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Female Urogenital Diseases and Pregnancy Complications

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Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Sunitinib

Protein Kinase Inhibitors

Angiogenesis Inhibitors

Growth Inhibitors

Enzyme Inhibitors

Two Intuvax (INN: ilixadencel) doses (10 million cells/dose) 14 days apart before nephrectomy, followed by Sunitinib treatment post-nephrectomy according to clinical practice until RECIST verified progressive disease or End-of-Study (78 weeks after screening).

Sunitinib treatment post-nephrectomy according to clinical practice until RECIST verified progressive disease or End-of-Study (78 weeks after screening).

Therapeutic dose (10 million cells/dose): allogeneic, pro-inflammatory dendritic cells.

Intuvax (INN: ilixadencel)

Cytostatic/cytotoxic drug: protein kinase inhibitor .

Börje Ljungberg, MD, Prof

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.

Patients, all planned for nephrectomy, will be stratified according to the Heng risk criteria (high risk patients vs. intermediate risk patients) and randomized in a 2:1 ratio to receive Intuvax (INN: ilixadencel)+ Sunitinib or Sunitinib alone.

Two doses of Intuvax (INN: ilixadencel) will be administered in to the primary tumour before nephrectomy. The control group will be scheduled for nephrectomy directly.

All patients will start Sunitinib treatment 5-8 weeks after operation.

Results from the phase I study, together with the results reported in the literature on the use of autologous dendritic cells (DCs) in combination with Sunitinib encourage Immunicum aktiebolag (AB) to further investigate the possibility of exploiting Intuvax (INN: ilixadencel) 10 million cells/dose when combined with Sunitinib for the treatment of mRCC patients.

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

An Open-label, Randomized, Controlled, Multicenter, Phase II Study Evaluating Safety and Efficacy of Intratumorally Administered Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy, Compared to Sunitinib Post-nephrectomy in Metastatic Renal Cell Carcinoma Patients

OS is the time from randomization until date of death. The patients who were alive at the end of study were followed for survival status (alive/date of death) through medical records, databases and public records according to the time frame below.

Due to censored data, estimates of upper 95% CI could not be determined in all reporting groups.

OS is the time from randomization until date of death. The patients who were alive at the end of study were followed for survival status (alive/date of death) through medical records, databases and public records according to the time frame below.

Due to censored data, upper 95% CI could not be determined in all reporting groups.

The 18-month survival percentage was defined as the percentage of patients alive 18 months after randomization.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by radiographic assessment: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Due to the large amount of censored data, estimates of median and/or a 95% CI could not be reliably determined in all reporting groups.

Baseline data are reported for the safety data set (all patients randomized) whereas PFS is analyzed for the full analysis set (FAS). Two patients in the safety data set were not included in the FAS since they withdrew prior to start of treatment.

Objective response rate was defined as the percentage of patients with complete response (CR) and partial response (PR).Tumor response was evaluated centrally according to the RECIST 1.1 guideline.

The best overall response is the best response recorded from the start of the treatment sunitinib until disease progression/recurrence; taking as reference for progressive disease (PD) the smallest measurements recorded since the treatment started. In general, the patient's best response assignment depended on the achievement of the measurement criteria.

Best overall response (CR, PR or SD) evaluated from Sunitinib-Start for patients with available data.

The duration of response was calculated for only those patients who responded. It was the time from first objective response to first observed progression of disease or death if the death was due to disease progression (whichever came first).

Disease control rate (DCR) also called Clinical Benefit Rate, was defined as the proportion of patients with CR or PR or SD.

The duration of SD was calculated for only those patients who exhibited a best response of SD response as per RECIST v1.1. It was the time from first SD response to first observed progression of disease or death if the death was due to disease progression (whichever came first), up to 18 months.

Due to the large amount of censored data, estimate of upper 95% CI could not be reliably determined in all reporting groups.

Relative number of tumor-infiltrating CD8+ T-cells in the resected primary tumor compared to number of infiltrating CD8+ T-cells in available diagnostic pre-biopsy (sample from either primary tumor or metastasis), was not to be evaluated as described in the protocol due to missing pre-biopsy samples). Instead an automated and validated quantification of percentage of CD8+ tissue in delineated tumor area was made.

TFS Trial Form Support

Accelovance

Mendus

Adverse events are presented overall by treatment, not further split by strata, since the split by strata is deemed to be relevant for efficacy endpoints only.

Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined

Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata)

Sunitinib-only, high and intermediate risk strata combined

Sunitinib-only, Total (Both Strata)

Two Intuvax (INN: ilixadencel) doses (10 million cells/dose) 14 days apart before nephrectomy, followed by Sunitinib treatment post-nephrectomy according to clinical practice until RECIST verified progressive disease or End-of-Study (78 weeks after screening).

Intuvax (INN: ilixadencel): Therapeutic dose (10 million cells/dose): allogeneic, pro-inflammatory dendritic cells.

Sunitinib: Cytostatic/cytotoxic drug: protein kinase inhibitor.

High-risk stratum.

Intuvax (INN: Ilixadencel)+ Nephrectomy+Sunitinib: High-risk Stratum

Sunitinib treatment post-nephrectomy according to clinical practice until RECIST verified progressive disease or End-of-Study (78 weeks after screening).

Sunitinib: Cytostatic/cytotoxic drug: protein kinase inhibitor.

High-risk stratum.

Nephrectomy+Sunitinib: High-risk Stratum

Two Intuvax (INN: ilixadencel) doses (10 million cells/dose) 14 days apart before nephrectomy, followed by Sunitinib treatment post-nephrectomy according to clinical practice until RECIST verified progressive disease or End-of-Study (78 weeks after screening).

Intuvax (INN: ilixadencel): Therapeutic dose (10 million cells/dose): allogeneic, pro-inflammatory dendritic cells.

Sunitinib: Cytostatic/cytotoxic drug: protein kinase inhibitor.

Intermediate-risk stratum.

Intuvax (INN: Ilixadencel)+ Nephrectomy+Sunitinib: Intermediate-risk Stratum.

Sunitinib treatment post-nephrectomy according to clinical practice until RECIST verified progressive disease or End-of-Study (78 weeks after screening).

Sunitinib: Cytostatic/cytotoxic drug: protein kinase inhibitor.

Intermediate-risk stratum.

Nephrectomy+Sunitinib: Intermediate-risk Stratum

Two Intuvax (INN: ilixadencel) doses (10 million cells/dose) 14 days apart before nephrectomy, followed by Sunitinib treatment post-nephrectomy according to clinical practice until RECIST verified progressive disease or End-of-Study (78 weeks after screening).

Intuvax (INN: ilixadencel): Therapeutic dose (10 million cells/dose): allogeneic, pro-inflammatory dendritic cells.

Sunitinib: Cytostatic/cytotoxic drug: protein kinase inhibitor.

High-risk and intermediate-risk strata combined.

Intuvax (INN: Ilixadencel)+ Nephrectomy+Sunitinib: Total

Sunitinib treatment post-nephrectomy according to clinical practice until RECIST verified progressive disease or End-of-Study (78 weeks after screening).

Sunitinib: Cytostatic/cytotoxic drug: protein kinase inhibitor.

High-risk and intermediate-risk strata combined.

Nephrectomy+Sunitinib: Total

Total

Age (4 arms/strata)

Age (2 total/combined groups)

The patients are presented both separately by risk stratum and treatment (4 groups) and by treatment group overall (2 groups) where high-risk and intermediate-risk strata are combined. This split of baseline characteristics provides transparency for efficacy outcomes that are analysed by these 6 groups.

Age, Continuous

Sex (4 arms/strata)

Sex (2 total/combined groups)

Sex: Female, Male

race (4 arms/strata)

Race (2 total/combined groups)

Race (NIH/OMB)

The 6 groups are not mutually exclusive. The patients are presented both separately by risk stratum and treatment (4 groups) and by treatment group overall (2 groups) where high-risk and intermediate-risk strata are combined. This split of baseline characteristics provides transparency for efficacy outcomes that are analysed by these 6 groups.

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

Chief Medical Officer

Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum

Intuvax (INN: Ilixadencel) + Sunitinib, High-risk

Sunitinib-only, High-risk

Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum

Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk

Sunitinib-only, intermediate-risk stratum

Sunitinib-only, Intermediate-risk

Overall Survival (OS) - Days (FAS)

Intuvax (INN: ilixadencel) + sunitinib, high and intermediate-risk strata combined

Overall Survival - Days (PPS)

18-Months' Overall Survival Percentage (FAS)

18-Months' Overall Survival Percentage (PPS)

Sunitinib-only High-risk

Progression Free Survival (PFS) From Start of Sunitinib According to RECIST 1.1.

Objective Response Rate (ORR) From Start of Sunitinib Treatment and Duration of Response in Each Subgroup.

Complete Response (CR)

Partial Response (PR)

Progressive Disease (PD)

Stable Disease (SD)

Non-CR/Non-PD

No Disease (ND)

Number of Participants With Specific Best Overall Response

Disease Control Rate

All patients randomized being evaluable for any high or intermediate stratum related efficacy endpoint.

Full Analysis Set (FAS)

Duration of Response

Duration of Clinical Benefit

Duration of Stable Disease

Time to Progression (TTP)

Percentage of Tumor Area With Infiltrating Cluster of Differentiation 8+ (CD8+) T-cells

Percentage of patients with the individual's confirmed best overall response scored as CR or PR at least 4 weeks apart from the CT/MRI with the initial best response of CR or PR. Tumor response was evaluated centrally according to the response evaluation criteria in solid tumors (RECIST) 1.1 guideline.

Confirmed Objective Response Rate

Number of patients with the individual's best overall response at initial CT/MRI confirmed by a best response level at least 4 weeks later in accordance with RECIST 1.1.

Confirmed Best Overall Response

Intuvax (INN: Ilixadencel)+ Nephrectomy+ Sunitinib: High-risk Stratum

Nephrectomy + Sunitinib: High-risk Stratum

Intuvax (INN Ilixadencel)+ Nephrectomy+Sunitinib: Intermediate-risk Stratum

Nephrectomy + Sunitinib: Intermediate-risk Stratum

Two Intuvax (INN: ilixadencel) doses (10 million cells/dose) 14 days apart before nephrectomy, followed by Sunitinib treatment post-nephrectomy according to clinical practice until RECIST verified progressive disease or End-of-Study (78 weeks after screening).

Intuvax (INN: ilixadencel): Therapeutic dose (10 million cells/dose): allogeneic, pro-inflammatory dendritic cells.

Sunitinib: Cytostatic/cytotoxic drug: protein kinase inhibitor.

High risk and intermediate risk strata combined.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intratumoral Vaccination With Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy vs Sunitinib Post-nephrectomy in Newly Diagnosed Metastatic Renal Cell Carcinoma (mRCC)	NCT02432846	Renal Cell Carc...	Intuvax (INN: i... Sunitinib	18 Years -	Mendus
Intratumoral Vaccination With Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy vs Sunitinib Post-nephrectomy in Newly Diagnosed Metastatic Renal Cell Carcinoma (mRCC)	NCT02432846	Renal Cell Carc...	Intuvax (INN: i... Sunitinib	18 Years -	Mendus
Intratumoral Vaccination With Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy vs Sunitinib Post-nephrectomy in Newly Diagnosed Metastatic Renal Cell Carcinoma (mRCC)	NCT02432846	Renal Cell Carc...	Intuvax (INN: i... Sunitinib	18 Years -	Mendus

Spots Global Cancer Trial Database for intuvax (inn: ilixadencel)