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IMA901 in Patients Receiving Sunitinib for Advanced/Metastatic Renal Cell Carcinoma

NCT01265901 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 339

Last updated 2017-10-12

No results posted yet for this study

Summary

The primary objective of the phase III study is to investigate whether IMA901 can prolong overall survival in patients with metastatic and/or locally advanced renal cell carcinoma (RCC) when added to standard first-line therapy with sunitinib.

Secondary objectives include a subgroup analysis of overall survival in patients defined by a certain biomarker signature, the investigation of progression-free survival, best tumor response, safety, and immunological parameters.

Conditions

  • Metastatic Renal Cell Carcinoma

Interventions

DRUG

Sunitinib

As per label.

BIOLOGICAL

GM-CSF

Intradermal injection of GM-CSF as adjuvant.

DRUG

Cyclophosphamide

One single low-dose i.v. infusion prior to the first vaccination

DRUG

IMA901

Intradermal vaccinations with IMA901 vaccine.

Sponsors & Collaborators

  • Immatics Biotechnologies GmbH

    lead INDUSTRY

Principal Investigators

  • Brian Rini, MD · Cleveland Clinic Taussig Cancer Institute

  • Tim Eisen, MD · Addenbrooke's Hospital University of Cambridge, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Romania
  • Russia
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT01265901 on ClinicalTrials.gov