Clinical trial NCT03769506: ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Head and Neck Cancer
Keywords: Rakuten Medical
ASP-1929
PIT
Photoimmunotherapy
HNC
HNSCC
Head and neck
EGFR
Cetuximab
Erbitux
RM-1929
Lead sponsor: Rakuten Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-07
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Overall Inclusion Criteria:

* 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
* 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 light illumination
* Have target tumors that are clearly measurable by contrast enhanced CT scan, or MRI scan with gadolinium if CT scan is not adequate or the patient has an allergy to CT contrast media.
* Have a life expectancy of \&gt; 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 agree 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

Overall Exclusion Criteria:

* Have a history of significant (\>= 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 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 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 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
* Have impaired hepatic function
* 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
* Have been previously treated or randomized to any trial using ASP-1929 or RM-1929 PIT as the study treatment

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 24 months
measure: Overall Survival (OS)
timeFrame: 24 months
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 24 months
measure: Duration of Response (DoR)
timeFrame: 24 months
measure: Event-Free Survival (EFS)
timeFrame: 24 months
measure: Eastern Cooperative Oncology Group (ECOG) performance status
timeFrame: 24 months
measure: Quality of Life (QoL) assessment - EORTC QLQ-C30
timeFrame: 24 months
measure: Quality of Life (QoL) assessment - EORTC QLQ H&N 35
timeFrame: 24 months
measure: Quality of Life (QoL) assessment - EQ 5D-5L
timeFrame: 24 months
measure: Population Pharmacokinetics (PK) of ASP-1929
timeFrame: 12 months
measure: Presence of Anti-Drug Antibodies (ADA) of ASP-1929
timeFrame: 24 months
measure: Complete Response (CR)
timeFrame: 24 months
measure: Complete Response by Biopsy (CRb)
timeFrame: 24 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Cancer Clinic
state: Florida
city: Tampa
country: United States
facility: Cancer Clinic
state: Florida
city: Atlanta
country: United States
facility: Cancer Clinic
state: Georgia
city: Lexington
country: United States
facility: Cancer Clinic
state: Kentucky
city: Philadelphia
country: United States
facility: Cancer Clinic 1
state: Pennsylvania
city: Philadelphia
country: United States
facility: Cancer Clinic 2
state: Pennsylvania
city: Houston
country: United States
facility: Cancer Clinic
state: Texas
city: Vadodara
country: India
facility: Cancer Clinic
state: Gujarat
city: Vadodara
country: India
facility: Cancer Clinic
state: Gujarat
city: Bangalore
country: India
facility: Cancer Clinic
state: Kamataka
city: Kochi
country: India
facility: Cancer Clinic
state: Kerala
city: Chennai
country: India
facility: Cancer Clinic
state: Tamilnadu
city: Hyderabad
country: India
facility: Cancer Clinic
state: Telangana
city: Kolkata
country: India
facility: Cancer Clinic
state: West Bengal
city: Mumbai
country: India
facility: Cancer Clinic
city: Nagoya-shi
country: Japan
facility: Cancer Clinic
state: Aichi
city: Sapporo-shi
country: Japan
facility: Cancer Clinic
state: Hokkaido
city: Okayama-shi
country: Japan
facility: Cancer Clinic
state: Okayama
city: Chuo-ku
country: Japan
facility: Cancer Clinic
state: Tokyo
city: Taichung
country: Taiwan
facility: Cancer Clinic
city: Taipei
country: Taiwan
facility: Cancer Clinic
city: Taoyuan
country: Taiwan
facility: Cancer Clinic
Study officials:
affiliation: Rakuten Medical
name: Ethan Chen, MD
role: STUDY_DIRECTOR
References:
citation: Kobayashi H, Furusawa A, Rosenberg A, Choyke PL. Near-infrared photoimmunotherapy of cancer: a new approach that kills cancer cells and enhances anti-cancer host immunity. Int Immunol. 2021 Jan 1;33(1):7-15. doi: 10.1093/intimm/dxaa037.
citation: Kobayashi H, Choyke PL. Near-Infrared Photoimmunotherapy of Cancer. Acc Chem Res. 2019 Aug 20;52(8):2332-2339. doi: 10.1021/acs.accounts.9b00273. Epub 2019 Jul 23.