Phase I study of first administration in humans aimed at defining a high-dose radiation therapy dose in patients with melanoma and cutaneous metastases

Switzerland (ICTRP)

ICTRP Trial ID
NCT04986696 (ICTRP)

Official title (approved by ethics committee)
A phase I, first-in-human, dose finding study of high dose rate radiotherapy in patients with skin metastases from melanoma (BASEC)

Academic title
A Phase I, First-in-human, Dose Finding Study of High Dose Rate Radiotherapy in Patients With Skin Metastases From Melanoma (ICTRP)

Public title
Irradiation of Melanoma in a Pulse (ICTRP)

Disease under investigation
Metastasis From Malignant Melanoma of Skin (Diagnosis) (ICTRP)

Intervention under investigation
Device: FLASH therapy (ICTRP)

Type of trial
Interventional (ICTRP)

Trial design
Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Inclusion/Exclusion criteria
Gender: All
Maximum age: N/A
Minimum age: 18 Years

Inclusion Criteria:

1. Signed study Informed Consent Form

2. Karnofsky Performance Status (KPS) = 50

3. Age = 18 years

4. Patients with metastatic melanoma and multiple skin metastases with a documented
clinical progression despite the systemic treatments (chemotherapy, and/or Programmed
cell death 1 (PD1), cytotoxic T-lymphocyte antigen-4 (CTLA4) inhibitors or tyrosine
kinase inhibitors (TKIs), such as v-raf murine sarcoma viral oncogene homolog B1
(BRAF) or mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors)

5. The size of the treated lesions should be = 5.5 cm in diameter and = 2.8 cm thick
(caliper-based measurement)

6. The treated lesions should be at least 5 cm apart and must not be located on the face.

7. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy
test (urine or serum) during screening

8. WOCBP must use a contraceptive method

Exclusion Criteria:

1. Previous radiotherapy in the treated area

2. Concomitant auto-immune disease with skin lesions

3. Concomitant use of radio-sensitizer drug

4. Women who are pregnant

5. Current, recent (within 10 days prior start of study treatment), or planned
participation in an experimental drug study. During the 4 weeks DLT period, the
patient will not be able to participate to any other clinical study.

6. Any serious underlying medical condition that could interfere with study treatment and
potential adverse events

7. Any mental or other impairment that may compromise compliance with the requirements of
the study
(ICTRP)

not available

Primary and secondary end points
Determination of maximum tolerated dose (MTD) or recommended phase II dose (RP2D), separately for skin metastases of small and large volumes. (ICTRP)

Percentage of patients with Hemorrhage related to the treated lesions, assessed visually by the investigator;Percentage of patients with Skin ulceration related to the treated lesions, assessed visually by the investigator;Percentage of patients with Pain related to the treated lesions, assessed with analogic visual pain scale;Local response of metastases "in the radiation field", measured with calipers;Frequency of Late side effects observed "in radiation field";Blinded Imaging Central Review (BICR) of photographs evaluating both tumor response and "in radiation field" normal tissue responses around the treated tumors;Optical coherence tomography (OCT) examination of the irradiated skin compared to the normal non-irradiated skin;Frequency of late adverse events (within 12 months post-treatment) for each dose (ICTRP)

Registration date
not available

Incorporation of the first participant
not available

Secondary sponsors
not available

Additional contacts
Jean Bourhis, MD, PhD;Lana Kandalaft, Pharm D, PhD;Jean Bourhis, MD, PhD, lana.kandalaft@chuv.ch; jean.bourhis@chuv.ch, +41 21 314 78 23;0041213144666, Centre Hospitalier Universitaire Vaudois, (ICTRP)

Secondary trial IDs
CHUV-DO-0023-IMPulse-2020 (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT04986696 (ICTRP)