Specific solid tumors or lymphomas (Cohort 1), or advanced MCC (Cohort 2)
Conditions
Interventions
Cohort 1 :
- Pembrolizumab 2 mg/kg every 3 weeks, intravenous, up to 17 cycles (resected melanoma)
- Pembrolizumab 2 mg/kg every 3 weeks, intravenous, up to 35 cycles (other malignancies)
Cohort 2 :
-
Sponsors
Fujita Tomoko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cohort 1 : 1) Participants aged 6 months to 17 years (12 years to 17 years for melanoma) at the time informed consent form or assent is provided. 2) Participants who meet any of the following criteria: - Has a confirmed diagnosis of relapsed or refractory classical hodgkin lymphoma (cHL) or primary mediastinal large B-cell lymphoma (PMBCL) after the most recent therapy. - Has surgically completely resected and histologically/pathologically confirmed diagnosis of Stage IIB, IIC (pathological or clinical), III or IV cutaneous melanoma (including acral) per American Joint Committee on Cancer (AJCC) 8th edition guidelines. - Has histologically confirmed diagnosis of locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma (including acral) per AJCC 8th edition guidelines not amenable to local therapy. - Has histologically/cytologically documented, locally-advanced, or metastatic solid malignancy that is incurable and has either (a) failed prior standard therapy, (b) for which no standard therapy exists, or (c) standard therapy is not considered appropriate by the participant and treating physician AND has a documented positive local microsatellite instability (MSI)-H or mismatch repair deficiency (dMMR) test result. - Has histologically/cytologically documented, locally-advanced, or metastatic solid malignancy that is incurable and has either (a) failed prior standard therapy, (b) for which no standard therapy exists, or (c) standard therapy is not considered appropriate by the participant and treating physician AND has a documented positive tumor mutational burden (TMB)-H (equal to or more than 10 mut/Mb) test result per FoundationOne CDx (F1CDx) assay. - Has histologically confirmed diagnosis of locoregional merkel cell carcinoma (MCC) that has recurred following standard locoregional therapy with surgery and/or radiation therapy and is not amenable to local therapy or metastatic MCC (Stage IV) as per AJCC 8th edition guidelines. Cohort 2 : 1) Participants must be >= 18 years of age at the time the informed consent form is provided. 2) Has histologically confirmed diagnosis of locoregional MCC that has recurred following standard locoregional therapy with surgery and/or radiation therapy and is not amenable to local therapy or metastatic MCC (Stage IV) as per AJCC 8th edition guidelines.
Exclusion criteria
Exclusion criteria: 1) Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137). 2) Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids. 3) Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. 4) Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention. 5) Known additional malignancy that is progressing or has required active treatment. 6) Known active CNS metastases and/or carcinomatous meningitis. 7) Severe hypersensitivity to pembrolizumab and/or any of its excipients. 8) Active autoimmune disease that has required systemic treatment in past 2 years. 9) History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. 10) Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort 1 : - Adverse events (AEs) - Pharmacokinetics parameters for pembrolizumab Cohort 2 : - Objective response rate (ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Cohort 1 : - ORR - Overall Survival (OS) - Other clinical response Cohort 2 : - OS - Other clinical response - AEs - Pharmacokinetics parameters for pembrolizumab | — |
Contacts
Public ContactMSDJRCT inquiry mailbox
MSD K.K.
Outcome results
None listed