Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy
A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 vs Physician's Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck Squamous Cell Carcinoma in Patients Who Have Failed or Progressed On or After at Least Two Lines of Therapy
- Head and Neck Cancer
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
Patients must have histologically confirmed locoregional persistent, recurrent or second
primary squamous cell carcinoma of the head and neck, not amenable to curative treatment.
Patients must have failed or progressed on or after at least 2 lines of therapy, one of
which must be prior platinum-based chemotherapy. (Treatments such as surgery followed by
chemotherapy and radiation, or surgery and radiation, or radiation, or surgery is
considered one line of therapy).
Patients must not have a history of significant reactions to cetuximab, not actively
undergoing treatment of or have a diagnosis of an active cancer other than nonmelanoma skin
cancer or HNSCC.
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Single (Outcomes Assessor)
Physician's Choice SOC
|docetaxel, cetuximab, methotrexate, paclitaxel||
UK Center for Clinical and Translational Science and nearby locations
- NCT ID
- Rakuten Medical, Inc.
Study ContactJeannie Hou
The study will have an Experimental Arm and a Control Arm.
Patients may receive repeated ASP-1929 PIT interventions for a period of up to 12 months after randomization until the patient has complete remission, progressive disease that is no longer amendable to study treatment, patient experiences intolerable side effects, or patient discontinues study treatment.
Patients may be treated with physician's choice SOC until the patient has progressive disease, patient experiences intolerable side effects, or patient discontinues study treatment.