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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
immatics Biotechnologies GmbH
ClinicalTrials.gov Identifier:
NCT01265901
First received: December 22, 2010
Last updated: September 30, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Metastatic Renal Cell Carcinoma
Drug: Sunitinib
Biological: IMA901 plus GM-CSF
Drug: Cyclophosphamide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Phase III Study Investigating IMA901 Multipeptide Cancer Vaccine in Patients Receiving Sunitinib as First-line Therapy for Advanced/Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by immatics Biotechnologies GmbH:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 2015 (estimated) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival in biomarker-defined subgroup [ Time Frame: 2015 (estimated) ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 2014 (estimated) ] [ Designated as safety issue: No ]
  • Best tumor response [ Time Frame: 2014 (estimated) ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: continuously ] [ Designated as safety issue: Yes ]
  • Cellular immunomonitoring [ Time Frame: 2014 (estimated) ] [ Designated as safety issue: No ]

Estimated Enrollment: 330
Study Start Date: December 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sunitinib Drug: Sunitinib
as per label
Other Name: Sutent
Experimental: IMA901 plus GM-CSF added to sunitinib Biological: IMA901 plus GM-CSF
After 1 cycle of sunitinib, intradermal vaccinations with IMA901 plus GM-CSF as adjuvant will be applied for a period of 4 months while continuing treatment with sunitinib
Other Names:
  • Sutent
  • TUMAP
  • Granulocyte macrophage-colony stimulating factor
  • Leukine
  • Sargramostim
Drug: Cyclophosphamide
One single low-dose i.v. infusion prior to the first vaccination
Other Names:
  • Endoxan (EU name)
  • Cytoxan (US name)

Detailed Description:

This is a multicenter, open-label, randomized phase III study to investigate whether therapeutic vaccination with IMA901, a mult-peptide cancer vaccine (TUMAP), can prolong overall survival in patients with metastatic and/or locally advanced RCC when added to standard first-line therapy with sunitinib (primary endpoint).

Secondary endpoints include a subgroup analysis of overall survival in patients who are positive for a prospectively defined primary biomarker signature (identified as being predictive for improved clinical outcome in IMA901-vaccinated patients in the previous phase II study), progression-free survival (PFS), best overall response, cellular immunomonitoring in a subset of patients, and safety. Safety analysis will be based on adverse events (AEs), physical examinations, vital signs, hematology, clinical chemistry, urinalysis and ECG changes.

Further endpoints include subgroup analyses of overall survival in patients who are positive for further prospectively defined biomarkers (identified in the previous phase II study), and exploratory screening of new biomarkers (to be investigated in patients' blood and paraffin sections from tumor tissue) to predict better clinical outcome as response to vaccination with IMA901. Biomarker sets will not be used for patient selection in this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged at least 18 years.
  2. HLA type: HLA-A*02-positive
  3. Metastatic and/or locally advanced RCC with clear cell histology (histological confirmation by local pathologist required). NOTE: prior nephrectomy is NOT required.
  4. Measurable and/or non-measurable tumor lesions as per RECIST 1.1
  5. Patients who are candidates for a first-line therapy with sunitinib.
  6. Favorable or intermediate risk according to the 6-score risk criteria in patients treated with VEGF-targeted agents according to Heng [Heng et al. 2009]. The patient has a favorable risk if none, or intermediate risk if one or two of the following criteria apply (if three or more criteria apply the patient is not eligible):

    1. Hemoglobin < LLN,
    2. Serum corrected calcium > ULN,
    3. Karnofsky performance status < 80%,
    4. Time from initial diagnosis to initiation of therapy < 1 year,
    5. Absolute neutrophil count > ULN,
    6. Platelets > ULN.
  7. Able to understand the nature of the study and give written informed consent.
  8. Willingness and ability to comply with the study protocol for the duration of the study.
  9. Female patients who are post menopausal (no menstrual period for a minimum of 1 year), or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or practice a medically acceptable method of birth control.
  10. Male patients willing to use contraception (upon study entry and during the course of the study or have undergone vasectomy.

Exclusion Criteria:

  1. Prior systemic therapy for metastatic disease. (Note: prior adjuvant treatment for non-metastatic disease is allowed, however adjuvant therapy must have been stopped ≥ 1 year before Visit C).
  2. History of or current brain metastases.
  3. Abnormal ≥ CTC Grade 3 laboratory values for hematology (Hb, WBC, neutrophils, lymphocytes, platelets), liver (serum bilirubin, ALAT or ASAT) and renal function (serum creatinine).
  4. Metastatic second malignancy.
  5. Localized second malignancy expected to influence the patient's life span.
  6. Patients with a history or evidence of systemic autoimmune disease, e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematodes (SLE), scleroderma, Sjögren's syndrome, Wegener's granulomatosis, Guillain-Barre syndrome.
  7. Known active hepatitis B or C infection.
  8. Known HIV infection.
  9. Active infections requiring oral or intravenous antibiotics.
  10. Any other known infection with a biological agent that can cause a severe disease and poses a severe danger to lab personnel working on patients' blood or tissue.
  11. Received study drug within any clinical study (including approved and experimental drugs) within 4 weeks before sunitinib start.
  12. Serious intercurrent illness, which according to the investigator, poses an undue risk for the patient when participating in the trial, including, but not limited to, any of the following:

    • Clinically significant cardiovascular disease (e.g., uncontrolled hypertension; clinically significant cardiac arrhythmia, clinically significant QT-prolongation),
    • New York Heart Association class III-IV congestive heart failure,
    • Symptomatic peripheral vascular disease,
    • Severe pulmonary dysfunction,
    • Psychiatric illness or social situation that would preclude study compliance.
  13. Less than 12 months since any of the following:

    • Myocardial infarction,
    • Severe or unstable angina,
    • Coronary or peripheral artery bypass graft,
    • Cerebrovascular event incl. transient ischemic attack,
    • Pulmonary embolism / deep vein thrombosis (DVT).
  14. Pregnancy or breastfeeding.
  15. Any condition which in the judgment of the investigator would place the patient at undue risk or interfere with the results of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01265901

  Show 106 Study Locations
Sponsors and Collaborators
immatics Biotechnologies GmbH
Investigators
Principal Investigator: Brian Rini, MD Cleveland Clinic Taussig Cancer Institute
Principal Investigator: Tim Eisen, MD Addenbrooke's Hospital University of Cambridge, UK
  More Information

No publications provided

Responsible Party: immatics Biotechnologies GmbH
ClinicalTrials.gov Identifier: NCT01265901     History of Changes
Other Study ID Numbers: IMA901-301, 2010-022459-45
Study First Received: December 22, 2010
Last Updated: September 30, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes
Germany: Paul-Ehrlich-Institut
Germany: Ethics Commission
Hungary: National Institute of Pharmacy
Hungary: Scientific and Medical Research Council Ethics Committee
Italy: The Italian Medicines Agency
Italy: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Russia: Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
United States: Food and Drug Administration
United States: Institutional Review Board
Netherlands: Ministry of Health, Welfare and Sport
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Independent Ethics Committee
Romania: Ethics Committee
Romania: National Agency for Medicines and Medical Devices
Norway: Regional Ethics Commitee
Norway: Norwegian Medicines Agency

Keywords provided by immatics Biotechnologies GmbH:
Metastatic Renal Cell Carcinoma
First line
Eligible for sunitinib

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Cyclophosphamide
Sunitinib
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014