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

NCT02429440 — Phase 1 / Phase 2, Unknown, 40 participants, University Hospital Tuebingen
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RegistryNCT02429440, acronym UroRCC
StatusUnknown
PhasePhase 1 / Phase 2
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment40 (Actual)
SponsorUniversity Hospital Tuebingen (Other)
ConditionsRenal Cell Cancer, Advanced Renal Cell Cancer
Interventionspeptide vaccine, Granulocyte Macrophage Colony Stimulating Factor, Montanide ISA-51 (Biological, drug)
Datesstart 2005-05-01, primary completion 2017-10-01 (estimated), completion 2018-06-01 (estimated), first posted 2015-04-29, last updated 2017-08-17

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-Summary

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).

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+Arms and interventions

ArmTypeInterventionsDescription
Study Arm 1ExperimentalBiological: peptide vaccine; Drug: Granulocyte Macrophage Colony Stimulating FactorIntradermal application of peptide vaccine in combination with Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)
Study Arm 2Active comparatorBiological: peptide vaccine; Drug: Montanide ISA-51Intradermal application of peptide vaccine with Montanide ISA-51
  • peptide vaccine (Biological): subcutaneous
  • Granulocyte Macrophage Colony Stimulating Factor (Drug), also known as GM-CSF: intradermal
  • Montanide ISA-51 (Drug): subcutaneous

+Outcome measures

Primary outcomes

  • Tolerability [Day 0-365]: Tolerability, as measured by number of Participants with Adverse Events

Secondary outcomes

  • All Cause Mortality [60 Months]: All cause Mortality, as measured as length of Overall Survival
  • Progression-free Survival [36 Months]: Progression-free Survival, as measured as time to radiographic progression
  • Immune Response [Day 0-365]: Immune Response, as as measured by in vitro and in vivo T cell response on day 0 and day 70. In selected cases additional immune response evaluation might be applicable.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Investigators

My Notes