CTRI/2018/12/016591
Active, Not Recruiting
Phase 4
A Prospective, Open-label, Phase 4 Study to Evaluate the Safety of Pembrolizumab (KEYTRUDA®) in Subjects with Unresectable or Metastatic Melanoma or PD-L1 positive Non-small Cell Lung Cancer (NSCLC) in India (Keynote-593) - KEYTRUDA®
Merck Sharp Dohme LLC a subsidiary of Merck and Co Inc0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: C439- Malignant melanoma of skin, unspecifiedHealth Condition 2: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
- Sponsor
- Merck Sharp Dohme LLC a subsidiary of Merck and Co Inc
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Melanoma Participant:
- •Has a histologically confirmed diagnosis of unresectable Stage III or metastatic melanoma (Stage IV) not amenable to local therapy
- •Has received no more than 1 line of prior systemic therapy for unresectable Stage III or Stage IV melanoma including mitogen activated protein kinase inhibitors
- •Has a Lactate Dehydrogenase (LDH) \=1\.5 times ULN
- •NSCLC Participant\-First Line Treatment:
- •Has a histologically or cytologically confirmed diagnosis of Stage IV NSCLC
- •Has a tumor that demonstrate PD\-L1 strong expression (PD\-L1 \=50%)
- •Do not have an EGFR sensitizing mutation AND are anaplastic lymphoma kinase (ALK) translocation negative
- •Has received no systemic anti\-cancer therapy for their metastatic NSCLC
- •NSCLC Participant\-Second Line Treatment and Beyond:
Exclusion Criteria
- •For NSCLC Participant only: Has a tumor specimen that is not evaluable for PD\-L1 expression by the central laboratory
- •Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment
- •Has received prior therapy with an anti\- programmed cell death 1 (PD\-1\), anti\-PD\-L1, or anti\- programmed cell death ligand 2 (PD\-L2\) agent or with an agent directed to another T\-cell receptor (i.e., cytotoxic T\-lymphocyte antigen\-4 \[CTLA\-4], OX\-40, CD137\) or has previously participated in a clinical trial for pembrolizumab (MK\-3475\)
- •Has received prior anti\-cancer therapy including investigational agent or device within 4 weeks, or completed palliative radiotherapy within 7 days, prior to enrollment
- •Has recovered from all AEs due to previous therapies to \= Grade 1 or baseline
- •Has recovered adequately from the toxicity and/or complications from major surgery prior to starting trial treatment
- •Is expected to require any other form of antineoplastic therapy while participating in the trial
- •Is on systemic corticosteroid therapy within 7 days before the planned date for first dose of treatment or any other form of immunosuppressive medication
- •Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (exceeding 10 mg daily dose of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of trial treatment
- •Has an active autoimmune disease that has required systemic treatment in the past 2 years
Outcomes
Primary Outcomes
Not specified
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