Peptide Vaccine and Temozolomide for Metastatic Melanoma Patients

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01543464

Enrollment

Registered

2012-03-05

Start date

2012-05-31

Completion date

2016-09-30

Last updated

2018-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Melanoma

Keywords

Indeolamine 2,3 dioxygenase, Survivin, Montanide, Imiquimod, GMCSF

Brief summary

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.

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.

Interventions

DRUGChemotherapy: 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Clinical benefit rate (CBR)	18 months	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).

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026