NCT03618134

Stereotactic Body Radiation Therapy and Durvalumab With or Without Tremelimumab Before Surgery in Treating Participants With Human Papillomavirus Positive Oropharyngeal Squamous Cell Caner

Terminated Phase 1, PHASE2 Last updated 18 November 2023

What this trial tests

Phase 1, PHASE2 trial testing Durvalumab in Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC (American Joint Committee on Cancer) v8 in 19 participants. Terminated before completion.

Timeline

4 October 2018

Primary endpoint
30 June 2023

30 June 2023

Quick facts

Lead sponsor	Jonsson Comprehensive Cancer Center
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	4 October 2018
Primary completion	30 June 2023
Estimated completion	30 June 2023
Sites	1 location across United States

Drugs / interventions tested

• Durvalumab — full drug profile →
• Modified Radical Neck Dissection
• Quality-of-Life Assessment
• Questionnaire Administration
• Stereotactic Body Radiation Therapy — full drug profile →
• Transoral Robotic Surgery
• Tremelimumab (TREMELIMUMAB) — full drug profile →

Conditions studied

• Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC (American Joint Committee on Cancer) v8 — all drugs for Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC (American Joint Committee on Cancer) v8 →
• Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 — all drugs for Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 →
• Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 — all drugs for Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 →
• Human Papillomavirus Positive — all drugs for Human Papillomavirus Positive →

Sponsor

Jonsson Comprehensive Cancer Center — full company profile →

Who can join

18 and older, any sex, with Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC (American Joint Committee on Cancer) v8 or Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase Ib/II trial studies the side effects and how well stereotactic body radiation therapy and durvalumab with or without tremelimumab before surgery work in treating participants with human papillomavirus positive oropharyngeal squamous cell cancer. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread. Giving stereotactic body radiation therapy and durvalumab with or without tremelimumab before surgery may work better in treating participants with oropharyngeal squamous cell cancer.

Publications & conference data

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

1. HPV-associated oropharyngeal cancer: epidemiology, molecular biology and clinical management.
   Lechner M, Liu J, Masterson L, Fenton TR. · · 2022 · cited 669× · PMID 35105976 · DOI 10.1038/s41571-022-00603-7
2. HPV-driven oropharyngeal cancer: current knowledge of molecular biology and mechanisms of carcinogenesis.
   Pan C, Issaeva N, Yarbrough WG. · · 2018 · cited 79× · PMID 31093365 · DOI 10.1186/s41199-018-0039-3
3. Neoadjuvant PD-1/PD-L1 Inhibitors for Resectable Head and Neck Cancer: A Systematic Review and Meta-analysis.
   Masarwy R, Kampel L, Horowitz G, Gutfeld O, et al · · 2021 · cited 68× · PMID 34473219 · DOI 10.1001/jamaoto.2021.2191
4. Deintensification of treatment for human papillomavirus-related oropharyngeal cancer: Current state and future directions.
   Bigelow EO, Seiwert TY, Fakhry C. · · 2020 · cited 55× · PMID 32247987 · DOI 10.1016/j.oraloncology.2020.104652
5. Consensuses, controversies, and future directions in treatment deintensification for human papillomavirus-associated oropharyngeal cancer.
   Kang JJ, Yu Y, Chen L, Zakeri K, et al · · 2023 · cited 52× · PMID 36305841 · DOI 10.3322/caac.21758
6. Therapeutic strategies of different HPV status in Head and Neck Squamous Cell Carcinoma.
   Sun Y, Wang Z, Qiu S, Wang R. · · 2021 · cited 43× · PMID 33867833 · DOI 10.7150/ijbs.58077
7. Immune deserts in head and neck squamous cell carcinoma: A review of challenges and opportunities for modulating the tumor immune microenvironment.
   Farlow JL, Brenner JC, Lei YL, Chinn SB. · · 2021 · cited 34× · PMID 34218062 · DOI 10.1016/j.oraloncology.2021.105420
8. Immunotherapy Advances in Locally Advanced and Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Its Relationship With Human Papillomavirus.
   Wang H, Zhao Q, Zhang Y, Zhang Q, et al · · 2021 · cited 33× · PMID 34305889 · DOI 10.3389/fimmu.2021.652054