- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02686944
A Study to Evaluate the Safety of Intuvax Administered Intra-tumorally in Patients With Gastrointestinal Stromal Tumors (GIST)
July 3, 2019 updated by: Mendus
A Phase I Open-label Study Evaluating Safety and Efficacy of Intratumorally Administered Intuvax in Patients With Progressing Gastrointestinal Stromal Tumors (GIST) During Ongoing Second, Third or Fourth Line Treatment With Tyrosine Kinase Inhibition Therapy. A Prospective Single Armed, Open Label Phase I Safety and Efficacy Study
The study is a prospective single armed, open label phase I study.
Patients with advanced or metastatic GIST and tumor progression despite ongoing treatment with second, third or fourth line TKI treatment, and with at least one measureable tumor lesion, will be eligible for the study.
A maximum of 12 patients will be included in this study.
The patients will continue with TKI treatment until the 3 months follow up visit.
If further tumor progression TKI will be withdrawn but if stable disease or objective response the patient will continue with TKI until progress.
The investigational product Intuvax will be injected into a tumor lesion at two or three treatment occasions; day 1, 14 days (±3 days) after the first vaccination, and 28 days (±3 days) after the second vaccination (patient 7-12 only).
Intuvax will be injected in a viable part of the tumor, using ultrasound-guided or CT technique for correct administration.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Stockholm, Sweden, SE-171 76
- Department of Breast and Endocrine Surgery, Section of Endocrine and Sarcoma Surgery, Karolinska University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Be informed of the nature of the study and have provided written informed consent.
- At least 18 years of age.
- Diagnosis of GIST (according to modified NIH criteria, 2011) where curative excision is no longer an option, i.e. confirmed unresectable or metastatic GIST, and that has progressed on second, third or fourth line tyrosine kinase inhibitor (TKI) treatment.
- Radiologically measurable tumor(s), i.e at least 3 cm in longest uni-dimensional diameter as measured by CT
- Clinical and/or CT verified disease progression despite ongoing second, third or fourth line treatment with a TKI
- Female who has been post-menopausal for more than one (1) year or female of childbearing potential using a highly efficient method of contraception (i.e. a method with less than 1% failure rate [e.g. sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomized partner with combined use of condom and/or birth control pills]) during study participation. Female of childbearing potential must have a negative blood pregnancy test at Screening, and if randomized to vaccination a negative blood or urine pregnancy test within one (1) day before each dose of Intuvax, or Male agreeing to use condoms during the study participation or male having a female partner who is using a highly efficient method of contraception as described above during the partner's study participation.
Exclusion Criteria:
- Performance status > ECOG 2
- Known major reaction/adverse event in connection with previously made vaccination (e.g. asthma, anaphylaxia or other serious reaction)
- Known major reaction/adverse event in connection with previous transfusions of blood products
- Active autoimmune disease requiring treatment with systemic immunosuppressive agents, e.g. inflammatory bowel disease, multiple sclerosis, sarcoidosis, psoriasis, autoimmune hemolytic anemia, rheumatoid arthritis, SLE, vasculitis, Sjögren's syndrome, scleroderma, autoimmune hepatitis, and other rheumatological diseases.
- Tested positive for HIV
- Active virus disease (HBV and HCV).
- Ongoing infection that requires treatment with parenteral antibiotics or antiviral medication
- Corticosteroid treatment per os exceeding 10mg/day within 7 days prior to the first injection of Intuvax. Inhaled, intranasal and local steroids accepted.
Inadequate laboratory parameters, i.e.:
- B-Leukocyte count < 3.0 x109/L
- B-Platelet count < 75 x109/L
- B-Hemoglobin < 100 g/L
- P-Prothrombincomplex (PK) >1.4
- P-APT time outside normal limit
- Previous organ transplantation
- Pregnant or lactating women
- Life expectancy less than 3 months.
- Investigational treatment (within 28 days) prior to the first injection of Intuvax
- Known blood dyscrasia (bleeding complication)
- Prior history of invasive cancer within 5 years before screening, except for adequately treated in situ carcinomas or non melanoma skin cancer
- History of alcohol or substance abuse
- patient will not be available for follow up assessments
- Any other reason that, in the opinion of the investigator, contraindicates that the patient participates in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intuvax (ilixadencel)
Intuvax (ilixadencel) will be administered 2 or 3 times. First injection Day 1 (pat 1-12), second injection 14 days after the first vaccination (pat 1-12), third injection 28 days after the second vaccination (only pat 7-12). Max 10 000 000 allogeneic dendritic cells/ml per injection. |
Therapeutic vaccine: allogeneic, proinflammatory dendritic cells, suspension for intratumoral injection
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in vital signs (heart rate, blood pressure, body temperature)
Time Frame: Up to 12 months after vaccination 1
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Up to 12 months after vaccination 1
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Changes in lab parameters (hematology and biochemistry) during the study versus baseline
Time Frame: Up to 12 months after vaccination 1
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Up to 12 months after vaccination 1
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Adverse events according to CTCAE v 4.03
Time Frame: Up to 12 months after vaccination 1
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Up to 12 months after vaccination 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor response by determining changes (PD, SD, PR, CR) in tumor diameter according to mRECIST
Time Frame: Every 3 months up to 12 months after vaccination 1
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Criteria based on the diameter of the contrast-enhanced portions of the tumor
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Every 3 months up to 12 months after vaccination 1
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Tumor response by determining changes (PD, SD, PR, CR) in tumor diameter according to RECIST 1.1.
Time Frame: Every 3 months up to 12 months after vaccination 1
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Criteria based on the maximal tumor diameter
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Every 3 months up to 12 months after vaccination 1
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Tumor response by determining changes (PD, SD, PR, CR) in tumor diameter according to Choi criteria
Time Frame: Every 3 months up to 12 months after vaccination 1
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Criteria based on unidimensional tumor size and tumor density on contrast-enhanced CT images.
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Every 3 months up to 12 months after vaccination 1
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Progression free survival according to mRECIST
Time Frame: Up to 12 months after vaccination 1
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Criteria based on the diameter of the contrast-enhanced portions of the tumor
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Up to 12 months after vaccination 1
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Progression free survival according to RECIST 1.1
Time Frame: Up to 12 months after vaccination 1
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Criteria based on the maximal tumor diameter
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Up to 12 months after vaccination 1
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Progression free survival according to Choi criteria
Time Frame: Up to 12 months after vaccination 1
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Criteria based on unidimensional tumor size and tumor density on contrast-enhanced CT images.
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Up to 12 months after vaccination 1
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Changes in WHO-ECOG score
Time Frame: Up to 12 months after vaccination 1
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Up to 12 months after vaccination 1
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Levels of autoimmunization parameters
Time Frame: Up to 3 months after vaccination 1
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Screening of autoantibodies against nuclear antigens (ANA), including the nuclear antigens SSA, SSB, Sm, RNP, Scl-70, Centromeres and Jo-1
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Up to 3 months after vaccination 1
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Levels of alloimmunization parameters
Time Frame: Up to 3 months after vaccination 1
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Screening of alloantibodies against HLA-A, B, C (MHC-class I) and HLA-DR (MHC-class II) antigens
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Up to 3 months after vaccination 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Study Director, Mendus
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2016
Primary Completion (Actual)
May 10, 2019
Study Completion (Actual)
May 10, 2019
Study Registration Dates
First Submitted
January 19, 2016
First Submitted That Met QC Criteria
February 16, 2016
First Posted (Estimate)
February 22, 2016
Study Record Updates
Last Update Posted (Actual)
July 5, 2019
Last Update Submitted That Met QC Criteria
July 3, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IM-103
- 2015-002689-22 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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