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Status unknownNCT02630368METROmaJXUpdated Feb 2, 2022

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

A Phase 1/2 interventional study of Cyclophosphamide and JX-594 dose escalation and Cyclophosphamide and JX-594 in Solid Tumors, Soft-tissue Sarcoma and Breast Cancer, sponsored by Institut Bergonié. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-02.

Sponsored by Institut Bergonié · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
197
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).
02

Conditions studied

  • Solid Tumors
  • Soft-tissue Sarcoma
  • Breast Cancer

Keywords

  • Advanced Soft-tissue Sarcoma
  • Advanced Breast Cancer
  • Maximum Tolerated Dose
  • Efficacy and safety
  • Immunotherapy
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 197 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Institut Bergonié is the lead sponsor of 119 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Main 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)
  7. At least three weeks since last chemotherapy, immunotherapy or any other pharmacological treatment and/or radiotherapy.
  8. Adequate hematological, renal, metabolic and hepatic functions.
  9. Women of childbearing potential must have a negative serum pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for six months after discontinuation of treatment.
  10. Patients informed of risks regarding drug interactions: patients receiving any substances that are inhibitors or inducers of CYP450 2B6 are ineligible
  11. Voluntarily signed and dated written informed consent prior to any study specific procedure.
  12. Patients with a social security in compliance with the French law.

Main 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.
  7. Known hypersensitivity to any involved study drug or any of its formulation components.
  8. Use of steroids (any route of administration), interferon/pegylated interferon or ribavirin that cannot be discontinued within 14 days prior to any JX-594 dose.
  9. No prior malignancy except for the following: adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage 1 or Stage 2 cancer from which the patient is currently in complete remission or any other cancer from which the patient has been disease-free for 3 years.
  10. Active cardiovascular disease, including but not limited to significant coronary artery disease (e.g. requiring angioplasty or stenting) or congestive heart failure within the preceding 12 months. (treatment by CP+JX)
  11. Inability to suspend treatment with anti-hypertensive medication for 48 hours prior to and 48 hours after all JX-594 treatments.
  12. Pulse oximetry O2 saturation \< 90% at rest on room air.
  13. Experienced a severe systemic reaction or side-effect as result of previous smallpox vaccination.
  14. Cardiac disease: LVEF out of normal limits ; cumulative dose of anthracyclines in excess of 450 mg/m²
  15. Known urinary tract obstruction
  16. Household contact exclusions for patients enrolled: children\< 1 year old ; People with skin disease (e.g., eczema, atopic dermatitis and related diseases...), Immunocompromised hosts (severe deficiencies in cell-mediated immunity, including AIDS, organ transplant recipients, hematologic malignancies)
  17. Vaccination within 4 weeks of the first dose of study treatment and while on trial is prohibited except for administration of inactivated vaccines.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
197 participants (estimated)

Study arms

  • Experimental
    Experimental phase I dose escalating

    Prospective open-labeled phase I trial. Combination of cyclophosphamide and JX-594 dose escalation. Metronomic cyclophosphamide will be administered orally, 50 mg twice daily, one week on/one week off. JX-594 will be administered, as designated by assigned dose-level, intraveinously, on Days 8 and 22 of cycle 1, and on days 8 of each subsequent cycles. One cycle consits of 28 days. Number of subjects : 14

    Drug: Cyclophosphamide and JX-594 dose escalation

  • Experimental
    Experimental group soft-tissue sarcoma, treatment by JX-594 + Metronomic cyclophosphamide

    Randomized non comparative phase II clinical trial : Arm 1. Experimental phase II soft-tissue sarcoma : Combination of cyclophosphamide and JX-594. Metronomic cyclophosphamide will be administered orally, 50 mg twice daily, one week on/one week off. JX-594 will be administered, as the dose recommended in the experimental phase I dose escalating study, intraveinously, on Days 8 and 22 of cycle 1, and on days 8 of each subsequent cycles. One cycle consits of 28 days. Number of subjects : 48

    Drug: Cyclophosphamide and JX-594

  • Experimental
    Control group soft-tissue sarcoma, treatment by JX-594 + Metronomic cyclophosphamide

    Randomized non comparative phase II clinical trial : Arm 2. Control-arm phase II soft-tissue sarcoma : Patients will be treated by metronomic cyclophosphamide. Cyclophosphamide will be administered 50 mg twice daily orally, one week on/one week off. One cycle consits of 28 days. Number of subjects : 24

    Drug: Cyclophosphamide

  • Experimental
    Experimental group breast cancer, treatment by JX-594 + Metronomic cyclophosphamide

    Single-arm phase II clinical trial. Experimental phase II Group breast cancer : Combination of cyclophosphamide and JX-594. Metronomic cyclophosphamide will be administered orally, 50 mg twice daily, one week on/one week off. JX-594 will be administered, as the dose recommended in the experimental phase I dose escalating study, intraveinously, on Days 8 and 22 of cycle 1, and on days 8 of each subsequent cycles. One cycle consits of 28 days. Number of subjects : 32

    Drug: Cyclophosphamide and JX-594

  • Experimental
    Experimental group soft-tissue sarcoma, treatment by Avelumab + ITJX-594 + Metronomic CP

    Experimental phase II soft-tissue sarcoma : Combination of avelumab in combination with intratumoral JX-594 and metronomic cyclophosphamide. Avelumab will be administered by intravenous infusion every 2 weeks, starting at Day 15 of cycle 1. Cyclophosphamide wil be administered orally, 50 mg twice daily, one Week on/one Week off, starting 7 days prior to cycle 1 day 1 ("impregnation phase"). JX-594 will be administered by intratumoral injection on day 1 of cycle 1, every 2 weeks, for a maximum of 4 injections. Number of subjects : 47

    Drug: Avelumab and JX-594 and Cyclophosphamide

  • Experimental
    Experimental group breast cancer, treatment by Avelumab + IT JX-594 + Metronomic CP

    Experimental phase II breast cancer : Combination of avelumab in combination with intratumoral JX-594 and metronomic cyclophosphamide. Avelumab will be administered by intravenous infusion every 2 weeks, starting at Day 15 of cycle 1. Cyclophosphamide wil be administered orally, 50 mg twice daily, one Week on/one Week off, starting 7 days prior to cycle 1 day 1 ("impregnation phase"). JX-594 will be administered by intratumoral injection on day 1 of cycle 1, every 2 weeks, for a maximum of 4 injections. Number of subjects : 32

    Drug: Avelumab and JX-594 and Cyclophosphamide

Interventions

  • DrugCyclophosphamide and JX-594 dose escalation

    Metronomic cyclophosphamide will be administered orally, 50 mg twice daily, one week on/one week off. JX-594 will be administered, as designated by assigned dose-level, intraveinously, on Days 8 and 22 of cycle 1, and on days 8 of each subsequent cycles. One cycle consits of 28 days.

    Also known as: Brand name : ENDOXAN, Brand name: Pexa-Vec

  • DrugCyclophosphamide and JX-594

    Metronomic cyclophosphamide will be administered orally, 50 mg twice daily, one week on/one week off. JX-594 will be administered, as the dose recommended in the experimental phase I dose escalating study, intraveinously, on Days 8 and 22 of cycle 1, and on days 8 of each subsequent cycles. One cycle consits of 28 days.

    Also known as: Brand name : ENDOXAN, Brand name: Pexa-Vec

  • DrugCyclophosphamide

    Metronomic cyclophosphamide will be administered orally, 50 mg twice daily, one week on/one week off.

    Also known as: Brand name : ENDOXAN

  • DrugAvelumab and JX-594 and Cyclophosphamide

    Avelumab will be administered by intravenous infusion (10 mg/kg) every 2 weeks, starting at Day 15 of cycle 1. Cyclophosphamide wil be administered bi-daily (50 mg x 2), starting 7 days prior to cycle 1 day 1 ("impregnation phase") and given on a week on/week off schedule. JX-594 will be administered by intratumoral injection (1 x109 p.f.u) on day 1 of cycle 1, every 2 weeks, for a maximum of 4 injections .

    Also known as: Brand name: ENDOXAN, Brand name: Pexa-Vec, Brand name: Avelumab

06

What researchers measure

Primary outcomes

  1. Phase Ib : Maximum Tolerated Dose evaluated on the first cycle (D1 to D28) of the combination of JX-594 And metronomic cyclophosphamide

    the MTD is defined as the highest dose at which no more than 1 in 6 of the patients in the cohort experienced a DLT in the first treatment cycle

    Time frame: during the first cycle (28 days)

  2. Phase II : Advanced soft-tissue sarcoma: Assessment of the antitumor activity of the association of JX-594 and metronomic cyclophosphamide based on 6 month non-progression (CR, PR or SD more than 24 weeks) following RECIST v1.1 criteria

    Non-progression is defined as complete or partial response or stable disease, as per RECIST v1.1

    Time frame: Phase II : 6 months after the beginning of treatment

  3. Phase II : Advanced Breast cancer: Assessment of the antitumor activity of the association of JX-594 and metronomic cyclophosphamide Efficacy will be defined based on objective response under treatment (CR or PR) following RECIST v1.1 criteria

    Objective response is defined as complete or partial response as per RECIST v1.1

    Time frame: Phase II : 6 months after the beginning of treatment

  4. Phase II : Advanced soft-tissue sarcoma: Assessment of the antitumor activity of Avelumab in combination with IT JX-594 and metronomic cyclophosphamide based on 6 month non-progression (CR, PR or SD more than 24 weeks) following RECIST v1.1 criteria

    Non-progression is defined as complete or partial response or stable disease, as per RECIST v1.1

    Time frame: Phase II : 6 months after the beginning of treatment

  5. Phase II : Advanced Breast cancer: Assessment of the antitumor activity of avelumab in combination with IT JX-594 and metronomic cyclophosphamide Efficacy will be defined based on objective response under treatment following RECIST v1.1 criteria

    Objective response is defined as complete or partial response as per RECIST v1.1

    Time frame: Phase II : 6 months after the beginning of treatment

Secondary outcomes

  1. Phase Ib : Recommended Phase II dose (RP2D) of the association of JX-594 and metronomic cyclophosphamide

    Data from all cycles will be used to define the dose level of JX-594 to be recommended for further investigations in phase II

    Time frame: Phase Ib : Throughout the 6 months of treatment period

  2. Phase Ib: Objective response under treatment as per RECIST V1.1

    Objective response is defined as complete or partial response as per RECIST v1.1

    Time frame: an average of 6 months

  3. Phase Ib: Best overall response as per RECIST V1.1

    - Best overall response is defined as the best response recorded from the start of the study treatment until the end of treatment taking into account any requirement for confirmation (as per RECIST v1.1).

    Time frame: an average of 6 months

  4. Phase Ib: 6-months non-progression as per RECIST V1.1

    Non-progression is defined as complete or partial response or stable disease, as per RECIST v1.1

    Time frame: 6-months after the beginning of treatment

  5. Phase Ib: 1-year progression-free survival as per RECIST V1.1

    PFS defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause)

    Time frame: 1-year after the beginning of treatment

  6. Phase Ib: 2-year progression-free survival as per RECIST V1.1

    PFS defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause)

    Time frame: 2-year after the beginning of treatment

  7. Phase Ib : Pharmacokinetics (PK): PK measurements expressed as Area Under the curve forJX-594

    Time frame: Day 8 of cycle 1, Day 15 of cycle 1, Day 22 of cycle 1, Day 1 of cycle 2, Day 8 of cycle 2, Day 22 of cycle 2, Day 8 of cycle 3, Day 8 of cycle 4, Day 8 of cycle 6 (Each cycle = 28 days)

  8. Phase Ib : Pharmacokinetics (PK): PK measurements expressed as half-life forJX-594

    Time frame: Day 8 of cycle 1, Day 15 of cycle 1, Day 22 of cycle 1, Day 1 of cycle 2, Day 8 of cycle 2, Day 22 of cycle 2, Day 8 of cycle 3, Day 8 of cycle 4, Day 8 of cycle 6 (Each cycle = 28 days)

  9. Phase Ib : Pharmacokinetics (PK): PK measurements expressed as Concentration peak forJX-594

    Time frame: Day 8 of cycle 1, Day 15 of cycle 1, Day 22 of cycle 1, Day 1 of cycle 2, Day 8 of cycle 2, Day 22 of cycle 2, Day 8 of cycle 3, Day 8 of cycle 4, Day 8 of cycle 6 (Each cycle = 28 days)

  10. Phase Ib : Dose-Limiting toxicity of the association of JX-594 and metronomic cyclophosphamide

    Time frame: during the first cycle (cycle = 28 days)

  11. Phase Ib : Predictive biomarkers analysis (cytokines levels)

    Time frame: baseline, day 8 of cycle 1, day 22 of cycle 1, day 8 of cycle 2, day 8 of cycle 4, day 8 of cycle 6. Each cycle = 28 days

  12. Phase Ib : Predictive biomarkers analysis (lymphocytes levels)

    Time frame: baseline, day 8 of cycle 1, day 22 of cycle 1, day 8 of cycle 2, day 8 of cycle 4, day 8 of cycle 6. Each cycle = 28 days

  13. Phase II : Best overall response defined as per RECIST v1.1 criteria

    Best overall response is defined as the best response recorded from the start of the study treatment until the end of treatment taking into account any requirement for confirmation (as per RECIST v1.1).

    Time frame: an average of 6 months

  14. Phase II : For sarcoma only: objective response following CHOI criteria

    Time frame: an average of 6 months

  15. Phase II : For sarcoma only: best overall response following CHOI criteria

    Time frame: an average of 6 months

  16. Phase II : For sarcoma only: 6- month non-progression following CHOI criteria

    Time frame: 6-months after the beginning of treatment

  17. Phase II : 1-year Progression-Free Survival (PFS) defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause), whichever occurs first

    PFS defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause)

    Time frame: one year after the beginning of treatment

  18. Phase II : 2-year Progression-Free Survival (PFS) defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause), whichever occurs first

    PFS defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause)

    Time frame: two years the beginning of treatment

  19. Phase II : 1-year Overall Survial (OS) defined as the time from study treatment initiation to death (of any cause)

    OS defined as the time from study treatment initiation to death (of any cause)

    Time frame: one year after the beginning of treatment

  20. Phase II : 2-year Overall Survial (OS) defined as the time from study treatment initiation to death (of any cause)

    OS defined as the time from study treatment initiation to death (of any cause)

    Time frame: two year after the beginning of treatment

  21. Phase II : Toxicity graded using the common toxicity criteria from the NCI v4.0

    assessef with NCI-CTCAE V4

    Time frame: an average of 6 months

  22. Predictive biomarkers (cytokines level)

    Time frame: baseline, day 8 of cycle 1, day 22 of cycle 1, day 8 of cycle 2, day 8 of cycle 4, day 8 of cycle 6. Each cycle = 28 days

  23. Predictive biomarkers (lymphocytes level)

    Time frame: baseline, day 8 of cycle 1, day 22 of cycle 1, day 8 of cycle 2, day 8 of cycle 4, day 8 of cycle 6. Each cycle = 28 days

  24. Phase II : Relationship between levels of anti-JX-594 antibodies and efficacy of CP + JX-594 in terms of 6-month non progression for sarcoma (as per RECIST V1.1)

    Time frame: Six months after the beginning of treatment

  25. Phase II : Relationship between levels of anti-JX-594 antibodies and efficacy of CP + JX-594 in terms of objective response for breast cancer (as per RECIST V1.1)

    Time frame: an average of 6 months

  26. Phase II : Relationship between activation of the pRB/E2F/TK pathway and efficacy of CP + JX-594 on available archived tumor tissue in terms of 6- month non progression for sarcoma (as per RECIST V1.1)

    Time frame: Phase II : Six months after the beginning of treatment

  27. Phase II : Relationship between activation of the pRB/E2F/TK pathway and efficacy of CP + JX-594 on available archived tumor tissue in terms objective response for breast cancer (as per RECIST V1.1)

    Time frame: an average of 6 months

  28. Phase II Soft-tissue sarcoma: antitumor actiivty of avelumab in combination with IT JX-594 and metronomic CP in terms of best overall response

    - Best overall response is defined as the best response recorded from the start of the study treatment until the end of treatment taking into account any requirement for confirmation (as per RECIST v1.1)

    Time frame: an average of 6 months

  29. Phase II Breast cancer: antitumor actiivty of avelumab in combination with IT JX-594 and metronomic CP in terms of best overall response

    - Best overall response is defined as the best response recorded from the start of the study treatment until the end of treatment taking into account any requirement for confirmation (as per RECIST v1.1)

    Time frame: an average of 6 months

  30. Phase II Breast cancer: antitumor actiivty of avelumab in combination with IT JX-594 and metronomic CP in terms of 6-month non-progression

    Non-progression is defined as complete or partial response or stable disease, as per RECIST v1.1

    Time frame: 6 months

  31. Phase II Soft-tissue sarcoma: antitumor actiivty of avelumab in combination with IT JX-594 and metronomic CP in terms of objective response Under treatment

    Objective response is defined as complete or partial response as per RECIST v1.1

    Time frame: an average of 6 months

  32. Phase II Soft-tissue sarcoma: antitumor actiivty of avelumab in combination with IT JX-594 and metronomic CP in terms of 1-year progression-free survival

    PFS defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause)

    Time frame: 1 year

  33. Phase II Breast cancer: antitumor actiivty of avelumab in combination with IT JX-594 and metronomic CP in terms of 1-year progression-free survival

    PFS defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause)

    Time frame: 1 year

  34. Phase II Soft-tissue sarcoma: antitumor actiivty of avelumab in combination with IT JX-594 and metronomic CP in terms of 2-year progression-free survival

    PFS defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause)

    Time frame: 2 years

  35. Phase II Breast cancer: antitumor activity of avelumab in combination with IT JX-594 and metronomic CP in terms of 2-year progression-free survival

    PFS defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause)

    Time frame: 2 years

  36. Phase II Soft-tissue sarcoma: antitumor activity of avelumab in combination with IT JX-594 and metronomic CP in terms of 1-year overall survival

    OS defined as the time from study treatment initiation to death (of any cause)

    Time frame: 1 year

  37. Phase II Breast cancer: antitumor activity of avelumab in combination with IT JX-594 and metronomic CP in terms of 1-year overall survival

    OS defined as the time from study treatment initiation to death (of any cause)

    Time frame: 1 year

  38. Phase II Soft-tissue sarcoma: antitumor activity of avelumab in combination with IT JX-594 and metronomic CP in terms of 2-year overall survival

    OS defined as the time from study treatment initiation to death (of any cause)

    Time frame: 2 year

  39. Phase II Breast cancer: antitumor activity of avelumab in combination with IT JX-594 and metronomic CP in terms of 2-year overall survival

    OS defined as the time from study treatment initiation to death (of any cause)

    Time frame: 2 year

  40. Phase II Soft-tissue sarcoma: safety profile of avelumab in combination with IT JX-594 and metronomic CP

    Safety profile will be assessed as per NCI-CTCAE v5

    Time frame: throughout the treatment period, an expected average of 6 months

  41. Phase II breast cancer: safety profile of avelumab in combination with IT JX-594 and metronomic CP

    Safety profile will be assessed as per NCI-CTCAE v5

    Time frame: throughout the treatment period, an expected average of 6 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02630368
Lead sponsor
Institut Bergonié
Collaborators
National Cancer Institute, France, Fondation ARC, Merck Sharp & Dohme LLC, Transgene
Responsible party
Sponsor
First posted
Dec 15, 2015
Start date
Sep 18, 2015
Primary completion
May 2023 (estimated)
Completion
Nov 2024 (estimated)
Last update
Feb 2, 2022

Study contacts

Antoine ITALIANO, MD, PhD
Contact
a.italiano@bordeaux.unicancer.fr
+33 524071947
Antoine ITALIANO, MD, PhD
study chair · Institut Bergonié

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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