IDO Peptid Vaccination for Stage III-IV Non Small-cell Lung Cancer Patients.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Combination Therapy With Nivolumab and PD-L1/IDO Peptide Vaccine to Patients With Metastatic Melanoma

NCT03047928

Metastatic Melanoma

COMPLETED PHASE1/PHASE2

Vaccine Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

NCT00019929

Lung Cancer

COMPLETED PHASE2

Evaluation of a Cancer Lysate Vaccine and Montanide (Registered Trademark) ISA-51 VG With or Without the IL-15 Super-Agonist N-803 as Adjuvant Therapy for PD-L1 Negative Non-Small Cell Lung Cancer

NCT05642195

Non-Small Cell Lung Cancer Non-Small Cell Lung Carcinoma Carcinoma, Non-Small-Cell Lung +1 more

SUSPENDED PHASE1/PHASE2

Comparison of Dendritic Cells Versus Montanide as Adjuvants in a Melanoma Vaccine

NCT00124124

Melanoma

COMPLETED PHASE1

PD-L1 Peptide Vaccination in High Risk Smoldering Multiple Myeloma

NCT03850522

Smoldering Multiple Myeloma

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Background: Non small-cell lung cancer (NSCLC) is a common disease with a poor prognosis when locally advanced or metastasized, despite advances in surgery, chemo- and radiation therapy.

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.

IDO has recently been recognized as an important factor in immune regulation and development of immune tolerance in the microenvironment of cancer cells. Cells that represent IDO at their surface are known to inhibit the immune system. IDO expression is seen both in cancer cells and antigen presenting cells. The vaccination against IDO expressing cells is therefore two-sided. The vaccination therapy is thought to block the development of immune tolerance induced by IDO expressing cells. At the same time the investigators aim to stimulate the production of IDO specific T-cells, hence facilitating the elimination of IDO positive tumour cells. The primary end points are safety and toxicity evaluation. Secondary end points are immunological and clinical response.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

NSCLC Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Indeolamine 2,3 deoxygenase

To inhibit immune suppression and tolerance, by blocking the IDO enzyme with vaccination against IDO.

Group Type EXPERIMENTAL

IDO peptide vaccination

Intervention Type BIOLOGICAL

Vaccination every second week

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IDO peptide vaccination

Vaccination every second week

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

\-

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.

\-

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No