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

• ClinicalTrials.gov Identifier: NCT02432846
• Recruitment Status: Completed
• First Posted: May 4, 2015
• Results First Posted: August 22, 2022
• Last Update Posted: August 22, 2022
• Sponsor: Mendus
• Collaborators: TFS Trial Form Support; Accelovance
• Information provided by (Responsible Party): Mendus

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Renal Cell Carcinoma, Metastatic
• Interventions: Biological: Intuvax (INN: ilixadencel); Drug: Sunitinib
• Enrollment: 88

Participant Flow

Recruitment Details

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).

Pre-assignment Details

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.

Arm/Group Title	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	Intuvax (INN: Ilixadencel)+ Nephrectomy+Sunitinib: Total	Nephrectomy+Sunitinib: Total
Arm/Group Description	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.	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.	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.	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.	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.	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.
Period Title: Overall Study (4 Arms/Strata)
Started	17	8	41	22	0	0
Completed	2	0	17	8	0	0
Not Completed	15	8	24	14	0	0
Reason Not Completed
Death	3	2	4	3	0	0
Adverse Event	0	1	1	0	0	0
Physician Decision	2	0	0	0	0	0
Withdrawal by Subject	2	0	1	1	0	0
Other (reason not specified)	0	0	2	1	0	0
Disease progression	8	5	15	9	0	0
Lost to Follow-up	0	0	1	0	0	0
Period Title: Overall Study (2 Total/Combined Groups)
Started	0	0	0	0	58	30
Completed	0	0	0	0	19	8
Not Completed	0	0	0	0	39	22
Reason Not Completed
Death	0	0	0	0	7	5
Adverse Event	0	0	0	0	1	1
Physician Decision	0	0	0	0	2	0
Withdrawal by Subject	0	0	0	0	3	1
Other (reason not specified)	0	0	0	0	2	1
Disease progression	0	0	0	0	23	14
Lost to Follow-up	0	0	0	0	1	0

Baseline Characteristics

Arm/Group Title		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	Intuvax (INN: Ilixadencel)+ Nephrectomy+Sunitinib: Total	Nephrectomy+Sunitinib: Total	Total
Arm/Group Description		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.	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.	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.	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.	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.	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 of all reporting groups
Overall Number of Baseline Participants		17	8	41	22	58	30	176
Baseline Analysis Population Description		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.
Age, Continuous [1] [2]; Mean (Standard Deviation); Unit of measure: Years
Age (4 arms/strata)	Number Analyzed	17 participants	8 participants	41 participants	22 participants	0 participants	0 participants	88 participants
		62.0 (9.6)	60.5 (7.7)	61.0 (8.4)	65.5 (10.3)			62.3 (9.1)
Age (2 total/combined groups)	Number Analyzed	0 participants	0 participants	0 participants	0 participants	58 participants	30 participants	88 participants
						61.3 (8.7)	64.2 (9.8)	62.3 (9.1)
		[1] Measure Description: Age at Screening Visit; [2] Measure Analysis Population Description: 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 [1]; Measure Type: Count of Participants; Unit of measure: Participants
Sex (4 arms/strata)	Number Analyzed	17 participants	8 participants	41 participants	22 participants	0 participants	0 participants	88 participants
	Female	2 11.8%	2 25.0%	11 26.8%	7 31.8%	0	0	22 25.0%
	Male	15 88.2%	6 75.0%	30 73.2%	15 68.2%	0	0	66 75.0%
Sex (2 total/combined groups)	Number Analyzed	0 participants	0 participants	0 participants	0 participants	58 participants	30 participants	88 participants
	Female	0	0	0	0	13 22.4%	9 30.0%	22 25.0%
	Male	0	0	0	0	45 77.6%	21 70.0%	66 75.0%
		[1] Measure Analysis Population Description: 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) [1]; Measure Type: Count of Participants; Unit of measure: Participants
race (4 arms/strata)	Number Analyzed	17 participants	8 participants	41 participants	22 participants	0 participants	0 participants	88 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0	0	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0	0	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0	0	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0	0	0 0.0%
	White	16 94.1%	6 75.0%	41 100.0%	22 100.0%	0	0	85 96.6%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0	0	0 0.0%
	Unknown or Not Reported	1 5.9%	2 25.0%	0 0.0%	0 0.0%	0	0	3 3.4%
Race (2 total/combined groups)	Number Analyzed	0 participants	0 participants	0 participants	0 participants	58 participants	30 participants	88 participants
	American Indian or Alaska Native	0	0	0	0	0 0.0%	0 0.0%	0 0.0%
	Asian	0	0	0	0	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0	0	0	0	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0	0	0	0	0 0.0%	0 0.0%	0 0.0%
	White	0	0	0	0	57 98.3%	28 93.3%	85 96.6%
	More than one race	0	0	0	0	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0	0	0	0	1 1.7%	2 6.7%	3 3.4%
		[1] Measure Analysis Population Description: 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.

Outcome Measures

1. Primary Outcome

Title	Overall Survival (OS) - Days (FAS)
Description	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.
Time Frame	From the randomization to the date of death, up to 5 years after the last participant's 18-month survival data.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk	Sunitinib-only, High-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk	Sunitinib-only, Intermediate-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata)	Sunitinib-only, Total (Both Strata)
Arm/Group Description:	Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, high-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, intermediate-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, high and intermediate risk strata combined
Overall Number of Participants Analyzed	16	8	40	22	56	30
Median (95% Confidence Interval); Unit of Measure: days
	323; (152 to 682)	282 [1]; (39 to NA)	1270 [1]; (852 to NA)	1099; (234 to 1368)	1082 [1]; (432 to NA)	770; (234 to 1241)

[1]

Upper 95% CI not reached due to censored data.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk, Sunitinib-only, High-risk
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	Exploratory superiority (non-powered)
Statistical Test of Hypothesis	P-Value	0.964
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.978
	Confidence Interval	(2-Sided) 95%; 0.371 to 2.579
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk, Sunitinib-only, Intermediate-risk
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	Exploratory superiority (non-powered)
Statistical Test of Hypothesis	P-Value	0.163
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.619
	Confidence Interval	(2-Sided) 95%; 0.314 to 1.222
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata), Sunitinib-only, Total (Both Strata)
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	Exploratory superiority (non-powered)
Statistical Test of Hypothesis	P-Value	0.250
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.732
	Confidence Interval	(2-Sided) 95%; 0.421 to 1.270
	Estimation Comments	[Not Specified]

2. Primary Outcome

Title	Overall Survival - Days (PPS)
Description	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.
Time Frame	From the randomization to the date of death, up to 5 years after the last patient's 18-month survival data.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk	Sunitinib-only, High-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk	Sunitinib-only, Intermediate-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata)	Sunitinib-only, Total (Both Strata)
Arm/Group Description:	Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, high-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, intermediate-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, high and intermediate-risk strata combined	Sunitinib-only, high and intermediate risk strata combined
Overall Number of Participants Analyzed	12	8	34	19	46	27
Median (95% Confidence Interval); Unit of Measure: days
	352 [1]; (240 to NA)	282 [1]; (39 to NA)	1745 [1]; (911 to NA)	1185 [1]; (678 to NA)	1265 [1]; (684 to NA)	1024; (342 to 1368)

[1]

Upper 95% CI not reached due to censored data.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk, Sunitinib-only, High-risk
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	Exploratory superiority (non-powered)
Statistical Test of Hypothesis	P-Value	0.596
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.756
	Confidence Interval	(2-Sided) 95%; 0.268 to 2.134
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk, Sunitinib-only, Intermediate-risk
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	Exploratory superiority (non-powered)
Statistical Test of Hypothesis	P-Value	0.285
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.661
	Confidence Interval	(2-Sided) 95%; 0.308 to 1.418
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata), Sunitinib-only, Total (Both Strata)
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	Exploratory superiority (non-powered)
Statistical Test of Hypothesis	P-Value	0.240
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.699
	Confidence Interval	(2-Sided) 95%; 0.378 to 1.290
	Estimation Comments	[Not Specified]

3. Primary Outcome

Title	18-Months' Overall Survival Percentage (FAS)
Description	The 18-month survival percentage was defined as the percentage of patients alive 18 months after randomization.
Time Frame	At 18 months (544 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk	Sunitinib-only, High-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk	Sunitinib-only, Intermediate-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata)	Sunitinib-only, Total (Both Strata)
Arm/Group Description:	Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, high-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, intermediate-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, high and intermediate risk strata combined
Overall Number of Participants Analyzed	16	8	40	22	56	30
Measure Type: Number; Unit of Measure: Percentage of participants
	30	38	77	76	63	66

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk, Sunitinib-only, High-risk, Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk, Sunitinib-only, Intermediate-risk
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	Exploratory superiority (non-powered)
Statistical Test of Hypothesis	P-Value	= 0.812
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

4. Primary Outcome

Title	18-Months' Overall Survival Percentage (PPS)
Description	The 18-month survival percentage was defined as the percentage of patients alive 18 months after randomization.
Time Frame	At 18 months (544 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk	Sunitinib-only, High-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk	Sunitinib-only, Intermediate-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata)	Sunitinib-only, Total (Both Strata)
Arm/Group Description:	Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, high-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, intermediate-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, high and intermediate risk strata combined
Overall Number of Participants Analyzed	12	8	34	19	46	27
Measure Type: Number; Unit of Measure: Percentage of participants
	31	38	82	84	68	70

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk, Sunitinib-only, High-risk, Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk, Sunitinib-only, Intermediate-risk
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	Exploratory superiority (non-powered)
Statistical Test of Hypothesis	P-Value	= 0.861
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

5. Secondary Outcome

Title	Progression Free Survival (PFS) From Start of Sunitinib According to RECIST 1.1.
Description	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.
Time Frame	From Sunitinib-Start to progressive disease or death, up to 18 months.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk	Sunitinib-only High-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk	Sunitinib-only, Intermediate-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata)	Sunitinib-only, Total (Both Strata)
Arm/Group Description:	Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, high-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, intermediate-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, high and intermediate risk strata combined
Overall Number of Participants Analyzed	13	6	33	19	46	25
Median (95% Confidence Interval); Unit of Measure: days
	254 [1]; (43 to NA)	NA [2]; (NA to NA)	478 [1]; (249 to NA)	417 [1]; (149 to NA)	360 [1]; (249 to NA)	337 [1]; (149 to NA)

[1]

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

[2]

Due to the large amount of censored data, estimates of median and 95% CI could not be reliably determined.

6. Secondary Outcome

Title	Objective Response Rate (ORR) From Start of Sunitinib Treatment and Duration of Response in Each Subgroup.
Description	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.
Time Frame	From start of sunitinib treatment up to 18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk	Sunitinib-only, High-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk	Sunitinib-only, Intermediate-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata)	Sunitinib-only, Total (Both Strata)
Arm/Group Description:	Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, high-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, intermediate-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, high and intermediate risk strata combined
Overall Number of Participants Analyzed	13	6	32	19	45	25
Measure Type: Number; Unit of Measure: Percentage of participants
	38.5	66.7	46.9	42.1	44.4	48.0

7. Secondary Outcome

Title	Number of Participants With Specific Best Overall Response
Description	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.
Time Frame	From start of sunitinib treatment up to 18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk	Sunitinib-only, High-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk	Sunitinib-only, Intermediate-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata)	Sunitinib-only, Total (Both Strata)
Arm/Group Description:	Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, high-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, intermediate-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, high and intermediate risk strata combined
Overall Number of Participants Analyzed	13	6	32	19	45	25
Measure Type: Count of Participants; Unit of Measure: Participants
Complete Response (CR)	1 7.7%	0 0.0%	4 12.5%	1 5.3%	5 11.1%	1 4.0%
Partial Response (PR)	4 30.8%	4 66.7%	11 34.4%	7 36.8%	15 33.3%	11 44.0%
Progressive Disease (PD)	4 30.8%	0 0.0%	3 9.4%	2 10.5%	7 15.6%	2 8.0%
Stable Disease (SD)	2 15.4%	2 33.3%	13 40.6%	7 36.8%	15 33.3%	9 36.0%
Non-CR/Non-PD	2 15.4%	0 0.0%	0 0.0%	1 5.3%	2 4.4%	1 4.0%
No Disease (ND)	0 0.0%	0 0.0%	1 3.1%	1 5.3%	1 2.2%	1 4.0%

8. Secondary Outcome

Title	Disease Control Rate
Description	Best overall response (CR, PR or SD) evaluated from Sunitinib-Start for patients with available data.
Time Frame	From start of sunitinib treatment up to 18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk	Sunitinib-only, High-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk	Sunitinib-only, Intermediate-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata)	Sunitinib-only, Total (Both Strata)
Arm/Group Description:	Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, high-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, intermediate-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, high and intermediate risk strata combined
Overall Number of Participants Analyzed	13	6	32	19	45	25
Measure Type: Count of Participants; Unit of Measure: Participants
	7 53.8%	6 100.0%	28 87.5%	15 78.9%	35 77.8%	21 84.0%

9. Secondary Outcome

Title	Duration of Response
Description	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).
Time Frame	From first date of CR or PR until date of PD or death, up to 18 months.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk	Sunitinib-only, High-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk	Sunitinib-only, Intermediate-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata)	Sunitinib-only, Total (Both Strata)	Full Analysis Set (FAS)
Arm/Group Description:	Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, high-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, intermediate-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, high and intermediate risk strata combined	All patients randomized being evaluable for any high or intermediate stratum related efficacy endpoint.
Overall Number of Participants Analyzed	5	4	15	8	20	12	32
Median (Full Range); Unit of Measure: days
	175.0; (101 to 219)	81.5; (42 to 126)	316.0; (1 to 512)	108.0; (1 to 409)	215.0; (1 to 512)	87.0; (1 to 409)	169.5; (1 to 512)

10. Secondary Outcome

Title	Duration of Clinical Benefit
Description	Disease control rate (DCR) also called Clinical Benefit Rate, was defined as the proportion of patients with CR or PR or SD.
Time Frame	From first date of clinical benefit (CR, PR or SD) until date of PD or death, up to 18 months.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk	Sunitinib-only, High-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk	Sunitinib-only, Intermediate-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata)	Sunitinib-only, Total (Both Strata)	Full Analysis Set (FAS)
Arm/Group Description:	Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, high-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, intermediate-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, high and intermediate risk strata combined	All patients randomized being evaluable for any high or intermediate stratum related efficacy endpoint.
Overall Number of Participants Analyzed	7	6	28	15	35	21	56
Median (Full Range); Unit of Measure: days
	212.0; (1 to 434)	60.0; (1 to 206)	323.5; (29 to 512)	295.0; (1 to 451)	219.0; (1 to 512)	133.0; (1 to 451)	211.0; (1 to 512)

11. Secondary Outcome

Title	Duration of Stable Disease
Description	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.
Time Frame	From first date of SD until PD or date of death, up to 18 months.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk	Sunitinib-only, High-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk	Sunitinib-only, Intermediate-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata)	Sunitinib-only, Total (Both Strata)	Full Analysis Set (FAS)
Arm/Group Description:	Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, high-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, intermediate-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, high and intermediate risk strata combined	All patients randomized being evaluable for any high or intermediate stratum related efficacy endpoint.
Overall Number of Participants Analyzed	2	2	13	7	15	9	24
Median (Full Range); Unit of Measure: days
	63.5; (1 to 126)	10.5; (1 to 20)	169.0; (29 to 427)	210.0; (50 to 449)	126.0; (1 to 427)	133.0; (1 to 449)	129.5; (1 to 449)

12. Secondary Outcome

Title	Time to Progression (TTP)
Description	Due to the large amount of censored data, estimate of upper 95% CI could not be reliably determined in all reporting groups.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk	Sunitinib-only, High-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk	Sunitinib-only, Intermediate-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata)	Sunitinib-only, Total (Both Strata)
Arm/Group Description:	Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, high-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, intermediate-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, high and intermediate risk strata combined
Overall Number of Participants Analyzed	13	6	33	19	46	25
Median (95% Confidence Interval); Unit of Measure: days
	169 [1]; (43 to NA)	143; (48 to 248)	388 [1]; (213 to NA)	417 [1]; (93 to NA)	254; (169 to 478)	251; (93 to 434)

[1]

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

13. Secondary Outcome

Title	Percentage of Tumor Area With Infiltrating Cluster of Differentiation 8+ (CD8+) T-cells
Description	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.
Time Frame	At resection of primary tumor.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk	Sunitinib-only, High-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk	Sunitinib-only, Intermediate-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata)	Sunitinib-only, Total (Both Strata)	Full Analysis Set (FAS)
Arm/Group Description:	Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, high-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, intermediate-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, high and intermediate risk strata combined	All patients randomized being evaluable for any high or intermediate stratum related efficacy endpoint.
Overall Number of Participants Analyzed	14	7	38	20	52	27	79
Median (Full Range); Unit of Measure: Percentage of tumor area
	1.0; (0 to 8)	1.1; (0 to 4)	1.2; (0 to 13)	0.8; (0 to 8)	1.1; (0 to 13)	0.8; (0 to 8)	1.1; (0 to 13)

14. Post-Hoc Outcome

Title	Confirmed Objective Response Rate
Description	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.
Time Frame	From start of sunitinib treatment up to 18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk	Sunitinib-only, High-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk	Sunitinib-only, Intermediate-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata)	Sunitinib-only, Total (Both Strata)
Arm/Group Description:	Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, high-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, intermediate-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, high and intermediate risk strata combined
Overall Number of Participants Analyzed	13	6	32	19	45	25
Measure Type: Number; Unit of Measure: Percentage of participants
	38.5	33.3	43.8	21.1	42.2	24.0

15. Post-Hoc Outcome

Title	Confirmed Best Overall Response
Description	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.
Time Frame	From start of sunitinib treatment up to 18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intuvax (INN: Ilixadencel) + Sunitinib, High-risk	Sunitinib-only, High-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk	Sunitinib-only, Intermediate-risk	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata)	Sunitinib-only, Total (Both Strata)
Arm/Group Description:	Intuvax (INN: ilixadencel) + sunitinib, high-risk stratum	Sunitinib-only, high-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, intermediate-risk stratum	Sunitinib-only, intermediate-risk stratum	Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined	Sunitinib-only, high and intermediate risk strata combined
Overall Number of Participants Analyzed	13	6	32	19	45	25
Measure Type: Count of Participants; Unit of Measure: Participants
Complete response (CR)	0 0.0%	0 0.0%	3 9.4%	0 0.0%	3 6.7%	0 0.0%
Partial response (PR)	5 38.5%	2 33.3%	11 34.4%	4 21.1%	16 35.6%	6 24.0%
Stable disease (SD)	1 7.7%	1 16.7%	10 31.3%	9 47.4%	11 24.4%	10 40.0%
Missing	7 53.8%	3 50.0%	8 25.0%	6 31.6%	15 33.3%	9 36.0%

Adverse Events

Time Frame	AEs and SAEs were collected from first dose to last follow-up, up to 18 months. All-cause mortality was collected from first dose up to 5 years after last participant's 18-month survival data.
Adverse Event Reporting Description	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.
Arm/Group Title	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata)		Sunitinib-only, Total (Both Strata)
Arm/Group Description	Intuvax (INN: ilixadencel) + sunitinib, high and intermediate risk strata combined		Sunitinib-only, high and intermediate risk strata combined
All-Cause Mortality
	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata)		Sunitinib-only, Total (Both Strata)
	Affected / at Risk (%)		Affected / at Risk (%)
Total	24/58 (41.38%)		17/30 (56.67%)
Serious Adverse Events
	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata)		Sunitinib-only, Total (Both Strata)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	27/58 (46.55%)		17/30 (56.67%)
Blood and lymphatic system disorders
Anaemia † 1	1/58 (1.72%)	2	0/30 (0.00%)	0
Pancytopenia † 1	1/58 (1.72%)	1	1/30 (3.33%)	1
Cardiac disorders
Left ventricular dysfunction † 1	0/58 (0.00%)	0	1/30 (3.33%)	1
Gastrointestinal disorders
Diarrhoea † 1	0/58 (0.00%)	0	2/30 (6.67%)	2
Gastrointestinal inflammation † 1	1/58 (1.72%)	1	0/30 (0.00%)	0
Intestinal perforation † 1	0/58 (0.00%)	0	1/30 (3.33%)	1
Nausea † 1	1/58 (1.72%)	1	0/30 (0.00%)	0
Pancreatitis acute † 1	1/58 (1.72%)	1	0/30 (0.00%)	0
Vomiting † 1	2/58 (3.45%)	2	0/30 (0.00%)	0
General disorders
Asthenia † 1	1/58 (1.72%)	1	2/30 (6.67%)	2
Death † 1	1/58 (1.72%)	1	0/30 (0.00%)	0
General physical health deterioration † 1	3/58 (5.17%)	3	1/30 (3.33%)	1
Multi-organ disorder † 1 [1]	0/58 (0.00%)	0	1/30 (3.33%)	1
Pyrexia † 1	0/58 (0.00%)	0	1/30 (3.33%)	1
Hepatobiliary disorders
Cholecystitis acute † 1	0/58 (0.00%)	0	1/30 (3.33%)	1
Infections and infestations
Gastrointestinal infection † 1	1/58 (1.72%)	1	0/30 (0.00%)	0
Lymphangitis † 1	1/58 (1.72%)	1	0/30 (0.00%)	0
Pneumonia † 1	0/58 (0.00%)	0	2/30 (6.67%)	2
Post procedural infection † 1	2/58 (3.45%)	2	0/30 (0.00%)	0
Septic shock † 1	0/58 (0.00%)	0	1/30 (3.33%)	1
Urinary tract infection † 1	2/58 (3.45%)	2	0/30 (0.00%)	0
Gastrointestinal viral infection † 1	1/58 (1.72%)	1	0/30 (0.00%)	0
Injury, poisoning and procedural complications
Humerus fracture † 1	1/58 (1.72%)	1	0/30 (0.00%)	0
Pelvic fracture † 1	1/58 (1.72%)	1	0/30 (0.00%)	0
Post procedural haemorrhage † 1	2/58 (3.45%)	2	0/30 (0.00%)	0
Procedural pain † 1	0/58 (0.00%)	0	1/30 (3.33%)	1
Wound evisceration † 1	0/58 (0.00%)	0	1/30 (3.33%)	1
Investigations
Blood thyroid stimulating hormone increased † 1	1/58 (1.72%)	1	0/30 (0.00%)	0
General physical condition abnormal † 1	1/58 (1.72%)	1	0/30 (0.00%)	0
Metabolism and nutrition disorders
Dehydration † 1	2/58 (3.45%)	2	0/30 (0.00%)	0
Hypercalcaemia † 1	1/58 (1.72%)	1	2/30 (6.67%)	2
Musculoskeletal and connective tissue disorders
Arthralgia † 1	1/58 (1.72%)	1	0/30 (0.00%)	0
Back pain † 1	1/58 (1.72%)	1	0/30 (0.00%)	0
Bone pain † 1	1/58 (1.72%)	1	0/30 (0.00%)	0
Muscular weakness † 1	0/58 (0.00%)	0	1/30 (3.33%)	1
Pathological fracture † 1	0/58 (0.00%)	0	2/30 (6.67%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion † 1	0/58 (0.00%)	0	1/30 (3.33%)	1
Metastatic bone disease prophylaxis † 1 [2]	1/58 (1.72%)	1	0/30 (0.00%)	0
Thyroid cancer † 1	1/58 (1.72%)	1	0/30 (0.00%)	0
Nervous system disorders
Aphasia † 1	1/58 (1.72%)	1	0/30 (0.00%)	0
Brain oedema † 1	1/58 (1.72%)	1	0/30 (0.00%)	0
Cerebrovascular accident † 1	1/58 (1.72%)	1	0/30 (0.00%)	0
Hemiparesis † 1	1/58 (1.72%)	1	0/30 (0.00%)	0
Paresis † 1	1/58 (1.72%)	1	1/30 (3.33%)	1
Sciatica † 1	0/58 (0.00%)	0	1/30 (3.33%)	1
Spinal cord compression † 1	1/58 (1.72%)	1	1/30 (3.33%)	1
Transient ischaemic attack † 1	0/58 (0.00%)	0	1/30 (3.33%)	1
Psychiatric disorders
Confusional state † 1	1/58 (1.72%)	1	0/30 (0.00%)	0
Renal and urinary disorders
Renal failure † 1	1/58 (1.72%)	1	0/30 (0.00%)	0
Reproductive system and breast disorders
Uterine haemorrhage † 1	1/58 (1.72%)	1	0/30 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea † 1	0/58 (0.00%)	0	1/30 (3.33%)	1
Pleural effusion † 1	1/58 (1.72%)	1	1/30 (3.33%)	1
Pulmonary embolism † 1	0/58 (0.00%)	0	1/30 (3.33%)	1
Pulmonary oedema † 1	0/58 (0.00%)	0	1/30 (3.33%)	1
1 Term from vocabulary, MedDRA (17.1); † Indicates events were collected by systematic assessment; [1] Listed as "Multi-organ failure"; [2] Recorded as "Metastatic pain"
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata)		Sunitinib-only, Total (Both Strata)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	54/58 (93.10%)		27/30 (90.00%)
Blood and lymphatic system disorders
Anaemia † 1	14/58 (24.14%)	19	4/30 (13.33%)	4
Neutropenia † 1	4/58 (6.90%)	5	1/30 (3.33%)	1
Thrombocytopenia † 1	5/58 (8.62%)	7	0/30 (0.00%)	0
Hypertension † 1	12/58 (20.69%)	18	6/30 (20.00%)	6
Hypotension † 1	4/58 (6.90%)	5	1/30 (3.33%)	1
Endocrine disorders
Hypothyroidism † 1	8/58 (13.79%)	9	3/30 (10.00%)	3
Gastrointestinal disorders
Abdominal pain † 1	3/58 (5.17%)	3	2/30 (6.67%)	2
Abdominal pain upper † 1	4/58 (6.90%)	4	3/30 (10.00%)	3
Constipation † 1	7/58 (12.07%)	7	2/30 (6.67%)	2
Diarrhoea † 1	14/58 (24.14%)	23	7/30 (23.33%)	13
Gastritis † 1	3/58 (5.17%)	3	0/30 (0.00%)	0
Gastrooesophageal reflux disease † 1	3/58 (5.17%)	8	1/30 (3.33%)	1
Nausea † 1	14/58 (24.14%)	21	7/30 (23.33%)	8
Oral pain † 1	3/58 (5.17%)	3	3/30 (10.00%)	3
Stomatitis † 1	6/58 (10.34%)	8	6/30 (20.00%)	10
Vomiting † 1	14/58 (24.14%)	21	0/30 (0.00%)	0
General disorders
Asthenia † 1	11/58 (18.97%)	19	5/30 (16.67%)	5
Fatigue † 1	14/58 (24.14%)	14	8/30 (26.67%)	11
General physical health deterioration † 1	3/58 (5.17%)	3	1/30 (3.33%)	1
Mucosal inflammation † 1	6/58 (10.34%)	10	1/30 (3.33%)	1
Pain † 1	3/58 (5.17%)	3	0/30 (0.00%)	0
Pyrexia † 1	11/58 (18.97%)	18	4/30 (13.33%)	6
Hepatobiliary disorders
Cholecystitis acute † 1	0/58 (0.00%)	0	2/30 (6.67%)	2
Infections and infestations
Pneumonia † 1	1/58 (1.72%)	1	2/30 (6.67%)	2
Urinary tract infection † 1	6/58 (10.34%)	6	2/30 (6.67%)	2
Nasopharyngitis † 1	3/58 (5.17%)	3	1/30 (3.33%)	1
Injury, poisoning and procedural complications
Procedural pain † 1	3/58 (5.17%)	3	3/30 (10.00%)	3
Investigations
Blood creatinine increased † 1	6/58 (10.34%)	9	4/30 (13.33%)	5
Gamma-glutamyltransferase increased † 1	3/58 (5.17%)	3	0/30 (0.00%)	0
Glomerular filtration rate decreased † 1	3/58 (5.17%)	3	1/30 (3.33%)	1
Neutrophil count decreased † 1	4/58 (6.90%)	5	4/30 (13.33%)	4
Platelet count decreased † 1	2/58 (3.45%)	3	3/30 (10.00%)	4
Metabolism and nutrition disorders
Decreased appetite † 1	10/58 (17.24%)	12	5/30 (16.67%)	5
Hypercalcaemia † 1	4/58 (6.90%)	6	2/30 (6.67%)	3
Hyperkalaemia † 1	3/58 (5.17%)	3	0/30 (0.00%)	0
Musculoskeletal and connective tissue disorders
Arthralgia † 1	5/58 (8.62%)	5	3/30 (10.00%)	3
Back pain † 1	10/58 (17.24%)	13	3/30 (10.00%)	3
Musculoskeletal pain † 1	4/58 (6.90%)	4	0/30 (0.00%)	0
Neck pain † 1	0/58 (0.00%)	0	2/30 (6.67%)	2
Pain in extremity † 1	5/58 (8.62%)	7	2/30 (6.67%)	2
Pathological fracture † 1	0/58 (0.00%)	0	3/30 (10.00%)	3
Nervous system disorders
Dizziness † 1	3/58 (5.17%)	3	3/30 (10.00%)	4
Dysgeusia † 1	9/58 (15.52%)	14	5/30 (16.67%)	7
Headache † 1	7/58 (12.07%)	8	1/30 (3.33%)	1
Paresis † 1	1/58 (1.72%)	1	2/30 (6.67%)	2
Psychiatric disorders
Anxiety † 1	5/58 (8.62%)	6	0/30 (0.00%)	0
Renal and urinary disorders
Haematuria † 1	3/58 (5.17%)	3	0/30 (0.00%)	0
Renal failure † 1 [1]	3/58 (5.17%)	3	4/30 (13.33%)	4
Renal impairment † 1	2/58 (3.45%)	3	2/30 (6.67%)	2
Respiratory, thoracic and mediastinal disorders
Cough † 1	4/58 (6.90%)	4	1/30 (3.33%)	1
Dyspnoea † 1	4/58 (6.90%)	4	2/30 (6.67%)	2
Epistaxis † 1	5/58 (8.62%)	8	2/30 (6.67%)	2
Skin and subcutaneous tissue disorders
Dry skin † 1	4/58 (6.90%)	4	2/30 (6.67%)	2
Palmar-plantar erythrodysaesthesia syndrome † 1	7/58 (12.07%)	8	3/30 (10.00%)	3
Pruritus † 1	3/58 (5.17%)	4	0/30 (0.00%)	0
Rash † 1	3/58 (5.17%)	4	1/30 (3.33%)	1
1 Term from vocabulary, MedDRA (17.1); † Indicates events were collected by systematic assessment; [1] Registered as "Renal failure acute" (in Intuvax [INN: ilixadencel] group, 1 subject [1 unique event], in sunitinib-only group, 2 subjects [2 unique events]) and "Renal failure chronic" (in each group, 2 subjects are affected by 2 unique events)

Limitations and Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Chief Medical Officer
• Organization: Immunicum Aktiebolag (AB)
• Phone: +46 (0)8 732 84 00
• EMail: info@immunicum.com

• Responsible Party: Mendus
• ClinicalTrials.gov Identifier: NCT02432846
• Other Study ID Numbers: IM-201; 2014-004510-28 ( EudraCT Number )
• First Submitted: April 15, 2015
• First Posted: May 4, 2015
• Results First Submitted: April 21, 2022
• Results First Posted: August 22, 2022
• Last Update Posted: August 22, 2022