Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients
- Conditions
- Head and Neck Cancer
- Registration Number
- JPRN-jRCT2080224527
- Lead Sponsor
- Rakuten Medical, Inc. (ICCC: IQVIA Services Japan K.K.)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 275
Inclusion Criteria including but not limited to:
- Patients with histologically confirmed locoregional persistent, recurrent or second primary squamous cell carcinoma of the head and neck, not amenable to curative treatment.
- Patient must have failed or progressed on or after at least 2 lines of therapy for squamous cell carcinoma of the head and neck, one of which must be prior systemic chemotherapy for treatment of their primary or recurrent head and neck cancer.
- Patients must have completed prior curative radiation therapy for treatment of their head and neck cancer.
- All locoregional head and neck tumor site(s) are accessible for light illumination treatment.
- Target tumors are clearly measurable by contrast enhanced CT scan.
- Life expectancy > 6 months.
- Male patients at least 18 years old.
- Female patients at least 18 years old.
- Patients must have an ECOG score of 0-1.
- Patients must understand the investigational nature of the trial, be willing to sign a written informed consent, and be willing to comply with all study procedures and follow-up.
Exclusion Criteria including but not limited to:
- Patients with a history of significant (>= Grade 3) cetuximab infusion reactions.
- Patients who have been treated with prior systemic chemotherapy or targeted small molecule therapy or radiation therapy within 2 weeks of trial Day 1 or who have not recovered from adverse events due to previously administered agent.
- Patients who have been treated with an anticancer monoclonal antibody therapy within 4 weeks of trial Day 1 or who have not recovered from adverse events due to previously administered agent.
- Patients who have been treated with an investigational agent or intervention within 4 weeks of trial Day 1 or who have not recovered from adverse events, due to previously administered agent or intervention.
- Present history of distant metastatic disease (M1).
- Patients who are actively undergoing treatment of or have a diagnosis of an active cancer other than nonmelanoma skin cancer or HNSCC.
- Tumor invading a major blood vessel unless the vessel has been embolized, stented or surgically ligated to prevent potential bleeding from a blood vessel.
- Patients must have a Hemoglobin >= 9.0 g/dL, WBC >= 2,000/microL, and Platelets >= 100,000/microL.
- Patients with impaired hepatic function.
- Patients with impaired renal function.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Progression-Free Survival(PFS)<br>Overall survival(OS)
- Secondary Outcome Measures
Name Time Method efficacy<br>pharmacokinetics<br>other<br>Objective Response Rate(ORR)<br>Complete Response(CR)<br>Complete Response by Biopsy(CRb)<br>Duration of Response(DoR)<br>Event-Free Survivial(EFS)<br>response rates using CT RECIST 1.1, Choi criteria, and CT tumor volumetrics<br>Eastern Cooperative Oncology Group (ECOG) performance status<br>European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the head and neck specific module (EORTC QLQ-H&N 35)<br>EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire<br>Presence of anti-drug antibodies (ADA)<br>Population PK