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UNKNOWNPHASE1/PHASE2

A Study of Metronomic CP and JX-594 in Patients With Advanced Breast Cancer and Advanced Soft-tissue Sarcoma (METROmaJX)

A Phase I/II Study of Metronomic Cyclophosphamide and Oncolytic Poxvirus JX-594 in Patients With Advanced Hormone-receptor Positive and Triple Negative Breast Cancer and Advanced Soft Tissue Sarcoma (METROmaJX)

NCT02630368•Institut Bergonié

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Summary

Assessment of the efficacy and safety of JX-594 and metronomic cyclophosphamide in patients with advanced soft-tissue sarcoma and advanced breast cancer, once the Maximum Tolerated Dose have been determined (phase I trial). Phase I study: this is a prospective open-labeled phase I trial based on a dose escalating study design assessing two dose levels of JX594 when prescribed in combination with metronomic cyclophosphamide. Phase II trials with two treatments strategies: Metronomic CP + JX-594: phase II study sarcoma: this is a monocentric, randomized two-arm non comparative phase 2 study assessing efficacy and safety of JX-594 in association with metronomic cyclophosphamide in patients with advanced soft-tissue sarcoma. Metronomic CP + JX-594: phase II study breast cancer: this is a monocentric, single-arm phase II study, assessing efficacy and safety of JX-594 in association with metronomic cyclophosphamide in patients with advanced breast cancer. Metronomic CP + JX-594 + Avelumab: phase II study sarcoma: this is a monocentric, single arm phase II study assessing efficacy and safety of avelumab in combination with IT JX-594 and metronomic cyclophosphamide in patients with advanced soft-tissue sarcoma. Metronomic CP + JX-594 + Avelumab:: phase II study breast cancer: this is a monocentric, single-arm phase II study, assessing efficacy and safety of avelumab in combination with IT JX-594 and metronomic cyclophosphamide in patients with advanced breast cancer.

Detailed Description

For the phase I study, this is a prospective open-label phase I trial based on a dose escalating study design assessing two dose level of JX-594 when associated to metronomic cyclophosphamide. For the phase II study, two distincts treatment strategies will be evaluated. First, treatment by JX-594 and metronomic cyclophosphamide: * stratum soft-tissue sarcoma, this is a monocenter, randomized non comparative phase II clinical trial. This phase II trial was based on an optimal 2-stage Simon's design. Randomization 2:1 with 2 patients randomized in experimental arm n°1 (association of metronomic cyclophosphamide and JX-594) and 1 patient randomized in control arm n°2 (treatment by metronomic cyclophosphamide alone). * stratum breast cancer, this is a monocenter, one-arm phase II clinical trial, based on two-stage optimal Simon's design (association of metronomic cyclophosphamide and JX-594). Second, treatment by Avelumab, intratumoral JX-594 and metronomic cyclophosphamide: * stratum soft-tissue sarcoma, this is a monocenter, single arm phase II clinical trial based on an optimal 2-stage Simon's design. * stratum breast cancer, this is a monocenter, one-arm phase II clinical trial, based on two-stage optimal Simon's design).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histology:
•* Phase Ib : Patient with histologically confirmed solid tumor
•* Phase II :
•* Patients with histologically confirmed HER2 negative breast cancer (treatment by CP+JX-594), or triple negative (treatment by avelumab + CP+JX-594)
•* Patients with histologically confirmed soft tissue sarcoma confirmed by the RRePS Network, b)Progressive disease or relapse, after standard therapy according to RECIST v1.1 criteria diagnosed on the basis of two CT scan or MRI obtained at an interval less than 6 months in the period of 12 months prior to inclusion and confirmed by central review
•2. Metastatic or unresectable locally advanced disease
•3. Age ≥ 18 years
•4. ECOG ≤ 1 (Phase Ib), ≤ 2 (Phase II JX+CP) and ≤ 1 (Phase II avelumab+JX+CP).
•5. Life expectancy \> 3 months,
•6. Measurable disease according to RECIST v1.1 outside any previously irradiated field. For patients treated by avelumab+JX+CP, at least one injectable site ≥ 2 cm and ≤ 8 cm in diameter and one distant non-injected measurable site (target site)
+6 more criteria

Exclusion Criteria

•1. Previous treatment with JX-594 or other vaccina vector based treatment .
•2. Concomitant diseases/conditions (non exhaustive list):
•1. Clinically significant immunodeficiency, such as HIV or active Hepatite B or C
•2. Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.
•3. History of severe exfoliative skins condition requiring systemic treatment for more than 4 weeks in the last two years.
•4. active autoimmune disease for patients treated by avelumab
•3. Active central nervous system metastasis (CNS)
•4. Participation to a study involving a medical or therapeutic intervention in the last 30 days.
•5. Previous enrolment in the present study.
•6. Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons.
+11 more criteria

Locations (1)

Institut Bergonie

Bordeaux, France

Key Dates

Start Date

September 18, 2015

Primary Completion Date

May 1, 2023

Completion Date

November 1, 2024

Last Updated

February 2, 2022

Enrollment

197

ESTIMATED participants

Conditions

Solid TumorsSoft-tissue SarcomaBreast Cancer

Interventions

Cyclophosphamide and JX-594 dose escalation

DRUG

Cyclophosphamide and JX-594

DRUG

Cyclophosphamide

DRUG

Avelumab and JX-594 and Cyclophosphamide

DRUG

Contacts

Antoine ITALIANO, MD, PhD

CONTACT

+33 524071947 a.italiano@bordeaux.unicancer.fr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Metronomic CP and JX-594 in Patients With Advanced Breast Cancer and Advanced Soft-tissue Sarcoma (METROmaJX)

Inclusion Criteria

Exclusion Criteria

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