Melanoma MedDRA version: 21.1 Level: LLT Classification code 10053571 Term: Melanoma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: KEYTRUDA (pembrolizumab, MK-3475)
Product Name: -
Product Code: [-]
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Pembrolizumab
CAS Number: 1374853-91-4
Current Sponsor c
Sponsors
MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. AJCC Stage IV (any T, any N, M1D) melanoma 2. Has at least 1 and no more than 5 measurable brain metastasis disease lesions as defined by RECIST 1.1, confirmed by BICR: -The measurable lesion(s) must be >=10 mm and =65 years) yes F.1.3.1 Number o
Exclusion criteria
Exclusion criteria: 1. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 10 days before the first dose of study intervention (based upon 5 times the expected half-life of dexamethasone). Participants with asthma that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study 2. Current or history of known leptomeningeal involvement. Participants with suspected LMD by clinical symptoms only (without imaging findings) should undergo CSF analysis to substantiate the diagnosis of LMD unless CSF analysis is contraindicated 3. Previous stereotactic or highly conformal radiotherapy within 2 weeks before the start of dosing for this study 4. Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug 5. Untreated or unresolved intracranial hemorrhage from CNS metastasis of more than punctate size on MRI assessment obtained within 28 days prior to study enrollment 6. Has any active infection requiring systemic therapy 7. Has a known additional malignancy that is progressing or requires active treatment within the past 2 years. Exceptions to the secondary malignancy exclusion include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, new nonulcerated primary melanoma 30 Gy, they must have recovered from the toxicity (resolved to <=Grade 1) and/or complications from the intervention prior to starting study intervention 16. History of whole brain irradiation 17. Prior treatment with anti-PD-L2, anti-CD137, any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways (except for study interventions noted in inclusion criteria) 18. Has received prior radiotherapy within 2 weeks of first dose of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To assess the safety and tolerability of investigational treatment combinations based on the proportion of participants with adverse events (AEs) 2. To evaluate the objective response rate (ORR) as assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1);Secondary Objective: 1. To evaluate the duration of response (DOR) as assessed by BICR per RECIST 1.1 2. To evaluate brain metastasis response rate (BMRR) as assessed by BICR per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) 3. To evaluate the brain metastasis duration of response (BM-DOR) as assessed by BICR per RANO-BM 4. To evaluate progression-free survival (PFS) as assessed by BICR per RECIST 1.1;Primary end point(s): 1. Percentage of participants who experience an adverse event (AE) 2. Percentage of participants who discontinue study treatment due to an AE 3. Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1);Timepoint(s) of evaluation of this end point: 1. Up to ~28 months 2. Up to ~24 months 3. Up to ~30 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Duration of response (DOR) per RECIST 1.1 2. Brain metastasis response rate (BMRR) per Response Assessment in Neuro- Oncology Brain Metastases (RANO-BM) 3. Brain metastasis duration of response (BM-DOR) per RANO-BM 4. Progression-free survival (PFS) per RECIST 1.1;Timepoint(s) of evaluation of this end point: 1. Up to ~30 months 2. Up to ~30 months 3. Up to ~30 months 4. Up to ~30 months | — |
Countries
Australia, France, Germany, Greece, Hungary, Israel, Italy, Poland, Spain, Switzerland, United States
Contacts
Public ContactDivisione Ricerca Clinica
MSD Italia Srl
Outcome results
None listed