Hokkaido Phase II Study of Photo-Immunotherapy Combination with ASP-1929 for Radio-resistant Recurrent or Persistent vulvar, vaginal lesions with EGFR-positive gynecologic cancers

JRCT ID: jRCT2011240034

Registered date:29/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Locally advanced or recurrent vulvar cancer, vaginal cancer, or cervical cancer
• Date of first enrollment: 01/10/2024
• Target sample size: 16
• Study type: Interventional

Intervention(s)

Antihistamines and corticosteroids are administered intravenously 30-60 minutes before ASP-1929 infusion as pre-medications.
Following pre-medications, ASP-1929 at a dose of 640 mg/m2 is infused intravenously over 2 hours.
The lesions are illuminated with red laser light (690 nm) using the investigational device 20-28 hours after the end of the intravenous infusion.
Each cycle designates Day 1 as the day of ASP-1929 administration, with treatment efficacy evaluated between Days 29 and 56. If a complete response is not observed, the patient may be retreated up to 3 times (up to 4 treatments in total). The investigators will determine the need for retreatment during Days 29-56 and start retreatment by Day 84.

Outcome(s)

• Primary Outcome: Tumor shrinkage effect in laser-illuminated lesions

Secondary Outcome

(Efficacy)
Treatment effect in laser-illuminated lesions: local complete response, duration of local disease control, duration of local therapeutic response,
Systemic treatment effect: overall response rate, disease control rate, progression-free survival, overall survival,
Patient-reported outcomes: pain score, patient QOL
(Safety) Adverse events (AEs), Grade 3 or higher AEs, serious AEs and failures

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

(1) Patients with unresectable disease or who are unwilling to undergo surgery
(2) Patients histologically diagnosed with vulvar cancer, vaginal cancer, or cervical cancer
(3) Patients with EGFR-stained and HE-stained specimens prepared in the "Registry Study on the Actual Treatment Status for Vulvar Cancer, Vaginal Cancer, and Locally Recurrent Cervical Cancer" and who have been confirmed to have EGFR expression (2+ or higher) through central pathological review of this clinical trial
(4) Patients previously treated with radiotherapy or chemoradiotherapy to the vulva or the pelvic region. However, those with lesions amenable to standard treatment, including radiotherapy, are excluded
(5) Patients with cervical cancer who have been treated with one or more chemotherapy regimens
(6) Patients with at least one measurable lesion in the vulva, vagina, or cervix, as defined by RECIST v1.1, that is suitable for laser illumination
(7) Patients with appropriate organ function, as indicated by laboratory values collected within 28 days before enrollment
(8) Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Scale of 0-2
(9) Patients aged 18 years or older at the time of informed consent
(10) Patients who can provide written informed consent of their own free will after understanding that they may withdraw consent at any time without disadvantages on future treatment and before undergoing any clinical trial-related procedures (excluding standard medical care)

Exclude criteria

(1) Patients with active double cancer (synchronous or multiple cancers, or metachronous double/multiple cancer within 5-year disease-free interval). However, patients can be enrolled if histological diagnosis of the recurrent lesion confirms the disease treated in this study
(2) Patients with uncontrolled major complications.These include, but are not limited to, critical bleeding or intense pain caused by the tumor, ongoing or active infection, symptomatic congestive heart failure, unstable angina, arrhythmias, or mental illness/social circumstances that may limit adherence to study requirements
(3) Patients requiring examinations or treatments expected to be exposed to intense light (ophthalmic examinations or elective surgical procedures not related to the investigational treatment) during the first 4 weeks after ASP-1929 administration
(4) Patients with a history of hypersensitivity to any of the ingredients of the drugs used in this study
(5) Patients who have received any treatment for the underlying disease within 4 weeks before enrollment
(6) Pregnant women, women of childbearing potential who cannot agree to use contraception from the time of consent until 7 months after the final dose of the investigational drug, or who cannot agree to refrain from breastfeeding from the time of consent until 2 months after the final dose of the investigational drug
(7) Patients with the following distant metastatic disease
1) Solitary or similar lesions in radiation-naive areas indicated for radiotherapy
2) Lesions refractory to other treatments
(8) Patients with the following lesions in the illuminated areas (vulva, vagina, or cervix)
1) Mucosal invasion of the rectum and lower urinary tract (bladder and urethra), including fistula formation
2) Suspected invasion of the pelvic wall (including invasion of internal and external iliac vessels and obturator nerve)
3) Suspected invasion reaching the abdominal cavity
(9) Patients with cervical cancer who are recommended to receive anti PD-1/PD-L1 drugs
(10) Patients deemed ineligible for the investigational drug or considered unable to be safely undergo laser illumination, based on the judgment of the principal investigator or the sub-investigator

Related Information

• Primary Sponsor: Watari Hidemichi
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,Rakuten Medical, Inc.