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

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ClinicalTrials.gov Identifier: NCT01265901
Recruitment Status : Completed
First Posted : December 23, 2010
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Immatics Biotechnologies GmbH

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Metastatic Renal Cell Carcinoma Drug: Sunitinib Biological: GM-CSF Drug: Cyclophosphamide Drug: IMA901 Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 339 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2010
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Sunitinib
Sunitib as Standard therapy per Label.
 Drug: Sunitinib
As per label.
Other Name: Sutent
Experimental: IMA901 plus GM-CSF added to sunitinib after single dose of cy
After 1 cycle of sunitinib, intradermal vaccinations with IMA901 plus GM-CSF as adjuvant after a single dose of cyclophosphamide will be applied for a period of 4 months while continuing treatment with sunitinib
 Drug: Sunitinib
As per label.
Other Name: Sutent

Biological: GM-CSF
Intradermal injection of GM-CSF as adjuvant.
Other Names:
  • 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)

Drug: IMA901
Intradermal vaccinations with IMA901 vaccine.
Other Name: IMA901 Vaccine


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: 2015 (estimated) ]

Secondary Outcome Measures :
  1. Overall survival in biomarker-defined subgroup [ Time Frame: 2015 (estimated) ]
  2. Progression-free survival [ Time Frame: 2014 (estimated) ]
  3. Best tumor response [ Time Frame: 2014 (estimated) ]
  4. Safety and tolerability [ Time Frame: continuously ]
  5. Cellular immunomonitoring [ Time Frame: 2014 (estimated) ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265901


Locations
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Sponsors and Collaborators
Immatics Biotechnologies GmbH
Investigators
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Principal Investigator: Brian Rini, MD Cleveland Clinic Taussig Cancer Institute
Principal Investigator: Tim Eisen, MD Addenbrooke's Hospital University of Cambridge, UK
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Immatics Biotechnologies GmbH
ClinicalTrials.gov Identifier: NCT01265901    
Other Study ID Numbers: IMA901-301
2010-022459-45 ( EudraCT Number )
First Posted: December 23, 2010    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: September 2017
Keywords provided by Immatics Biotechnologies GmbH:
Metastatic Renal Cell Carcinoma
First line
Eligible for sunitinib
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
 Male Urogenital Diseases
Cyclophosphamide
Sunitinib
Molgramostim
Sargramostim
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Angiogenesis Inhibitors