IMP321 (Eftilagimod Alpha) as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma
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ClinicalTrials.gov Identifier: NCT02614833 |
Recruitment Status :
Completed
First Posted : November 25, 2015
Last Update Posted : October 5, 2021
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Condition or disease | Intervention/treatment | Phase |
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Adenocarcinoma Breast Stage IV | Biological: IMP321 (eftilagimod alpha) Drug: Placebo Drug: Paclitaxel | Phase 2 |
This is a multicentre, placebo-controlled, double-blind, 1:1 randomised Phase IIb study in female hormone receptor-positive metastatic breast cancer patients. The study comprises of two stages.
Stage 1 is the open-label, safety run-in stage consisting of cohort 1 and 2 to confirm the (RPTD) of IMP321 in combination with paclitaxel.
Stage 2 is placebo-controlled, double-blind randomisation stage, paclitaxel + IMP321 at the RPTD will be compared to paclitaxel + placebo.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 242 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | AIPAC (Active Immunotherapy PAClitaxel): A Multicentre, Phase IIb, Randomised,Double Blind, Placebo-controlled Study in Hormone Receptor-positive Metastatic Breast Carcinoma Patients Receiving IMP321 (LAG-3Ig Fusion Protein) or Placebo as Adjunctive to a Standard Chemotherapy Treatment Regimen of Paclitaxel |
Study Start Date : | December 2015 |
Actual Primary Completion Date : | March 2020 |
Actual Study Completion Date : | May 2021 |
Arm | Intervention/treatment |
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Experimental: Paclitaxel + IMP321 at the RPTD
The chemo-immunotherapy phase consists of 6 cycles of 4 weeks. Patient will receive weekly paclitaxel at Days 1, 8 and 15 with adjunctive treatment of study agent, either IMP321, on Days 2 and 16 of each 4-week cycle. After completion of the 6-cycle chemo-immunotherapy phase, responding or stable patients will receive study agent (IMP321) every 4 weeks during the maintenance phase for an additional period of up to 12 injections
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Biological: IMP321 (eftilagimod alpha)
In the placebo-controlled, double-blind randomisation stage, paclitaxel + IMP321 at the RPTD will be compared to paclitaxel + placebo Drug: Paclitaxel Paclitaxel will be given in both treatment arms (classified as Non IMP) |
Active Comparator: Comparator: Paclitaxel + Placebo
The chemo-immunotherapy phase consists of 6 cycles of 4 weeks. Patient will receive weekly paclitaxel at Days 1, 8 and 15 with adjunctive treatment of study agent, placebo, on Days 2 and 16 of each 4-week cycle. After completion of the 6-cycle chemo-immunotherapy phase, responding or stable patients will receive study agent (placebo) every 4 weeks during the maintenance phase for an additional period of up to 12 injections
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Drug: Placebo
In the placebo-controlled, double-blind randomisation stage, paclitaxel + placebo will be compared to paclitaxel + IMP321 at the RPTD Drug: Paclitaxel Paclitaxel will be given in both treatment arms (classified as Non IMP) |
- Stage 1 to determine the recommended phase two dose for the randomised phase [ Time Frame: Up to 12 months ]
- Assessment of Progression-Free Survival (PFS) [ Time Frame: Up to 37 month ]
- Assessment of the safety and tolerability of IMP321 as compared to placebo [ Time Frame: Up to 19 months ]
- Assessment of the overall survival (OS) [ Time Frame: Up to 48 month ]
- Stage 1: Evaluation of the pharmacokinetic e.g. Peak Plasma Concentration [Cmax] [ Time Frame: Up to 12 months ]
- Assessment of the change in quality of life (QOL) [ Time Frame: Up to 37 months ]
- Evaluation of the time to next treatment [ Time Frame: Up to 37 months ]
- Evaluation of objective response rate (ORR) [ Time Frame: Up to 37 months ]
- Evaluation of stable disease [ Time Frame: Up to 37 months ]
- Stage 1: assessment of Immuno-monitoring in a defined subset of 60 patients during the randomised stage [ Time Frame: Up to 37 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Able to give written informed consent and to comply with the protocol
- Metastatic oestrogen receptor positive and/or progesterone receptor positive breast adenocarcinoma, histologically proven by biopsy of the primary tumour and/or metastasis
- Female of age 18 years or above
- Patients who are indicated to received first line chemotherapy with weekly paclitaxel
- Evidence of measurable disease as defined by Response Evaluation Criteria version 1.1
6 Laboratory criteria: haematology and biochemistry results within the limits normally expected for the patient population.
Exclusion Criteria:
- Prior chemotherapy for metastatic breast adenocarcinoma
- Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy
- Inflammatory carcinoma
- Candidate for treatment with trastuzumab (or other Her2/neu targeted agents)
- Systemic chemotherapy, radiation therapy or any other investigational agent within 4 weeks, endocrine therapy within 1 week prior to first dose of study treatment or CDK4/6 inhibitors within 5 times half-life (acc.to SPC) prior to first dose of study treatment and until completion of study treatment
- Symptomatic known cerebral and/or leptomeningeal metastases
- Serious intercurrent infection
- Evidence of severe or uncontrolled cardiac disease (NYHA III-IV) within 6 months prior to first dose of study treatment
- Active acute or chronic infection
- Active autoimmune disease requiring immunosuppressive therapy
- Previous malignancies within the last three years other than breast carcinoma
- Patients with prior organ or stem cell transplantation
- Any condition requiring continuous systemic treatment with either corticosteroids or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614833
Study Director: | Immutep S.A.S | Immutep S.A.S. |
Responsible Party: | Immutep S.A.S. |
ClinicalTrials.gov Identifier: | NCT02614833 |
Other Study ID Numbers: |
IMP321 P011 |
First Posted: | November 25, 2015 Key Record Dates |
Last Update Posted: | October 5, 2021 |
Last Verified: | October 2021 |
Hormone receptor positive |
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Paclitaxel |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |