ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy
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|ClinicalTrials.gov Identifier: NCT03769506|
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : October 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Combination Product: ASP-1929 Photoimmunotherapy Drug: Physician's Choice SOC||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||275 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 Photoimmunotherapy Versus 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, of Which at Least One Line Must Be Systemic Therapy|
|Actual Study Start Date :||May 9, 2019|
|Estimated Primary Completion Date :||December 15, 2020|
|Estimated Study Completion Date :||December 15, 2021|
Active Comparator: ASP-1929 Photoimmunotherapy
Use of ASP-PIT therapy
Combination Product: ASP-1929 Photoimmunotherapy
Use of ASP-PIT therapy
Active Comparator: Physician's Choice SOC
docetaxel, cetuximab, methotrexate, paclitaxel
Drug: Physician's Choice SOC
docetaxel, cetuximab, methotrexate, or paclitaxel
- Progression-Free Survival [ Time Frame: 24 months ]Time to progression of disease
- Overall survival [ Time Frame: 24 months ]Duration of survival between the two treatment arms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769506
|Contact: Sumera Raoof, MD, MPH||+1 email@example.com|
|Study Director:||Sarah Arron, MD||Rakuten Medical, Inc.|