Adjuvant Antigen Specific Immunotherapy in Patients With Advanced Renal Cell Carcinoma Using Tumor Associated Peptides (UroRCC)

University Hospital Tuebingen

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Renal Cell Cancer; Advanced Renal Cell Cancer

Treatments: Biological: peptide vaccine; Drug: Granulocyte Macrophage Colony Stimulating Factor; Drug: Montanide ISA-51

Study type: Interventional

Funder types: Other

Identifiers

NCT02429440

231/2004

Details and patient eligibility

About

Clinical Phase I/II study to investigate the feasibility and tolerability of synthetic adjuvant peptide immunisation in combination with immune adjuvants (granulocyte macrophage colony stimulating factor; Montanide ISA-51) in patients with advanced renal cell cancer (RCC).

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced renal cell carcinoma clinical stage T3 or T4, N0, M0
• N+, M0
• M1 (after complete metastasectomy)
• ECOG performance status 0 or 1
• age >18 years
• at least 4 weeks since last administration of radiation- or chemotherapy
• Serum levels of bilirubin <2 mg/dl, creatinine<2mg/dl

Exclusion criteria

• detectable distant metastasis in radiological imaging (M1)
• patients unable to consent
• severe cardiopulmonary disorder (NYHA >= 3)
• presence of secondary malignancy
• Immunosuppressive medication (last application of glucocorticoids > 4 weeks)
• seizure
• pregnancy
• simultaneous participation in other active or passive immunisation treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Study Arm 1

Experimental group

Description:

Intradermal application of peptide vaccine in combination with Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)

Treatment:

Drug: Granulocyte Macrophage Colony Stimulating Factor

Biological: peptide vaccine

Study Arm 2

Active Comparator group

Description:

Intradermal application of peptide vaccine with Montanide ISA-51

Treatment:

Drug: Montanide ISA-51

Biological: peptide vaccine