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. 2017 Apr 4;28(6):1388–1398. doi: 10.1093/annonc/mdx076

Table 3.

Selection of ongoing phase 2/3 trials of pembrolizumab in melanoma and NSCLC

Trial Phase Indication Estimated enrollment Intervention/arms Status
Melanoma
 NCT02362594 3 Stage III, high-risk melanoma after complete resection 900

  1. Pembrolizumab

  2. Placebo

 Currently recruiting
 KEYNOTE-054
 NCT02752074 3 Unresectable or metastatic melanoma 600

  1. Pembrolizumab  + epacadostat

  2. Pembrolizumab  + placebo

 Currently recruiting
 KEYNOTE-252/ECHO-301
 NCT02263508 3 Unresected melanoma 660

  1. Pembrolizumab  +  talimogene laherparepvec

  2. Pembrolizumab  + placebo

 Currently recruiting
 MasterKey-265
 NCT02506153 3 Stage III-IV, high-risk melanoma that has been removed by surgery 1378

  1. Chemotherapy (IFN-α2b) or ipi

  2. Pembrolizumab

 Currently recruiting
NSCLC
 NCT01905657 2/3 NSCLC with disease progression after platinum-containing therapy 1034

  1. Pembrolizumab (low dose)

  2. Pembrolizumab (high dose)

  3. Docetaxel

 Active, not recruiting
 KEYNOTE-010a
 NCT02142738 3 Previously untreated, PD-L1+-strong NSCLC 305

  1. Pembrolizumab

  2. Platinum-based chemotherapyb

 Active, not recruiting
 KEYNOTE-024
 NCT02039674 1/2 Previously untreated, metastatic NSCLC 308

  1. Pembrolizumab + paclitaxel + carboplatin

  2. Pembrolizumab + paclitaxel + carboplatin + bevacizumab

  3. Pembrolizumab  + pemetrexed + carboplatin

  4. Pembrolizumab  + ipilimumab

  5. Pembrolizumab  + erlotinib

  6. Pembrolizumab  + gefitinib

 Currently recruiting
 KEYNOTE-021
 NCT02578680 3 Previously untreated non-squamous, metastatic NSCLC 570

  1. [Pembrolizumab  + pemetrexed (with folic acid) + cisplatin] or [carboplatin + pembrolizumab + pemetrexed]

  2. [Placebo + pemetrexed (with folic acid) + cisplatin] or [carboplatin + placebo + pembrolizumab]

 Currently recruiting
 KEYNOTE-189
 NCT02220894 KEYNOTE-042 3 Previously untreated, PD-L1+ NSCLC 1240

  1. Pembrolizumab

  2. [Carboplatin + pacli- taxel] or carboplatin + pemetrexed (SOC)

 Currently recruiting
 NCT02775435 KEYNOTE-407 3 First-line, metastatic, squamous NSCLC 560

  1. Pembrolizumab + [paclitaxel or nab-paclitaxel] + carboplatin

  2. Placebo + [paclitaxel or nab-paclitaxel] + carboplatin

 Currently recruiting
 NCT02504372 KEYNOTE-091 3 NSCLC after resection 1380

  1. Pembrolizumab

  2. Placebo

 Currently recruiting
Melanoma or NSCLC
 NCT02085070 2 Melanoma + NSCLC with at least 2 untreated brain metastases 64 Pembrolizumab (OL) Currently recruiting
a

Some study results have now been published [64].

b

Investigator’s choice of: paclitaxel + carboplatin, pemetrexed + carboplatin, pemetrexed + cisplatin, gemcitabine + carboplatin, gemcitabine + cisplatin.

IFN-α2b, interferon alpha 2b; ipi, ipilimumab; NSCLC, non-small cell lung cancer; OL, open label; SOC, standard of care.