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Intratumoral Vaccination With Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy vs Sunitinib Post-nephrectomy in Newly Diagnosed Metastatic Renal Cell Carcinoma (mRCC)

NCT02432846 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2022-08-22

Study results available
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Summary

The purpose of this study is to compare tumor response, progression free survival (PFS) and overall survival (OS) in newly diagnosed mRCC patients treated with Intuvax (INN: ilixadencel) pre-nephrectomy followed by Sunitinib post-nephrectomy vs Sunitinib post-nephrectomy patients.

Conditions

  • Renal Cell Carcinoma, Metastatic

Interventions

BIOLOGICAL

Intuvax (INN: ilixadencel)

Therapeutic dose (10 million cells/dose): allogeneic, pro-inflammatory dendritic cells.

DRUG

Sunitinib

Cytostatic/cytotoxic drug: protein kinase inhibitor .

Sponsors & Collaborators

  • TFS Trial Form Support

    collaborator INDUSTRY

  • Accelovance

    collaborator INDUSTRY

  • Mendus

    lead INDUSTRY

Principal Investigators

  • Börje Ljungberg, MD, Prof · Umeå University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2021-01-31
Completion
2021-01-31
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • France
  • Hungary
  • Latvia
  • Poland
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02432846 on ClinicalTrials.gov