NCT02614833

IMP321 (Eftilagimod Alpha) as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma

Version 0 to 1 · Immutep S.A.S.

Patch inspector

Version 0 to 1

4 operations 3 path groups ctgov_internal_history

Severity is deterministic uncalibrated triage metadata, not validated review priority. Operation-level severity is inferred from deterministic path rules. Rule matches shown per operation are approximate previews (they skip the pipeline's suppression passes); the authoritative classification is the stored event record.

Plain-language summary

Manual review pending.

Rules fired

eligibility_criteria_changesecondary_outcome_any_change

Value signals

None recorded.

Provenance

Source: ctgov_internal_history
Fetched: 2026-06-18 18:59:18+00
Raw hash: 1b90ea0d076703b27028a50b8a217af47a24c9526dbadf04d739c0090691bcb2
Payload: Source URL

Eligibility Criteria and population definition changes. Triage: High 1 ops

replace /protocolSection/eligibilityModule/eligibilityCriteria

Triage: High

Eligibility Change Operation 4

Matched rules

eligibility_criteria_change Eligibility criteria changes can alter the studied population.

Before

<p>Inclusion Criteria:</p><p>Key Inclusion</p><ol><li>Able to give written informed consent and to comply with the protocol</li><li>Stage IV oestrogen receptor positive and&#x2F;or progesterone receptor positive breast adenocarcinoma, histologically proven by biopsy of the primary tumour and&#x2F;or metastasis</li><li>Female of age 18 years or above</li><li>Patients who are indicated to received first line chemotherapy with weekly paclitaxel</li><li>All patients with reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug.</li><li>ECOG performance status 0-1</li><li>Expected survival longer than three months transaminases in case of liver metastases)</li><li>Evidence of measurable disease as defined by RECIST version 1.1</li></ol><p>10. Laboratory criteria: haematology and biochemistry results within the limits normally expected for the patient population.</p><p>Exclusion Criteria:</p><ol><li>Prior chemotherapy for metastatic breast adenocarcinoma</li><li>Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy</li><li>Prior high-dose chemotherapy requiring hematopoietic stem cell rescue</li><li>Inflammatory carcinoma</li><li>Candidate for treatment with trastuzumab (or other Her2&#x2F;neu targeted agents)</li><li>Systemic chemotherapy, endocrine therapy, or any other investigational agent within 4 weeks prior to first dose of study treatment and until completion of study treatment</li><li>Known cerebral or leptomeningeal metastases</li><li>Women who are pregnant or lactating</li><li>Serious intercurrent infection within 4 weeks prior to first dose of study treatment</li><li>QTcF &gt;480 ms, family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes (TdP)</li><li>Uncontrolled electrolyte disorders that can worsen the effects of a QTc-prolonging drug (e.g., hypocalcaemia, hypokalaemia, hypomagnesemia)</li><li>Evidence of severe or uncontrolled cardiac disease (NYHA III-IV) within 6 months prior to first dose of study treatment including: myocardial infarction, severe&#x2F;unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 4.03 Grade ≥2, atrial fibrillation of any grade, coronary&#x2F;peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, ventricular arrhythmias requiring medication or symptomatic pulmonary embolism</li><li>Active acute or chronic infection</li><li>Active autoimmune disease requiring immunosuppressive therapy</li><li>Known HIV positivity</li><li>History of Hepatitis B or C exposure, currently controlled by antiviral therapy</li><li>Life threatening illness unrelated to cancer</li><li>Previous malignancies within the last three years other than breast carcinoma, except successfully treated squamous cell carcinoma of the skin, superficial bladder cancer, and in situ carcinoma of the cervix</li><li>Any current disorder that would impede the patient&#x27;s ability to provide informed consent or to comply with the protocol</li><li>Any condition requiring continuous systemic treatment with either corticosteroids (&gt;10 mg daily prednisone equivalents) or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.
Inhaled or topical steroids and physiological replacement doses of up to 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease</li><li>Past history of severe allergic episodes and&#x2F; or Quincke&#x27;s oedema</li><li>Alcohol or substance abuse disorder</li><li>Known hypersensitivity to any of the components of the study agents</li><li>Participation in another clinical study within 4 weeks prior to screening</li><li>Unwilling or unable to follow protocol requirements</li><li>In the clinical judgment of the Investigator, the patient is unsuitable for participation in this study</li><li>Persons with any kind of dependency on the Investigator or employed by the sponsor or Investigator</li><li>Persons held in an institution by legal or official order</li></ol>

After

<p>Inclusion Criteria:</p><p>Key Inclusion</p><ol><li>Able to give written informed consent and to comply with the protocol</li><li>Stage IV oestrogen receptor positive and&#x2F;or progesterone receptor positive breast adenocarcinoma, histologically proven by biopsy of the primary tumour and&#x2F;or metastasis</li><li>Female of age 18 years or above</li><li>Patients who are indicated to received first line chemotherapy with weekly paclitaxel</li><li>All patients with reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug.</li><li>Eastern Cooperative Oncology Group performance status 0-1</li><li>Expected survival longer than three months transaminases in case of liver metastases</li><li>Evidence of measurable disease as defined by Response Evaluation Criteria version 1.1</li></ol><p>10. Laboratory criteria: haematology and biochemistry results within the limits normally expected for the patient population.</p><p>Exclusion Criteria:</p><ol><li>Prior chemotherapy for metastatic breast adenocarcinoma</li><li>Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy</li><li>Prior high-dose chemotherapy requiring hematopoietic stem cell rescue</li><li>Inflammatory carcinoma</li><li>Candidate for treatment with trastuzumab (or other Her2&#x2F;neu targeted agents)</li><li>Systemic chemotherapy, endocrine therapy, or any other investigational agent within 4 weeks prior to first dose of study treatment and until completion of study treatment</li><li>Known cerebral or leptomeningeal metastases</li><li>Women who are pregnant or lactating</li><li>Serious intercurrent infection within 4 weeks prior to first dose of study treatment</li><li>QTcF &gt;480 ms, family or personal history of long or short QT syndrome, Brugada syndrome or known history of controlled QT prolongation, or Torsade de Pointes (TdP)</li><li>Uncontrolled electrolyte disorders that can worsen the effects of a corrected QT-prolonging drug (e.g., hypocalcaemia, hypokalaemia, hypomagnesemia)</li><li>Evidence of severe or uncontrolled cardiac disease (NYHA III-IV) within 6 months prior to first dose of study treatment including: myocardial infarction, severe&#x2F;unstable angina, ongoing cardiac dysrhythmias of NCI Common Toxicity Criteria for adverse events version 4.03 Grade ≥2, atrial fibrillation of any grade, coronary&#x2F;peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, ventricular arrhythmias requiring medication or symptomatic pulmonary embolism</li><li>Active acute or chronic infection</li><li>Active autoimmune disease requiring immunosuppressive therapy</li><li>Known HIV positivity</li><li>History of Hepatitis B or C exposure, currently controlled by antiviral therapy</li><li>Life threatening illness unrelated to cancer</li><li>Previous malignancies within the last three years other than breast carcinoma, except successfully treated squamous cell carcinoma of the skin, superficial bladder cancer, and in situ carcinoma of the cervix</li><li>Any current disorder that would impede the patient&#x27;s ability to provide informed consent or to comply with the protocol</li><li>Any condition requiring continuous systemic treatment with either corticosteroids (&gt;10 mg daily prednisone equivalents) or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.
Inhaled or topical steroids and physiological replacement doses of up to 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease</li><li>Past history of severe allergic episodes and&#x2F; or Quincke&#x27;s oedema</li><li>Alcohol or substance abuse disorder</li><li>Known hypersensitivity to any of the components of the study agents</li><li>Participation in another clinical study within 4 weeks prior to screening</li><li>Unwilling or unable to follow protocol requirements</li><li>In the clinical judgment of the Investigator, the patient is unsuitable for participation in this study</li><li>Persons with any kind of dependency on the Investigator or employed by the sponsor or Investigator</li><li>Persons held in an institution by legal or official order</li></ol>

Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 1 ops

replace /protocolSection/outcomesModule/secondaryOutcomes/2/description

Triage: High

Secondary Outcome Change Operation 3

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

The pharmacokinetic population will take all patients into account who receieved IMP321 in stage 1 with sufficient plasma concentration data to calculate reliable estimates of at least one parameter

After

The pharmacokinetic population will take all patients into account who received IMP321 in stage 1 with sufficient plasma concentration data to calculate reliable estimates of at least one parameter

Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 2 ops

replace /protocolSection/statusModule/lastUpdateSubmitDate

Triage: Uncategorized

Uncategorized Operation 1

Before

2015-11-22

After

2015-11-26

replace /protocolSection/statusModule/lastUpdatePostDateStruct/date

Triage: Uncategorized

Uncategorized Operation 2

Before

2015-11-25

After

2015-11-30

Raw JSON Patch

[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2015-11-26"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2015-11-30"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
    "value": "The pharmacokinetic population will take all patients into account who received IMP321 in stage 1 with sufficient plasma concentration data to calculate reliable estimates of at least one parameter"
  },
  {
    "op": "replace",
    "path": "/protocolSection/eligibilityModule/eligibilityCriteria",
    "value": "<p>Inclusion Criteria:</p><p>Key Inclusion</p><ol><li>Able to give written informed consent and to comply with the protocol</li><li>Stage IV oestrogen receptor positive and&#x2F;or progesterone receptor positive breast adenocarcinoma, histologically proven by biopsy of the primary tumour and&#x2F;or metastasis</li><li>Female of age 18 years or above</li><li>Patients who are indicated to received first line chemotherapy with weekly paclitaxel</li><li>All patients with reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug.</li><li>Eastern Cooperative Oncology Group performance status 0-1</li><li>Expected survival longer than three months transaminases in case of liver metastases</li><li>Evidence of measurable disease as defined by Response Evaluation Criteria version 1.1</li></ol><p>10. Laboratory criteria: haematology and biochemistry results within the limits normally expected for the patient population.</p><p>Exclusion Criteria:</p><ol><li>Prior chemotherapy for metastatic breast adenocarcinoma</li><li>Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy</li><li>Prior high-dose chemotherapy requiring hematopoietic stem cell rescue</li><li>Inflammatory carcinoma</li><li>Candidate for treatment with trastuzumab (or other Her2&#x2F;neu targeted agents)</li><li>Systemic chemotherapy, endocrine therapy, or any other investigational agent within 4 weeks prior to first dose of study treatment and until completion of study treatment</li><li>Known cerebral or leptomeningeal metastases</li><li>Women who are pregnant or lactating</li><li>Serious intercurrent infection within 4 weeks prior to first dose of study treatment</li><li>QTcF &gt;480 ms, family or personal history of long or short QT syndrome, Brugada syndrome or known history of controlled QT prolongation, or Torsade de Pointes (TdP)</li><li>Uncontrolled electrolyte disorders that can worsen the effects of a corrected QT-prolonging drug (e.g., hypocalcaemia, hypokalaemia, hypomagnesemia)</li><li>Evidence of severe or uncontrolled cardiac disease (NYHA III-IV) within 6 months prior to first dose of study treatment including: myocardial infarction, severe&#x2F;unstable angina, ongoing cardiac dysrhythmias of NCI Common Toxicity Criteria for adverse events version 4.03 Grade ≥2, atrial fibrillation of any grade, coronary&#x2F;peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, ventricular arrhythmias requiring medication or symptomatic pulmonary embolism</li><li>Active acute or chronic infection</li><li>Active autoimmune disease requiring immunosuppressive therapy</li><li>Known HIV positivity</li><li>History of Hepatitis B or C exposure, currently controlled by antiviral therapy</li><li>Life threatening illness unrelated to cancer</li><li>Previous malignancies within the last three years other than breast carcinoma, except successfully treated squamous cell carcinoma of the skin, superficial bladder cancer, and in situ carcinoma of the cervix</li><li>Any current disorder that would impede the patient&#x27;s ability to provide informed consent or to comply with the protocol</li><li>Any condition requiring continuous systemic treatment with either corticosteroids (&gt;10 mg daily prednisone equivalents) or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.\nInhaled or topical steroids and physiological replacement doses of up to 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease</li><li>Past history of severe allergic episodes and&#x2F; or Quincke&#x27;s oedema</li><li>Alcohol or substance abuse disorder</li><li>Known hypersensitivity to any of the components of the study agents</li><li>Participation in another clinical study within 4 weeks prior to screening</li><li>Unwilling or unable to follow protocol requirements</li><li>In the clinical judgment of the Investigator, the patient is unsuitable for participation in this study</li><li>Persons with any kind of dependency on the Investigator or employed by the sponsor or Investigator</li><li>Persons held in an institution by legal or official order</li></ol>"
  }
]