A Phase 2 interventional study of Intuvax (INN: ilixadencel) and Sunitinib in Renal Cell Carcinoma, Metastatic, sponsored by Mendus. Completed at 28 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-22.
Sponsored by Mendus · Phase 2, Interventional, and Treatment
The purpose of this study is to compare tumor response, progression free survival (PFS) and overall survival (OS) in newly diagnosed mRCC patients treated with Intuvax (INN: ilixadencel) pre-nephrectomy followed by Sunitinib post-nephrectomy vs Sunitinib post-nephrectomy patients.
Patients, all planned for nephrectomy, will be stratified according to the Heng risk criteria (high risk patients vs. intermediate risk patients) and randomized in a 2:1 ratio to receive Intuvax (INN: ilixadencel)+ Sunitinib or Sunitinib alone.
Two doses of Intuvax (INN: ilixadencel) will be administered in to the primary tumour before nephrectomy. The control group will be scheduled for nephrectomy directly.
All patients will start Sunitinib treatment 5-8 weeks after operation.
Results from the phase I study, together with the results reported in the literature on the use of autologous dendritic cells (DCs) in combination with Sunitinib encourage Immunicum aktiebolag (AB) to further investigate the possibility of exploiting Intuvax (INN: ilixadencel) 10 million cells/dose when combined with Sunitinib for the treatment of mRCC patients.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 88 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Mendus is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Adequate hematological parameters, i.e:
or Male agreeing to use condoms from Screening until 90 days after last dose of Intuvax and/or until completed sunitinib treatment whichever occurs later, or male having a female partner who is using a highly efficient method of contraception as described above.
Exclusion Criteria:
Abnormal and clinical significant coagulation parameters at the discretion of the Investigator, i.e.:
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).
Biological: Intuvax (INN: ilixadencel) · Drug: Sunitinib
Sunitinib treatment post-nephrectomy according to clinical practice until RECIST verified progressive disease or End-of-Study (78 weeks after screening).
Drug: Sunitinib
Therapeutic dose (10 million cells/dose): allogeneic, pro-inflammatory dendritic cells.
Also known as: COMBIG-DC
Cytostatic/cytotoxic drug: protein kinase inhibitor .
Also known as: Sutent
Overall Survival (OS) - Days (FAS)
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.
Overall Survival - Days (PPS)
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.
18-Months' Overall Survival Percentage (FAS)
The 18-month survival percentage was defined as the percentage of patients alive 18 months after randomization.
Time frame: At 18 months (544 days)
18-Months' Overall Survival Percentage (PPS)
The 18-month survival percentage was defined as the percentage of patients alive 18 months after randomization.
Time frame: At 18 months (544 days)
Progression Free Survival (PFS) From Start of Sunitinib According to RECIST 1.1.
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.
Objective Response Rate (ORR) From Start of Sunitinib Treatment and Duration of Response in Each Subgroup.
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
Number of Participants With Specific Best Overall Response
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
Disease Control Rate
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
Duration of Response
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.
Duration of Clinical Benefit
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.
Duration of Stable Disease
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.
Time to Progression (TTP)
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.
Percentage of Tumor Area With Infiltrating Cluster of Differentiation 8+ (CD8+) T-cells
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.
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).
| Milestone | 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 |
|---|---|---|---|---|---|---|
| Started | 17 | 8 | 41 | 22 | 0 | 0 |
| Completed | 2 | 0 | 17 | 8 | 0 | 0 |
| Not completed | 15 | 8 | 24 | 14 | 0 | 0 |
| Withdrew: Death | 3 | 2 | 4 | 3 | 0 | 0 |
| Withdrew: Adverse event | 0 | 1 | 1 | 0 | 0 | 0 |
| Withdrew: Physician decision | 2 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 | 1 | 1 | 0 | 0 |
| Withdrew: Other (reason not specified) | 0 | 0 | 2 | 1 | 0 | 0 |
| Withdrew: Disease progression | 8 | 5 | 15 | 9 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 | 0 | 0 | 0 |
| Milestone | 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 |
|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 58 | 30 |
| Completed | 0 | 0 | 0 | 0 | 19 | 8 |
| Not completed | 0 | 0 | 0 | 0 | 39 | 22 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 7 | 5 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 1 | 1 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 2 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 3 | 1 |
| Withdrew: Other (reason not specified) | 0 | 0 | 0 | 0 | 2 | 1 |
| Withdrew: Disease progression | 0 | 0 | 0 | 0 | 23 | 14 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 1 | 0 |
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.
| days | 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) |
|---|---|---|---|---|---|---|
| Overall Survival (OS) - Days (FAS) | 323 (152 to 682) | 282 (39 to NA) | 1270 (852 to NA) | 1099 (234 to 1368) | 1082 (432 to NA) | 770 (234 to 1241) |
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.
| days | 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) |
|---|---|---|---|---|---|---|
| Overall Survival - Days (PPS) | 352 (240 to NA) | 282 (39 to NA) | 1745 (911 to NA) | 1185 (678 to NA) | 1265 (684 to NA) | 1024 (342 to 1368) |
The 18-month survival percentage was defined as the percentage of patients alive 18 months after randomization.
| Percentage of participants | 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) |
|---|---|---|---|---|---|---|
| 18-Months' Overall Survival Percentage (FAS) | 30 | 38 | 77 | 76 | 63 | 66 |
The 18-month survival percentage was defined as the percentage of patients alive 18 months after randomization.
| Percentage of participants | 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) |
|---|---|---|---|---|---|---|
| 18-Months' Overall Survival Percentage (PPS) | 31 | 38 | 82 | 84 | 68 | 70 |
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.
| days | 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) |
|---|---|---|---|---|---|---|
| Progression Free Survival (PFS) From Start of Sunitinib According to RECIST 1.1. | 254 (43 to NA) | NA (NA to NA) | 478 (249 to NA) | 417 (149 to NA) | 360 (249 to NA) | 337 (149 to NA) |
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.
| Percentage of participants | 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) |
|---|---|---|---|---|---|---|
| Objective Response Rate (ORR) From Start of Sunitinib Treatment and Duration of Response in Each Subgroup. | 38.5 | 66.7 | 46.9 | 42.1 | 44.4 | 48.0 |
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.
| Participants | 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) |
|---|---|---|---|---|---|---|
| Complete Response (CR) | 1 | 0 | 4 | 1 | 5 | 1 |
| Partial Response (PR) | 4 | 4 | 11 | 7 | 15 | 11 |
| Progressive Disease (PD) | 4 | 0 | 3 | 2 | 7 | 2 |
| Stable Disease (SD) | 2 | 2 | 13 | 7 | 15 | 9 |
| Non-CR/Non-PD | 2 | 0 | 0 | 1 | 2 | 1 |
| No Disease (ND) | 0 | 0 | 1 | 1 | 1 | 1 |
Best overall response (CR, PR or SD) evaluated from Sunitinib-Start for patients with available data.
| Participants | 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) |
|---|---|---|---|---|---|---|
| Disease Control Rate | 7 | 6 | 28 | 15 | 35 | 21 |
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).
| days | 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) |
|---|---|---|---|---|---|---|---|
| Duration of Response | 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) |
Disease control rate (DCR) also called Clinical Benefit Rate, was defined as the proportion of patients with CR or PR or SD.
| days | 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) |
|---|---|---|---|---|---|---|---|
| Duration of Clinical Benefit | 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) |
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.
| days | 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) |
|---|---|---|---|---|---|---|---|
| Duration of Stable Disease | 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) |
Due to the large amount of censored data, estimate of upper 95% CI could not be reliably determined in all reporting groups.
| days | 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) |
|---|---|---|---|---|---|---|
| Time to Progression (TTP) | 169 (43 to NA) | 143 (48 to 248) | 388 (213 to NA) | 417 (93 to NA) | 254 (169 to 478) | 251 (93 to 434) |
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.
| Percentage of tumor area | 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) |
|---|---|---|---|---|---|---|---|
| Percentage of Tumor Area With Infiltrating Cluster of Differentiation 8+ (CD8+) T-cells | 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) |
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.
| Percentage of participants | 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) |
|---|---|---|---|---|---|---|
| Confirmed Objective Response Rate | 38.5 | 33.3 | 43.8 | 21.1 | 42.2 | 24.0 |
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.
| Participants | 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) |
|---|---|---|---|---|---|---|
| Complete response (CR) | 0 | 0 | 3 | 0 | 3 | 0 |
| Partial response (PR) | 5 | 2 | 11 | 4 | 16 | 6 |
| Stable disease (SD) | 1 | 1 | 10 | 9 | 11 | 10 |
| Missing | 7 | 3 | 8 | 6 | 15 | 9 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata) | 24/58 (41.4%) | 27/58 (46.6%) | 54/58 (93.1%) |
| Sunitinib-only, Total (Both Strata) | 17/30 (56.7%) | 17/30 (56.7%) | 27/30 (90%) |
| Event | Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata) | Sunitinib-only, Total (Both Strata) |
|---|---|---|
| AstheniaGeneral disorders | 1/58 | 2/30 |
| DiarrhoeaGastrointestinal disorders | 0/58 | 2/30 |
| Pathological fractureMusculoskeletal and connective tissue disorders | 0/58 | 2/30 |
| HypercalcaemiaMetabolism and nutrition disorders | 1/58 | 2/30 |
| PneumoniaInfections and infestations | 0/58 | 2/30 |
| General physical health deteriorationGeneral disorders | 3/58 | 1/30 |
| Post procedural haemorrhageInjury, poisoning and procedural complications | 2/58 | 0/30 |
| VomitingGastrointestinal disorders | 2/58 | 0/30 |
| DehydrationMetabolism and nutrition disorders | 2/58 | 0/30 |
| Post procedural infectionInfections and infestations | 2/58 | 0/30 |
| Event | Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata) | Sunitinib-only, Total (Both Strata) |
|---|---|---|
| FatigueGeneral disorders | 14/58 | 8/30 |
| AnaemiaBlood and lymphatic system disorders | 14/58 | 4/30 |
| DiarrhoeaGastrointestinal disorders | 14/58 | 7/30 |
| NauseaGastrointestinal disorders | 14/58 | 7/30 |
| VomitingGastrointestinal disorders | 14/58 | 0/30 |
| HypertensionBlood and lymphatic system disorders | 12/58 | 6/30 |
| StomatitisGastrointestinal disorders | 6/58 | 6/30 |
| AstheniaGeneral disorders | 11/58 | 5/30 |
| PyrexiaGeneral disorders | 11/58 | 4/30 |
| Back painMusculoskeletal and connective tissue disorders | 10/58 | 3/30 |
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(years) | 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 |
|---|---|---|---|---|---|---|---|
| Age (4 arms/strata) | 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) | — | — | — | — | 61.3 ± 8.7 | 64.2 ± 9.8 | 62.3 ± 9.1 |
| Sex: Female, Male(Participants) | 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 |
|---|---|---|---|---|---|---|---|
| Sex (4 arms/strata) — Female | 2 | 2 | 11 | 7 | 0 | 0 | 22 |
| Sex (4 arms/strata) — Male | 15 | 6 | 30 | 15 | 0 | 0 | 66 |
| Sex (2 total/combined groups) — Female | 0 | 0 | 0 | 0 | 13 | 9 | 22 |
| Sex (2 total/combined groups) — Male | 0 | 0 | 0 | 0 | 45 | 21 | 66 |
| Race (NIH/OMB)(Participants) | 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 |
|---|---|---|---|---|---|---|---|
| race (4 arms/strata) — American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| race (4 arms/strata) — Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| race (4 arms/strata) — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| race (4 arms/strata) — Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| race (4 arms/strata) — White | 16 | 6 | 41 | 22 | 0 | 0 | 85 |
| race (4 arms/strata) — More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| race (4 arms/strata) — Unknown or Not Reported | 1 | 2 | 0 | 0 | 0 | 0 | 3 |
| Race (2 total/combined groups) — American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (2 total/combined groups) — Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (2 total/combined groups) — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (2 total/combined groups) — Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (2 total/combined groups) — White | 0 | 0 | 0 | 0 | 57 | 28 | 85 |
| Race (2 total/combined groups) — More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (2 total/combined groups) — Unknown or Not Reported | 0 | 0 | 0 | 0 | 1 | 2 | 3 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mendus