Vaccination With Peptides in Combination With Either Ipilimumab or Vemurafenib for the Treatment of Unresectable Stage III or IV Malignant Melanoma

NCT02077114 | Completed Phase 1 DMC

• 1 other identifier: MM1304
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess whether a vaccine containing a small fragment of the protein IDO, which may be present in cancer cells and cells of the immune system, is safe to use in combination with either Ipilimumab or Vemurafenib in the treatment of malignant melanoma that has metastasized.

Conditions

Malignant Melanoma With Metastasis

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events during and after treatment as a Measure of Safety and Tolerability.

  Primary endpoints will be assessed according to CTCAE ver. 4.0

  Ipilimumab+vaccine combination: Day 84. Vemurafenib+vaccine combination: Day 56.

Secondary Outcomes (1)

• Vaccine related immune response

  Ipilimumab: Day 1 (before first treatnent), day 21, day 42, day 63 and at day 84. Thereafter every 12 weeks until progression or up to 104 weeks. Vemurafenib: Day 1, day 28, day 56. Thereafter every 28 days until progression or up to week 104 weeks.

Study Arms (2)

Ipilimumab

EXPERIMENTAL

Patient who according to standard criteria are candidates to treatment with Ipilimumab

Biological: Vaccine consisting of a peptide derived from the protein IDO

Vemurafenib

EXPERIMENTAL

Patients who according to standard criteria are candidates to treatment with Vemurafenib

Biological: Vaccine consisting of a peptide derived from the protein IDO

Interventions

Vaccine consisting of a peptide derived from the protein IDO BIOLOGICAL

All patients will receive seven vaccines containing IDOlong

Also known as: IDOlong

Ipilimumab; Vemurafenib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Measurable disease according to RECIST 1.1
• ECOG performance status ≤ 2
• Patients with asymptomatic brain metastases allowed (treatment with systemic glucocorticoids is not compatible with participation)
• Women of childbearing potential must have negative s-hCG prior to initiation of treatment, and use effective contraception during treatment and up to 26 weeks after the last treatment. Safe contraception include: Birth control pills, intrauterine devices, depot injection of progesterone, subdermal implantation (eg Implanon), hormonal vaginal ring and transdermal patch.
• Histologic confirmed stage III (non-operable) or stage IV melanoma with BRAF V600 documented mutation
• Patients should be fully recovered from any previous systemic or topical treatment for metastatic malignant melanoma
• Adequate haematological, renal and hepatic function:
• Neutrophils ≥ 1.5 x 10\^9 / l
• Platelet count ≥ 100 x 10\^9 / l
• Hemoglobin ≥ 5.6 mmol / l
• Serum creatinine ≤ 1.5 times upper normal limit
• AST or ALT ≤ 2.5 times upper normal limit (≤ 5 times upper normal limit if it is considered that an increase due to liver metastases)
• Serum bilirubin ≤ 1.5 times upper normal limit
• Alkaline phosphatase ≤ 2.5 times upper normal limit (≤ 5 times upper normal limit if it is considered that an increase due to liver metastases)

You may not qualify if:

• Concomitant immunosuppressive therapy including prednisolone and methotrexate
• Known infection with HIV, hepatitis B and C virus, even if infection remain stable with medical treatment
• Other malignancy within the past three years, other than squamous cell and basal cell skin carcinoma
• Serious somatic disease, severe asthma, severe COPD, poorly controlled cardiovascular disease or diabetes
• Patients must not have undergone major intestinal surgery within the last 28 days.
• Severe allergies or previous anaphylactoid reactions
• Pregnant or lactating women
• Psychiatric illness that is perceived by the investigator to likely affect patient compliance
• Known hypersensitivity to ingredients in the adjuvant substances Montanide or Aldara cream
• At least one of the following within the past six months: myocardial infarction, severe / unstable angina pectoris, symptomatic congestive heart failure, cerebrovascular event or transient ischaemic attack, pulmonary embolism, poorly controlled hypertension,
• Congenital long QT syndrome, previous or current significant ventricular or atrial dysrhythmia ≥ 2nd degree (NCI CTCAE version 4.0)
• Corrected QT interval ≥ 450 msec at baseline
• Uncontrolled medical illness such as infection requiring intravenous antibiotics
• Other severe acute, chronic or psychiatric condition or abnormal laboratory value, which can increase the risk associated with Vemurafenib treatment
• Autoimmune diseases: History of inflammatory bowel disease, including Crohn's disease and ulcerative colitis, systemic autoimmune disease eg. rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis, including Wegener granulomatosis. Patients with motor neuropathy believed to be of autoimmune origin such as Guillain-Barre and Myasthenia gravis can not be included in the study.

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Department of Oncology, Herlev Hospital

Herlev, 2730, Denmark

Location

Related Links

• Related Info

Study Officials

• Jon Bjørn, MD

  Center for Cancer Immune Therapy

  PRINCIPAL INVESTIGATOR

• Inge Marie Svane, MD, PhD, Professor

  Center for Cancer Immune Therapy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: March 4, 2014
• Study Start: February 1, 2014
• Primary Completion: September 1, 2014
• Last Updated: September 26, 2014

Record last verified: 2014-09

Locations

DK (1)