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Synergism of Immunomodulation and Tumor Ablation

NCT03101475 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-05-31

No results posted yet for this study

Summary

This is a single-arm, open-label, multi-center early phase II study. This proof of concept study will investigate whether the combined use of local tumor ablation/radiation plus immunomodulating drugs may induce a significant immune response in patient with incurable liver metastases from colorectal cancer (CRC) (+/- limited extrahepatic disease) being stable or in partial remission after completion of 4-6 months first line systemic therapy.

The primary objective of the study is to show an overall response rate of lesions not treated by ablation/radiotherapy including the extrahepatic lesions (according to iRECIST criteria) higher than 10%. With the continuation of first line systemic treatment, no further responses are expected.

Secondary objectives are:

* To establish the feasibility and safety of the combined treatment modalities;
* To study the impact of the local technique (RFA/Radiotherapy) on the results;
* To investigate biomarkers to predict response to the combined treatment

Conditions

Interventions

DRUG

Durvalumab (MEDI4736)

Durvalumab (MEDI4736) 1500mg Q4W in combination with tremelimumab for up to 4 doses/cycles, followed by durvalumab (MEDI4736) 1500mg Q4W for up to a maximum of 8 months with the last administration on week 48 unless there is unacceptable toxicity.

DRUG

Tremelimumab

Tremelimumab (75 mg IV Q4W) in combination with durvalumab (MEDI4736) (1500mg Q4W) for up to 4 doses/cycles

RADIATION

Sterotactic body radiation therapy (SBRT)

delivered in 3 fractions of 10 Gy over 1 week starting 8 to 14 days after first dose of immunotherapy

OTHER

Radiofrequency ablation (RFA)

performed percutaneously under CT, MRI or sonographic guidance 8 to 14 days after start of immunotherapy

Sponsors & Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Theo Ruers · The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis, The Netherlands

  • Jenny Seligmann · Leeds Teaching Hospitals NHS Trust - St. James's University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-23
Primary Completion
2021-03-03
Completion
2022-02-23

Countries

  • Austria
  • France
  • Germany
  • Netherlands
  • Sweden
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03101475 on ClinicalTrials.gov