PROTOCOL NRG-HN004 - STUDY REOPENED TO PHASE II PORTION WITH PROTOCOL AMENDMENT 3

STUDY IS NOW OPEN TO PHASE II PORTION WITH PROTOCOL AMENDMENT 3:

 

The NCI Central Institutional Review Board (CIRB) has approved this protocol amendment. Protocol documents can be obtained from the CTSU website. Documentation of IRB approval of the amendment must be submitted to the CTSU Regulatory Office prior to enrolling participants.

 

Per protocol-specified dose limiting toxicity analyses in the lead-in component of this phase II/III trial, MEDI4736 (durvalumab) was declared safe and feasible to administer concurrently with RT for patients with HNSCC with a contraindication to cisplatin. Intravenous MEDI4736 1500 mg was delivered at weeks -2, 2, 6, 10, 14, 18, and 22 with RT (70 Gy in 35 daily fractions weeks 1-7). Pending IRB approval of amendment 3, the phase II portion of the study is open to enrollment of 234 patients to the two treatment arms. 

 

Treatment Arm

Dose

RT+MEDI4736

1500 mg IV Weeks -2, 2, 6, 10, 14, 18, and 22 with RT
70 Gy in 7 weeks (conventional fractionation)

RT+Cetuximab

400 mg/m2 loading dose prior to RT then 250 mg/m2 weekly x 7 cycles concurrent with RT
70 Gy in 7 weeks (conventional fractionation)

 

The Canadian Cancer Trials Group (CCTG) has joined the study and will file the CTA with Health Canada. Canadian member sites will enroll through the CCTG. We will update you on when this is complete.

 

The following updated documents are now available on the CTSU website:

  • Participant Brochure under the "CIRB Documents/Amendment Review" tab
  • Pathology and Correlative Instructions under the "Supplemental Documents" tab
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