Clinical trial • Phase III • Oncology
MOLGRAMOSTIM for Breast cancer|HER2 positive breast cancer
Phase III trial of MOLGRAMOSTIM for Breast cancer|HER2 positive breast cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Breast cancer|HER2 positive breast cancer
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 18-10-2023
- First CTIS Authorization Date
- 19-02-2024
Trial design
Randomised, commercially available 0,9 % sterile saline solution with marketing authorization will be utilized as the placebo.-controlled Phase III trial in Poland, Germany, Ireland and others.
- Randomised
- Yes
- Comparator
- Commercially available 0,9 % Sterile Saline solution with marketing authorization will be utilized as the placebo.
- Biomarker Stratified
- True, HLA-A*02 status (HLA-A*02-positive vs non-HLA-A*02)
- Target Sample Size
- 350
- Trial Duration For Participant
- 1095
Stratification factors
- Estrogen-receptor/progesterone-receptor status (ER/PR status)
Eligibility
Recruits 350 No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants must be > 18 years; informed consent is required from participants. No assent procedures or specific vulnerable-population consent handling are described in the available record..
- Pregnancy Exclusion
- Negative pregnancy test or evidence of post-menopausal status
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants must be > 18 years; informed consent is required from participants. No assent procedures or specific vulnerable-population consent handling are described in the available record.
Inclusion criteria
- {"criterion_text":"-Aged > 18 years\n-Negative pregnancy test or evidence of post-menopausal status\n-If of childbearing potential, willing to use a form of highly effective contraception\n-HLA-A*02-positive, unless being enrolled in the third non-HLA-A*02 arm\n-Histologically confirmed diagnosis of HER2/neu positive primary breast cancer\n-Completion of both neoadjuvant and adjuvant trastuzumab-based standard of care breast cancer therapy\n-Stage I, II, or III at presentation with pathologic evidence of residual invasive carcinoma in the breast or axillary lymph nodes (residual disease) at surgery following completion of neoadjuvant therapy OR Stage III at presentation with pathologic complete response (pCR) at surgery following completion of neoadjuvant therapy\n-The subject can begin study therapy within one year of completion of adjuvant trastuzumab-based therapy and any other standard therapies, but study therapy can be administered concurrently with endocrine therapy. Concurrent neratinib is prohibited.\n-No clinical evidence of residual or persistent breast cancer\n-ECOG 0-2\n-Adequate organ function"}
Exclusion criteria
- {"criterion_text":"-Stage IV cancer or metastatic breast cancer at any time\n-Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment. Note: Subjects on effective antiretroviral therapy with an undetectable viral load for a minimum of 6 months of the anticipated start of treatment are eligible for this trial\n-Inflammatory breast cancer\n-Receiving other investigational agents\n-Receiving chemotherapy\n-Requiring long-term systemic treatment with corticosteroids or other immunosuppressive therapy\n-History of immunodeficiency or active autoimmune disease\n-A history of serious allergic reactions, including anaphylaxis, to human granulocyte-macrophage colony-stimulating factors such as sargramostim, yeast-derived products, or any component of the investigational product\n-Other malignancies except adequately treated in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin\n-Active infection"}
Endpoints
Primary endpoints
- {"endpoint_text":"-IBCFS is defined as the time from randomization (or first dose of study medication if in the non-randomized arm) until the date of ipsilateral invasive breast cancer recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or any cause mortality.","definition_or_measurement_approach":"Defined as time from randomization (or first dose if in non-randomized arm) to first occurrence of ipsilateral invasive breast cancer recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or death from any cause."}
Secondary endpoints
- {"endpoint_text":"-IDFS is defined as the time from randomization (or first dose of study medication if in the non-randomized arm) until the date of ipsilateral invasive breast cancer recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, or any cause mortality.","definition_or_measurement_approach":"Defined as time from randomization (or first dose if in non-randomized arm) to first occurrence of ipsilateral invasive breast cancer recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, or death from any cause."}
- {"endpoint_text":"-The overall survival (OS) in the study population as defined as the time from randomization (or first dose of study medication if in the non-randomized arm) until death from any cause.","definition_or_measurement_approach":"Defined as time from randomization (or first dose if in non-randomized arm) to death from any cause."}
- {"endpoint_text":"-Quality of life as assessed by QLQ-C30 and FACT-GP5.","definition_or_measurement_approach":"Measured using the EORTC QLQ-C30 questionnaire and FACT-GP5 instruments as specified in the protocol."}
- {"endpoint_text":"-The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment.","definition_or_measurement_approach":"AEs/SAEs will be recorded and categorized by type, CTCAE v5.0 grade, seriousness, duration, and assessed relationship to study treatment."}
Other endpoints
- {"endpoint_text":"-Exploratory Endpoints: • Immune response will be measured by Delayed-Type Hypersensitivity (DTH) tests and immunologic assays. • Safety, efficacy, and immune response as defined above in non-HLA-A*02 breast cancer subjects","definition_or_measurement_approach":"Immune response assessment via Delayed-Type Hypersensitivity (DTH) tests and immunologic assays; applies also to safety and efficacy measures in non-HLA-A*02 subjects as exploratory analyses."}
Recruitment
- Planned Sample Size
- 350
- Recruitment Window Months
- 72
- Consent Approach
- Informed consent is obtained from participants using subject information sheets and ICFs. Pre-screening ICFs, main ICFs, pregnancy follow-up ICFs and site-specific ICF materials are available; multiple language versions are provided for participating countries. No assent procedures for minors are described.
Geography
- Total Number Of Participants
- 350
Poland
- Earliest CTIS Part Ii Submission Date
- 19-01-2024
- Latest Decision Or Authorization Date
- 23-02-2024
- Processing Time Days
- 35
- Number Of Sites
- 11
- Number Of Participants
- 20
Sites
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- Institue of Oncology
- Principal Investigator Name
- Rodryg Ramlau
- Principal Investigator Email
- rramlau@gmail.com
- Contact Person Name
- Rodryg Ramlau
- Contact Person Email
- rramlau@gmail.com
- Site Name
- Zachodniopomorskie Centrum Onkologii
- Department Name
- Oddzial Onkologii Klinicznej
- Principal Investigator Name
- Katarzyna Hetman
- Principal Investigator Email
- khetman@onkologia.szczecin.pl
- Contact Person Name
- Katarzyna Hetman
- Contact Person Email
- khetman@onkologia.szczecin.pl
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
- Department Name
- Oddzial Kliniczny Onkologii
- Principal Investigator Name
- Piotr Wysocki
- Principal Investigator Email
- piotr.wysocki@uj.edu.pl
- Contact Person Name
- Piotr Wysocki
- Contact Person Email
- piotr.wysocki@uj.edu.pl
- Site Name
- Instytut Centrum Zdrowia Matki Polki
- Department Name
- klinika onkologii
- Principal Investigator Name
- Ewa Kalinka
- Principal Investigator Email
- ewakalinka@wp.pl
- Contact Person Name
- Ewa Kalinka
- Contact Person Email
- ewakalinka@wp.pl
- Site Name
- Mruk-Med I Sp. z o.o.
- Department Name
- Oddzial Onkologii Klinicznej
- Principal Investigator Name
- Andrzej Mruk
- Principal Investigator Email
- kmruk@vp.pl
- Contact Person Name
- Andrzej Mruk
- Contact Person Email
- kmruk@vp.pl
- Site Name
- Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
- Department Name
- Oncology
- Principal Investigator Name
- Renata Duchnowska
- Principal Investigator Email
- rduchnowska@wim.mil.pl
- Contact Person Name
- Renata Duchnowska
- Contact Person Email
- rduchnowska@wim.mil.pl
- Site Name
- Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
- Department Name
- Oncology
- Principal Investigator Name
- Wojciech Rogowski
- Principal Investigator Email
- wojciech.rogowski.apple@gmail.com
- Contact Person Name
- Wojciech Rogowski
- Contact Person Email
- wojciech.rogowski.apple@gmail.com
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Oncology
- Principal Investigator Name
- Zbigniew Nowecki
- Principal Investigator Email
- zbigniew.nowecki@nio.gov.pl
- Contact Person Name
- Zbigniew Nowecki
- Contact Person Email
- zbigniew.nowecki@nio.gov.pl
- Site Name
- Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
- Department Name
- Oddzial Onkologii Klinicznej
- Principal Investigator Name
- Marek Jasiowska
- Principal Investigator Email
- badaniakliniczne@rydygierkrakow.pl
- Contact Person Name
- Marek Jasiowska
- Contact Person Email
- badaniakliniczne@rydygierkrakow.pl
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Opolskie Centrum Onkologii Im Prof Tadeusza Koszarowskiego W Opolu
- Department Name
- Klinika Onkologii
- Principal Investigator Name
- Barbara Radecka
- Principal Investigator Email
- brad@onkologia.opole.pl
- Contact Person Name
- Barbara Radecka
- Contact Person Email
- brad@onkologia.opole.pl
- Site Name
- Przychodnia Lekarska Komed Roman Karaszewski
- Department Name
- Osrodek Badan Klinicznych III
- Principal Investigator Name
- Bogusława Karaszewska
- Principal Investigator Email
- komed.badania@gmail.com
- Contact Person Name
- Bogusława Karaszewska
- Contact Person Email
- komed.badania@gmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 08-01-2024
- Latest Decision Or Authorization Date
- 21-02-2024
- Processing Time Days
- 44
- Number Of Participants
- 40
Ireland
- Earliest CTIS Part Ii Submission Date
- 30-04-2025
- Latest Decision Or Authorization Date
- 03-06-2025
- Processing Time Days
- 34
- Number Of Sites
- 1
- Number Of Participants
- 25
Romania
- Earliest CTIS Part Ii Submission Date
- 16-05-2025
- Latest Decision Or Authorization Date
- 11-06-2025
- Processing Time Days
- 26
- Number Of Sites
- 5
- Number Of Participants
- 25
Italy
- Earliest CTIS Part Ii Submission Date
- 31-10-2023
- Latest Decision Or Authorization Date
- 21-02-2024
- Processing Time Days
- 113
- Number Of Participants
- 31
Spain
- Earliest CTIS Part Ii Submission Date
- 22-11-2023
- Latest Decision Or Authorization Date
- 19-02-2024
- Processing Time Days
- 89
- Number Of Participants
- 75
Belgium
- Earliest CTIS Part Ii Submission Date
- 09-07-2025
- Latest Decision Or Authorization Date
- 25-07-2025
- Processing Time Days
- 16
- Number Of Sites
- 1
- Number Of Participants
- 25
France
- Earliest CTIS Part Ii Submission Date
- 21-12-2023
- Latest Decision Or Authorization Date
- 20-02-2024
- Processing Time Days
- 61
- Number Of Participants
- 20
Austria
- Earliest CTIS Part Ii Submission Date
- 03-09-2025
- Latest Decision Or Authorization Date
- 29-09-2025
- Processing Time Days
- 26
- Number Of Sites
- 1
- Number Of Participants
- 20
Portugal
- Earliest CTIS Part Ii Submission Date
- 19-05-2025
- Latest Decision Or Authorization Date
- 09-09-2025
- Processing Time Days
- 113
- Number Of Sites
- 2
- Number Of Participants
- 25
Sponsor
Primary sponsor
- Full Name
- Greenwich LifeSciences Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- GLSI-100 (GP2 + GM-CSF)
- Active Substance
- MOLGRAMOSTIM
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRADERMAL
- Route
- INTRADERMAL
- Authorisation Status
- authorised
- Maximum Dose
- 500 mEq/Aµg milliequivalent(s)/microgram
- Investigational Product Name
- Leukine
- Active Substance
- SARGRAMOSTIM
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRADERMAL
- Route
- INTRADERMAL
- Authorisation Status
- authorised
- Maximum Dose
- 125 mEq/Aµg milliequivalent(s)/microgram
- Investigational Product Name
- Commercially available 0,9 % Sterile Saline solution (placebo)
- Modality
- Other
- Authorisation Status
- Commercially available with marketing authorization (placebo)
- Combination Treatment
- Yes
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