ASP-1929 + Pembrolizumab for Head and Neck Cancer (ECLIPSE Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Rakuten Medical, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults with recurrent squamous cell carcinoma of the head and neck, which hasn't spread to distant parts of the body. Participants must not have had previous treatments that would interfere with this study.

Inclusion Criteria

My cancer is a type of squamous cell carcinoma in the head or neck, but not in the nasopharynx.

My cancer has not spread to distant parts of my body.

I am fully active or can carry out light work.

My CPS score is 1 or higher from an approved test.

My tumor can be measured and is accessible for testing.

I have never received anti-PD-1 or anti-PD-L1 treatments.

Exclusion Criteria

I have had a severe reaction to cetuximab.

I have never received ASP-1929 treatment.

I haven't had major surgery or serious injury in the last 4 weeks and don't expect to need major surgery soon.

I have had a transplant of tissue or an organ from another person.

I do not have any active infections like TB, Hepatitis B, or C.

I have not had severe tumor bleeding in the last 3 months.

I do not have any serious illnesses that would stop me from following the study's requirements.

I have upcoming procedures that involve significant light exposure within 4 weeks after ASP-1929 PIT treatment.

I am currently on treatment for an active infection.

I have cancer that has spread to my brain or spinal cord.

I have lung scarring or inflammation not caused by an infection.

I haven't had chemotherapy, targeted therapy, or radiation in the last 2 weeks and have recovered from any side effects.

Treatment Details

The study tests ASP-1929 photoimmunotherapy combined with pembrolizumab against either pembrolizumab alone or along with chemotherapy (carboplatin or cisplatin and a choice of 5-fluorouracil, paclitaxel, or docetaxel). The goal is to see if combining therapies improves survival.

3Treatment groups

Experimental Treatment

Active Control

Group I: 640 mg/m^2 ASP-1929 Photoimmunotherapy + pembrolizumabExperimental Treatment2 Interventions

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.

Group II: 320 mg/m^2 ASP-1929 Photoimmunotherapy + pembrolizumabExperimental Treatment2 Interventions

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.

Group III: Pembrolizumab or pembrolizumab + chemotherapy (Control)Active Control6 Interventions

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

ASP-1929 Photoimmunotherapy is already approved in Japan for the following indications:

🇯🇵 Approved in Japan as ASP-1929 for: