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)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 4

Conditions

Melanoma

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: Pembrolizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT03715205

3475-593

MK-3475-593 (Other Identifier)

KEYNOTE 593 (Other Identifier)

Details and patient eligibility

About

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%).

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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//IIIC/IV (including any future updates to the American Joint Committee on Cancer [AJCC] guideline) 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 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 (noninfectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease
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