INCLUSION & EXCLUSION

CRITERIA ANTI-PD1/ ANTI-PDL1

STUDY
No. Study Inclusion Criteria Exclusion Criteria
1. Nivolumab versus • Aged >18 years • Active brain metastases
chemotherapy in patients • Histologically confirmed • Had previous treatment with anti-PD-1,
with advanced melanoma • Unresectable stage IIIC/IV metastatic anti-PD-L1, or anti-PD-L2 antibodies
who progressed after anti- melanoma • Had grade 4 toxic effects
CTLA-4 treatment • ECOG 0-1 • Primary ocular melanoma
(CheckMate 037): a • WBC >2000 × 10⁹ cells/L • Active/known/ suspected autoimmune
randomised, controlled, • ANC >1500 × 10⁹ cells/L disease
open-label, phase 3 trial • Platelet 100 × 10⁹ cells/L • Active brain/ leptomeningeal metastasis
• Hb >9 g/dL • Grade 2/worse eye pain or reduction of
• Cr <1·5x ULN visual activity related to previous anti-
• CCT > 40 mL/ min CTLA-4 treatment
• AST/ALT <3x ULN • Previous malignancies
• Bilirubin <1·5 x ULN
2. Nivolumab versus • Stage IIIB/IV squamous-cell NSCLC with • Unstable brain metastases
Docetaxel in Advanced disease recurrence after 1 prior • Autoimmune disease
Squamous-Cell Non–Small- platinum-containing regimen • Symptomatic interstitial lung disease
Cell Lung Cancer • >18 years of age • Systemic immunosuppression
• ECOG 0 or 1 • Prior therapy with T-cell costimulation or
checkpoint-targeted agents, or prior
docetaxel therapy.
• Received more than 1 prior systemic
therapy for metastatic disease
No. Study Inclusion Criteria Exclusion Criteria
3. Pembrolizumab in patients • >18 yo • Autoimmune disease requiring systemic
with advanced non-small- • Locally advanced /metastatic NSCLC corticosteroids or immunosuppression
cell lung cancer (KEYNOTE- • ECOG 0 or 1 • Active CNS metastases (unless clinically
001): 3-year results from • At least one measurable lesion per stable for ≥4 weeks)
an open-label, phase 1 immune-related response criteria and a
study contemporaneous biopsy sample.
• Treatment naive cohort: had not
received systemic therapy for advanced
disease or adjuvant therapy within the
previous year, had no EGFR or ALK
alteration and had tumours positive for
PD-L1 expression.
• Previously treated cohorts: had
received at least one or at least two
previous systemic therapies for
advanced disease.
No. Study Inclusion Criteria Exclusion Criteria
4. Pembrolizumab versus • >18 yo • Disease progressed within 3 months of
methotrexate, docetaxel, • Histologically or cytologically confirmed completing definitive treatment for
or cetuximab for recurrent SCC of the oral cavity, oropharynx, locoregionally advanced or recurrent
or metastatic head-and- hypopharynx, or larynx, incurable by disease
neck squamous cell local therapies • Received previous immune checkpoint
carcinoma (KEYNOTE-040): • Eisease progression during or after inhibitor therapy
a randomised, open-label, platinum-containing treatment for
phase 3 study recurrent or metastatic disease (or
both)
• Or recurrence or progression within 3–6
months of previous multimodal therapy
containing platinum for locally
advanced disease
• Received two or fewer lines of therapy
for recurrent or metastatic disease
• Had known HPV p16 status for
oropharyngeal cancer
• Had known programmed death ligand 1
(PD-L1) expression status
• At least 1 measurable lesion according
to RECIST
• ECOG 0 atau 1
No. Study Inclusion Criteria Exclusion Criteria
5. Safety and efficacy of • >18 yo • Clinical evidence of ascites
pembrolizumab • Histologically/cytologically confirmed • Active autoimmune disease that required
monotherapy in patients recurrent or metastatic gastric or systemic treatment in the preceding 2
with previously treated gastroesophageal junction years
advanced gastric and adenocarcinoma (only Siewert types II • Diagnosis of immunodeficiency
gastroesophageal junction and III) incurable by locally approved • Previously received anticancer
cancer: phase 2 clinical therapies monoclonal antibody therapy or targeted
KEYNOTE-059 trial • Measurable disease small-molecule or radiation therapy
• Disease progression after 2 or more within 4 or 2 weeks before the study
prior chemotherapy regimens that • Active central nervous system metastases
included a fluoropyrimidine and a or carcinomatous meningitis
platinum doublet (as adjuvant • History of or active noninfectious
treatment or for metastatic disease) pneumonitis
• Had human epidermal growth factor • Active infection necessitating systemic
receptor 2 (HER2)/neu–negative (or therapy
HER2/neu–positive, if previously • Previously received immune checkpoint
treated with trastuzumab) disease blocking therapy.
• ECOG 0 or 1
• Adequate organ function
• Life expectancy of 3 months or longer.