ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03769506|
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : April 1, 2021
|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 :||September 30, 2024|
|Estimated Study Completion Date :||December 30, 2024|
Active Comparator: ASP-1929 Photoimmunotherapy
Use of ASP1929 PIT therapy
Combination Product: ASP-1929 Photoimmunotherapy
Use of ASP-1929 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.|