
• Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
• Dementia or altered mental status that would prohibit informed consent
• Uncontrolled pleural, pericardial effusion, or ascites requiring recurrent drainage procedures
• Active or history of autoimmune disease or immune deficiency
• Positive human immunodeficiency virus (HIV) test at screening
• Positive hepatitis B surface antigen (HBsAg) or positive total hepatitis B core antibody (HBcAb) test at screening. Participants with a positive HBsAg or total HBcAb test followed by a negative hepatitis B virus (HBV) deoxyribonucleic acid (DNA) test at screening are eligible
• Positive hepatitis C virus (HCV) antibody test at screening. Participants with a positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) tes
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method