Peptide Vaccine and Temozolomide for Metastatic Melanoma Patients

This study has been terminated.
(Diminished rectruitment)
Copenhagen University Hospital at Herlev
Information provided by (Responsible Party):
Inge Marie Svane, Herlev Hospital Identifier:
First received: February 8, 2012
Last updated: August 17, 2015
Last verified: August 2015
The aim of the study is to assess if treatment with IDO/Survivin peptide vaccine can enhance the efficacy of temozolomide chemotherapy in patients with metastatic malignant melanoma.

Condition Intervention Phase
Malignant Melanoma
Drug: Chemotherapy: Temozolomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combination of IDO/Survivin Peptide Vaccine, GM-CSF, Imiquimod and Temozolomide Chemotherapy for Patients With Metastatic Malignant Melanoma

Resource links provided by NLM:

Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Clinical benefit rate (CBR) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Primary endpoint is clinical benefit rate defined as complete remission rate + partial response + stable disease for a minimum of 6 months plus assessment of time to progression (TTP).

Enrollment: 41
Study Start Date: May 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccine+adjuvants+temozolomide treatment
Experimental arm
Drug: Chemotherapy: Temozolomide
Vaccine: 250 microgram IDO5 peptide + 250 microgram Survivin peptide + 500 microL Montanide every 2nd week Adjuvants: 75 microgram GM-CSF + 1 application Imiquimod every 2nd week

Detailed Description:
Secondarily to studying the efficacy of the treatment; the investigators examine if treatment with IDO/Survivin peptide can induce a measurable cellular T-cell response when the vaccine is given in combination with temozolomide treatment for melanoma patients.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histological verified malignant melanoma
  2. Metastatic disease (brain metastasis allowed if asymptomatic)
  3. Evaluable disease recording to RECIST v. 1.1
  4. Age > 18 years
  5. Performance status, PS=0, PS=1 or PS=2
  6. Life expectancy > 3 months
  7. Adequate bone marrow function
  8. Leucocyte count > 2,5 * 109/L
  9. Granulocyte count > 1,5 * 109/L
  10. Thrombocyte count > 100 * 109/l
  11. Creatinine < 2,5 * UNL 130 micromol/L
  12. Adequate liver function
  13. ASAT < 100 U/L
  14. Bilirubin < 300 U/L
  15. S-hCG negative (fertile women)
  16. Written informed consent
  17. Inclusion at least 4 weeks after major abdominal surgery
  18. If radiotherapy for brain metastases prior to inclusion, then progressive disease proven by new brain MR-scan before inclusion

Exclusion Criteria:

  1. Treatment with immune suppressors (ie. prednisone) not allowed
  2. Other malignancies 3 years prior to inclusion except benign skin lesions
  3. Severe medical condition, severe asthma, severe COL, severe heart- or diabetic disease
  4. Acute/Chronic infection with HIV, hepatitis or tuberculosis
  5. Known severe allergic reactions
  6. Former anaphylactic reactions
  7. Active autoimmune diseases
  8. Pregnant or nourishing women
  9. Psychiatric disease resulting in non-compliance
  10. Known allergic reactions towards Montanide, Imiquimod, Temozolomide or Leukine
  11. Simultaneously treatment with other experimental drugs

Patients cannot be treated with chemotherapy, radiotherapy (except locally) or immunotherapy 14 days within inclusion.

  Contacts and Locations
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Please refer to this study by its identifier: NCT01543464

Trine Zeeberg Iversen
Brønshøj, Copenhagen, Denmark, 2700
Sponsors and Collaborators
Inge Marie Svane
Copenhagen University Hospital at Herlev
Principal Investigator: Trine Zeeberg Iversen, MD Center for Cancer ImmuneTherapy
Study Director: Inge Marie Svane, MD, PhD, Prof. Center for Cancer ImmunoTherapy
  More Information

No publications provided

Responsible Party: Inge Marie Svane, MD, PhD & Professor, Herlev Hospital Identifier: NCT01543464     History of Changes
Other Study ID Numbers: MM1120
Study First Received: February 8, 2012
Last Updated: August 17, 2015
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Herlev Hospital:
Indeolamine 2,3 dioxygenase

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Adjuvants, Immunologic
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Immunologic Factors
Interferon Inducers
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 27, 2015