Status:
RECRUITING
Precision Radiation of Immune Checkpoint Therapy Resistant Melanoma Metastases
Lead Sponsor:
Karolinska University Hospital
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
A phase II open-label multicenter trial evaluating response rate (RR) in patients receiving precision radiation (SBRT) to melanoma metastasis that have progressed on PD-1 inhibitor therapy. Patients w...
Eligibility Criteria
Inclusion
- 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.
- Patients on adjuvant treatment with PD-1 inhibitors that during the treatment develop unresectable biopsy confirmed metastases can also be included in the study.
- Have at least one new or progressing lesion safely amenable to irradiation in the opinion of the treating radiation oncologist AND at least one, not-to-be-irradiated new or progressing lesion measurable by CT or MRI per RECIST 1.1 criteria where up to four radiation target fields are allowed
- No contraindication for continuing immunotherapy after the radiotherapy intervention
Exclusion
- 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.
- Concomitant therapy with any anti-tumor medications, other than PD-1/CTLA-4 inhibitors or 30 days before and after treatment in this trial.
- Prior radiotherapy preventing the study intervention with precision radiotherapy
- Location, size or number of metastases is deemed as excessive or not appropriate for precision radiotherapy
- Central nervous system (CNS) metastases at baseline, with the exception of those subjects who have previously-treated CNS metastases (surgery ± radiotherapy, radiosurgery, or gamma knife) and who meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or anticonvulsants.
- Prior malignancy. Subjects who have had another malignancy should be disease-free for 5 years, or should have a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma
Key Trial Info
Start Date :
March 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04793737
Start Date
March 8 2021
End Date
December 1 2025
Last Update
March 5 2025
Active Locations (1)
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1
Division of Head-Neck, Lung and Skin cancers, Theme Cancer, Karolinska University Hospital
Stockholm, Sweden