AzTrials
AzTrials

Gastrointestinal Stromal TumorPhase 1GISTNCT02686944

A Study to Evaluate the Safety of Intuvax Administered Intra-tumorally in Patients With Gastrointestinal Stromal Tumors

A Phase 1 study testing Intuvax (ilixadencel) in people with Gastrointestinal Stromal Tumor, run by Mendus at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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, third or fourth line TKI treatment, and with at least one measureable tumor lesion, will be eligible for the study. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastrointestinal Stromal Tumor
What is being tested?
Intuvax (ilixadencel)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteSweden
Study dates
1 Jun 2016to 10 May 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 23Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Department of Breast and Endocrine Surgery, Section of Endocrine and Sarcoma Surgery, Karolinska University Hospital

    Stockholm, SE-171 76

Other trials in Sweden

About this study

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

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.

Being tested
Intuvax (ilixadencel)
Keywords
GIST
Medical subject headings
Gastrointestinal Stromal Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intuvax (ilixadencel)Biological

    Also called ilixadencel

    Therapeutic vaccine: allogeneic, proinflammatory dendritic cells, suspension for intratumoral injection

Study groups in NCT02686944
Study groupRoleWhat they receive
Intuvax (ilixadencel)ExperimentalIntuvax (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.
Receives: Biological: Intuvax (ilixadencel)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in vital signs (heart rate, blood pressure, body temperature)

    Measured: Up to 12 months after vaccination 1

  2. Changes in lab parameters (hematology and biochemistry) during the study versus baseline

    Measured: Up to 12 months after vaccination 1

  3. Adverse events according to CTCAE v 4.03

    Measured: Up to 12 months after vaccination 1

Secondary outcomes (9)

  1. Tumor response by determining changes (PD, SD, PR, CR) in tumor diameter according to mRECIST

    Criteria based on the diameter of the contrast-enhanced portions of the tumor

    Measured: Every 3 months up to 12 months after vaccination 1

  2. Tumor response by determining changes (PD, SD, PR, CR) in tumor diameter according to RECIST 1.1.

    Criteria based on the maximal tumor diameter

    Measured: Every 3 months up to 12 months after vaccination 1

  3. Tumor response by determining changes (PD, SD, PR, CR) in tumor diameter according to Choi criteria

    Criteria based on unidimensional tumor size and tumor density on contrast-enhanced CT images.

    Measured: Every 3 months up to 12 months after vaccination 1

  4. Progression free survival according to mRECIST

    Criteria based on the diameter of the contrast-enhanced portions of the tumor

    Measured: Up to 12 months after vaccination 1

  5. Progression free survival according to RECIST 1.1

    Criteria based on the maximal tumor diameter

    Measured: Up to 12 months after vaccination 1

  6. Progression free survival according to Choi criteria

    Criteria based on unidimensional tumor size and tumor density on contrast-enhanced CT images.

    Measured: Up to 12 months after vaccination 1

  7. Changes in WHO-ECOG score

    Measured: Up to 12 months after vaccination 1

  8. Levels of autoimmunization parameters

    Screening of autoantibodies against nuclear antigens (ANA), including the nuclear antigens SSA, SSB, Sm, RNP, Scl-70, Centromeres and Jo-1

    Measured: Up to 3 months after vaccination 1

  9. Levels of alloimmunization parameters

    Screening of alloantibodies against HLA-A, B, C (MHC-class I) and HLA-DR (MHC-class II) antigens

    Measured: Up to 3 months after vaccination 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2016 (estimated)
  2. Study start1 Jun 2016
  3. Primary completion10 May 2019
  4. Study completion10 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02686944
Sponsor's protocol ID
IM-103
Other IDs
2015-002689-22, 2015
Acronym
GIST
Status last verified
Jul 2019
First submitted
19 Jan 2016
Last updated
5 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Intuvax (ilixadencel) in people with Gastrointestinal Stromal Tumor, run by Mendus at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in vital signs (heart rate, blood pressure, body temperature) (time frame: Up to 12 months after vaccination 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02686944.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in