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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
135
Use of ASP-1929 PIT therapy
docetaxel, cetuximab, methotrexate, paclitaxel
Cancer Clinic
Miami, Florida, United States
Cancer Clinic
Tampa, Florida, United States
Progression-Free Survival (PFS)
PFS, defined as the time from randomization to the first occurrence of disease progression (PD), as determined by the Central Radiographic Review according to RECIST 1.1 with modifications, or death from any cause, whichever occurs first.
Time frame: 24 months
Overall Survival (OS)
OS, defined by the time interval between the patient randomization and death due to any cause.
Time frame: 24 months
Objective Response Rate (ORR)
ORR, defined by the percentage of patients with the best overall response of complete response (CR) or partial response (PR) by RECIST 1.1 with modifications.
Time frame: 24 months
Duration of Response (DoR)
DoR, defined as the time from first objective response (CR or PR) to the date of the first documented tumor progression, as determined by Central Radiographic Review according to RECIST 1.1 criteria with modifications or date of death due to any cause, whichever occurs first.
Time frame: 24 months
Event-Free Survival (EFS)
EFS, defined as the time interval from randomization to a \>20% increase in tumor size from baseline (CT or MRI scan at screening) by Central Radiographic Review according to RECIST 1.1 with modifications, development of new locoregional disease, distant metastatic disease, or death, whichever occurs first.
Time frame: 24 months
Eastern Cooperative Oncology Group (ECOG) performance status
Time frame: 24 months
Quality of Life (QoL) assessment - EORTC QLQ-C30
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Cancer Clinic
Atlanta, Georgia, United States
Cancer Clinic
Lexington, Kentucky, United States
Cancer Clinic 1
Philadelphia, Pennsylvania, United States
Cancer Clinic 2
Philadelphia, Pennsylvania, United States
Cancer Clinic
Houston, Texas, United States
Cancer Clinic
Vadodara, Gujarat, India
Cancer Clinic
Vadodara, Gujarat, India
Cancer Clinic
Bangalore, Kamataka, India
...and 12 more locations
Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). EORTC QLQ-C30 is a 30-item questionnaire developed to assess QoL of head and neck cancer participants and consists of five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease. It has four-point scales for the first 28 items. The minimum value is 1 and maximum value is 4. Higher scores mean a worse outcome. Overall health was evaluated as a 7-point response scale as the other two questions in that scale. The minimum value is 1 and maximum value is 7. Higher scores mean a better outcome.
Time frame: 24 months
Quality of Life (QoL) assessment - EORTC QLQ H&N 35
Change from baseline in EORTC head and neck specific module (EORTC QLQ H\&N 35). EORTC QLQ-H\&N35 is a 35-item questionnaire developed to assess QoL of head and neck cancer participants and consists of 7 multiple-item scales that assess the symptom of pain, swallowing, senses (taste/smell), speech, social eating, social contact and sexuality. Also, six single-item scales are included to survey the presence of symptomatic problems associated with teeth, mouth=opening, dry mouth, sticky saliva, coughing, and feeling ill. The minimum value is 1 and maximum value is 4. It has 2-point scales for the last 5 items. The minimum value is 1 and maximum value is 2. For all items and scales, high scores indicate more problems.
Time frame: 24 months
Quality of Life (QoL) assessment - EQ 5D-5L
Change from baseline in EuroQol 5-Dimension 5-Level (EQ 5D-5L) Questionnaire. EQ-5D-5L is a 5-dimension (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) questionnaire developed to assess the patient-generated health state index score from the societal perspective and subjective perceived health. For each dimension, levels of perceived problems are coded from level 1 (minimum) to level 5 (maximum): no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems/inability (5). A second part of the questionnaire provides a visual analogue scale (VAS) for individually perceived health from 0 to 100 (corresponding to the worst to the best imaginable health).
Time frame: 24 months
Population Pharmacokinetics (PK) of ASP-1929
Estimate covariate effects of ASP-1929 PK through compartmental PK modeling.
Time frame: 12 months
Presence of Anti-Drug Antibodies (ADA) of ASP-1929
Time frame: 24 months
Complete Response (CR)
CR, defined as the proportion of patients with tumor response of CR, as determined by Central Radiographic Review according to RECIST 1.1 with modifications.
Time frame: 24 months
Complete Response by Biopsy (CRb)
CR by histopathologic biopsy of target tumor(s) and a repeated confirmatory histopathologic CR biopsy at least 3 months after initial CR histopathologic biopsy of the target tumor(s) for patients who demonstrate a clinical CR but not an image CR per RECIST 1.1 with modifications, as determined by the Investigator.
Time frame: 24 months