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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Precision Radiation (SBRT)
RadiationPrecision radiation of melanoma metastases
Treatment groups
27 Participants
are divided into 1 treatment groupGroup A: Precision Radiation (SBRT)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall response rate (ORR) in non-irradiated lesions
Overall response rate (ORR) in non-irradiated lesions according to RECIST 1.1
Time frame
From date of precision radiation start until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 24 monthsSecondary outcomes
1
Median PFS (months)
Median PFS (months) at 6 and 12 months according to RECIST 1.1
Time frame
6 and 12 months2
PFS rate (%)
PFS rate (%) at 6 and 12 months according to RECIST 1.1
Time frame
6 and 12 months3
Median OS (months)
Median OS (months) at 6 and 12 months according to RECIST 1.1
Time frame
6 and 12 months4
Response rate (RR) in the patient's irradiated lesions
Response rate (RR) in the patient's irradiated lesions according to RECIST 1.1
Time frame
From radiation start to end of follow-up, progression or death (3, 6, 9, 12, 15, 18, 21, 24 months)Other outcomes
1
Exploratory outcome measure: Predictive biomarkers
Translational research to investigate predictive biomarkers based on sequential tumor biopsies and/or fine needle tumor aspirations and blood
Time frame
From date of diagnosis until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov