Trials / Terminated
TerminatedNCT05265013
ASP-1929 Photoimmunotherapy Combined With Pembrolizumab in Patients With Recurrent Head and Neck Cancer, With or Without Metastases
A Phase 2 Single-arm Study of ASP-1929 Photoimmunotherapy Combined With Pembrolizumab in Patients With Locoregional Recurrent Squamous Cell Carcinoma of the Head and Neck, With or Without Metastases, Not Amenable to Curative Local Treatment
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Rakuten Medical, Inc. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
A Phase 2 Single-arm Study of ASP-1929 Photoimmunotherapy Combined With Pembrolizumab in Patients With Locoregional Recurrent Squamous Cell Carcinoma of the Head and Neck, With or Without Metastases, Not Amenable to Curative Local Treatment
Detailed description
A Single-arm Study of ASP-1929 Photoimmunotherapy Combined With Pembrolizumab. Patients will receive the approved label dose of pembrolizumab, which is administered every 3 weeks on days 1 and 22 of each treatment cycle. On Day 8 of each cycle, patients will receive ASP-1929 followed by illumination at accessible tumor sites using the investigational PIT690 Laser System on Day 9. Each treatment cycle, which is driven by ASP-1929 PIT frequency of administration, will last 42 days. Patients will be treated with ASP-1929 PIT and pembrolizumab for up to 12 months with a maximum of 8 treatment cycles.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | ASP-1929 Photoimmunotherapy | ASP-1929 640 mg/m\^2 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 |
| BIOLOGICAL | pembrolizumab | 200 mg every three weeks on days 1 and 22 of each 6-week cycle, 30 minute IV infusion |
Timeline
- Start date
- 2022-04-19
- Primary completion
- 2023-11-20
- Completion
- 2024-03-29
- First posted
- 2022-03-03
- Last updated
- 2024-11-04
Locations
5 sites across 1 country: Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05265013. Inclusion in this directory is not an endorsement.