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AzTrials

Renal Cell CancerPhase 1/2UroRCCNCT02429440

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

A Phase 1/2 study testing peptide vaccine, Granulocyte Macrophage Colony Stimulating Factor and Montanide ISA-51 in people with Renal Cell Cancer and Advanced Renal Cell Cancer, run by University Hospital Tuebingen.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Cancer, Advanced Renal Cell Cancer
What is being tested?
peptide vaccine, Granulocyte Macrophage Colony Stimulating Factor and Montanide ISA-51
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
May 2005to Jun 2018
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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).

Being tested
peptide vaccine, Granulocyte Macrophage Colony Stimulating Factor, Montanide ISA-51
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • peptide vaccineBiological

    subcutaneous

  • Granulocyte Macrophage Colony Stimulating FactorDrug

    Also called GM-CSF

    intradermal

  • Montanide ISA-51Drug

    subcutaneous

Study groups in NCT02429440
Study groupRoleWhat they receive
Study Arm 1ExperimentalIntradermal application of peptide vaccine in combination with Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)
Receives: Biological: peptide vaccine; Drug: Granulocyte Macrophage Colony Stimulating Factor
Study Arm 2Active comparatorIntradermal application of peptide vaccine with Montanide ISA-51
Receives: Biological: peptide vaccine; Drug: Montanide ISA-51

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tolerability

    Tolerability, as measured by number of Participants with Adverse Events

    Measured: Day 0-365

Secondary outcomes (3)

  1. All Cause Mortality

    All cause Mortality, as measured as length of Overall Survival

    Measured: 60 Months

  2. Progression-free Survival

    Progression-free Survival, as measured as time to radiographic progression

    Measured: 36 Months

  3. Immune Response

    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.

    Measured: Day 0-365

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2015 (estimated)
  2. Study startMay 2005
  3. Primary completionOct 2017 (estimated)
  4. Study completionJun 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02429440
Sponsor's protocol ID
231/2004
Acronym
UroRCC
Status last verified
Aug 2017
First submitted
14 Apr 2015
Last updated
17 Aug 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing peptide vaccine, Granulocyte Macrophage Colony Stimulating Factor and Montanide ISA-51 in people with Renal Cell Cancer and Advanced Renal Cell Cancer, run by University Hospital Tuebingen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tolerability (time frame: Day 0-365). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02429440.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2017.

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