Last updated 15 days ago
Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02)
315 patients around the world
Available in Spain, United States, Chile, Argentina
Merck Sharp & Dohme LLC
5Research sites
315Patients around the world
This study is for people with
Skin cancer
Melanoma
Requirements for the patient
To 120 Years
All Gender
Medical requirements
- Has histologically or cytologically confirmed melanomaHas unresectable Stage III or Stage IV melanoma, not amenable to local therapyHas been untreated for advanced disease.Has provided a tumor biopsyIf capable of producing sperm, male participants agree to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention (7 days):Abstains from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent ORUses contraception unless confirmed to be azoospermicA female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:Is not a WOCBP ORIs a WOCBP and Uses a contraceptive method that is highly effective, with low user dependency, or be abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is:MK-4280A: 120 daysMK-1308A: 120 daysMK-7684: 50 daysMK-3475: 120 daysLenvatinib: 30 daysATRA: 30 daysHas adequate organ functionHas resolution of toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia and Grade 2 neuropathy)
- Has a diagnosis of immunodeficiency or is receiving immunosuppressive therapy within 7 days before the first dose of study interventionHas a known additional malignancy that is progressing or requires active treatment within the past 2 yearsHas known central nervous system (CNS) metastases and/or carcinomatous meningitisHas ocular or mucosal melanomaHas an active autoimmune disease that has required systemic treatment in the past 2 yearsHas an active infection requiring systemic therapyHas known history of human immunodeficiency virus (HIV)Has history of Hepatitis B or known Hepatitis C virus infectionHas a history of (noninfectious) pneumonitisHas a history of active tuberculosis (TB)Has received prior systemic anticancer therapy within 4 weeks prior to randomizationHas received prior radiotherapy within 2 weeks of first dose of study interventionHas had major surgery <3 weeks prior to first dose of study interventionHas received a live vaccine within 30 days before the first dose of study interventionHas participated in a study of an investigational agent within 4 weeks prior to the first dose of study interventionHas had an allogeneic tissue/solid organ transplantHas a known psychiatric or substance abuse disorder that would interfere with requirements of the studyParticipants who receive lenvatinib have the following additional exclusion criteria:Has a pre-existing Grade ≥3 gastrointestinal or non-gastrointestinal fistulaHas radiographic evidence of encasement of invasion of a major blood vessel, or of intratumoral cavitationHas clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study interventionHas clinically significant cardiovascular disease within 12 months from first dose of study interventionHas urine protein ≥1 g/24-hour.Has presence of gastrointestinal condition including malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib
Sites
Clínica Adventista Belgrano - CABA - Buenos Aires
Recruiting
Sanatorio Finochietto
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
CIDO SpA-Oncology
Recruiting
IC La Serena Research - La Serena
Recruiting
StudyMK-3475-02B
SponsorMerck Sharp & Dohme LLC
Conditions
Melanoma
Requirements
To 120 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04305054
