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

Completed · Phase 2

Conditions studied: Renal Cell Carcinoma, Metastatic

In brief

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.

Key facts

Study ID: NCT02432846
Run by: Mendus
People needed: 88
Starts: 2015-04-01
Expected to finish: 2021-01-31
Last updated by the study team: 2022-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Newly (<6 months) diagnosed RCC (histological/cytological verification is optional) with at least one (1) CT-verified metastasis ≥10mm for which complete metastasectomy is not planned. US patients must have verified clear-cell tumor histology
Planned resection of primary tumor
Primary tumor diameter ≥40 mm
Candidate for first-line therapy with sunitinib initiated 5-8 weeks after nephrectomy
Female or male ≥18 years of age
Willing and able to provide informed consent
Adequate hematological parameters, i.e:
B-Leukocyte count ≥4.5 x10e9/L
B-Platelet count ≥150 x10e9/L
B-Hemoglobin ≥90 g/L
S-creatinine and S-bilirubin ≤ 1.5 x upper limit of normal (ULN). Serum alanine aminotransferase (S-ALAT) and serum aspartate aminotransferase (S-ASAT) ≤ 2.5 x ULN (or ≤5 in case of liver metastases)
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]) Female of childbearing potential must have a negative from Screening until 90 days after last dose of Intuvax and/or until completed sunitinib treatment whichever occurs later.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.

You may not qualify if…

Life expectancy less than 4 months
Central nervous system (CNS) metastasis that is symptomatic or progressing or untreated or that required current therapy (e.g. evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases)
Active autoimmune disease which requires treatment with systemic immunosuppressive agents, e.g. inflammatory bowel disease, multiple sclerosis, sarcoidosis, psoriasis, autoimmune hemolytic anemia, rheumatoid arthritis, systemic lupus erythematosus (SLE), vasculitis, Sjögren's syndrome, scleroderma, autoimmune hepatitis, and other rheumatological diseases
Treatment with per oral systemic corticosteroids exceeding 10mg/day within seven (7) days before Screening until nephrectomy (inhaled, intranasal and local steroids accepted irrespective of dose)
Known cardiomyopathy and/or clinical significant abnormal ECG findings at Screening disqualifying the patient from nephrectomy and from subsequent sunitinib treatment
Karnofsky performance status <70%
National Cancer Institute (NCI) Common Terminology criteria for Adverse Events (CTCAE) Grade 3 hemorrhage within 28 days before Screening
Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
Clinically significant gastrointestinal abnormalities
Uncontrolled hypertension, or uncontrolled diabetes mellitus
Pulmonary embolism within 12 months before screening
Prior history of invasive cancer within 5 years before screening, except for adequately treated in situ carcinomas or non-melanoma skin cancer
Ongoing infection that requires parenteral treatment with antibiotics
Active or latent virus disease (HIV, hepatitis B and hepatitis C)
Eastern Cooperative Oncology Group (ECOG) performance status >2 after optimization of analgesics
Abnormal and clinical 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 summary of product characteristics (SmPC) / United States prescribing information (USPI) for the administered treatment
Known major adverse reaction/event in connection with previously made vaccination (e.g. asthma, anaphylaxis or other serious reaction)
Known hypersensitivity or allergy sunitinib or to chemically related products or likely to be exacerbated to by any component of the study products
Prior systemic antitumour therapy within 28 days before Screening Visit. However, local radiation therapy to any area except for the abdominal/retroperitoneal area including the kidney tumour is allowed
Exposure to other investigational products within 28 days prior to Screening Visit
patients on anticoagulants for whom temporarily stop and start, supported by low molecular weight heparin (or other anticoagulation therapy at the discretion of the investigator and or per local standard of care) during vaccination and nephrectomy, is not an option
History of alcohol or substance abuse
Any reason that, in the opinion of the Investigator, contraindicates that the patient participates in the study

Where it is running

University of Illinois — Chicago, Illinois, United States
Rush University — Chicago, Illinois, United States
University of Iowa — Iowa City, Iowa, United States
Health Partners Institute — Saint Paul, Minnesota, United States
Duke Cancer Institute — Durham, North Carolina, United States
University Hospital Olomouc — Olomouc, Czechia
Centre Hospitalier Universitaire d'Angers — Angers, France
Centre Hospitalier Universitaire de Toulouse-Hôpital Rangueil — Toulouse, France
University of Debrecen — Debrecen, Hungary
Szent-Györgyi Albert Klinikai Központ — Szeged, Hungary
Pauls Stradins Clinical University Hospital — Riga, Latvia
Riga East Clinical University Hospital — Riga, Latvia
Niepubliczny Zakład Opieki Zdrowotnej Vesalius Sp. z o.o. — Krakow, Poland
Wojewodzki Szpital Specjalistyczny — Lublin, Poland
Military Institute of Medicine — Warsaw, Poland
Mazowiecki Szpital Onkologiczny — Wieliszew, Poland
Hospital Universitari Germans Trias i Pujol — Badalona, Spain
Hospital Clinic de Barcelona — Barcelona, Spain
Hospital de la Santa Creu i Sant Pau — Barcelona, Spain
Hospital Universitario 12 de Octubre — Madrid, Spain
Hospital Universitario Puerta de Hierro Majadahonda — Majadahonda, Spain
Hospital Universitari Parc Tauli — Sabadell, Spain
Sahlgrenska University Hospital — Gothenburg, Sweden
Karolinska University Hospital — Huddinge, Sweden
Umeå University Hospital — Umeå, Sweden

Full record on ClinicalTrials.gov

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