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

NCT02686944 | Completed Phase 1

• 2 other identifiers: IM-1032015-002689-22
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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, 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 If further tumor progression TKI will be withdrawn but if stable disease or objective response the patient will continue with TKI until progress.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.

Conditions

Gastrointestinal Stromal Tumor

Keywords

GIST

Outcome Measures

Primary Outcomes (3)

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

  Up to 12 months after vaccination 1

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

  Up to 12 months after vaccination 1

• Adverse events according to CTCAE v 4.03

  Up to 12 months after vaccination 1

Secondary Outcomes (9)

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

  Every 3 months up to 12 months after vaccination 1

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

  Every 3 months up to 12 months after vaccination 1

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

  Every 3 months up to 12 months after vaccination 1

• Progression free survival according to mRECIST

  Up to 12 months after vaccination 1

• Progression free survival according to RECIST 1.1

  Up to 12 months after vaccination 1

Study Arms (1)

Intuvax (ilixadencel)

EXPERIMENTAL

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.

Biological: Intuvax (ilixadencel)

Interventions

Intuvax (ilixadencel) BIOLOGICAL

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

Also known as: ilixadencel

Intuvax (ilixadencel)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mendus: lead

Study Sites (1)

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

Stockholm, SE-171 76, Sweden

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Study Director

  Mendus

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: February 22, 2016
• Study Start: June 1, 2016
• Primary Completion: May 10, 2019
• Study Completion: May 10, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)