ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy

Sponsor

Rakuten Medical, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03769506

Collaborator

(none)

275

Enrollment

Locations

Arms

67.7

Anticipated Duration (Months)

7.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Combination Product: ASP-1929 Photoimmunotherapy Drug: Physician's Choice SOC	Phase 3

Detailed Description

The study will have an Experimental Arm and a Control Arm.

Experimental 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.

Control Arm:

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 Design

Study Type:

Interventional

Anticipated Enrollment :

275 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Progression-Free Survival [24 months]
Time to progression of disease
Overall survival [24 months]
Duration of survival between the two treatment arms

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 illumination
Have target tumors that are clearly measurable by contract 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

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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33139
2	Rush University Medical Center	Chicago	Illinois	United States	60612
3	University of Kentucky	Lexington	Kentucky	United States	40536
4	Karmanos Cancer Institute	Detroit	Michigan	United States	48201
5	Henry Ford Hospital	Detroit	Michigan	United States	48202
6	Virginia Piper Cancer Institute, Part of Allina Health	Minneapolis	Minnesota	United States	55407
7	University of Minnesota	Minneapolis	Minnesota	United States	55455
8	New York Head & Neck Institute - Center for Head and Neck Oncology	New York	New York	United States	10075
9	Providence Cancer Center	Portland	Oregon	United States	97213
10	Thomas Jefferson University - Sidney Kimmel Medical College	Philadelphia	Pennsylvania	United States	19107
11	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19107
12	Vanderbilt University	Nashville	Tennessee	United States	37203
13	UT Southwestern Medical Center	Dallas	Texas	United States	75390
14	MD Anderson Cancer Center	Houston	Texas	United States	77030
15	University of Virginia	Charlottesville	Virginia	United States	22903
16	UZ Antwerpen	Edegem		Belgium	B-2650
17	UZ Leuven - Gasthuisberg	Leuven		Belgium	B-3000
18	Office of Anthanassios Argiris, MD	Maroussi	Athens	Greece	15123
19	Aichi Cancer Center	Nagoya-shi	Aichi	Japan	464-8681
20	National Cancer Center Hospital East	Kashiwa-shi	Chiba	Japan	277-8577
21	Kurume University Hospital	Kurume-shi	Fukuoka	Japan	830-0011
22	Hokkaido University Hospital	Sapporo-shi	Hokkaido	Japan	060-8648
23	Kobe University Hospital	Kobe-shi	Hyogo	Japan	650-0017
24	Miyagi Cancer Center	Natori-shi	Miyagi	Japan	981-1293
25	Okayama University Hospital	Okayama-shi	Okayama	Japan	700-8558
26	Osaka International Cancer Institute	Osaka-shi	Osaka	Japan	541-8567
27	National Cancer Center Hospital	Chuo-ku	Tokyo	Japan	104-0045
28	Cancer Institute Hospital of JFCR	Koto-ku	Tokyo	Japan	135-8550
29	Hospital Universitari Vall d'Hebron	Barcelona		Spain	08035
30	HM University Sanchinarro Hospital	Madrid		Spain	28050
31	Kaohsiung Chang Gung Memorial Hospital	Niaosong	Kaohsiung	Taiwan	833
32	National Taiwan University Hospital	Zhongzheng	Taipei	Taiwan	100
33	Changhua Christian Medical Foundation	Changhua		Taiwan	50004
34	China Medical University Hospital	Taichung		Taiwan	40705
35	Taichung Veterans General Hospital	Taichung		Taiwan	40705
36	Taipei Veterans General Hospital	Taipei		Taiwan	11217
37	Chang Gung Memorial Hospital	Taoyuan		Taiwan	333