Phase I Safety Study of Dendritic Cell Vaccine to Treat Patients With Hepatocellular Carcinoma

NCT01974661 | Completed Phase 1 DMC

• 2 other identifiers: IM-1022013-001787-31
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to answer the question "Is it possible to inject the COMBIG-DC vaccine in a hepatic tumor without getting unacceptable side effects"?

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Registration of adverse events as a measure of safety and tolerability

  * Changes in vital signs from baseline (heart rate, blood pressure, body temperature) * Changes in lab parameters from baseline * Short term worsening in ECOG and/or Child Pugh and/or MELD score * Local procedural injuries, assessed by MRI or ultrasound

  Up to 6 months after last patient's last vaccination

Secondary Outcomes (10)

• To evaluate systemic inflammatory response

  Until 3 months after last vaccination

• To evaluate tumor control

  Until 6 months after last patient's last vaccination

• Long term changes in ECOG scores

  3 and 6 months after last vaccination

• Change in body weight

  3 and 6 months after last vaccination

• To evaluate systemic immunological response

  Up to 3 months after last vaccination

Other Outcomes (1)

• Local tissue changes in injected/non-injected tumor and surrounding tissue, assessed by MRI

  1 month after each vaccination

Study Arms (1)

COMBIG-DC

EXPERIMENTAL

COMBIG-DC (allogeneic dendritic cells) Cancer Vaccine 3 vaccinations: 5, 10 or 20 million cells per injection

Biological: COMBIG-DC (ilixadencel)

Interventions

COMBIG-DC (ilixadencel) BIOLOGICAL

Allogenic dendrite-cell based therapeutic vaccine

Also known as: ilixadencel

COMBIG-DC

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 hepatocellular carcinoma according to EASL criteria or pathology.
• Radiologically measurable liver tumor(s), i.e. at least 20 mm in longest uni-dimensional diameter as measured by CT/MRI
• Not eligible for curatively aiming treatment or TACE. Tumor stage B or C according to BCLC.
• For patients included according to Amendment 3: tumour stage A, B or C according to BCLC and
• eligible for TACE or having received not more than 1 previous TACE treatment.

You may not qualify if:

• Performance status \> ECOG 2
• Liver function according to Child-Pugh \>7 points.
• 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 disease (HBV and HCV) requiring antiviral treatment
• Ongoing infection that requires treatment with antibiotics or antiviral medication
• Treatment with immunosuppressive treatments like corticosteroids (Immunosuppression (within 28 days) prior to the first injection of COMBIG-DC. Inhaled, intranasal and local steroids accepted), or mTor inhibitors within 28 days before first vaccination.
• Patients with prior history of malignancy other than HCC, within the preceding 3 years OR with relaps after complete response, except for 5 years follow-up of adequately treated in situ carcinoma without recurrences or non-melanoma skin cancer.
• Inadequate laboratory parameters, i.e.:
• P-Prothrombincomplex (PK) \>1.4,
• Platelet count \<50 75 x109/L
• Leukocyte count \<3.0 x 109/L
• P-APT time outside normal limit

Sponsors & Collaborators

• Mendus: lead
• Uppsala University: collaborator

Study Sites (1)

Dept. of Transplantation and Liver Surgery, Sahlgrenska University Hospital

Gothenburg, SE-413 45, Sweden

Location

Related Publications (1)

• Rizell M, Sternby Eilard M, Andersson M, Andersson B, Karlsson-Parra A, Suenaert P. Phase 1 Trial With the Cell-Based Immune Primer Ilixadencel, Alone, and Combined With Sorafenib, in Advanced Hepatocellular Carcinoma. Front Oncol. 2019 Jan 21;9:19. doi: 10.3389/fonc.2019.00019. eCollection 2019.

  PMID: 30719425 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Magnus Rizell, MD, PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 21, 2013
• First Posted: November 1, 2013
• Study Start: October 1, 2013
• Primary Completion: June 28, 2017
• Study Completion: June 28, 2017
• Last Updated: September 29, 2017

Record last verified: 2017-09

Locations

SE (1)