A clinical study to evaluate safety and efficacy of a new vaccine in combination with standard treatment compared to standard treatment in patients with metastatic renal cancer

Phase 1

Conditions: Metastatic Renal Cell Carcinoma
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2014-004510-28-HU

Lead Sponsor: Immunicum AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

1) Newly (<6 months) diagnosed RCC (histological/cytological verification is optional) with at least one (1) CT-verified metastasis =10 mm for which complete metastasectomy is not planned. US patients
must have verified clear-cell tumor histology
2) Planned resection of primary tumor
3) Primary tumor diameter =40 mm
4) Candidate for first-line therapy with sunitinib initiated five (5) to eight (8) weeks after nephrectomy
5) Female or male =18 years of age
6) Willing and able to provide informed consent
7) Adequate hematological parameters, i.e.:
• B-Leukocyte count =4.5 x109/L
• B-Platelet count =150 x109/L
• B-Hemoglobin (Hb) =90 g/L
8) Serum-creatinine and serum-bilirubin =1.5 × ULN. Serum-ALAT and serum-ASAT =2.5 × ULN (or =5 in case of liver metastases)
9) Female who has been post-menopausal for more than one (1) year or female of childbearing potential agreeing to use a highly efficient method of contraception (i.e. a method with less than 1% failure rate [e.g. sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomized partner or combined birth control pills]) from Screening until 90 days after last dose of Intuvax and/or until completed sunitinib treatment whichever occurs later. Female of childbearing potential must have a negative blood pregnancy test at Screening, and if randomized to vaccination a negative blood or urine pregnancy test within one (1) day before each dose of Intuvax) and must not be lactating
or
Male agreeing to use condoms from Screening until 90 days after last dose of Intuvax and/or until completed sunitinib treatment whichever occurs later, or male having a female partner who is using a highly efficient method of contraception as described above
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1) Life expectancy less than 4 months
2) Central nervous system (CNS) metastasis that is symptomatic or
progressing or untreated or that requires current therapy (e.g. evidence
of new or enlarging CNS metastasis or new neurological symptoms
attributable to CNS metastases)
3) Active autoimmune disease which requires treatment with systemic immunosuppressive agents, e.g. inflammatory bowel disease, multiple sclerosis, sarcoidosis, psoriasis, autoimmune hemolytic anemia, rheumatoid arthritis, SLE, vasculitis, Sjögren's syndrome, scleroderma, autoimmune hepatitis, and other rheumatological diseases
4) Treatment with per oral systemic corticosteroids exceeding 10
mg/day within 7 days before Screening until Nephrectomy (inhaled,
intranasal, and local steroids acceptable irrespective of dose)
5) Known cardiomyopathy and/or clinically significant abnormal ECG
findings at Screening disqualifying the patient from nephrectomy and
subsequent sunitinib treatment
6) Karnofsky performance status <70%
7) National Cancer Institute (NCI) Common Terminology criteria for Adverse Events (CTCAE) Grade 3 hemorrhage within 28 days before Screening
8) Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
9) Clinically significant gastrointestinal abnormalities
10) Uncontrolled hypertension, or uncontrolled diabetes mellitus
11) Pulmonary embolism within 12 months before Screening
12) Prior history of invasive cancer within 5 years before Screening,
except for adequately treated in situ carcinomas or non-melanoma skin
cancer
13) Ongoing infection that requires parenteral treatment with antibiotics
14) Active or latent virus disease (HIV, HBV and HCV)
15) ECOG performance status >2 after optimization of analgesics
16) Abnormal or clinically significant coagulation parameters at the
discretion of the investigator, i.e.:
• Prothrombin Time - International Normalized Ratio (PT-INR)
• Activated Partial Thromboplastin Time (APTT)
Patients being treated with anticoagulants are excluded if the
coagulation parameters are outside the therapeutic intervals as
described in the SmPC/USPI for the administered treatment
17) Known major adverse reaction/event in connection with previously made vaccination (e.g. asthma, anaphylaxis or other serious reaction)
18) Known hypersensitivity or allergy to sunitinib or to chemically
related products or likely to be exacerbated by any component of the
study products
19) Prior systemic antitumor therapy within 28 days before Screening Visit. However, local radiation therapy to any area except for the abdominal/retroperioneal area including the kidney tumor is allowed
20) Exposure to other investigational products within 28 days prior to Screening Visit
21) Patients on anticoagulants for whom temporarily stop and start,
support

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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