Peptide Vaccinations Plus GM-CT-01 in Melanoma

NCT01723813 | Terminated Phase 1

• 1 other identifier: LUC 10-001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the intravenous and/or GM-CT-01 administration can correct Tumor Infiltrating Lymphocytes (TIL) anergy and induce a more efficient and long-lasting anti-tumoral immune response following peptide vaccination.

Conditions

Metastatic Melanoma

Keywords

Immunotherapy; Tumor-specific peptides; GM-CT-01

Outcome Measures

Primary Outcomes (2)

• Number of participants with adverse events

  Change from baseline in adverse events will be recorded at each patient's visit and up to 30 days after last administration of study drugs. Measurements will use the Common Toxicity Criteria for Adverse Effects 4,0 scale

  30 days after last administration of Study drugs

• Response rate in both arms

  Efficacy of the combination of a peptide vaccine and GM-CT-01 injections measures performed by CT-scan or MRI

  Change from baseline at week 7 and week 20

Secondary Outcomes (4)

• Response rate in group 2 versus group 1

  Change from baseline at week 7 and week 20

• Time to Progression

  From date of inclusion until the date of first documented progression or date of death from any cause, which ever came first, assessed up to 100 weeks

• Overall Survival

  From day of inclusion to date of death

• Immunogenicity of the treatment

  Change from baseline at week 20

Other Outcomes (2)

• Translational research

  baseline and at progression

• Pharmacokinetics of GM-CT-01

  Change from baseline at days 46 to 48

Study Arms (2)

Group 1 : peptides + GM-CT-01 IV

EXPERIMENTAL

Tumor specific peptides: MAGE-3.A1 and / or NA17.A2 plus Galectin-3 inhibitor: GM-CT-01 systemic injections

Biological: Tumor specific peptides: MAGE-3.A1 and / or NA17.A2; Biological: Galectin-3 inhibitor: GM-CT-01 systemic injections

Group 2 : peptides + GM-CT-01 IV+PT

EXPERIMENTAL

Tumor specific peptides: MAGE-3.A1 and / or NA17.A2 plus Galectin-3 inhibitor: GM-CT-01 systemic injections and Galectin-3 inhibitor: GM-CT-01 Peri-tumoral administration

Biological: Tumor specific peptides: MAGE-3.A1 and / or NA17.A2; Biological: Galectin-3 inhibitor: GM-CT-01 systemic injections; Biological: Galectin-3 inhibitor: GM-CT-01 Peri-tumoral administration

Interventions

Tumor specific peptides: MAGE-3.A1 and / or NA17.A2 BIOLOGICAL

Each peptide will be given at a dose of 300 µg in 1 ml of sodium chloride 0.9%, every 3 weeks on 6 occasions, and will be administered at one site in arm or thigh, 20% of the dose intradermally and 80% of the dose subcutaneously.

Group 1 : peptides + GM-CT-01 IV; Group 2 : peptides + GM-CT-01 IV+PT

Galectin-3 inhibitor: GM-CT-01 systemic injections BIOLOGICAL

Systemic injection of GM-CT-01: GM-CT-01 will be administered by slow intravenous infusions at a dose of 280 mg/m2, on days +3, +6, +9, +12, +15, +18 after each of the 3rd, 4th, 5th and 6th vaccination.

Group 1 : peptides + GM-CT-01 IV; Group 2 : peptides + GM-CT-01 IV+PT

Galectin-3 inhibitor: GM-CT-01 Peri-tumoral administration BIOLOGICAL

GM-CT-01 will be injected peri-tumoral at a dose of 100 µg per tumor injected, on days +3, +6, +9, +12, +15, +18 after each of the 3rd, 4th, 5th and 6th vaccination. If a patient has one or two superficial metastases at day 43 of the treatment, one of these lesions will be treated. If a patient has more than two superficial metastases at day 43, two of these lesions will be treated.

Group 2 : peptides + GM-CT-01 IV+PT

Eligibility Criteria

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

You may qualify if:

• Patients with histologically proven cutaneous melanoma at one of the following American Joint Committee on Cancer stages : Regional metastatic disease (any T; N2c or N3; M0), no amenable to curative treatment by surgery or isolated limb perfusion.Distant metastatic disease (any T; any N; M1a, M1b or M1c\*).\*except uncontrolled brain metastasis and except Lactate dehydrogenase \>1.5 upper normal value
• HLA-A1 or HLA-A2 (by serology or molecular biology)
• At least one of the two following conditions:
• MAGE-3 gene expression by the tumor if patient is HLA-A1 NA17 gene expression by the tumor if patient is HLA-A2 (determined by reverse transcription and polymerase chain reaction amplification).
• Measurable Disease. Patients must have at least 1 measurable metastasis at study entry for all patients. In addition, patients candidates for enrollment in Group 2 who will receive peri-tumoral injections of GM-CT-01 must have at least 1 superficial metastasis (cutaneous, subcutaneous or superficial lymph node metastasis, with its largest diameter equal to or greater than 5, 5, or 10 mm, respectively) at study entry.
• Age ≥ 18 years.
• Karnofsky Performance status ≥70 or WHO performance status of 0 or 1
• Expected survival of at least 6 months.
• Laboratory values :
• Platelet count ≥100x103/μL Leukocyte count ≥ 3x103/μL Hemoglobin ≥ 9 g/dL Aspartate transaminase and Alanine transaminase ≤ 2 times upper normal value Serum creatinine ≤1.5 times upper normal value Total bilirubin ≤ 1.5 times upper normal value Lactate dehydrogenase ≤ 1.5 times upper normal value
• Viral serology : negative antibodies for Hepatitis C Virus \& HIV; negative antigens for Hepatitis B Virus.
• Patient should agree to perform biopsies and blood collections for translational research.
• Signed informed consent from the patient must be obtained.

You may not qualify if:

• Uncontrolled brain or central nervous system metastasis.
• Clinically significant cardiovascular disease (including cardiac insufficiency New York Heart Association grade III and IV, unstable angina, arrythmia, myocardial infarction, symptomatic congestive heart failure) in the past 12 months before enrollment.
• Other serious acute or chronic illnesses, e.g. active infections requiring antibiotics, bleeding disorders or other conditions requiring concurrent medications not allowed during this study.
• Other malignancy within 3 years prior to entry in the study, except for treated non-melanoma skin cancer and in situ cervical carcinoma.
• Lack of availability for immunological and clinical follow-up assessments.
• Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
• Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment.
• Subject (male or female) not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months after the end of treatment.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jean-Francois BAURAIN, MD, PhD

  Cliniques univeristaires Saint-Luc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2012
• First Posted: November 8, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: March 12, 2019

Record last verified: 2019-03

Locations

BE (1)