KEYNOTE-017 (Cancer Immunotherapy Trials Network 09)
KEYNOTE-017 showed that pembrolizumab given as the first treatment shrinks more than half of advanced Merkel cell carcinomas, whether or not the tumour carries the Merkel cell polyomavirus.
Overview
KEYNOTE-017 was a single-arm phase 2 trial of first-line pembrolizumab in advanced Merkel cell carcinoma run by the Cancer Immunotherapy Trials Network. It tested PD-1 blockade before chemotherapy, on the reasoning that chemotherapy responses in this disease are short and immunosuppressive.
The objective response rate was 56 percent in the first 26 patients (NEJM 2016) and remained 56 percent in the full cohort of 50 (JCO 2019), with responses in both virus-positive and virus-negative tumours and most responses lasting beyond two years. Grade 3 or worse treatment-related events occurred in a minority and were manageable.
Pembrolizumab was approved for Merkel cell carcinoma in December 2018. Together with JAVELIN Merkel 200 it moved immunotherapy to the first line and made chemotherapy a fallback for the minority who do not respond.
- 56 out of 100 people had their tumour shrink with Pembrolizumab.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
- These results apply to the people the trial enrolled: Advanced Merkel cell carcinoma, no prior systemic therapy: pembrolizumab. People in a different situation may not see the same effect.
- Only 50 people took part, so the numbers are less certain than in a large trial.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
Similar pages
not linked directly; found by shared links- TrialA Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participants With Merkel Cell Carcinoma (MK-3475-G21/KEYNOTE-G21)
Shares Merkel cell carcinoma, Merck & Co. (MSD), Pembrolizumab.
- TrialKEYNOTE-629
Shares Merck & Co. (MSD), PD-1, Immune checkpoint inhibitors, Pembrolizumab.
- TrialPlacebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Car
Shares Merkel cell carcinoma, Pembrolizumab.
- TrialKEYNOTE-170
Shares Merck & Co. (MSD), PD-1, Immune checkpoint inhibitors, Pembrolizumab.
- TrialJAVELIN Merkel 200
Shares Oncogenic viruses, Merkel cell carcinoma, Immune checkpoint inhibitors.
- TreatmentRetifanlimab
Shares Oncogenic viruses, Merkel cell carcinoma, PD-1, Immune checkpoint inhibitors.
- TrialA Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849
Shares Merck & Co. (MSD), Pembrolizumab.
- TrialA Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) (Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180)) in Japanese Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC) or Locally Advanced (LA) Unresectable cSCC (MK-3475A-E39)
Shares Merck & Co. (MSD), Pembrolizumab.