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

NCT02821182 | Completed Phase 2

• 1 other identifier: EC UZG 2016/0540
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• Efficacy

  Objective 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.

  12 weeks

Secondary Outcomes (1)

• Immunologic responses

  12 weeks

Study Arms (1)

Anti-PD1 treatment in combination with SBRT

EXPERIMENTAL

Patients receiving anti-PD1 treatment will be treated with high-dose radiotherapy to one lesion in 3 fractions prior to the second cycle of systemic therapy.

Radiation: stereotactic body radiotherapy

Interventions

stereotactic body radiotherapy RADIATION

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.

Anti-PD1 treatment in combination with SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• GZA Ziekenhuizen Campus Sint-Augustinus: collaborator

Study Sites (1)

University Hospital Ghent

Ghent, West Vlaanderen, 9000, Belgium

Location

Related Publications (1)

• De Wolf K, Kruse V, Sundahl N, van Gele M, Chevolet I, Speeckaert R, Brochez L, Ost P. A phase II trial of stereotactic body radiotherapy with concurrent anti-PD1 treatment in metastatic melanoma: evaluation of clinical and immunologic response. J Transl Med. 2017 Jan 31;15(1):21. doi: 10.1186/s12967-017-1123-x.

  PMID: 28137295 DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: July 1, 2016
• Study Start: September 1, 2016
• Primary Completion: September 9, 2018
• Study Completion: December 31, 2019
• Last Updated: December 29, 2022

Record last verified: 2022-12

Locations

BE (1)