NCT02841748

A Randomized, Double-Blind Phase II Study of Adjuvant Pembrolizumab Versus Placebo in Head and Neck Cancers at High Risk for Recurrence- the PATHWay Study

Active, enrolled Phase 2 Last updated 1 October 2025

What this trial tests

Phase 2 trial testing Pembrolizumab in Head and Neck Cancer in 100 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

10 May 2017

Primary endpoint
20 June 2026

25 June 2026

Quick facts

Lead sponsor	University of Chicago
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	100
Start date	10 May 2017
Primary completion	20 June 2026
Estimated completion	25 June 2026
Sites	4 locations across United States

Drugs / interventions tested

• Pembrolizumab (pembrolizumab) — full drug profile →
• Placebo

Conditions studied

• Head and Neck Cancer — all drugs for Head and Neck Cancer →
• Squamous Cell Carcinoma of the Head and Neck — all drugs for Squamous Cell Carcinoma of the Head and Neck →

Sponsor

University of Chicago

Who can join

18 and older, any sex, with Head and Neck Cancer or Squamous Cell Carcinoma of the Head and Neck. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A placebo-controlled, randomized study using adjuvant pembrolizumab treatment for one year in order to potentially improve progression free survival in a squamous cell carcinoma of the head and neck cohort at high-risk for recurrence.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of squamous cell carcinoma of the head and neck (HNSCC).
   Cohen EEW, Bell RB, Bifulco CB, Burtness B, et al · · 2019 · cited 528× · PMID 31307547 · DOI 10.1186/s40425-019-0662-5
2. Tumor microenvironment: an evil nexus promoting aggressive head and neck squamous cell carcinoma and avenue for targeted therapy.
   Bhat AA, Yousuf P, Wani NA, Rizwan A, et al · · 2021 · cited 119× · PMID 33436555 · DOI 10.1038/s41392-020-00419-w
3. Immune Modulation of Head and Neck Squamous Cell Carcinoma and the Tumor Microenvironment by Conventional Therapeutics.
   Miyauchi S, Kim SS, Pang J, Gold KA, et al · · 2019 · cited 107× · PMID 30814108 · DOI 10.1158/1078-0432.ccr-18-0871
4. Recent Advances and Future Directions in Clinical Management of Head and Neck Squamous Cell Carcinoma.
   Muzaffar J, Bari S, Kirtane K, Chung CH. · · 2021 · cited 97× · PMID 33477635 · DOI 10.3390/cancers13020338
5. Biological mechanisms of immune escape and implications for immunotherapy in head and neck squamous cell carcinoma.
   Moy JD, Moskovitz JM, Ferris RL. · · 2017 · cited 80× · PMID 28324750 · DOI 10.1016/j.ejca.2016.12.035
6. Immune Evasion by Head and Neck Cancer: Foundations for Combination Therapy.
   Horton JD, Knochelmann HM, Day TA, Paulos CM, et al · · 2019 · cited 65× · PMID 30961829 · DOI 10.1016/j.trecan.2019.02.007
7. New developments in the management of head and neck cancer - impact of pembrolizumab.
   Saleh K, Eid R, Haddad FG, Khalife-Saleh N, et al · · 2018 · cited 60× · PMID 29497306 · DOI 10.2147/tcrm.s125059
8. Immunotherapy in head and neck cancer: aiming at EXTREME precision.
   Szturz P, Vermorken JB. · · 2017 · cited 48× · PMID 28571578 · DOI 10.1186/s12916-017-0879-4