Metastatic Renal Cell Carcinoma
Conditions
Interventions
Product Name: Intuvax
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: ilixadencel
Current Sponsor code: Intuvax
Other descriptive name: ALLOGENEIC PROINFLAMMATORY DENDRITIC CELLS
Co
Sponsors
Immunicum AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Newly (=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
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 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, 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 22) History of alcohol or substance abuse 23) Any reason that, in the opinion of the Investigator, contraindicates that the patient participates in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives are: - To evaluate median overall survival (OS) from randomization in metastatic renal cell carcinoma (mRCC) patients overall and by subgroup, i.e. in high-risk and in intermediate-risk patients separately, receiving two (2) vaccine doses of Intuvax pre-nephrectomy, followed by sunitinib initiated five (5) to eight (8) weeks post-nephrectomy and in non-vaccinated mRCC patients receiving sunitinib initiated five (5) to eight (8) weeks post-nephrectomy - To evaluate 18-month survival rate from randomization in mRCC patients overall and by subgroup, i.e. in high-risk and in intermediaterisk patients separately, receiving two (2) vaccine doses of Intuvax prenephrectomy followed by sunitinib post-nephrectomy and in nonvaccinated patients receiving sunitinib post-nephrectomy;Secondary Objective: The secondary objectives are (to be evaluated in vaccinated and nonvaccinated patients overall, and in each subgroup (intermediate- and high risk patients) : - To evaluate safety and tolerability - To evaluate PFS according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria from Sunitinib Start Visit - To evaluate response and its duration according to RECIST 1.1 criteria from Sunitinib Start Visit - To evaluate time to progression (TTP) from Sunitinib Start Visit - To evaluate the number of infiltrating CD8+ T-cells in available diagnostic pre-biopsy (sample from either primary tumor or metastasis acceptable) and in the resected primary renal tumor;Primary end point(s): - OS from randomization overall in mRCC patients and by each subgroup, i.e. in high-risk and in intermediate-risk mRCC patients - 18-month survival rate from randomization overall in mRCC patients and by each subgroup, i.e. in high-risk and in intermediate-risk mRCC patients;Timepoint(s) of evaluation of this end point: End of study (LVLS or the last subject's safety evaluation [up to 30 days after the last subject's last dose of an IMP], whichever occurs l | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Frequency and proportion of AEs including clinical significant changes in laboratory tests and vital signs from Screening - PFS from start of sunitinib according to RECIST 1.1* - Proportion of Objective Response Rate (ORR) from start of sunitinib treatment and duration of response in each subgroup* - TTP from start of sunitinib treatment* - Relative number of tumor infiltrating CD8+ T-cells in the resected primary tumor compared to relative number of infiltrating CD8+ T-cells in available diagnostic pre-biopsy (sample from either primary tumor or metastasis acceptable) *Note: For intermediate-risk patients included in the trial according to protocol versions before version Final 4.0, baseline for PFS, ORR and duration of response, and TTP is defined as the first imaging assessment after nephrectomy;Timepoint(s) of evaluation of this end point: End of study (LVLS or the last subject's safety evaluation [up to 30 days after the last subject's last dose of an IMP], whichever occurs later) | — |
Countries
Czech Republic, Hungary, Latvia, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactManagement
Immunicum AB
Outcome results
None listed