Recurrent Head and Neck Squamous Cell CarcinomaPhase 3ECLIPSENCT06699212
A Study of ASP-1929 Photoimmunotherapy in Combination With Pembrolizumab in First-line Treatment of Locoregional Recurrent Squamous Cell Carcinoma of the Head and Neck With No Distant Metastases
A Phase 3 study testing ASP-1929 Photoimmunotherapy, Pembrolizumab and Carboplatin in people with Recurrent Head and Neck Squamous Cell Carcinoma, run by Rakuten Medical, Inc. at 22 sites in 3 countries.
Trial summary
The goal of this clinical trial is to learn if ASP-1929 photoimmunotherapy (PIT) in combination with pembrolizumab works to treat recurrent squamous cell cancer of the head and neck (HNSCC) with no distant metastases. It will also learn about the safety of ASP-1929 PIT in combination with pembrolizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Head and Neck Squamous Cell Carcinoma
- What is being tested?
- ASP-1929 Photoimmunotherapy, Pembrolizumab and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 22 sitesin 3 countries
- Study dates
- 24 Dec 2024to Sep 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological evidence of squamous cell carcinoma of a head and neck primary site (per American Joint Committee on Cancer [AJCC], other than nasopharynx or cuSCC).
- Appropriate for SOC first-line treatment of their recurrent head and neck cancer with pembrolizumab ± chemotherapy.
- No known history of any distant metastatic disease (M1 by AJCC eighth edition).
- Tumors with at least one PIT-accessible and RECIST 1.1 measurable lesion as assessed by investigator.
- Anti-PD-1 and anti-PD-L1-treatment naïve.
- Combined positive score (CPS) ≥ 1 as determined locally by an FDA-approved test
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- Have results from testing of human papillomavirus (HPV) status for oropharyngeal cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of screening
- Adequate hematologic, renal, and hepatic organ function
- Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and must be willing to use a highly effective birth control while on study or be surgically sterile or abstain from heterosexual sexual activity for the course of the study through 180 days after the last dose of study treatment. Male patients must agree to use a highly effective method of contraception starting with the first dose of study medication through 120 days after the last dose of study treatment.
Who cannot join
- Diagnosed and/or treated for additional malignancy within 2 years before randomization except for those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, basal cell skin cancer, localized prostate cancer, or ductal carcinoma in situ). Patients with a history of other prior cancer treated with complete surgical resection and with no evidence of disease may be eligible based on discussion with the Medical Monitor.
- History of significant (Grade ≥ 3) cetuximab infusion reactions
- Prior allogeneic tissue/solid organ transplant
- Known or active central nervous system metastases and/or carcinomatous meningitis
- Life expectancy of less than 3 months
- Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
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- Evidence of interstitial lung disease or current active, noninfectious pneumonitis
- Active infection requiring systemic therapies such as antibiotic, antifungal, or antiviral intervention
- Known or active bacterial, viral, or fungal infection including tuberculosis, Hepatitis B (e.g., HBV DNA is detected), or Hepatitis C (e.g., RNA [qualitative] is detected)
- Known history of testing positive for human immunodeficiency virus or acquired immunodeficiency syndrome (AIDS)-related illness
- Prior or ongoing Grade ≥ 3 tumor hemorrhage within 12 weeks of randomization
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Prior systemic chemotherapy or targeted small molecule therapy or radiation therapy within 2 weeks of C1D1 or has not recovered (i.e., Grade ≤ 1 or at baseline) from adverse events (AEs) due to previously administered agent
- Prior anticancer monoclonal antibody therapy or investigational agent or intervention within 4 weeks of C1D1 or has not recovered (i.e., Grade ≤ 1 or at baseline) from AEs due to previously administered agent
- Prior receipt of ASP-1929 at any time
- Receiving chronic systemic steroid therapy (in doses exceeding 10 mg per day of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior to randomization
- Received a live vaccine within 4 weeks of randomization; seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed
- Requiring future examinations or treatments within 4 weeks after an ASP-1929 PIT treatment exposing the patient to significant light (e.g., eye examinations, surgical procedures, endoscopy) that is unrelated to the ASP-1929 PIT treatment
- Major surgery or significant traumatic injury within 4 weeks before randomization, or anticipation of the need for major surgery during the course of study treatment
Trial locations and contacts
22 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 3 countries
Taiwan9 sites, 9 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807377
Hui-Ching Wang, joellewang66@gmail.com
Hui-Ching Wang, MD
- Recruiting
China Medical University
Taichung, 404327
Ming-Yu Lien, MD, leinmirain@hotmail.com
Ming-Yu Lien, MD
- Recruiting
Taichung Veterans General Hospital
Taichung, 407219
Chen-Chi Wang, entccwang@msn.com
Chen-Chi Wang, MD
- Recruiting
Chi Mei Hospital
Tainan, 736402
Cheng-Yao Lin, MD, d930827@mail.chimei.org.tw
Cheng-Yao Lin, MD
- Recruiting
National Taiwan University Hospital
Taipei, 100225
Pei-Jen Lou, pjlou@ntu.edu.tw
Pei-Jen Lou, MD
- Recruiting
MacKay Memorial Hospital
Taipei, 104217
Yi-Shing Leu, ent.lys@gmail.com
Yi-Shing Leu, MD
- Recruiting
Taipei Veterans General Hospital
Taipei, 112201
Cheng-Hsien Wu, MD, wu_ch@vghtpe.gov.tw
Cheng-Hsien Wu, MD
- Recruiting
Taipei Municipal Wanfang Hospital
Taipei, 116081
Kuan-Chou Lin, kclin0628@hotmail.com
Kuan-Chou Lin, MD
- Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan City, 333423
Kai-Ping Chang, dr.kpchang@gmail.com
Kai-Ping Chang, MD
United States8 sites, 7 recruiting
- Recruiting
City of Hope
Duarte, California, 91010
Elizabeth Kim, elikim@coh.org
Krupal Patel, MD
- Recruiting
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
Wendy Leak, wjleak@mdanderson.org
Ann Gillenwater, MD
- Withdrawn
University of Kentucky Medical Center
Lexington, Kentucky, 40536
- Recruiting
University of Miami
Miami, Florida, 33136
Dhamini Gajjala, dxg2825@med.miami.edu
Francisco Jose Civantos, MD
- Recruiting
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
Jack Peters, john.peters2@jefferson.edu
David Cognetti, MD
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Sopha Dionson, sdionson@brownhealth.org
Ariel Birnbaum, MD
- Recruiting
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Brenna O'Bryan, medoncresearch@avera.org
William Spanos, MD
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
Monica Rengifo Pardo, mrengifopardo@TGH.org
Matthew Mifsud, MD
Japan5 sites, 5 recruiting
- Recruiting
Aichi Cancer Center
Aichi, 464-8681
Nobuhiro Hanai, MD, 81-52-762-6111
Nobuhiro Hanai, MD
- Recruiting
Hiroshima University Hospital
Hiroshima, 734-8551
Tsutomu Ueda, MD, 81-82-257-5555
Tsutomu Ueda, MD
- Recruiting
Kyoto Prefectural University of Medicine
Kyoto, 602-8566
Shigeru Hirano, MD, 81-75-251-5111
Shigeru Hirano, MD
- Recruiting
Tokyo Medical University Hospital
Tokyo, 160-0023
Kiyoaki Tsukahara, MD, 81-3-3342-6111
Kiyoaki Tsukahara, MD
- Recruiting
Tottori University Hospital
Yonago, 683-8504
Kazunori Fujiwara, MD, 81-859-33-1111
Kazunori Fujiwara, MD
About this study
Official title: A Phase 3 Multicenter, Randomized, Open-label Study of ASP-1929 Photoimmunotherapy in Combination With Pembrolizumab Versus Standard of Care in the First-line Treatment of Patients With Locoregional Recurrence of Squamous Cell Carcinoma of the Head and Neck (HNSCC) With No Distant Metastases
The goal of this clinical trial is to learn if ASP-1929 photoimmunotherapy (PIT) in combination with pembrolizumab works to treat recurrent squamous cell cancer of the head and neck (HNSCC) with no distant metastases. It will also learn about the safety of ASP-1929 PIT in combination with pembrolizumab.
Researchers will compare ASP-1929 PIT in combination with pembrolizumab to pembrolizumab alone or pembrolizumab plus chemotherapy (carboplatin or cisplatin, plus 5-fluorouracil or paclitaxel or docetaxel) according to physician's choice (control arm).
The overall primary study hypothesis being tested is whether ASP-1929 PIT plus pembrolizumab combination treatment improves the overall survival (OS) of the population defined by the inclusion/exclusion criteria over the control arm.
Read the detailed description
This is a phase 3 multicenter, randomized study designed to evaluate the efficacy and safety of ASP-1929 photoimmunotherapy (PIT) in combination with pembrolizumab versus pembrolizumab-based standard of care (SOC) as first-line treatment of locoregional recurrent HNSCC in patients with no distant metastases.
Patients will be enrolled into the study starting with 3 treatment arms, ASP-1929 PIT at doses of 320 mg/m^2 or 640 mg/m^2 in combination with pembrolizumab treatment arms or a SOC treatment arm in which patients may receive pembrolizumab alone or pembrolizumab plus chemotherapy according to physician's choice.
Treatment assignment within the SOC treatment arm will be based on the decision of the site investigator. To ensure that the SOC treatment arm is appropriately balanced, a 50% enrollment cap will be imposed on pembrolizumab monotherapy and pembrolizumab plus chemotherapy, so that approximately the same number of patients will have been treated within each category.
At the start of the study all patients will be randomized 2:2:1 ratio to ASP-1929 PIT 320 mg/m^2 plus pembrolizumab versus ASP-1929 PIT 640 mg/m^2 plus pembrolizumab versus SOC (pembrolizumab alone or pembrolizumab plus chemotherapy according to physician's choice).
An interim analysis (IA) will be conducted for this study as part of the dose optimization process. Patient enrollment will continue during the period of preparation and conduct of this IA. Based on the findings from the first interim analysis (IA1), the Sponsor will have the option to close one of the two ASP-1929 PIT treatment arms for enrollment. The final decision on the optimized ASP-1929 PIT dose for this study will be made in agreement with the US Food and Drug Administration (FDA).
- Being tested
- ASP-1929 Photoimmunotherapy, Pembrolizumab, Carboplatin, Cisplatin, 5-fluorouracil
- Keywords
- HNSCC, Squamous Cell Carcinoma of Head and Neck, Head and Neck Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck, immunotherapy, medical device, laser phototherapy, Epidermal Growth Factor Receptor, PD-1 Inhibitor, Immune Checkpoint Inhibitor, Alluminox, Rakuten Medical, ASP-1929, photoimmunotherapy, head and neck
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP-1929 PhotoimmunotherapyCombination product
Also called cetuximab sarotalocan, PIT690 Laser System
ASP-1929 IV infusion followed by illumination with light dose of 50 J/cm^2 for superficial lesions and 100 J/cm for interstitial lesions within 24 +/- 4 hours after the end of ASP-1929 infusion (up to 24 months)
PembrolizumabBiological
Also called Keytruda
200 mg Q3W or 400 mg Q6W, IV infusion over 30 minutes (up to 24 months)
CarboplatinDrug
Area under the curve (AUC) 5 mg/mL/min IV infusion, Q3W up to 6 cycles
CisplatinDrug
100 mg/m^2 IV infusion, Q3W up to 6 cycles
5-fluorouracilDrug
1000 mg/m^2 per day from Days 1-4 of each cycle, IV infusion, Q3W up to 6 cycles
PaclitaxelDrug
100 mg/m^2 IV infusion given on Days 1 and 8, Q3W up to 6 cycles or 175 mg/m^2 IV infusion given on Day 1, Q3W up to 6 cycles
DocetaxelDrug
75 mg/m^2 IV Infusion, Q3W up to 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| 320 mg/m^2 ASP-1929 Photoimmunotherapy + pembrolizumab | Experimental | ASP-1929 320 mg/m^2 IV infusion followed by illumination with 690 nm red light at accessible tumor sites using the investigational PIT690 Laser System (24 ± 4 hours after end of ASP-1929 infusion). Treatment with ASP-1929 PIT will be repeated every 4 to 6 weeks depending on clinical judgement of investigators.
Pembrolizumab: 200 mg every 3 weeks (Q3W) IV infusion over 30 minutes for the first 6 cycles. After the first 6 cycles, pembrolizumab dosing regimen can be converted from 200 mg Q3W to 400 mg every 6 weeks (Q6W) at the investigator's discretion.
Treatment in the experimental arm will start with the infusion of pembrolizumab on Cycle 1 Day 1 (C1D1) after which ASP-1929 Photoimmunotherapy will follow 7 days later, on Treatment 1 Day 1 (T1D1). Patients will be treated with ASP-1929 PIT and pembrolizumab for up to 24 months. Receives: Combination Product: ASP-1929 Photoimmunotherapy; Biological: Pembrolizumab |
| 640 mg/m^2 ASP-1929 Photoimmunotherapy + pembrolizumab | Experimental | ASP-1929 640 mg/m^2 IV infusion followed by illumination with 690 nm red light at accessible tumor sites using the investigational PIT690 Laser System (24 ± 4 hours after end of ASP-1929 infusion). Treatment with ASP-1929 PIT will be repeated every 4 to 6 weeks depending on clinical judgement of investigators.
Pembrolizumab: 200 mg every 3 weeks (Q3W) IV infusion over 30 minutes for the first 6 cycles. After the first 6 cycles, pembrolizumab dosing regimen can be converted from 200 mg Q3W to 400 mg every 6 weeks (Q6W) at the investigator's discretion.
Treatment in the experimental arm will start with the infusion of pembrolizumab on Cycle 1 Day 1 (C1D1) after which ASP-1929 Photoimmunotherapy will follow 7 days later, on Treatment 1 Day 1 (T1D1). Patients will be treated with ASP-1929 PIT and pembrolizumab for up to 24 months. Receives: Combination Product: ASP-1929 Photoimmunotherapy; Biological: Pembrolizumab |
| Pembrolizumab or pembrolizumab + chemotherapy (Control) | Active comparator | Patients in the control arm will receive physician's choice SOC. Patients randomized to SOC may only be treated with one of the following SOC options:
1. Pembrolizumab alone
2. Pembrolizumab + platinum (cisplatin or carboplatin) + 5-fluorouracil (5-FU) or taxane (paclitaxel or docetaxel)
Pembrolizumab: 200 mg Q3W IV infusion over 30 minutes for the first 6 cycles. After the first 6 cycles, pembrolizumab administration can be switched from 200 mg Q3W to 400 mg Q6W at the investigator's discretion.
Cisplatin or carboplatin: AUC 5 mg/mL/min or 100 mg/m^2 IV infusion on Day 1 of each cycle, Q3W for up to 6 cycles
5-FU: 1000 mg/m^2 IV infusion per day from Days 1-4 of each cycle, Q3W for up to 6 cycles
Paclitaxel: At investigator's choice, 100 mg/m^2 IV infusion on Day 1 and Day 8 of each 21-day cycle or paclitaxel 175 mg/m^2 IV infusion on Day 1 of each 21-day cycle for up to 6 cycles
Docetaxel: 75 mg/m^2 IV infusion on Day 1 of each cycle, Q3W for up to 6 cycles Receives: Biological: Pembrolizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: 5-fluorouracil; Drug: Paclitaxel; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
OS is defined as the time from randomization until death due to any cause.
Measured: Up to approximately 48 months
Secondary outcomes (15)
Complete response rate (CRR) per modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) as assessed by central reviewer
CRR is defined as the proportion of patients with best overall response of confirmed CR
Measured: Up to approximately 48 months
Overall response rate (ORR) per modified RECIST 1.1 as assessed by central reviewer
ORR is defined as the proportion of patients with best overall response of confirmed CR or confirmed partial response (PR)
Measured: Up to approximately 48 months
Progression-free survival (PFS) per modified RECIST 1.1 as assessed by central reviewer
PFS is defined as the time from randomization to the first documented tumor progression or death due to any cause, whichever occurs first.
Measured: Up to approximately 48 months
OS rates at 12, 18, and 24 months
OS rates at 12, 18, and 24 months are defined as the proportions of patients who are alive at these time points
Measured: 12, 18, and 24 months
Duration of Response (DOR) per modified RECIST 1.1 as assessed by central reviewer
DOR is defined as the time from first response (CR or PR) that is subsequently confirmed to the time of disease progression or death due to any cause, whichever occurs first
Measured: Up to approximately 48 months
Duration of CR per modified RECIST 1.1 as assessed by central reviewer
Duration of CR is defined as the time from first response (CR) that is subsequently confirmed to the time of disease progression or death due to any cause, whichever occurs first
Measured: Up to approximately 48 months
Time to response (TTR)
TTR is defined as the time from randomization to the first confirmed response (CR or PR)
Measured: Up to approximately 25 months
CRR from randomization to End of Treatment as assessed by the central reviewer
CRR (confirmed response) from randomization to end of treatment is defined as the proportion of patients with the best overall response of CR, where the CR occurs anytime during the study treatment period (e.g., CR after Progressive Disease [PD] will be counted).
Measured: Up to approximately 25 months
Proportion of treatment-emergent adverse events (TEAEs) by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
TEAEs refer to any AEs that begin or worsen on or after the start of any study treatment through 30 days after the last dose of study treatment and any additional immune-related adverse events (irAEs) that begin between 30 days and 90 days after the last dose of anti-PD1 treatment. In addition, any serious AE with an onset date more than 30 days after the last dose of study treatment assessed by the investigator as related to study treatment will be considered a TEAE.
Measured: Up to approximately 48 months
Proportion of treatment-related adverse events (TRAEs) by CTCAE v5.0
Any TEAE (defined in Outcome 10) for which there is a reasonable possibility that the investigational treatment caused the adverse event.
Measured: Up to approximately 48 months
Proportion of serious adverse events (SAEs) by CTCAE v5.0
An AE or suspected adverse reaction is considered 'serious' if, in the view of either the Investigator or Sponsor, it meets one or more of the following criteria (21 CFR 312.32 (a)): Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, or Is a congenital anomaly/birth defect or Important medical event.
Measured: Up to approximately 48 months
Quality of Life assessment: EORTC Core Quality of Life Questionnaire- Core 30 (EORTC QLQ-C30)
EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Each scale or item score is standardized to a range of 0 to 100. Higher scores on the functional scales reflect better functioning, whereas higher scores on the symptom scales indicate more severe symptoms or greater levels of distress. Similarly, higher scores on the global health status scale denote better overall health and quality of life. Thus, an optimal quality of life profile is characterized by high scores on the functional and global health status scales, combined with low scores on the symptom scales. The summed scores of Functional scales, Symptom scales, and Global health status domains of EORTC-QLQ-C30 are compared between treatment arms.
Measured: Up to approximately 28 months
Quality of Life assessment: EORTC Quality of Life Questionnaire Head and Neck Module (QLQ-H&N35)
EORTC QLQ-H\&N35 is a 35-item questionnaire developed to assess QoL of head and neck cancer participants and consists of 7 multi-item scales that assess pain, swallowing, senses, speech, social eating, social contact and sexuality. Each scale or item score is standardized to a range of 0 to 100. Lower score on each scale represents fewer symptoms and less impact on the patient's daily life. The summed scores of the scales of EORTC-QLQ-H\&N35 are compared between treatment arms.
Measured: Up to approximately 28 months
Population pharmacokinetics (PK) - Clearance (Experimental Arm Only)
A structural compartment model with population factors such as age, race, ECOG, and sex will be utilized to analyze concentration levels. The clearance estimates associated with different factors will be reported.
Measured: Before the start of 1st ASP-1929 infusion, 0.25 hours, 4 hours, 24 hours, 192 hours, 360 hours after end of 1st infusion; same timepoints for 2nd ASP-1929 infusion
Presence of anti-drug antibodies (ADAs) (Experimental Arm Only)
Average concentration level of ADAs at baseline and 15 days after ASP-1929 infusion for the first 2 treatments.
Measured: Before the start of 1st ASP-1929 infusion, 15 days after end of 1st infusion; same timepoints for 2nd ASP-1929 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start24 Dec 2024
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 412 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rakuten Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ethan Chen, MD, Study director, Rakuten Medical, Inc.Rebecca Cheng, MD, Study director, Rakuten Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699212
- Sponsor's protocol ID
- ASP-1929-381
- Other IDs
- ECLIPSE
- Acronym
- ECLIPSE
- Status last verified
- Oct 2025
- First submitted
- 7 Aug 2024
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Multicenter, Randomized, Open-label Study of ASP-1929 Photoimmunotherapy in Combination With Pembrolizumab Versus Standard of Care in the First-line Treatment of Patients With Locoregional Recurrence of Squamous Cell Carcinoma of the Head and Neck (HNSCC) With No Distant Metastases
- ClinicalTrials.gov ID
- NCT06699212
- Acronym / sponsor ID
- ECLIPSE / ASP-1929-381
- Keywords
- HNSCC, Squamous Cell Carcinoma of Head and Neck, Head and Neck Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck, immunotherapy, medical device, laser phototherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 412 participants (estimated)
- Lead sponsor
- Rakuten Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Dec 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if ASP-1929 photoimmunotherapy (PIT) in combination with pembrolizumab works to treat recurrent squamous cell cancer of the head and neck (HNSCC) with no distant metastases. It will also learn about the safety of ASP-1929 PIT in combination with pembrolizumab.
Researchers will compare ASP-1929 PIT in combination with pembrolizumab to pembrolizumab alone or pembrolizumab plus chemotherapy (carboplatin or cisplatin, plus 5-fluorouracil or paclitaxel or docetaxel) according to physician's choice (control arm).
The overall primary study hypothesis being tested is whether ASP-1929 PIT plus pembrolizumab combination treatment improves the overall survival (OS) of the population defined by the inclusion/exclusion criteria over the control arm.
Detailed description
This is a phase 3 multicenter, randomized study designed to evaluate the efficacy and safety of ASP-1929 photoimmunotherapy (PIT) in combination with pembrolizumab versus pembrolizumab-based standard of care (SOC) as first-line treatment of locoregional recurrent HNSCC in patients with no distant metastases.
Patients will be enrolled into the study starting with 3 treatment arms, ASP-1929 PIT at doses of 320 mg/m^2 or 640 mg/m^2 in combination with pembrolizumab treatment arms or a SOC treatment arm in which patients may receive pembrolizumab alone or pembrolizumab plus chemotherapy according to physician's choice.
Treatment assignment within the SOC treatment arm will be based on the decision of the site investigator. To ensure that the SOC treatment arm is appropriately balanced, a 50% enrollment cap will be imposed on pembrolizumab monotherapy and pembrolizumab plus chemotherapy, so that approximately the same number of patients will have been treated within each category.
At the start of the study all patients will be randomized 2:2:1 ratio to ASP-1929 PIT 320 mg/m^2 plus pembrolizumab versus ASP-1929 PIT 640 mg/m^2 plus pembrolizumab versus SOC (pembrolizumab alone or pembrolizumab plus chemotherapy according to physician's choice).
An interim analysis (IA) will be conducted for this study as part of the dose optimization process. Patient enrollment will continue during the period of preparation and conduct of this IA. Based on the findings from the first interim analysis (IA1), the Sponsor will have the option to close one of the two ASP-1929 PIT treatment arms for enrollment. The final decision on the optimized ASP-1929 PIT dose for this study will be made in agreement with the US Food and Drug Administration (FDA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 320 mg/m^2 ASP-1929 Photoimmunotherapy + pembrolizumab | Experimental | Combination Product: ASP-1929 Photoimmunotherapy, Biological: PembrolizumabASP-1929 320 mg/m^2 IV infusion followed by illumination with 690 nm red light at accessible tumor sites using the investigational PIT690 Laser System (24 ± 4 hours after end of ASP-1929 infusion). Treatment with ASP-1929 PIT will be repeated every 4 to 6 weeks depending on clinical judgement of investigators. Pembrolizumab: 200 mg every 3 weeks (Q3W) IV infusion over 30 minutes for the first 6 cycles. After the first 6 cycles, pembrolizumab dosing regimen can be converted from 200 mg Q3W to 400 mg every 6 weeks (Q6W) at the investigator's discretion. Treatment in the experimental arm will start with the infusion of pembrolizumab on Cycle 1 Day 1 (C1D1) after which ASP-1929 Photoimmunotherapy will follow 7 days later, on Treatment 1 Day 1 (T1D1). Patients will be treated with ASP-1929 PIT and pembrolizumab for up to 24 months. |
| 640 mg/m^2 ASP-1929 Photoimmunotherapy + pembrolizumab | Experimental | Combination Product: ASP-1929 Photoimmunotherapy, Biological: PembrolizumabASP-1929 640 mg/m^2 IV infusion followed by illumination with 690 nm red light at accessible tumor sites using the investigational PIT690 Laser System (24 ± 4 hours after end of ASP-1929 infusion). Treatment with ASP-1929 PIT will be repeated every 4 to 6 weeks depending on clinical judgement of investigators. Pembrolizumab: 200 mg every 3 weeks (Q3W) IV infusion over 30 minutes for the first 6 cycles. After the first 6 cycles, pembrolizumab dosing regimen can be converted from 200 mg Q3W to 400 mg every 6 weeks (Q6W) at the investigator's discretion. Treatment in the experimental arm will start with the infusion of pembrolizumab on Cycle 1 Day 1 (C1D1) after which ASP-1929 Photoimmunotherapy will follow 7 days later, on Treatment 1 Day 1 (T1D1). Patients will be treated with ASP-1929 PIT and pembrolizumab for up to 24 months. |
| Pembrolizumab or pembrolizumab + chemotherapy (Control) | Active comparator | Biological: Pembrolizumab, Drug: Carboplatin, Drug: Cisplatin, Drug: 5-fluorouracil, Drug: Paclitaxel, Drug: DocetaxelPatients in the control arm will receive physician's choice SOC. Patients randomized to SOC may only be treated with one of the following SOC options: 1. Pembrolizumab alone 2. Pembrolizumab + platinum (cisplatin or carboplatin) + 5-fluorouracil (5-FU) or taxane (paclitaxel or docetaxel) Pembrolizumab: 200 mg Q3W IV infusion over 30 minutes for the first 6 cycles. After the first 6 cycles, pembrolizumab administration can be switched from 200 mg Q3W to 400 mg Q6W at the investigator's discretion. Cisplatin or carboplatin: AUC 5 mg/mL/min or 100 mg/m^2 IV infusion on Day 1 of each cycle, Q3W for up to 6 cycles 5-FU: 1000 mg/m^2 IV infusion per day from Days 1-4 of each cycle, Q3W for up to 6 cycles Paclitaxel: At investigator's choice, 100 mg/m^2 IV infusion on Day 1 and Day 8 of each 21-day cycle or paclitaxel 175 mg/m^2 IV infusion on Day 1 of each 21-day cycle for up to 6 cycles Docetaxel: 75 mg/m^2 IV infusion on Day 1 of each cycle, Q3W for up to 6 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histological or cytological evidence of squamous cell carcinoma of a head and neck primary site (per American Joint Committee on Cancer [AJCC], other than nasopharynx or cuSCC).
- Appropriate for SOC first-line treatment of their recurrent head and neck cancer with pembrolizumab ± chemotherapy.
- No known history of any distant metastatic disease (M1 by AJCC eighth edition).
- Tumors with at least one PIT-accessible and RECIST 1.1 measurable lesion as assessed by investigator.
- Anti-PD-1 and anti-PD-L1-treatment naïve.
Key exclusion criteria (19 listed)
- Diagnosed and/or treated for additional malignancy within 2 years before randomization except for those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, basal cell skin cancer, localized prostate cancer, or ductal carcinoma in situ). Patients with a history of other prior cancer treated with complete surgical resection and with no evidence of disease may be eligible based on discussion with the Medical Monitor.
- History of significant (Grade ≥ 3) cetuximab infusion reactions
- Prior allogeneic tissue/solid organ transplant
- Known or active central nervous system metastases and/or carcinomatous meningitis
- Life expectancy of less than 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP-1929 PhotoimmunotherapyAlso: cetuximab sarotalocan, PIT690 Laser SystemASP-1929 IV infusion followed by illumination with light dose of 50 J/cm^2 for superficial lesions and 100 J/cm for interstitial lesions within 24 +/- 4 hours after the end of ASP-1929 infusion (up to 24 months) | Combination product | 320 mg/m^2 ASP-1929 Photoimmunotherapy + pembrolizumab, 640 mg/m^2 ASP-1929 Photoimmunotherapy + pembrolizumab |
| PembrolizumabAlso: Keytruda200 mg Q3W or 400 mg Q6W, IV infusion over 30 minutes (up to 24 months) | Biological | 320 mg/m^2 ASP-1929 Photoimmunotherapy + pembrolizumab, 640 mg/m^2 ASP-1929 Photoimmunotherapy + pembrolizumab, Pembrolizumab or pembrolizumab + chemotherapy (Control) |
| CarboplatinArea under the curve (AUC) 5 mg/mL/min IV infusion, Q3W up to 6 cycles | Drug | Pembrolizumab or pembrolizumab + chemotherapy (Control) |
| Cisplatin100 mg/m^2 IV infusion, Q3W up to 6 cycles | Drug | Pembrolizumab or pembrolizumab + chemotherapy (Control) |
| 5-fluorouracil1000 mg/m^2 per day from Days 1-4 of each cycle, IV infusion, Q3W up to 6 cycles | Drug | Pembrolizumab or pembrolizumab + chemotherapy (Control) |
| Paclitaxel100 mg/m^2 IV infusion given on Days 1 and 8, Q3W up to 6 cycles or 175 mg/m^2 IV infusion given on Day 1, Q3W up to 6 cycles | Drug | Pembrolizumab or pembrolizumab + chemotherapy (Control) |
| Docetaxel75 mg/m^2 IV Infusion, Q3W up to 6 cycles | Drug | Pembrolizumab or pembrolizumab + chemotherapy (Control) |
Primary outcome
Overall survival (OS)
Time frame: Up to approximately 48 months
OS is defined as the time from randomization until death due to any cause.
15 secondary outcomes
Complete response rate (CRR) per modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) as assessed by central reviewer
Time frame: Up to approximately 48 months
Overall response rate (ORR) per modified RECIST 1.1 as assessed by central reviewer
Time frame: Up to approximately 48 months
Progression-free survival (PFS) per modified RECIST 1.1 as assessed by central reviewer
Time frame: Up to approximately 48 months
OS rates at 12, 18, and 24 months
Time frame: 12, 18, and 24 months
Duration of Response (DOR) per modified RECIST 1.1 as assessed by central reviewer
Time frame: Up to approximately 48 months
Duration of CR per modified RECIST 1.1 as assessed by central reviewer
Time frame: Up to approximately 48 months
Time to response (TTR)
Time frame: Up to approximately 25 months
CRR from randomization to End of Treatment as assessed by the central reviewer
Time frame: Up to approximately 25 months
Proportion of treatment-emergent adverse events (TEAEs) by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: Up to approximately 48 months
Proportion of treatment-related adverse events (TRAEs) by CTCAE v5.0
Time frame: Up to approximately 48 months
Proportion of serious adverse events (SAEs) by CTCAE v5.0
Time frame: Up to approximately 48 months
Quality of Life assessment: EORTC Core Quality of Life Questionnaire- Core 30 (EORTC QLQ-C30)
Time frame: Up to approximately 28 months
Quality of Life assessment: EORTC Quality of Life Questionnaire Head and Neck Module (QLQ-H&N35)
Time frame: Up to approximately 28 months
Population pharmacokinetics (PK) - Clearance (Experimental Arm Only)
Time frame: Before the start of 1st ASP-1929 infusion, 0.25 hours, 4 hours, 24 hours, 192 hours, 360 hours after end of 1st infusion; same timepoints for 2nd ASP-1929 infusion
Presence of anti-drug antibodies (ADAs) (Experimental Arm Only)
Time frame: Before the start of 1st ASP-1929 infusion, 15 days after end of 1st infusion; same timepoints for 2nd ASP-1929 infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ethan Chen, MD study director
Rakuten Medical, Inc.
Rebecca Cheng, MD study director
Rakuten Medical, Inc.
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ASP-1929 Photoimmunotherapy, Pembrolizumab and Carboplatin in people with Recurrent Head and Neck Squamous Cell Carcinoma, run by Rakuten Medical, Inc. at 22 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Taiwan, United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ASP-1929-381 Study Team (858-207-3113, clinicaltrialinfo@rakuten-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: Up to approximately 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.