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History of Changes for Study: NCT02686944
A Study to Evaluate the Safety of Intuvax Administered Intra-tumorally in Patients With Gastrointestinal Stromal Tumors (GIST)
Latest version (submitted July 3, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 16, 2016 None (earliest Version on record)
2 February 25, 2017 Recruitment Status, Contacts/Locations, Study Status, Outcome Measures, Arms and Interventions, Oversight, Eligibility, Study Design, Study Description and Study Identification
3 April 27, 2017 Study Status
4 September 27, 2017 Arms and Interventions and Study Status
5 February 23, 2018 Arms and Interventions, Outcome Measures, Study Status and Study Identification
6 November 8, 2018 Recruitment Status, Study Status and Contacts/Locations
7 June 18, 2019 Study Status
8 July 3, 2019 Recruitment Status, Study Status and Study Design
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Study NCT02686944
Submitted Date:  February 16, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: EudraCT-no: 2015-002689-22
Brief Title: A Study to Evaluate the Safety of Intuvax Administered Intra-tumorally in Patients With Gastrointestinal Stromal Tumors (GIST)
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-Line Treatment With Sunitinib. A Prospective Single Armed, Open Label Phase I Safety and Efficacy Study
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2015
Overall Status: Not yet recruiting
Study Start: February 2016
Primary Completion: June 2017 [Anticipated]
Study Completion: June 2017 [Anticipated]
First Submitted: January 19, 2016
First Submitted that
Met QC Criteria:
February 16, 2016
First Posted: February 22, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 16, 2016
Last Update Posted: February 22, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Mendus
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: 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-line Sunitinib 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 Sunitinib treatment until the 3 months follow up visit. If further tumor progression Sunitinib will be withdrawn but if stable disease or objective response the patient will continue with Sunitinib 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.
Detailed Description:
Open or close this module Conditions
Conditions: Gastrointestinal Stromal Tumor
Keywords: GIST
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 12 [Anticipated]
Open or close this module Arms and Interventions
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 000000 allogeneic dendritic cells/ml per injection.

Biological: Intuvax (suspension for intratumoral injection)
Therapeutic vaccine: allogeneic, proinflammatory dendritis cells
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Changes in vital signs (heart rate, blood pressure, body temperature)
[ Time Frame: Within 6 hours after each vaccination of Intuvax and at 3 and 6 months versus baseline ]

2. Changes in lab parameters (biochemistry, haematology)
[ Time Frame: Just before vaccination 1, at 14 days after vaccination 1, at 28 days after vaccination 2, at 3 and 6 months after vaccination 1 ]

3. Adverse events
[ Time Frame: At time of vaccination 1 and through study completion, an average of 6 months ]

4. 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:
1. Tumor response by determining changes (PD, SD, PR, CR) in tumor diameter according to mRECIST
[ Time Frame: Within 2 weeks of vaccination 1 and at 3 and 6 months after vaccination 1 ]

Criteria based on the diameter of the contrast-enhanced portions of the tumor
2. Tumor response by determining changes (PD, SD, PR, CR) in tumor diameter according to RECIST 1.1.
[ Time Frame: Within 2 weeks of vaccination 1 and at 3 and 6 months after vaccination 1 ]

Criteria based on the maximal tumor diameter
3. Tumor response by determining changes (PD, SD, PR, CR) in tumor diameter according to Choi criteria
[ Time Frame: Within 2 weeks of vaccination 1 and at 3 and 6 months after vaccination 1 ]

Criteria based on unidimensional tumor size and tumor density on contrast-enhanced CT images.
4. Progression free survival according to mRECIST
[ Time Frame: Within 2 weeks of vaccination 1 and at 3 and 6 months after vaccination 1 ]

Criteria based on the diameter of the contrast-enhanced portions of the tumor
5. Progression free survival according to RECIST 1.1
[ Time Frame: Within 2 weeks of vaccination 1 and at 3 and 6 months after vaccination 1 ]

Criteria based on the maximal tumor diameter
6. Progression free survival according to Choi criteria
[ Time Frame: Within 2 weeks of vaccination 1 and at 3 and 6 months after vaccination 1 ]

Criteria based on unidimensional tumor size and tumor density on contrast-enhanced CT images.
7. Changes in WHO-ECOG score
[ Time Frame: At 3 and 6 months versus baseline ]

8. Levels of autoimmunization parameters
[ Time Frame: Within 2 weeks of vaccination 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
9. Levels of alloimmunization parameters
[ Time Frame: Within 2 weeks of vaccination 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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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 both first (imatinib) and second line (Sunitinib) 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-line treatment with Sunitinib
  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 (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 < 4.5 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. Any reason that, in the opinion of the investigator, contraindicates that the patient participates in the study.
Open or close this module Contacts/Locations
Central Contact Person: Linda Barkemo
Telephone: +46 31 405050
Email: linda.barkemo@immunicum.com
Study Officials: Linda Barkemo
Study Director
Mendus
Locations: Sweden
Department of Breast and Endocrine Surgery, Section of Endocrine and Sarcoma Surgery, Karolinska University Hospital
Stockholm, Sweden, SE-171 76
Contact:Contact: Robert Bränström, MD, PhD +46 8 51779213 robert.branstrom@ki.se
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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