Clinical trial · Interventional
IDO Peptid Vaccination for Stage III-IV Non Small-cell Lung Cancer Patients.
IDO Peptid Vaccination in Combination With Immune Stimulating Agent Aldara and the Adjuvant Montanide, for Treatment of Patients With Locally Advanced or Metastatic Non Small-cell Lung Cancer. A First-in-man Phase I Trial.
NCT01219348CI-TRIAL-00018855IDOvaccinecompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Title: IDO peptid vaccination in combination with immune stimulating agent Aldara and the adjuvant Montanide, for treatment of patients with locally advanced or metastatic non small-cell lung cancer. A first-in-man phase I trial. Hypothesis: In this trial the investigators assess a new immunotherapeutic strategy targeting the immune inhibiting enzyme, IDO to investigate the potential of vaccination against IDO as a possible anticancer target.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IDO peptide vaccination | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Indeolamine 2,3 deoxygenase
- description
- To inhibit immune suppression and tolerance, by blocking the IDO enzyme with vaccination against IDO.
- interventionNames
- Biological: IDO peptide vaccination
Primary outcomes (1)
- measure
- evidence of toxicity
- timeFrame
- 12 months
- description
- CTCAE = Common Terminology Criteria for Adverse Events v. 3.0 will be used for registration of toxicity
Secondary outcomes (1)
- measure
- evaluation of immunological and clinical responses
- timeFrame
- 18 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
1\. Histological or cytological verified non small cell lung cancer 2. Metastatic or locally advanced incurable stage III-IV NSCLC 3. Patients need to be off chemotherapy treatment 4. Evaluable disease according to RECIST V. 1,1 criteria 5. Patients must be HLA-A2 positive 6. Patients \> 18 years old 7. Performance status 0-1 8. Life expectancy of \> 3 months 9. Acceptable bone marrow function, defined as
a. White blood cell count \> 2,5 \* 109 /l b. Neutrophil count\> 1,5 \* 109 /l c. Platelet count \> 75 \* 109/l 10. Creatinin measured \< 2,5 \* upper limit value 11. Acceptable liver function, defined as
1. ASAT \< 100 U/L
2. Bilirubin \< 30 U/L 12. Women with child-bearing potential must have controlled s-hcg before inclusion 13. Patients must provide written informed concent before inclusion 13. Termination of chemotherapy treatment \> 28 days before inclusion
14\. Termination of radiotherapy treatment \> 28 days before inclusion
15\. Inclusion at least \> 4 weeks after complicated gastric surgery
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Exclusion Criteria:
1. Other malignancies except from non-melanoma skin cancer in the previous 5 years until study inclusion
2. Brain metastasis are allowed after radical excision, and if the patient at least 1 month afterwards is not in clinical or radiographic progression
3. Patients with active gastric ulcer disease; patients taking antacid treatment can be included.
4. Severe medical condition, severe asthma, severe COLD, severe arteriosclerosis or diabetic disease
5. Acute or chronic infection (ie. HIV, hepatitis, tuberculosis)
6. Severe allergic reaction or previous anaphylactic shock
7. Autoimmune diseases (ie. autoimmune neutropenia/thrombopenia, hæmolytic anaemia, systemic lupus erythematosis, Sjøgrens disease, sclerodermia, Goodpastures syndrome, Addisons disease, active Graves disease)
8. Pregnant or lactating women
9. Psychiatric disease, which can influence compliance
10. Known hypersensitivity towards the adjuvance Montanide, the Aldara creme, or adhesive tape.
11. Treatment with immunosuppressive therapy (ie. dexamethasone, methotrexate)
12. Treatment with other experimental therapy
13. Treatment with other anti-cancer therapy, except from treatment of osteoporosis
14. No systemic chemotherapy, immunotherapy or radiation therapy (except locally) are allowed until 28 days before inclusion.
\-References
Publications (2)
- DERIVEDIversen TZ, Engell-Noerregaard L, Ellebaek E, Andersen R, Larsen SK, Bjoern J, Zeyher C, Gouttefangeas C, Thomsen BM, Holm B, Thor Straten P, Mellemgaard A, Andersen MH, Svane IM. Long-lasting disease stabilization in the absence of toxicity in metastatic lung cancer patients vaccinated with an epitope derived from indoleamine 2,3 dioxygenase. Clin Cancer Res. 2014 Jan 1;20(1):221-32. doi: 10.1158/1078-0432.CCR-13-1560. Epub 2013 Nov 11. PMID 24218513
- DERIVEDAndersen MH. The specific targeting of immune regulation: T-cell responses against Indoleamine 2,3-dioxygenase. Cancer Immunol Immunother. 2012 Aug;61(8):1289-97. doi: 10.1007/s00262-012-1234-4. Epub 2012 Mar 3. PMID 22388712