Peptide Vaccine and Temozolomide for Metastatic Melanoma Patients

Phase 2

Terminated

• Conditions: Malignant Melanoma

• Registration Number: NCT01543464
• Lead Sponsor: Inge Marie Svane

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.

Study Timeline

• Study First Submitted: 2012-02-08
• Study First Submitted QC: 2012-03-02
• Study First Posted: 2012-03-05
• Study Start: 2012-05
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-16
• Last Update Posted: 2018-03-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Trine Zeeberg Iversen; 🇩🇰 Brønshøj, Copenhagen, Denmark