Trial Outcomes & Findings for Intratumoral Vaccination With Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy vs Sunitinib Post-nephrectomy in Newly Diagnosed Metastatic Renal Cell Carcinoma (mRCC) (NCT NCT02432846)

Last Updated: 2022-08-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

88 participants

Primary outcome timeframe

From the randomization to the date of death, up to 5 years after the last participant's 18-month survival data.

Results posted on

2022-08-22

Participant Flow

The first patient's first visit was 28 April 2015 and last patient's last visit was 17 June 2019. Patients were recruited from Sweden (n=31), France (n=4), United States (n=2), Czech Republic (n=6), Latvia (n=6), Poland (n=12), Spain (n=18), Hungary (n=5), United Kingdom (n=4).

117 patients with newly diagnosed metastatic renal cell cancer were screened according to the inclusion and exclusion criteria. The 88 eligible patients were randomized to either of two treatments: Intuvax (INN: ilixadencel) + Sunitinib or Sunitinib-only. Patients were stratified according to Heng criteria, as either high-risk or intermediate-risk. Results are presented by risk stratum and treatment (4 groups) and by treatment overall (2 groups), i.e. the 6 groups are not mutually exclusive.

Participant milestones

Participant milestones
Measure	Intuvax (INN: Ilixadencel)+ 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. High-risk stratum.	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.	Intuvax (INN Ilixadencel)+ 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. Intermediate-risk stratum.	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.	Intuvax (INN: Ilixadencel)+ Nephrectomy+Sunitinib: Total 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.	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.
Overall Study (4 Arms/Strata) STARTED	17	8	41	22	0	0
Overall Study (4 Arms/Strata) COMPLETED	2	0	17	8	0	0
Overall Study (4 Arms/Strata) NOT COMPLETED	15	8	24	14	0	0
Overall Study (2 Total/Combined Groups) STARTED	0	0	0	0	58	30
Overall Study (2 Total/Combined Groups) COMPLETED	0	0	0	0	19	8
Overall Study (2 Total/Combined Groups) NOT COMPLETED	0	0	0	0	39	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Intuvax (INN: Ilixadencel)+ 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. High-risk stratum.	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.	Intuvax (INN Ilixadencel)+ 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. Intermediate-risk stratum.	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.	Intuvax (INN: Ilixadencel)+ Nephrectomy+Sunitinib: Total 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.	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.
Overall Study (4 Arms/Strata) Death	3	2	4	3	0	0
Overall Study (4 Arms/Strata) Adverse Event	0	1	1	0	0	0
Overall Study (4 Arms/Strata) Physician Decision	2	0	0	0	0	0
Overall Study (4 Arms/Strata) Withdrawal by Subject	2	0	1	1	0	0
Overall Study (4 Arms/Strata) Other (reason not specified)	0	0	2	1	0	0
Overall Study (4 Arms/Strata) Disease progression	8	5	15	9	0	0
Overall Study (4 Arms/Strata) Lost to Follow-up	0	0	1	0	0	0
Overall Study (2 Total/Combined Groups) Death	0	0	0	0	7	5
Overall Study (2 Total/Combined Groups) Adverse Event	0	0	0	0	1	1
Overall Study (2 Total/Combined Groups) Physician Decision	0	0	0	0	2	0
Overall Study (2 Total/Combined Groups) Withdrawal by Subject	0	0	0	0	3	1
Overall Study (2 Total/Combined Groups) Other (reason not specified)	0	0	0	0	2	1
Overall Study (2 Total/Combined Groups) Disease progression	0	0	0	0	23	14
Overall Study (2 Total/Combined Groups) Lost to Follow-up	0	0	0	0	1	0

Baseline Characteristics

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.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intuvax (INN: Ilixadencel)+ Nephrectomy+Sunitinib: High-risk Stratum n=17 Participants 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.	Nephrectomy+Sunitinib: High-risk Stratum n=8 Participants 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.	Intuvax (INN: Ilixadencel)+ Nephrectomy+Sunitinib: Intermediate-risk Stratum. n=41 Participants 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.	Nephrectomy+Sunitinib: Intermediate-risk Stratum n=22 Participants 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.	Intuvax (INN: Ilixadencel)+ Nephrectomy+Sunitinib: Total n=58 Participants 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.	Nephrectomy+Sunitinib: Total n=30 Participants 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.	Total n=176 Participants Total of all reporting groups
Age, Continuous Age (4 arms/strata)	62.0 years STANDARD_DEVIATION 9.6 • n=17 Participants • 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.	60.5 years STANDARD_DEVIATION 7.7 • n=8 Participants • 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.	61.0 years STANDARD_DEVIATION 8.4 • n=41 Participants • 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.	65.5 years STANDARD_DEVIATION 10.3 • n=22 Participants • 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.	—	—	62.3 years STANDARD_DEVIATION 9.1 • n=88 Participants • 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 Age (2 total/combined groups)	—	—	—	—	61.3 years STANDARD_DEVIATION 8.7 • n=58 Participants • 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.	64.2 years STANDARD_DEVIATION 9.8 • n=30 Participants • 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.	62.3 years STANDARD_DEVIATION 9.1 • n=88 Participants • 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.
Sex: Female, Male Sex (4 arms/strata) · Female	2 Participants n=17 Participants • 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.	2 Participants n=8 Participants • 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.	11 Participants n=41 Participants • 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.	7 Participants n=22 Participants • 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.	0 Participants 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.	0 Participants 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.	22 Participants n=88 Participants • 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.
Sex: Female, Male Sex (4 arms/strata) · Male	15 Participants n=17 Participants • 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.	6 Participants n=8 Participants • 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.	30 Participants n=41 Participants • 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.	15 Participants n=22 Participants • 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.	0 Participants 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.	0 Participants 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.	66 Participants n=88 Participants • 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.
Sex: Female, Male Sex (2 total/combined groups) · Female	0 Participants 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.	0 Participants 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.	0 Participants 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.	0 Participants 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.	13 Participants n=58 Participants • 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.	9 Participants n=30 Participants • 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.	22 Participants n=88 Participants • 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.
Sex: Female, Male Sex (2 total/combined groups) · Male	0 Participants 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.	0 Participants 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.	0 Participants 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.	0 Participants 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.	45 Participants n=58 Participants • 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.	21 Participants n=30 Participants • 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.	66 Participants n=88 Participants • 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.
Race (NIH/OMB) race (4 arms/strata) · American Indian or Alaska Native	0 Participants n=17 Participants • 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.	0 Participants n=8 Participants • 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.	0 Participants n=41 Participants • 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.	0 Participants n=22 Participants • 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.	0 Participants 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.	0 Participants 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.	0 Participants n=88 Participants • 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.
Race (NIH/OMB) race (4 arms/strata) · Asian	0 Participants n=17 Participants • 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.	0 Participants n=8 Participants • 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.	0 Participants n=41 Participants • 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.	0 Participants n=22 Participants • 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.	0 Participants 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.	0 Participants 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.	0 Participants n=88 Participants • 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.
Race (NIH/OMB) race (4 arms/strata) · Native Hawaiian or Other Pacific Islander	0 Participants n=17 Participants • 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.	0 Participants n=8 Participants • 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.	0 Participants n=41 Participants • 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.	0 Participants n=22 Participants • 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.	0 Participants 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.	0 Participants 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.	0 Participants n=88 Participants • 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.
Race (NIH/OMB) race (4 arms/strata) · Black or African American	0 Participants n=17 Participants • 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.	0 Participants n=8 Participants • 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.	0 Participants n=41 Participants • 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.	0 Participants n=22 Participants • 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.	0 Participants 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.	0 Participants 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.	0 Participants n=88 Participants • 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.
Race (NIH/OMB) race (4 arms/strata) · White	16 Participants n=17 Participants • 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.	6 Participants n=8 Participants • 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.	41 Participants n=41 Participants • 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.	22 Participants n=22 Participants • 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.	0 Participants 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.	0 Participants 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.	85 Participants n=88 Participants • 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.
Race (NIH/OMB) race (4 arms/strata) · More than one race	0 Participants n=17 Participants • 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.	0 Participants n=8 Participants • 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.	0 Participants n=41 Participants • 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.	0 Participants n=22 Participants • 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.	0 Participants 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.	0 Participants 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.	0 Participants n=88 Participants • 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.
Race (NIH/OMB) race (4 arms/strata) · Unknown or Not Reported	1 Participants n=17 Participants • 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.	2 Participants n=8 Participants • 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.	0 Participants n=41 Participants • 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.	0 Participants n=22 Participants • 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.	0 Participants 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.	0 Participants 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.	3 Participants n=88 Participants • 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.
Race (NIH/OMB) Race (2 total/combined groups) · American Indian or Alaska Native	0 Participants 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.	0 Participants 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.	0 Participants 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.	0 Participants 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.	0 Participants n=58 Participants • 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.	0 Participants n=30 Participants • 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.	0 Participants n=88 Participants • 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.
Race (NIH/OMB) Race (2 total/combined groups) · Asian	0 Participants 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.	0 Participants 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.	0 Participants 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.	0 Participants 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.	0 Participants n=58 Participants • 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.	0 Participants n=30 Participants • 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.	0 Participants n=88 Participants • 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.
Race (NIH/OMB) Race (2 total/combined groups) · Native Hawaiian or Other Pacific Islander	0 Participants 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.	0 Participants 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.	0 Participants 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.	0 Participants 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.	0 Participants n=58 Participants • 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.	0 Participants n=30 Participants • 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.	0 Participants n=88 Participants • 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.
Race (NIH/OMB) Race (2 total/combined groups) · Black or African American	0 Participants 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.	0 Participants 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.	0 Participants 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.	0 Participants 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.	0 Participants n=58 Participants • 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.	0 Participants n=30 Participants • 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.	0 Participants n=88 Participants • 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.
Race (NIH/OMB) Race (2 total/combined groups) · White	0 Participants 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.	0 Participants 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.	0 Participants 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.	0 Participants 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.	57 Participants n=58 Participants • 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.	28 Participants n=30 Participants • 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.	85 Participants n=88 Participants • 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.
Race (NIH/OMB) Race (2 total/combined groups) · More than one race	0 Participants 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.	0 Participants 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.	0 Participants 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.	0 Participants 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.	0 Participants n=58 Participants • 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.	0 Participants n=30 Participants • 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.	0 Participants n=88 Participants • 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.
Race (NIH/OMB) Race (2 total/combined groups) · Unknown or Not Reported	0 Participants 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.	0 Participants 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.	0 Participants 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.	0 Participants 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.	1 Participants n=58 Participants • 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.	2 Participants n=30 Participants • 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.	3 Participants n=88 Participants • 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.

PRIMARY outcome

Timeframe: From the randomization to the date of death, up to 5 years after the last participant's 18-month survival data.

Outcome measures

Outcome measures
Measure	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk n=16 Participants Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, High-risk n=8 Participants Sunitinib-only, high-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk n=40 Participants Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, Intermediate-risk n=22 Participants Sunitinib-only, intermediate-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata) n=56 Participants Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, Total (Both Strata) n=30 Participants Sunitinib-only, high and intermediate risk strata combined	Full Analysis Set (FAS) All patients randomized being evaluable for any high or intermediate stratum related efficacy endpoint.
Overall Survival (OS) - Days (FAS)	323 days Interval 152.0 to 682.0	282 days Interval 39.0 to Upper 95% CI not reached due to censored data.	1270 days Interval 852.0 to Upper 95% CI not reached due to censored data.	1099 days Interval 234.0 to 1368.0	1082 days Interval 432.0 to Upper 95% CI not reached due to censored data.	770 days Interval 234.0 to 1241.0	—

PRIMARY outcome

Timeframe: From the randomization to the date of death, up to 5 years after the last patient's 18-month survival data.

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.

Outcome measures

Outcome measures
Measure	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk n=12 Participants Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, High-risk n=8 Participants Sunitinib-only, high-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk n=34 Participants Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, Intermediate-risk n=19 Participants Sunitinib-only, intermediate-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata) n=46 Participants Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, Total (Both Strata) n=27 Participants Sunitinib-only, high and intermediate risk strata combined	Full Analysis Set (FAS) All patients randomized being evaluable for any high or intermediate stratum related efficacy endpoint.
Overall Survival - Days (PPS)	352 days Interval 240.0 to Upper 95% CI not reached due to censored data.	282 days Interval 39.0 to Upper 95% CI not reached due to censored data.	1745 days Interval 911.0 to Upper 95% CI not reached due to censored data.	1185 days Interval 678.0 to Upper 95% CI not reached due to censored data.	1265 days Interval 684.0 to Upper 95% CI not reached due to censored data.	1024 days Interval 342.0 to 1368.0	—

PRIMARY outcome

Timeframe: At 18 months (544 days)

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

Outcome measures

Outcome measures
Measure	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk n=16 Participants Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, High-risk n=8 Participants Sunitinib-only, high-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk n=40 Participants Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, Intermediate-risk n=22 Participants Sunitinib-only, intermediate-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata) n=56 Participants Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, Total (Both Strata) n=30 Participants Sunitinib-only, high and intermediate risk strata combined	Full Analysis Set (FAS) All patients randomized being evaluable for any high or intermediate stratum related efficacy endpoint.
18-Months' Overall Survival Percentage (FAS)	30 Percentage of participants	38 Percentage of participants	77 Percentage of participants	76 Percentage of participants	63 Percentage of participants	66 Percentage of participants	—

PRIMARY outcome

Timeframe: At 18 months (544 days)

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

Outcome measures

Outcome measures
Measure	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk n=12 Participants Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, High-risk n=8 Participants Sunitinib-only, high-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk n=34 Participants Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, Intermediate-risk n=19 Participants Sunitinib-only, intermediate-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata) n=46 Participants Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, Total (Both Strata) n=27 Participants Sunitinib-only, high and intermediate risk strata combined	Full Analysis Set (FAS) All patients randomized being evaluable for any high or intermediate stratum related efficacy endpoint.
18-Months' Overall Survival Percentage (PPS)	31 Percentage of participants	38 Percentage of participants	82 Percentage of participants	84 Percentage of participants	68 Percentage of participants	70 Percentage of participants	—

SECONDARY outcome

Timeframe: From Sunitinib-Start to progressive disease or death, up to 18 months.

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.

Outcome measures

Outcome measures
Measure	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk n=13 Participants Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, High-risk n=6 Participants Sunitinib-only, high-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk n=33 Participants Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, Intermediate-risk n=19 Participants Sunitinib-only, intermediate-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata) n=46 Participants Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, Total (Both Strata) n=25 Participants Sunitinib-only, high and intermediate risk strata combined	Full Analysis Set (FAS) All patients randomized being evaluable for any high or intermediate stratum related efficacy endpoint.
Progression Free Survival (PFS) From Start of Sunitinib According to RECIST 1.1.	254 days Interval 43.0 to Due to the large amount of censored data, estimate of upper 95% CI could not be reliably determined.	NA days Due to the large amount of censored data, estimates of median and 95% CI could not be reliably determined.	478 days Interval 249.0 to Due to the large amount of censored data, estimate of upper 95% CI could not be reliably determined.	417 days Interval 149.0 to Due to the large amount of censored data, estimate of upper 95% CI could not be reliably determined.	360 days Interval 249.0 to Due to the large amount of censored data, estimate of upper 95% CI could not be reliably determined.	337 days Interval 149.0 to Due to the large amount of censored data, estimate of upper 95% CI could not be reliably determined.	—

SECONDARY outcome

Timeframe: From start of sunitinib treatment up to 18 months

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.

Outcome measures

Outcome measures
Measure	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk n=13 Participants Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, High-risk n=6 Participants Sunitinib-only, high-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk n=32 Participants Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, Intermediate-risk n=19 Participants Sunitinib-only, intermediate-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata) n=45 Participants Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, Total (Both Strata) n=25 Participants Sunitinib-only, high and intermediate risk strata combined	Full Analysis Set (FAS) All patients randomized being evaluable for any high or intermediate stratum related efficacy endpoint.
Objective Response Rate (ORR) From Start of Sunitinib Treatment and Duration of Response in Each Subgroup.	38.5 Percentage of participants	66.7 Percentage of participants	46.9 Percentage of participants	42.1 Percentage of participants	44.4 Percentage of participants	48.0 Percentage of participants	—

SECONDARY outcome

Timeframe: From start of sunitinib treatment up to 18 months

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.

Outcome measures

Outcome measures
Measure	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk n=13 Participants Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, High-risk n=6 Participants Sunitinib-only, high-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk n=32 Participants Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, Intermediate-risk n=19 Participants Sunitinib-only, intermediate-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata) n=45 Participants Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, Total (Both Strata) n=25 Participants Sunitinib-only, high and intermediate risk strata combined	Full Analysis Set (FAS) All patients randomized being evaluable for any high or intermediate stratum related efficacy endpoint.
Number of Participants With Specific Best Overall Response Complete Response (CR)	1 Participants	0 Participants	4 Participants	1 Participants	5 Participants	1 Participants	—
Number of Participants With Specific Best Overall Response Partial Response (PR)	4 Participants	4 Participants	11 Participants	7 Participants	15 Participants	11 Participants	—
Number of Participants With Specific Best Overall Response Progressive Disease (PD)	4 Participants	0 Participants	3 Participants	2 Participants	7 Participants	2 Participants	—
Number of Participants With Specific Best Overall Response Stable Disease (SD)	2 Participants	2 Participants	13 Participants	7 Participants	15 Participants	9 Participants	—
Number of Participants With Specific Best Overall Response Non-CR/Non-PD	2 Participants	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants	—
Number of Participants With Specific Best Overall Response No Disease (ND)	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	—

SECONDARY outcome

Timeframe: From start of sunitinib treatment up to 18 months

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

Outcome measures

Outcome measures
Measure	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk n=13 Participants Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, High-risk n=6 Participants Sunitinib-only, high-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk n=32 Participants Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, Intermediate-risk n=19 Participants Sunitinib-only, intermediate-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata) n=45 Participants Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, Total (Both Strata) n=25 Participants Sunitinib-only, high and intermediate risk strata combined	Full Analysis Set (FAS) All patients randomized being evaluable for any high or intermediate stratum related efficacy endpoint.
Disease Control Rate	7 Participants	6 Participants	28 Participants	15 Participants	35 Participants	21 Participants	—

SECONDARY outcome

Timeframe: From first date of CR or PR until date of PD or death, up to 18 months.

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).

Outcome measures

Outcome measures
Measure	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk n=5 Participants Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, High-risk n=4 Participants Sunitinib-only, high-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk n=15 Participants Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, Intermediate-risk n=8 Participants Sunitinib-only, intermediate-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata) n=20 Participants Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, Total (Both Strata) n=12 Participants Sunitinib-only, high and intermediate risk strata combined	Full Analysis Set (FAS) n=32 Participants All patients randomized being evaluable for any high or intermediate stratum related efficacy endpoint.
Duration of Response	175.0 days Interval 101.0 to 219.0	81.5 days Interval 42.0 to 126.0	316.0 days Interval 1.0 to 512.0	108.0 days Interval 1.0 to 409.0	215.0 days Interval 1.0 to 512.0	87.0 days Interval 1.0 to 409.0	169.5 days Interval 1.0 to 512.0

SECONDARY outcome

Timeframe: From first date of clinical benefit (CR, PR or SD) until date of PD or death, up to 18 months.

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

Outcome measures

Outcome measures
Measure	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk n=7 Participants Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, High-risk n=6 Participants Sunitinib-only, high-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk n=28 Participants Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, Intermediate-risk n=15 Participants Sunitinib-only, intermediate-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata) n=35 Participants Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, Total (Both Strata) n=21 Participants Sunitinib-only, high and intermediate risk strata combined	Full Analysis Set (FAS) n=56 Participants All patients randomized being evaluable for any high or intermediate stratum related efficacy endpoint.
Duration of Clinical Benefit	212.0 days Interval 1.0 to 434.0	60.0 days Interval 1.0 to 206.0	323.5 days Interval 29.0 to 512.0	295.0 days Interval 1.0 to 451.0	219.0 days Interval 1.0 to 512.0	133.0 days Interval 1.0 to 451.0	211.0 days Interval 1.0 to 512.0

SECONDARY outcome

Timeframe: From first date of SD until PD or date of death, up to 18 months.

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.

Outcome measures

Outcome measures
Measure	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk n=2 Participants Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, High-risk n=2 Participants Sunitinib-only, high-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk n=13 Participants Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, Intermediate-risk n=7 Participants Sunitinib-only, intermediate-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata) n=15 Participants Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, Total (Both Strata) n=9 Participants Sunitinib-only, high and intermediate risk strata combined	Full Analysis Set (FAS) n=24 Participants All patients randomized being evaluable for any high or intermediate stratum related efficacy endpoint.
Duration of Stable Disease	63.5 days Interval 1.0 to 126.0	10.5 days Interval 1.0 to 20.0	169.0 days Interval 29.0 to 427.0	210.0 days Interval 50.0 to 449.0	126.0 days Interval 1.0 to 427.0	133.0 days Interval 1.0 to 449.0	129.5 days Interval 1.0 to 449.0

SECONDARY outcome

Timeframe: Time from Sunitinib-Start to date of either PD according to RECIST 1.1 or clinical progression as evaluated by the Investigator, 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.

Outcome measures

Outcome measures
Measure	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk n=13 Participants Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, High-risk n=6 Participants Sunitinib-only, high-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk n=33 Participants Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, Intermediate-risk n=19 Participants Sunitinib-only, intermediate-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata) n=46 Participants Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, Total (Both Strata) n=25 Participants Sunitinib-only, high and intermediate risk strata combined	Full Analysis Set (FAS) All patients randomized being evaluable for any high or intermediate stratum related efficacy endpoint.
Time to Progression (TTP)	169 days Interval 43.0 to Due to the large amount of censored data, estimate of upper 95% CI could not be reliably determined.	143 days Interval 48.0 to 248.0	388 days Interval 213.0 to Due to the large amount of censored data, estimate of upper 95% CI could not be reliably determined.	417 days Interval 93.0 to Due to the large amount of censored data, estimate of upper 95% CI could not be reliably determined.	254 days Interval 169.0 to 478.0	251 days Interval 93.0 to 434.0	—

SECONDARY outcome

Timeframe: At resection of primary tumor.

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.

Outcome measures

Outcome measures
Measure	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk n=14 Participants Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, High-risk n=7 Participants Sunitinib-only, high-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk n=38 Participants Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, Intermediate-risk n=20 Participants Sunitinib-only, intermediate-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata) n=52 Participants Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, Total (Both Strata) n=27 Participants Sunitinib-only, high and intermediate risk strata combined	Full Analysis Set (FAS) n=79 Participants All patients randomized being evaluable for any high or intermediate stratum related efficacy endpoint.
Percentage of Tumor Area With Infiltrating Cluster of Differentiation 8+ (CD8+) T-cells	1.0 Percentage of tumor area Interval 0.0 to 8.0	1.1 Percentage of tumor area Interval 0.0 to 4.0	1.2 Percentage of tumor area Interval 0.0 to 13.0	0.8 Percentage of tumor area Interval 0.0 to 8.0	1.1 Percentage of tumor area Interval 0.0 to 13.0	0.8 Percentage of tumor area Interval 0.0 to 8.0	1.1 Percentage of tumor area Interval 0.0 to 13.0

POST_HOC outcome

Timeframe: From start of sunitinib treatment up to 18 months

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.

Outcome measures

Outcome measures
Measure	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk n=13 Participants Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, High-risk n=6 Participants Sunitinib-only, high-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk n=32 Participants Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, Intermediate-risk n=19 Participants Sunitinib-only, intermediate-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata) n=45 Participants Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, Total (Both Strata) n=25 Participants Sunitinib-only, high and intermediate risk strata combined	Full Analysis Set (FAS) All patients randomized being evaluable for any high or intermediate stratum related efficacy endpoint.
Confirmed Objective Response Rate	38.5 Percentage of participants	33.3 Percentage of participants	43.8 Percentage of participants	21.1 Percentage of participants	42.2 Percentage of participants	24.0 Percentage of participants	—

POST_HOC outcome

Timeframe: From start of sunitinib treatment up to 18 months

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.

Outcome measures

Outcome measures
Measure	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk n=13 Participants Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, High-risk n=6 Participants Sunitinib-only, high-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk n=32 Participants Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, Intermediate-risk n=19 Participants Sunitinib-only, intermediate-risk stratum	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata) n=45 Participants Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, Total (Both Strata) n=25 Participants Sunitinib-only, high and intermediate risk strata combined	Full Analysis Set (FAS) All patients randomized being evaluable for any high or intermediate stratum related efficacy endpoint.
Confirmed Best Overall Response Complete response (CR)	0 Participants	0 Participants	3 Participants	0 Participants	3 Participants	0 Participants	—
Confirmed Best Overall Response Partial response (PR)	5 Participants	2 Participants	11 Participants	4 Participants	16 Participants	6 Participants	—
Confirmed Best Overall Response Stable disease (SD)	1 Participants	1 Participants	10 Participants	9 Participants	11 Participants	10 Participants	—
Confirmed Best Overall Response Missing	7 Participants	3 Participants	8 Participants	6 Participants	15 Participants	9 Participants	—

Adverse Events

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

Serious events: 27 serious events

Other events: 54 other events

Deaths: 24 deaths

Sunitinib-only, Total (Both Strata)

Serious events: 17 serious events

Other events: 27 other events

Deaths: 17 deaths

Serious adverse events

Other adverse events

Additional Information

Chief Medical Officer

Immunicum Aktiebolag (AB)

Phone: +46 (0)8 732 84 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place