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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)

Pembrolizumab plus epacadostat, pembrolizumab monotherapy, and the EXTREME regimen as first line treatment for R/M HNSCC (KEYNOTE-669/ECHO-304)

Ishii Takeaki

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

JPCT@msd.com

MSDJRCT inquiry mailbox

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

+81-3-6272-1957

JPCT@msd.com

completed

Feb. 16, 2018

Interventional

randomized controlled trial, open, active control, Multi-site

treatment purpose

3

1)Measurable disease based on RECIST v1.1.
2)Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
3)Adequate organ function per protocol-defined criteria.
4)Documentation of results from testing of human papilloma virus (HPV) status for oropharyngeal cancer.
5)Baseline archival tumor specimen available or willing to undergo a prestudy treatment tumor core or excisional biopsy of a tumor lesion not previously irradiated, to obtain the specimen.

1)Carcinoma of the nasopharynx, salivary gland, unknown primary origin, or nonsquamous histologies as primary tumors.
2)Disease progression within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.
3)Use of protocol-defined prior/concomitant therapy.
4)Known additional malignancy that is progressing or has required active treatment within the past 3 years.
5)Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
6)Active autoimmune disease that has required systemic treatment in past 2 years.
7)Known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority.
8)Known history of or is positive for active hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (defined as HCV RNA [qualitative] is detected).

Both

Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)

Experimental
Nonproprietary name:MK-3475(Pembrolizumab) ,INCB024360(Epacadostat)
Pharmacological classification code:429 Other antitumor drugs
Group1(MK-3475+INCB024360):
Pembrolizumab 200 mg IV infusion every 3 weeks (Q3W) <35 cycles; AND Epacadostat 100 mg PO twice daily (BID) <35 cycles.
Group 2(MK-3475 monotherapy):
Pembrolizumab 200 mg IV infusion Q3W <=35 cycles.

Active Comparator
Nonproprietary name:Cetuximab, Cisplatin, Carboplatin, 5-Fluorouracil
Pharmacological classification code:42 Antitumor drugs
Cetuximab 400 mg/m2 IV infusion Cycle 1 Day 1;
followed by cetuximab 250 mg/m2 IV infusion every week (QW) until disease progression or unacceptable toxicity; AND Cisplatin 100 mg/m2
IV infusion OR Carboplatin area under the curve 5 (AUC 5) IV infusion Q3W <6 cycles; AND 5-fluorouracil (5-FU) 1000 mg/m2/day continuous IV infusion over Days 1 to 4 Q3W <6 cycles.

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

Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Experiencing Adverse Events (AEs)
Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Discontinuing Study Treatment Due to AEs

Nov. 14, 2017