Clinical Trials /

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

NCT02630368

Description:

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.

Related Conditions:
  • Breast Carcinoma
  • Malignant Solid Tumor
  • Soft Tissue Sarcoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: IB 2014-02
  • SECONDARY ID: 2014-001078-33
  • NCT ID: NCT02630368

Conditions

  • Solid Tumors
  • Soft-tissue Sarcoma
  • Breast Cancer

Interventions

DrugSynonymsArms
Cyclophosphamide and JX-594 dose escalationBrand name : ENDOXAN, Brand name: Pexa-VecExperimental phase I dose escalating
Cyclophosphamide and JX-594Brand name : ENDOXAN, Brand name: Pexa-VecExperimental group breast cancer, treatment by JX-594 + Metronomic cyclophosphamide
CyclophosphamideBrand name : ENDOXANControl group soft-tissue sarcoma, treatment by JX-594 + Metronomic cyclophosphamide
Avelumab and JX-594 and CyclophosphamideBrand name: ENDOXAN, Brand name: Pexa-Vec, Brand name: AvelumabExperimental group breast cancer, treatment by Avelumab + IT JX-594 + Metronomic CP

Purpose

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).
    

Trial Arms

NameTypeDescriptionInterventions
Experimental phase I dose escalatingExperimentalProspective 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
  • Cyclophosphamide and JX-594 dose escalation
Experimental group soft-tissue sarcoma, treatment by JX-594 + Metronomic cyclophosphamideExperimentalRandomized 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
  • Cyclophosphamide and JX-594
Control group soft-tissue sarcoma, treatment by JX-594 + Metronomic cyclophosphamideExperimentalRandomized 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
  • Cyclophosphamide
Experimental group breast cancer, treatment by JX-594 + Metronomic cyclophosphamideExperimentalSingle-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
  • Cyclophosphamide and JX-594
Experimental group soft-tissue sarcoma, treatment by Avelumab + ITJX-594 + Metronomic CPExperimentalExperimental 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
  • Avelumab and JX-594 and Cyclophosphamide
Experimental group breast cancer, treatment by Avelumab + IT JX-594 + Metronomic CPExperimentalExperimental 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
  • Avelumab and JX-594 and Cyclophosphamide

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 or with
             PD1/PDL1 antagonist for treatment by avelumab.

          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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Phase Ib : Maximum Tolerated Dose evaluated on the first cycle (D1 to D28) of the combination of JX-594 And metronomic cyclophosphamide
Time Frame:during the first cycle (28 days)
Safety Issue:
Description: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

Secondary Outcome Measures

Measure:Phase Ib : Recommended Phase II dose (RP2D) of the association of JX-594 and metronomic cyclophosphamide
Time Frame:Phase Ib : Throughout the 6 months of treatment period
Safety Issue:
Description:Data from all cycles will be used to define the dose level of JX-594 to be recommended for further investigations in phase II
Measure:Phase Ib: Objective response under treatment as per RECIST V1.1
Time Frame:an average of 6 months
Safety Issue:
Description:Objective response is defined as complete or partial response as per RECIST v1.1
Measure:Phase Ib: Best overall response as per RECIST V1.1
Time Frame:an average of 6 months
Safety Issue:
Description:- 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).
Measure:Phase Ib: 6-months non-progression as per RECIST V1.1
Time Frame:6-months after the beginning of treatment
Safety Issue:
Description:Non-progression is defined as complete or partial response or stable disease, as per RECIST v1.1
Measure:Phase Ib: 1-year progression-free survival as per RECIST V1.1
Time Frame:1-year after the beginning of treatment
Safety Issue:
Description:PFS defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause)
Measure:Phase Ib: 2-year progression-free survival as per RECIST V1.1
Time Frame:2-year after the beginning of treatment
Safety Issue:
Description:PFS defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause)
Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure:Phase Ib : Dose-Limiting toxicity of the association of JX-594 and metronomic cyclophosphamide
Time Frame:during the first cycle (cycle = 28 days)
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Phase II : Best overall response defined as per RECIST v1.1 criteria
Time Frame:an average of 6 months
Safety Issue:
Description: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).
Measure:Phase II : For sarcoma only: objective response following CHOI criteria
Time Frame:an average of 6 months
Safety Issue:
Description:
Measure:Phase II : For sarcoma only: best overall response following CHOI criteria
Time Frame:an average of 6 months
Safety Issue:
Description:
Measure:Phase II : For sarcoma only: 6- month non-progression following CHOI criteria
Time Frame:6-months after the beginning of treatment
Safety Issue:
Description:
Measure: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
Time Frame:one year after the beginning of treatment
Safety Issue:
Description:PFS defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause)
Measure: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
Time Frame:two years the beginning of treatment
Safety Issue:
Description:PFS defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause)
Measure:Phase II : 1-year Overall Survial (OS) defined as the time from study treatment initiation to death (of any cause)
Time Frame:one year after the beginning of treatment
Safety Issue:
Description:OS defined as the time from study treatment initiation to death (of any cause)
Measure:Phase II : 2-year Overall Survial (OS) defined as the time from study treatment initiation to death (of any cause)
Time Frame:two year after the beginning of treatment
Safety Issue:
Description:OS defined as the time from study treatment initiation to death (of any cause)
Measure:Phase II : Toxicity graded using the common toxicity criteria from the NCI v4.0
Time Frame:an average of 6 months
Safety Issue:
Description:assessef with NCI-CTCAE V4
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Phase II Soft-tissue sarcoma: antitumor actiivty of avelumab in combination with IT JX-594 and metronomic CP in terms of best overall response
Time Frame:an average of 6 months
Safety Issue:
Description:- 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)
Measure:Phase II Breast cancer: antitumor actiivty of avelumab in combination with IT JX-594 and metronomic CP in terms of best overall response
Time Frame:an average of 6 months
Safety Issue:
Description:- 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)
Measure:Phase II Breast cancer: antitumor actiivty of avelumab in combination with IT JX-594 and metronomic CP in terms of 6-month non-progression
Time Frame:6 months
Safety Issue:
Description:Non-progression is defined as complete or partial response or stable disease, as per RECIST v1.1
Measure: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
Time Frame:an average of 6 months
Safety Issue:
Description:Objective response is defined as complete or partial response as per RECIST v1.1
Measure: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
Time Frame:1 year
Safety Issue:
Description:PFS defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause)
Measure: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
Time Frame:1 year
Safety Issue:
Description:PFS defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause)
Measure: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
Time Frame:2 years
Safety Issue:
Description:PFS defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause)
Measure: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
Time Frame:2 years
Safety Issue:
Description:PFS defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause)
Measure: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
Time Frame:1 year
Safety Issue:
Description:OS defined as the time from study treatment initiation to death (of any cause)
Measure:Phase II Breast cancer: antitumor activity of avelumab in combination with IT JX-594 and metronomic CP in terms of 1-year overall survival
Time Frame:1 year
Safety Issue:
Description:OS defined as the time from study treatment initiation to death (of any cause)
Measure: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
Time Frame:2 year
Safety Issue:
Description:OS defined as the time from study treatment initiation to death (of any cause)
Measure:Phase II Breast cancer: antitumor activity of avelumab in combination with IT JX-594 and metronomic CP in terms of 2-year overall survival
Time Frame:2 year
Safety Issue:
Description:OS defined as the time from study treatment initiation to death (of any cause)
Measure:Phase II Soft-tissue sarcoma: safety profile of avelumab in combination with IT JX-594 and metronomic CP
Time Frame:throughout the treatment period, an expected average of 6 months
Safety Issue:
Description:Safety profile will be assessed as per NCI-CTCAE v5
Measure:Phase II breast cancer: safety profile of avelumab in combination with IT JX-594 and metronomic CP
Time Frame:throughout the treatment period, an expected average of 6 months
Safety Issue:
Description:Safety profile will be assessed as per NCI-CTCAE v5

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Institut Bergonié

Trial Keywords

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

Last Updated

October 23, 2020