Phase 2
Completed N=88
Intratumoral Vaccination With Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy vs Sunitinib Post-nephrectomy in Newly Diagnosed Metastatic Renal Cell Carcinoma (mRCC)
Source: ClinicalTrials.gov NCT02432846 ↗Enrolled (actual)
88
Serious AEs
50.0%
Results posted
Aug 2022
Primary outcomePrimary: Overall Survival (OS) - Days (FAS) — 323; 282; 1270; 1099 days — p=0.964
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) - Days (FAS) |
323; 282; 1270; 1099; 1082; 770 | 0.964 |
| PRIMARY Overall Survival - Days (PPS) |
352; 282; 1745; 1185; 1265; 1024 | 0.596 |
| PRIMARY 18-Months' Overall Survival Percentage (FAS) |
30; 38; 77; 76; 63; 66 | = 0.812 |
| PRIMARY 18-Months' Overall Survival Percentage (PPS) |
31; 38; 82; 84; 68; 70 | = 0.861 |
| SECONDARY Progression Free Survival (PFS) From Start of Sunitinib According to RECIST 1.1. |
254; NA; 478; 417; 360; 337 | — |
| SECONDARY Objective Response Rate (ORR) From Start of Sunitinib Treatment and Duration of Response in Each Subgroup. |
38.5; 66.7; 46.9; 42.1; 44.4; 48.0 | — |
| SECONDARY Number of Participants With Specific Best Overall Response |
1; 0; 4; 1; 5; 1 | — |
| SECONDARY Disease Control Rate |
7; 6; 28; 15; 35; 21 | — |
| SECONDARY Duration of Response |
175.0; 81.5; 316.0; 108.0; 215.0; 87.0 | — |
| SECONDARY Duration of Clinical Benefit |
212.0; 60.0; 323.5; 295.0; 219.0; 133.0 | — |
| SECONDARY Duration of Stable Disease |
63.5; 10.5; 169.0; 210.0; 126.0; 133.0 | — |
| SECONDARY Time to Progression (TTP) |
169; 143; 388; 417; 254; 251 | — |
| SECONDARY Percentage of Tumor Area With Infiltrating Cluster of Differentiation 8+ (CD8+) T-cells |
1.0; 1.1; 1.2; 0.8; 1.1; 0.8 | — |
Eligibility Criteria
Inclusion Criteria
- Newly ( 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
Data sourced from ClinicalTrials.gov (NCT02432846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.