Actively Recruiting
Precision Radiation of Immune Checkpoint Therapy Resistant Melanoma Metastases
Led by Karolinska University Hospital · Updated on 2025-03-05
27
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate tumor response, survival and adverse effects after precision radiotherapy (SBRT) in melanoma patients with ongoing PD-1 inhibitor treatment that have tumor progression.
CONDITIONS
Official Title
Precision Radiation of Immune Checkpoint Therapy Resistant Melanoma Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 and above
- ECOG performance status of 0-1
- Signed and dated written informed consent before starting study procedures
- Initiated PD-1 inhibitor treatment as first-line therapy for unresectable metastatic cutaneous melanoma, on treatment at least 3 months with progression
- Includes patients with primary or secondary resistance to PD-1 inhibitor treatment
- Patients on adjuvant PD-1 inhibitors who develop unresectable biopsy-confirmed metastases
- At least one new or progressing lesion suitable for radiation and at least one measurable non-irradiated lesion per RECIST 1.1, allowing up to four radiation target fields
- No contraindication for continuing immunotherapy after radiation intervention
You will not qualify if you...
- Unable to understand or follow study procedures
- Pregnant or breastfeeding; must use safe contraception during and 3 months after study treatment
- Need for systemic corticosteroids (>10 mg prednisone daily) or other immunosuppressive treatment within 30 days before study
- Active infection requiring systemic therapy
- Use of other anti-tumor medications besides PD-1/CTLA-4 inhibitors within 30 days before and after study treatment
- Prior radiotherapy preventing precision radiotherapy in this study
- Metastases location, size, or number unsuitable for precision radiotherapy
- Central nervous system metastases at baseline, except previously treated CNS metastases that are asymptomatic and require no steroids or anticonvulsants
- Prior malignancy unless disease-free for 5 years or completely resected non-melanomatous skin carcinoma or treated in situ carcinoma
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Division of Head-Neck, Lung and Skin cancers, Theme Cancer, Karolinska University Hospital
Stockholm, Sweden
Actively Recruiting
Research Team
H
Hildur Helgadottir, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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