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Trial record 1 of 1 for:    NCT02686944
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A Study to Evaluate the Safety of Intuvax Administered Intra-tumorally in Patients With Gastrointestinal Stromal Tumors (GIST)

This study is currently recruiting participants.
Verified September 2017 by Immunicum AB
Sponsor:
ClinicalTrials.gov Identifier:
NCT02686944
First Posted: February 22, 2016
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Immunicum AB
  Purpose
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 If further tumor progression TKI will be withdrawn but if stable disease or objective response the patient will continue with TKI until progress.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.

Condition Intervention Phase
Gastrointestinal Stromal Tumor Biological: Intuvax (suspension for intratumoral injection) (ilixadencel) Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Immunicum AB:

Primary Outcome Measures:
  • Changes in vital signs (heart rate, blood pressure, body temperature) [ Time Frame: Within 6 hours after each vaccination of Intuvax and at 3-monthly intervals versus baseline ]
  • Changes in lab parameters (hematology and biochemistry) during the study versus baseline [ Time Frame: Just before vaccination 1, at 14 days after vaccination 1, at 28 days after vaccination 2, at 3-monthly intervals after vaccination 1 ]
  • Adverse events according to CTCAE v 4.03 [ Time Frame: At time of vaccination 1 and through study completion, an average of 6 months ]
  • Changes in lab parameters (coagulation) [ Time Frame: Just before vaccination 1, at 14 days after vaccination 1 and at 28 days after vaccination 2 ]

Secondary Outcome Measures:
  • Tumor response by determining changes (PD, SD, PR, CR) in tumor diameter according to mRECIST [ Time Frame: Within 2 weeks before vaccination 1 and at 3-monthly intervals after vaccination 1 ]
    Criteria based on the diameter of the contrast-enhanced portions of the tumor

  • Tumor response by determining changes (PD, SD, PR, CR) in tumor diameter according to RECIST 1.1. [ Time Frame: Within 2 weeks before vaccination 1 and at 3-monthly intervals after vaccination 1 ]
    Criteria based on the maximal tumor diameter

  • Tumor response by determining changes (PD, SD, PR, CR) in tumor diameter according to Choi criteria [ Time Frame: Within 2 weeks before vaccination 1 and at 3-monthly intervals after vaccination 1 ]
    Criteria based on unidimensional tumor size and tumor density on contrast-enhanced CT images.

  • Progression free survival according to mRECIST [ Time Frame: Within 2 weeks before vaccination 1 and at 3-monthly intervals after vaccination 1 ]
    Criteria based on the diameter of the contrast-enhanced portions of the tumor

  • Progression free survival according to RECIST 1.1 [ Time Frame: Within 2 weeks before vaccination 1 and at 3-monthly intervals after vaccination 1 ]
    Criteria based on the maximal tumor diameter

  • Progression free survival according to Choi criteria [ Time Frame: Within 2 weeks before vaccination 1 and at 3-monthly intervals after vaccination 1 ]
    Criteria based on unidimensional tumor size and tumor density on contrast-enhanced CT images.

  • Changes in WHO-ECOG score [ Time Frame: At 3, 6, 9 and 12 months versus baseline ]
  • Levels of autoimmunization parameters [ Time Frame: Within 2 weeks before vaccination 1 and at 3 months after vaccination 1 ]
    Screening of autoantibodies against nuclear antigens (ANA), including the nuclear antigens SSA, SSB, Sm, RNP, Scl-70, Centromeres and Jo-1

  • Levels of alloimmunization parameters [ Time Frame: Within 2 weeks before vaccination 1 and at 3 months after vaccination 1 ]
    Screening of alloantibodies against HLA-A, B, C (MHC-class I) and HLA-DR (MHC-class II) antigens


Estimated Enrollment: 12
Actual Study Start Date: June 2016
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intuvax

Intuvax 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.

Biological: Intuvax (suspension for intratumoral injection) (ilixadencel)
Therapeutic vaccine: allogeneic, proinflammatory dendritic cells
Other Name: ilixadencel

  Eligibility

Information from the National Library of Medicine

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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be informed of the nature of the study and have provided written informed consent.
  2. At least 18 years of age.
  3. 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.
  4. Radiologically measurable tumor(s), i.e at least 3 cm in longest uni-dimensional diameter as measured by CT
  5. Clinical and/or CT verified disease progression despite ongoing second, third or fourth line treatment with a TKI
  6. 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:

  1. Performance status > ECOG 2
  2. Known major reaction/adverse event in connection with previously made vaccination (e.g. asthma, anaphylaxia or other serious reaction)
  3. Known major reaction/adverse event in connection with previous transfusions of blood products
  4. 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.
  5. Tested positive for HIV
  6. Active virus disease (HBV and HCV).
  7. Ongoing infection that requires treatment with parenteral antibiotics or antiviral medication
  8. Corticosteroid treatment per os exceeding 10mg/day within 7 days prior to the first injection of Intuvax. Inhaled, intranasal and local steroids accepted.
  9. 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
  10. Previous organ transplantation
  11. Pregnant or lactating women
  12. Life expectancy less than 3 months.
  13. Investigational treatment (within 28 days) prior to the first injection of Intuvax
  14. Known blood dyscrasia (bleeding complication)
  15. Prior history of invasive cancer within 5 years before screening, except for adequately treated in situ carcinomas or non melanoma skin cancer
  16. History of alcohol or substance abuse
  17. patient will not be available for follow up assessments
  18. Any other reason that, in the opinion of the investigator, contraindicates that the patient participates in the study.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT02686944


Contacts
Contact: Study Director info@immunicum.com
Contact: Study Director

Locations
Sweden
Department of Breast and Endocrine Surgery, Section of Endocrine and Sarcoma Surgery, Karolinska University Hospital Recruiting
Stockholm, Sweden, SE-171 76
Contact: Robert Bränström, MD, PhD         
Sponsors and Collaborators
Immunicum AB
Investigators
Study Director: Study Director Immunicum AB
  More Information

Responsible Party: Immunicum AB
ClinicalTrials.gov Identifier: NCT02686944     History of Changes
Other Study ID Numbers: EudraCT-no: 2015-002689-22
First Submitted: January 19, 2016
First Posted: February 22, 2016
Last Update Posted: September 29, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Immunicum AB:
GIST

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases