Clinical Trials /

Study to Evaluate the Safety of Pembrolizumab in Participants With Unresectable or Metastatic Melanoma or Non-small Cell Lung Cancer in India (MK-3475-593/KEYNOTE-593)

NCT03715205

Description:

This study has been designed to evaluate the safety of pembrolizumab in participants in India with unresectable or metastatic melanoma and participants with non-small cell lung cancer (NSCLC) who are either untreated (programmed cell death ligand 1 [PD-L1] ≥50%) or have experienced disease progression after a platinum-containing systemic therapy (PD-L1 ≥1%).

Related Conditions:
  • Melanoma
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 4

Trial Eligibility

Document

Title

  • Brief Title: Study to Evaluate the Safety of Pembrolizumab in Participants With Unresectable or Metastatic Melanoma or Non-small Cell Lung Cancer in India (MK-3475-593/KEYNOTE-593)
  • Official Title: 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)

Clinical Trial IDs

  • ORG STUDY ID: 3475-593
  • SECONDARY ID: MK-3475-593
  • NCT ID: NCT03715205

Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Melanoma

Interventions

DrugSynonymsArms
PembrolizumabKEYTRUDA®, MK-3475Cohort A: Melanoma

Purpose

This study has been designed to evaluate the safety of pembrolizumab in participants in India with unresectable or metastatic melanoma and participants with non-small cell lung cancer (NSCLC) who are either untreated (programmed cell death ligand 1 [PD-L1] ≥50%) or have experienced disease progression after a platinum-containing systemic therapy (PD-L1 ≥1%).

Trial Arms

NameTypeDescriptionInterventions
Cohort A: MelanomaExperimentalParticipants with unresectable or metastatic melanoma receive 200 mg of pembrolizumab as an intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 cycles.
  • Pembrolizumab
Cohort B: NSCLCExperimentalParticipants with NSCLC who are either treatment naïve or have progressed after prior treatment receive 200 mg of pembrolizumab as an IV infusion every Q3W for up to 35 cycles.
  • Pembrolizumab

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:

          -  Has a histologically or cytologically confirmed diagnosis of stage IIIB/IV or
             recurrent NSCLC

          -  Has a tumor that expresses programmed cell death ligand 1 (PD-L1) ≥1%

          -  Has received prior treatment with at least two cycles of a platinum-containing doublet
             for Stage IIIB/IV or recurrent disease

          -  Has received an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor
             (either erlotinib, gefitinib, or afatinib) if they have an EGFR sensitizing mutation

          -  Has received crizotinib if they have an ALK translocation

        NSCLC participants must also meet the following requirements:

          -  Have a life expectancy of at ≥3 months

          -  Provide a formalin fixed tumor tissue sample for PD-L1 biomarker analysis from a
             recent biopsy of a tumor lesion not previously irradiated; For first line, biopsies
             obtained PRIOR to the administration of any systemic therapy administered for the
             treatment of a tumor (such as neoadjuvant/adjuvant/definitive therapy) will not be
             permitted for analysis. For second line treatment and beyond, no systemic
             antineoplastic therapy may be administered between the PD-L1 biopsy and initiating
             study medication

          -  Have documented evidence of the EGFR mutation status or ALK translocation status. If
             unable to provide documentation of these molecular changes, formalin-fixed
             paraffin-embedded tumor tissue of any age should be submitted for testing

          -  Have measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1
             (RECIST 1.1) as assessed by the local site investigator/radiologist

          -  Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

          -  Women of childbearing potential (WOCP) must have a negative urine or serum pregnancy
             test within 72 hours prior to receiving the first dose of trial treatment. If the
             urine test is positive or cannot be confirmed as negative, a serum pregnancy test will
             be required

          -  WOCP must be willing to use an adequate method of contraception for the course of the
             study through 120 days after the last dose of trial treatment

          -  Men of childbearing potential must agree to use an adequate method of contraception
             starting with the first dose of study therapy through 120 days after the last dose of
             study therapy

        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

          -  Has a known additional malignancy that is progressing or requires active treatment
             with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the
             skin, or carcinoma in situ (e.g., cervical cancer in situ, breast carcinoma) that have
             undergone potentially curative therapy

          -  Has had an allogeneic tissue/solid organ transplant

          -  Has a history of or current radiographically detectable central nervous system
             metastases and/or carcinomatous meningitis

          -  Has a severe hypersensitivity (≥ Grade 3) to any excipients in pembrolizumab

          -  Has a history of (non-infectious) pneumonitis that required steroids or current
             pneumonitis

          -  Has an active infection requiring systemic therapy including known history of active
             tuberculosis (Bacillus tuberculosis)

          -  Has a known history of human immunodeficiency virus (HIV) infection

          -  Has a known history of or is positive for hepatitis B (hepatitis B surface antigen
             [HbsAg] reactive) or hepatitis C (HCV) ribonucleic acid (RNA) [qualitative] is
             detected

          -  Has a known psychiatric or substance abuse disorder that would interfere with
             cooperation with the requirements of the trial

          -  If participant received prior radiation therapy to a symptomatic metastatic lesion,
             has recovered to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
             Grade 1 or Grade 0 AEs due to radiation therapy

          -  Is a regular user of any illicit drug or has a recent history (within the last 3
             months) of substance abuse including alcohol

          -  Is pregnant or breastfeeding or expecting to conceive or father children within the
             projected duration of the study, starting with the screening visit through 120 days
             after the last dose of trial treatment

          -  Has received a live vaccine within 30 days before the first dose of trial treatment

          -  Has a history or current evidence of any condition, therapy, or laboratory abnormality
             that might confound the results of the study, interfere with participation for the
             full duration of the study, or is not in the best interest of the participant to
             participate, in the opinion of the treating investigator
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of Adverse Events (AEs)
Time Frame:From time of signing the informed consent form (ICF) until the end of follow-up (up to approximately 25 months)
Safety Issue:
Description:Percentage of participants experiencing an AE defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy

Details

Phase:Phase 4
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Merck Sharp & Dohme Corp.

Trial Keywords

  • programmed cell death 1 (PD-1, PD1 )
  • programmed cell death ligand 1 (PD-L1, PDL1)
  • programmed cell death ligand 2 (PD-L2, PDL2)

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