CTRI/2023/05/052728 [Registered on: 16/05/2023] Trial Registered Prospectively
Last Modified On:
07/08/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological Medical Device
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy
Scientific Title of Study
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
Amrita Institute of Medical Sciences and Research Centre
Department of Head and Neck surgery and oncology, Tower -1, 4th Floor, Amrita Lane, Ponekkara, Edappally PO, Kochi, PIN 682041, India Ernakulam
91-9440334104
drkrishnakumart@gmail.com
Dr Rajesh Kantharia
Bankers Superspeciality Hospital
OPD No. 3, Head and Neck oncosurgery department, Ground floor, Opp-Mahalakshmi Party Plot, Tulsidham-GIDC Road, Manjalpur, PIN 390011, India Vadodara
91-9825860896
rajeshkantharia9@gmail.com
Dr Nemade Onkar
Basavatarakam Indo American Cancer Hospital & Research Institute
Department of surgical oncology, room no 100, First floor, block 1, Road No 10, Banjara Hills, Hyderabad, PIN 500034, India Hyderabad
91-9494715011
drhemantnemade@gmail.com
Dr Venkatraman Radhakrishnan
Cancer Institute (WIA)
Clinical Trial Services Unit, No-72, Bhagavan Aditya Jain Complex, 38, Sardar Patel Road, Adyar, PIN 600036, India Chennai
91-9498082771
r.venkatraman@cancerinstitutewia.org
Dr Ghanish Panjwani
Kailash Cancer Hospital and Research Center
Department of Clinical Research, 1st floor, Muniseva Ashram, Goraj, Waghodia, PIN 391760, India Vadodara
91-9771415482
ghanish.panjwani@greenashram.org
Dr Vijay Shivashankar N Pillai
Mazumdar Shaw Medical Centre
Department of Clinical Research Basement of Narayana Institute of Cardiac Sciences, No. 258/A, Bommasandra Industrial Area, Anekal Taluk, Hosur Road, PIN 560099, India Bangalore Rural
91-9449061932
vijay.pillai.dr@narayanahealth.org
Dr Kapila Manikantan
Tata Medical Center
Dept of Head and Neck Surgery Room no.206, LDU 2nd floor Tata Medical Center, 14 MAR (E-W), DH Block (Newtown), Action Area I, PIN 700160, India Kolkata
91-9482529764
kapila.manikantan@gmail.com
Dr Kumar Prabhash
Tata Memorial Centre
OPD No.204, Homi Bhabha block, Department of Medical Oncology, Tata Memorial Hospital, Mumbai Dr. E Borges Road, Parel, PIN 400012, India Mumbai
Institutional Ethics Committee, Cancer Institute (WIA)
Approved
Institutional Review Board, Tata Medical Center
Approved
Narayana Health Medical Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
Malignant neoplasm of larynx
Patients
Malignant neoplasm of lip
Patients
Malignant neoplasm of base of tongue
Patients
Malignant neoplasm of other and unspecified parts of tongue
Patients
Malignant neoplasm of gum
Patients
Malignant neoplasm of floor of mouth
Patients
Malignant neoplasm of palate
Patients
Malignant neoplasm of other and unspecified parts of mouth
Patients
Malignant neoplasm of tonsil
Patients
Malignant neoplasm of oropharynx
Patients
Malignant neoplasm of pyriform sinus
Patients
Malignant neoplasm of hypopharynx
Patients
Secondary and unspecified malignant neoplasm of lymph nodes of head, face and neck
Patients
Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx
Intervention / Comparator Agent
Type
Name
Details
Intervention
ASP-1929 Photoimmunotherapy
ASP-1929 640 mg/m2 IV infusion on Day 1 followed by light illumination with 690 nm light on Day 2, for a maximum of 8 cycles in the 12-month treatment period after randomization. An ASP-1929 photoimmunotherapy treatment cycle includes the ASP-1929 infusion and light illumination followed by a 28-day assessment period to include an end-of-cycle assessment visit and tumor imaging.
Comparator Agent
Physician’s Choice Standard of Care (SOC)
docetaxel 30 mg/m2 IV every week, or 40 mg/m2 IV every week, or 60 mg/m2 IV every 3-4 weeks, or 75 mg/m2 IV every 3-4 weeks; or cetuximab 400 mg/m2 IV loading dose followed by weekly 250 mg/m2 IV; or methotrexate 40 mg/m2 IV every week, or 60 mg/m2 IV every week; or paclitaxel 80 mg/m2 IV every week
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
Have a histologically confirmed locoregional persistent, recurrent or second primary squamous cell carcinoma of the head and neck, not amenable to curative treatment
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 platinum-based chemotherapy for treatment of their primary or recurrent head and neck cancer, unless in the opinion of the medical oncologist, the use of platinum-based chemotherapy is contraindicated or not recommended
Have completed prior curative radiation therapy for treatment of their head and neck region
Have locoregional head and neck tumor site(s) that are all accessible to illumination
Have target tumors that are clearly measurable by contrast enhanced CT scan
Have a life expectancy of > 6 months, based on Investigator judgment
Male participants must agree to use contraception during the treatment period and for at least 6 months after the last ASP-1929 infusion
Female patients of childbearing potential must not be pregnant or breastfeeding and agrees to follow the contraceptive guidance during the treatment period and for at least 6 months after the last dose of trial intervention and must refrain from breastfeeding for at least 2 months after the last ASP-1929 infusion
Have an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
ExclusionCriteria
Details
Have a history of significant (greater than or equal to Grade 3) cetuximab infusion reactions
Have been treated with prior systematic chemotherapy or targeted small molecule therapy or radiation therapy within 2 weeks of trial Day 1 or not recovered (ie, less than or equal to Grade 1 or at baseline) from adverse events due to a previously administered agent
Have been treated with an anticancer monoclonal antibody therapy within 4 weeks of trial Day 1 or have not recovered (ie, less than or equal to Grade 1 or at baseline) from adverse events due to previously administered agent
Have been treated with an investigational agent or intervention within 4 weeks of trial Day 1 or have not recovered (ie, less than or equal to Grade 1 or at baseline) from adverse events, due to previously administered agent or intervention
Have a present history of distant metastatic disease (M1)
Have an active undergoing treatment or have a diagnosis of an active cancer other than nonmelanoma skin cancer or HNSCC
Have a tumor in enhanced CT or MRI scan invading a major blood vessel, unless the vessel has been embolized, stented or surgically ligated to prevent potential bleeding from a blood vessel
With a hemoglobin < 9.0 g/dL, WBC < 2000/μL, and platelets < 100 x 1000/μL
Have impaired hepatic function defined as alkaline phosphatase (hepatic; alkaline phosphatase [ALP]) > 2 times upper limit of normal, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times the upper limit of normal, or total serum bilirubin > 2 mg/dL (patients with Gilbert’s disease will be excluded if they have a bilirubin greater than or equal to 5 mg/dL)
Have impaired renal function
Have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with trial requirements
Require examinations or treatments within 4 weeks after ASP-1929 administration where they would be exposed to significant light (eg, eye examinations, elective surgical procedures) unrelated to the study treatment
Have been previously treated or randomized to any trial using ASP-1929 or RM-1929 PIT as the study treatment
Method of Generating Random Sequence
Stratified block randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Progression-Free Survival (PFS), defined as the time from randomization to the first occurrence of disease progression (PD), as determined by the investigator according to RECIST 1.1, or death from any cause, whichever one occurs first
Overall Survival (OS), defined by the time interval between the patient randomization and death due to any cause.
24 months
Secondary Outcome
Outcome
TimePoints
Objective Response Rate (ORR), defined by the percentage of patients with the best overall response of complete response (CR) or partial response (PR) by RECIST 1.1. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters
24 months
Complete Response (CR), defined as disappearance of all target lesions, as determined by Central Radiographic Review according to RECIST 1.1 criteria with modifications. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to 10mm.
24 months
Complete Response by Biopsy (CRb), defined by histopathologic biopsy of target tumor(s) and a repeat confirmatory histopathologic CR biopsy at least 3 months after initial CR histopathologic biopsy of the target tumor(s) for patients that do not demonstrate a CR by RECIST 1.1 with modifications. CR: Disappearance of all target lesions.
24 months
Duration of Response (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. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
24 months
Event-Free Survival (EFS), defined as the time interval from randomization to a 20% increase in tumor size from baseline (defined as CT scan at screening) by RECIST 1.1 with modifications, development of new locoregional disease, distant metastatic disease, or death.
24 months
Objective unique target and non-target tumor(s) assessment and response rates using RECIST 1.1 with modifications, Choi criteria with modifications, and CT tumor volumetrics
24 months
ECOG performance status
24 months
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), the head and neck specific module (EORTC QLQ H&N 35), and the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
24 months
Presence of anti-drug antibodies (ADA)
12 months
Estimate the effects of covariates (body size, age, gender, race, ECOG) of ASP-1929 PK through compartmental PK modeling
12 months
Target Sample Size
Total Sample Size="275" Sample Size from India="80"
A Phase 3, randomized,
double-arm, open-label, controlled, multi-centre 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. Approximately 275 patients
with locoregional, recurrent HNSCC are to be enrolled to receive either
ASP-1929 PIT or the physician’s choice of SOC. The objective of the study is to
evaluate the efficacy and safety of ASP-1929 PIT as a monotherapy for the
treatment of locoregional, recurrent HNSCC 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. The primary outcome measures are
progression-free survival (PFS) and overall survival (OS). The key secondary
endpoint is objective response rate (ORR).
