trialsTrialCompleted

Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)

A phase 3 trial of Pembrolizumab, Epacadostat, Cetuximab, Cisplatin and Carboplatin in Head and neck squamous cell carcinoma, run by Incyte Corporation, completed.

Also called: KEYNOTE-669

Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304) is a phase 3 interventional study registered as NCT03358472 by Incyte Corporation, with 89 participants recorded, started 2017-12-01 and reaching its primary completion in 2018-07-19. Interventions recorded: Pembrolizumab, Epacadostat, Cetuximab, Cisplatin, Carboplatin, 5-Fluorouracil. Conditions recorded: Head and Neck Cancer.

Linked to the drug Epacadostat because the registry names it among its interventions and Head and neck squamous cell carcinoma among its conditions. Registry record only: no result has been read by an editor.

Setting

A Phase 3 Randomized, Open-Label Clinical Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen as First Line Treatment for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)

Phase

Phase 3

Sponsor

Incyte Corporation

Registry

Started

2017-12-01

Reported

2019

Enrolled

89 enrolled

Outcomes

In plain words

What these results mean for people, not percentages

89 enrolled

Objective Response Rate (ORR) of Pembrolizumab + Epacadostat, Pembrolizumab Monotherapy and the EXTREME Regimenprimaryresponse endpoint

31.4 vs 21.1 out of 100 had their tumour shrink with Pembrolizumab + Epacadostat compared with Pembrolizumab; 10.3 more per 100.
Roughly one extra person helped for every 10 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
Other groups: EXTREME 34.3 of 100.

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: A Phase 3 Randomized, Open-Label Clinical Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen as First Line Treatment for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304). People in a different situation may not see the same effect.
Only 89 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.

89 enrolled.

Objective Response Rate (ORR) of Pembrolizumab + Epacadostat, Pembrolizumab Monotherapy and the EXTREME Regimenprimary

Pembrolizumab + Epacadostat31.4 of 100

n = 35

Pembrolizumab21.1 of 100

n = 19

EXTREME34.3 of 100

n = 35

Download

95% CI 16.9 to 49.3; Figures from the ClinicalTrials.gov results section (first posted 2019-09-10), not from a publication · 95% CI 6.1 to 45.6 · 95% CI 19.1 to 52.2

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Objective Response Rate (ORR) of Pembrolizumab + Epacadostat, Pembrolizumab Monotherapy and the EXTREME Regimenprimary	Pembrolizumab + Epacadostat	35	31.4%	-	-	link
	Pembrolizumab	19	21.1%
	EXTREME	35	34.3%

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cancers

Head and neck squamous cell carcinoma Recurrent or metastatic head and neck squamous cell carcinoma

drugs

ApprovedCytotoxic chemotherapy (platinum)

ApprovedMonoclonal antibody (anti-EGFR)

Cetuximab · Erbitux

ApprovedCytotoxic chemotherapy (platinum)

Cisplatin · Platinol (generic)

NegativeSmall molecule (IDO1 inhibitor)

ApprovedMonoclonal antibody (anti-PD-1)

Pembrolizumab · Keytruda / Keytruda Qlex (SC)

companies