Clinical trial · Interventional
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
NCT01543464CI-TRIAL-00032126terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Diminished rectruitment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy: Temozolomide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vaccine+adjuvants+temozolomide treatment
- description
- Experimental arm
- interventionNames
- Drug: Chemotherapy: Temozolomide
Primary outcomes (1)
- measure
- Clinical benefit rate (CBR)
- timeFrame
- 18 months
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.