ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
Summary
- Conditions
- Head and Neck Cancer
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The study will have an Experimental Arm and a Control Arm. Experimental 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, pati...
The study will have an Experimental Arm and a Control Arm. Experimental 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. Control Arm: 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.
Tracking Information
- NCT #
- NCT03769506
- Collaborators
- Not Provided
- Investigators
- Study Director: Sarah Arron, MD Rakuten Medical, Inc.
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