Precision Radiation of Immune Checkpoint Therapy Resistant Melanoma Metastases
ConditionMetastatic Melanoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska University Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Age 18 and above
ECOG performance status of 0-1
Signed and dated written informed consent before the start of specific protocol procedures.
Patient has initiated PD-1 inhibitor treatment (alone or in combination with CTLA-4 inhibitor) as the first line of therapy for unresectable metastatic cutaneous melanoma and been on the treatment for at least 3 months and progressed on the treatment. Patients with primary or secondary resistance to the PD-1 inhibitor treatment will be included. Progression is defined as at least 30% enlargement of at least one metastasis or appearance of new metastasis. A fine-needle aspiration (FNA) biopsy from a progressing lesion or a new lesion is recommended to confirm the presence of viable tumor cells.
Disqualifiers
Inability to understand given information or undergo study procedures according to protocol
Pregnant or breast-feeding. Patients must agree to use safe contraception during and for 3 months after study treatment.
A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 30 days before start of study treatment. Inhaled or topical steroids and adrenal replacement doses >10 mg daily prednisone equivalents are permitted.
Has an active infection requiring systemic therapy.
Trial design
Treatments tested in this trial
- Precision Radiation (SBRT)
Treatment groups
27 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov