ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed At Least Two Lines of Therapy

Active:	Yes
Cancer Type:	Head and Neck Cancer Skin Cancer (Non-Melanoma) Unknown Primary	NCT ID:	NCT03769506
Trial Phases:	Phase III	Protocol IDs:	ASP-1929-301 (primary) NCI-2019-01324
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Rakuten Medical, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT03769506

Summary

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

Objectives

The study will have an Experimental Arm and a Control Arm.

Experimental Arm:

Patients may receive repeated ASP-1929 PIT interventions for up to a maximum of 8 cycles
within 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, patient discontinues study treatment, or chooses to
withdraw. Repeat ASP-1929 treatment cycles will be administered no less than 4 weeks from
the previous ASP-1929 infusion.

Control Arm:

Patients may be treated with physician's choice standard of care until the patient has
progressive disease, patient experiences intolerable side effects, discontinues study
treatment, or chooses to withdraw.

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