De-Escalation Therapy for Human Papillomavirus Negative Disease

Phase 2 Completed 35 enrolled University of Chicago

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study is looking to see if nivolumab, an immunotherapy drug, given with carboplatin and paclitaxel (2 chemotherapy agents) during induction therapy in advanced stage HPV negative patients can significantly shrink the subject's cancer.

Timeline

Start: 2019-08-26
Primary completion: 2023-11-01
Completion: 2023-11-01

Outcome

Met primary endpoint

paper The primary end point was met, with a DRR following neoadjuvant nivolumab/chemotherapy of 53% (95% CI, 35-70). PMID 40048190 ↗

Publications

Rosenberg AJ, Juloori A, Jelinek MJ, Agrawal N, Cursio JF, Cipriani N, Lingen MW, Izumchenko E, Katipally R, Chin J, Ginat D, Pasternak-Wise O, Gooi Z, Blair E, Pearson AT, Haraf DJ, Vokes EE. Neoadjuvant Nivolumab Plus Chemotherapy Followed by Response-Stratified Chemoradiation Therapy in HPV-Negative Head and Neck Cancer: The DEPEND Phase 2 Nonrandomized Clinical Trial. JAMA Oncol. 2025 May 1;11(5):492-501. doi: 10.1001/jamaoncol.2025.0081.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	—	Intravenous
Subject	Cisplatin	Other / unclassified	—	Intravenous
Subject	Nivolumab	Monoclonal antibody	360 mg	Intravenous
Subject	Paclitaxel	Small molecule	100 mg	Intravenous
Subject	fluorouracil	Small molecule	—	Intravenous
Background	Hydroxyurea	Other / unclassified	—	Oral
Background	filgrastim	Protein / enzyme biologic	—	—