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A Phase II Trial of Stereotactic Body Radiotherapy With Concurrent Anti-PD1 Treatment in Metastatic Melanoma.

A Phase II Trial of Stereotactic Body Radiotherapy With Concurrent Anti-PD1 Treatment in Metastatic Melanoma.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02821182
Enrollment
20
Registered
2016-07-01
Start date
2016-09-01
Completion date
2019-12-31
Last updated
2022-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Brief summary

We hypothesize that combining anti-PD1 treatment with radiotherapy might result in improved clinical response rates and PFS compared to anti-PD1 treatment in monotherapy. The current phase II trial aims at exploring the suggested benefits of the combination and aims to improve local and distant tumour responses by exploiting the pro-immunogenic effects of radiotherapy in addition to anti-PD1 treatment.

Interventions

RADIATIONstereotactic body radiotherapy

In patients with metastatic melanoma, anti-PD-1 treatment will be combined with stereotactic body radiotherapy (SBRT). A total dose of 24 Gy SBRT will be delivered in 3 fractions to one measurable lesion and fractions will be separated \>48h and \<96h.

Sponsors

GZA Ziekenhuizen Campus Sint-Augustinus
CollaboratorOTHER
University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations. * Histologically confirmed diagnosis of melanoma * At least 3 extracranial measurable metastatic lesions per RECIST v1.1. All radiology studies must be performed within 28 days prior to registration * First line anti-PD1 treatment. * Karnofsky Performance status \> 60 * Age 18 years or older * Female participants of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study treatment * Female participants who are breastfeeding or plan to breastfeed should be instructed to discontinue nursing during treatment. * Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study treatment * Demonstrate adequate organ function defined as the following: * AST and ALT ≤2.5 X ULN or ≤5 X ULN with liver metastases * Serum total bilirubin ≤1.5 X ULN or direct bilirubin ≤ULN for patient with total bilirubin level \>1.5 ULN * Serum creatinine ≤1.5 X ULN * Absolute neutrophil count \>1,000 /mcL * Platelets \>75,000 /mcL * Hemoglobin \>9 g/dL or \> 5.6 mmol/L * No history of active autoimmune disease requiring systemic treatment within the past 3 months or documented history of clinically severe autoimmune disease, or syndrome that requires systemic steroids or immunosuppressive agents * 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 * No evidence of interstitial lung disease * No uncontrolled central nervous metastases and/or carcinomatous meningitis. * No prior radiotherapy interfering with SBRT. * No concomitant therapy with IL-2, interferon, other immunotherapy regimens, chemotherapy, immunosuppressive agent or chronic use of systemic corticosteroids. * No active infection requiring systemic therapy * No known history of human immunodeficiency virus (HIV) * No known active Hepatitis B or Hepatitis C * Did not receive a live vaccine within 30 days prior to start of study treatment * No mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study * Patient not unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study

Design outcomes

Primary

MeasureTime frameDescription
Efficacy12 weeksObjective responses will be measured using RECIST v1.1. Objective responses will be defined as the number of patients with complete or partial responses as best response during follow-up.

Secondary

MeasureTime frameDescription
Immunologic responses12 weeksImmunologic responses will be assessed using peripheral blood samples, analyzed with FACS phenotyping, functional testing and ELISA. Changes in immunological parameters in tissue will be analyzed using immunohistochemistry.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026