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Trial record 1 of 1 for:    Safety of UV1 vaccination in combination with ipilimumab in patients with unresectable or metastatic malignant melanoma
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Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02275416
First Posted: October 27, 2014
Last Update Posted: April 4, 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. Read our disclaimer for details.
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Ultimovacs AS
  Purpose
This study, with 20 patients participating, will examine the safety and tolerability for the ipilimumab/UV1 combination in patients with unresectable or metastatic malignant melanoma.

Condition Intervention Phase
Malignant Melanoma Drug: Ipilimumab Biological: UV1 vaccine Biological: GM-CSF Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by Ultimovacs AS:

Primary Outcome Measures:
  • Safety and tolerability profile. Frequency/ severity of adverse and serious adverse events. Biochemistry and hematology results, vital signs and ECOG [ Time Frame: Up to 53 weeks ]
    Frequency and severity of adverse events and serious adverse events. Biochemistry and hematology results, vital signs and ECOG performance status will be assessed.


Secondary Outcome Measures:
  • Immunological response. Number of T-cell responses including time to T-cell response, level of response and duration of response. [ Time Frame: Up to 53 weeks ]
    Number of T-cell responses including time to T-cell response, level of response and duration of response.

  • Treatment response. Tumour response evaluated by CT scan every 12th week. [ Time Frame: Up to 48 weeks ]
    Tumour response evaluated by CT scan every 12th week.

  • Health Related Quality of Life (HRQL) [ Time Frame: Up to 53 weeks ]
    HRQL measured by use of patient questionnaire EORTC QLQ-C30


Other Outcome Measures:
  • Explore potential biomarkers for efficacy and safety of the ipilimumab/UV1 combination [ Time Frame: Up to 48 weeks ]
    Exploratory biomarker analysis.


Enrollment: 12
Study Start Date: November 2014
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ipilimumab & UV1 vaccine & GM-CSF
Ipilimumab (3 mg/kg) every 3rd week for a total of 4 doses. GM-CSF (75 μg) followed by UV1 vaccine (300 μg) will be injected intradermally in the lower abdomen before and between treatments of ipilimumab and thereafter every 4th week up to 28 weeks, and thereafter at week 36 and 48.
Drug: Ipilimumab
Other Name: Yervoy
Biological: UV1 vaccine
Other Name: UV1
Biological: GM-CSF
Other Name: Leukine

Detailed Description:

This is a phase I/IIa, national, open label, single arm, interventional study examining safety and tolerability for the ipilimumab/UV1 combination in patients with unresectable or metastatic malignant melanoma. Patients that have signed the informed consent form will be asked to take part in the study. All patients will receive ipilimumab together with the UV1 vaccine and rranulocyte-macrophage colony-stimulating factor (GM-CSF). Ipilimumab will be given every 3rd week for a total of 4 doses. The UV1 vaccine and GM-CSF will be given before and between treatments of ipilimumab. The maximum number of UV1/GM-CSF will be 10 doses.

Immunoresponders maybe followed up every third months for 5 years after the first UV1 treatment. Follow-up is onging.

  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. Histologically or cytologically confirmed diagnosis of unresectable or metastatic malignant melanoma, including cutaneous, ocular, mucosal and unknown primary tumour.
  2. Unresectable Stage III or Stage IV melanoma (AJCC 2010)
  3. Prior adjuvant melanoma therapy is permitted; any number of previous treatments for melanoma is permitted.
  4. ECOG performance status of 0 or 1 (see Error! Reference source not found.).
  5. Men and women ≥ 18 years of age
  6. Adequate hematologic, renal and hepatic function, specifically:

    1. WBC ≥ 2500/μL
    2. Absolute neutrophil count (ANC) ≥ 1000/uL
    3. Platelets ≥ 75 x 103/μL
    4. Haemoglobin ≥ 9 g/dL
    5. Creatinine ≤ 2.5 x ULN
    6. AST/ALT ≤ 3 x ULN for patients without liver metastasis; ≤ 5 x ULN for patients with liver metastasis
    7. Total bilirubin ≤ 3 x ULN, (except patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
  7. Women of childbearing potential and men must be using an acceptable method as described in the protocol to prevent pregnancy.
  8. Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.

Exclusion Criteria:

  1. History of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis (scleroderma and variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies (e.g. Guillain-Barre syndrome). Patients with vitiligo are not excluded.
  2. MRI detected active brain metastasis witch require other therapies such as surgery and/or radiation therapy. Patients already treated for their brain metastasis, surgery or radiation therapy, and have had stable disease for more than two month and NOT requiring steroids may however be included in this study.
  3. Uncontrolled infectious diseases - requires negative tests for clinically suspected human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV).
  4. History of or current immunodeficiency disease, splenectomy or splenic irradiation
  5. Prior allogeneic stem cell transplantation
  6. Pregnancy
  7. Women who are breastfeeding
  8. Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of Adverse Events, such as a condition associated with frequent diarrhoea
  9. History of allergic reaction to parenteral administered recombinant protein product
  10. History of another malignancy that in the opinion of the investigator may compromise the outcome of the study
  11. Any reason why, in the opinion of the investigator, the patient should not participate.
  12. Known serious reactions or hypersensitivity to any components of the UV1 vaccine or similar peptide based vaccines
  13. Known hypersensitivity to GM-CSF
  14. Known hypersensitivity to any of the excipients of the investigational products
  15. Concomitant use of antithrombotic agents with the exception of platelet inhibitors.
  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): NCT02275416


Locations
Norway
Oslo University Hospital, Radiumhospitalet
Oslo, Norway, 0379
Sponsors and Collaborators
Ultimovacs AS
Oslo University Hospital
Investigators
Principal Investigator: Tormod Guren, MD PhD Oslo University Hospital
  More Information

Responsible Party: Ultimovacs AS
ClinicalTrials.gov Identifier: NCT02275416     History of Changes
Other Study ID Numbers: UV1/hTERT-MM
2013-005582-39 ( EudraCT Number )
First Submitted: September 12, 2014
First Posted: October 27, 2014
Last Update Posted: April 4, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Melanoma
Nevi and Melanomas
Vaccines
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs