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Combination of IDO/Survivin Peptide Vaccine, GM-CSF, Imiquimod and Temozolomide Chemotherapy for Patients With Metastatic Malignant Melanoma

Phase 2
18 Years
Open (Enrolling)
Malignant Melanoma

Thank you

Trial Information

Combination of IDO/Survivin Peptide Vaccine, GM-CSF, Imiquimod and Temozolomide Chemotherapy for Patients With Metastatic Malignant Melanoma

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.

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

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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical benefit rate (CBR)

Outcome Description:

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).

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

Trine Zeeberg Iversen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Center for Cancer ImmuneTherapy


Denmark: Danish Medicines Agency

Study ID:




Start Date:

May 2012

Completion Date:

September 2014

Related Keywords:

  • Malignant Melanoma
  • Indeolamine 2,3 dioxygenase
  • Survivin
  • Montanide
  • Imiquimod
  • Melanoma