Phase 1
Completed N=38
Study of Pembrolizumab (MK-3475) in Participants With Advanced Non-small Cell Lung Cancer (MK-3475-025/KEYNOTE-025)
Source: ClinicalTrials.gov NCT02007070 ↗Enrolled (actual)
38
Serious AEs
36.8%
Results posted
Dec 2016
Primary outcomePrimary: Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Strongly PD-L1 Positive Participants — 27.3 Percentage of Participants
Summary
This study is being done to evaluate the safety and efficacy of pembrolizumab (MK-3475) in participants with advanced non-small cell lung cancer (NSCLC) tumors that are positive for programmed cell death ligand 1 (PD-L1): the hypothesis is that treatment with pembrolizumab will result in a clinically meaningful Overall Response Rate (ORR).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Strongly PD-L1 Positive Participants |
27.3 | — |
| PRIMARY Number of Participants Experiencing Adverse Events (AEs) |
38 | — |
| PRIMARY Number of Participants Discontinuing Study Drug Due to AEs |
4 | — |
| SECONDARY Progression Free Survival (PFS) by RECIST 1.1 in Strongly PD-L1 Positive Participants |
4.1 | — |
| SECONDARY Duration of Response (DOR) by RECIST 1.1 in Strongly PD-L1 Positive Participants |
NA | — |
| SECONDARY Overall Survival (OS) in Strongly PD-L1 Positive Participants |
17.9 | — |
| SECONDARY ORR Per Immune-Related Response Criteria (irRC) in Strongly PD-L1 Positive Participants |
25.0 | — |
| SECONDARY PFS Per irRC in Strongly PD-L1 Positive Participants |
5.2 | — |
| SECONDARY DOR Per irRC in Strongly PD-L1 Positive Participants |
503.0 | — |
| SECONDARY ORR Per RECIST 1.1 in PD-L1 Positive Participants |
21.6 | — |
| SECONDARY PFS by RECIST 1.1 in PD-L1 Positive Participants |
3.9 | — |
| SECONDARY DOR by RECIST 1.1 in PD-L1 Positive Participants |
694.0 | — |
| SECONDARY OS in PD-L1 Positive Participants |
19.2 | — |
| SECONDARY ORR Per irRC in PD-L1 Positive Participants |
21.1 | — |
| SECONDARY PFS Per irRC in PD-L1 Positive Participants |
4.2 | — |
| SECONDARY DOR Per irRC in PD-L1 Positive Participants |
757.0 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) that is PD-L1 positive per central laboratory review
- At least one measurable lesion
- Radiographic progression of NSCLC after treatment with a platinum-containing doublet for Stage IIIB/IV or recurrent disease
- Eastern Cooperative Oncology Group (ECOG) Performance Scale 0 or 1
- Adequate organ function
Exclusion Criteria
- Systemic cytotoxic chemotherapy, biological therapy, or major surgery within 3 weeks of the first dose of trial treatment
- Systemic steroid therapy within 3 days prior to the first dose of trial treatment or any other form of immunosuppressive medication
- Expected to require any other form of systemic or localized antineoplastic therapy while on trial
- History of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cancer
- Active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Active autoimmune disease or documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody
- Concurrent or past history of interstitial lung disease
- Pregnant or breast-feeding, or expecting to conceive or father children within the projected duration of the study, starting with screening visit through 120 days after the last dose of pembrolizumab
Data sourced from ClinicalTrials.gov (NCT02007070). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.