Trial · NCT04150562
Avelumab (Bavencio) With IL-15 in Subjects With Clear-Cell Renal Carcinoma
NCT04150562, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2022-05-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Avelumab (Bavencio) With IL-15 in Subjects With Clear-Cell Renal Carcinoma. Trials, record NCT04150562. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04150562
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Avelumab (Bavencio) With IL-15 in Subjects With Clear-Cell Renal Carcinoma
- NCT number
- NCT04150562
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Clear-Cell Renal Carcinoma
- Interventions
- rhIL-15, Avelumab
- First posted
- 2019-11-04
- Last updated
- 2022-05-17
- Results first posted
- 2022-05-17
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (Complete Response + Partial Response) | Following start of study medication while on treatment, approximately 2 months. | Response was assessed using the Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST)v1.1. Immune related complete response (irCR) is at least two radiographic determinations of complete response (CR - e.g., disappearance of all target lesions) at least 4 weeks apart and before Immune related progressive disease (irPD - defined as at least two consecutive radiographic determinations of progressive disease ((PD - e.g., appearance of one or more new lesions) at least 4 weeks apart). at least 4 weeks apart). Immune related partial response (irPR) is at least two radiographic determinations of partial response (PR - e.g., 30% decrease of target lesions) or better at least 4 weeks apart and before irPD (and not qualifying for an irCR). |
| Secondary | Duration of Response | Following start of study medication while on treatment, up to 1-2 months. | Duration of response is defined as the time from the initial response (irCR, irPR or irSD) to progression or death, whichever comes first. Response was assessed using the Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST)v1.1. Immune related complete response (irCR) is at least two radiographic determinations of complete response (CR) at least 4 weeks apart and before Immune related progressive disease (irPD - defined as at least two consecutive radiographic determinations of progressive disease (PD) at least 4 weeks apart). Immune related partial response (irPR) is at least two radiographic determinations of partial response (PR) or better at least 4 weeks apart and before irPD (and not qualifying for an irCR). Immune related stable disease (irSD) is at least one radiographic assessment of stable disease (SD) (or better) ≥ 6 weeks after the first trial treatment administration and before irPD (and not qualifying for irCR or irPR). |
| Secondary | Progression-free Survival | Monitoring frequency is every two cycles through completion of study then annually until progressive disease is noted, an average of 73 days. | Progression free survival is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, or death, whichever comes first. Progression was assessed using the Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST)v1.1. Immune related progressive disease (irPD) is defined as at least two consecutive radiographic determinations of progressive disease (PD - e.g., appearance of one or more new lesions) at least 4 weeks apart). |
| Secondary | Overall Survival | time from the date of study enrollment until time of death from any cause, an average of 167 days | Overall survival is defined as the time from the date of study enrollment until time of death from any cause. |
| Secondary | Number of Grade 3 Adverse Events Possibly, Probably or Definitely Related to Treatment of rhIL-15 + Avelumab | 4 cycles (each cycle is 28 days), up to 112 days | Adverse events were assessed using the Common Terminology Criteria for Adverse Events (CTCAE)v5.0. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse events. |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | Date treatment consent signed to date off study, approximately 13 months and 24 days. | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (Complete Response + Partial Response) | Following start of study medication while on treatment, approximately 2 months. | proportion of participants | NUMBER | |
| SECONDARY | Duration of Response | Following start of study medication while on treatment, up to 1-2 months. | Days | MEDIAN | |
| SECONDARY | Progression-free Survival | Monitoring frequency is every two cycles through completion of study then annually until progressive disease is noted, an average of 73 days. | Days | MEDIAN | |
| SECONDARY | Overall Survival | time from the date of study enrollment until time of death from any cause, an average of 167 days | Days | MEDIAN | |
| SECONDARY | Number of Grade 3 Adverse Events Possibly, Probably or Definitely Related to Treatment of rhIL-15 + Avelumab | 4 cycles (each cycle is 28 days), up to 112 days | adverse events | NUMBER | |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | Date treatment consent signed to date off study, approximately 13 months and 24 days. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (Complete Response + Partial Response) | Arm 1- Safety Run-in Dose Level 1 | Immune related complete response (irCR) | 0 | proportion of participants | |
| Overall Response Rate (Complete Response + Partial Response) | Arm 1- Safety Run-in Dose Level 1 | Immune related partial response (irPR) | 0 | proportion of participants | |
| Duration of Response | Arm 1- Safety Run-in Dose Level 1 | 13 | Full Range 0 to 26 | Days | |
| Progression-free Survival | Arm 1- Safety Run-in Dose Level 1 | 73 | Full Range 62 to 84 | Days | |
| Overall Survival | Arm 1- Safety Run-in Dose Level 1 | 167 | Full Range 147 to 187 | Days | |
| Number of Grade 3 Adverse Events Possibly, Probably or Definitely Related to Treatment of rhIL-15 + Avelumab | Arm 1- Safety Run-in Dose Level 1 | Grade 3 | 0 | adverse events | |
| Number of Grade 3 Adverse Events Possibly, Probably or Definitely Related to Treatment of rhIL-15 + Avelumab | Arm 1- Safety Run-in Dose Level 1 | Grade 4 | 0 | adverse events | |
| Number of Grade 3 Adverse Events Possibly, Probably or Definitely Related to Treatment of rhIL-15 + Avelumab | Arm 1- Safety Run-in Dose Level 1 | Grade 5 | 0 | adverse events | |
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | Arm 1- Safety Run-in Dose Level 1 | 2 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1- Safety Run-in Dose Level 1 | 2 | |
| Overall Study | STARTED | Arm 2-Dose Expansion | 0 | |
| Overall Study | COMPLETED | Arm 1- Safety Run-in Dose Level 1 | 2 | |
| Overall Study | COMPLETED | Arm 2-Dose Expansion | 0 | |
| Overall Study | NOT COMPLETED | Arm 1- Safety Run-in Dose Level 1 | 0 | |
| Overall Study | NOT COMPLETED | Arm 2-Dose Expansion | 0 |
Source ClinicalTrials.gov
Adverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Alanine aminotransferase increased | Investigations | Arm 1- Safety Run-in Dose Level 1 | 1 | 2 | 1 |
| other | Alkaline phosphatase increased | Investigations | Arm 1- Safety Run-in Dose Level 1 | 1 | 2 | 2 |
| other | Anemia | Blood and lymphatic system disorders | Arm 1- Safety Run-in Dose Level 1 | 1 | 2 | 4 |
| other | Anorexia | Metabolism and nutrition disorders | Arm 1- Safety Run-in Dose Level 1 | 1 | 2 | 1 |
| other | Aspartate aminotransferase increased | Investigations | Arm 1- Safety Run-in Dose Level 1 | 1 | 2 | 1 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Arm 1- Safety Run-in Dose Level 1 | 1 | 2 | 1 |
| other | Chills | General disorders | Arm 1- Safety Run-in Dose Level 1 | 1 | 2 | 1 |
| other | Constipation | Gastrointestinal disorders | Arm 1- Safety Run-in Dose Level 1 | 1 | 2 | 1 |
| other | Creatinine increased | Investigations | Arm 1- Safety Run-in Dose Level 1 | 1 | 2 | 1 |
| other | Dehydration | Metabolism and nutrition disorders | Arm 1- Safety Run-in Dose Level 1 | 1 | 2 | 1 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1- Safety Run-in Dose Level 1 | 2 | 2 |
| Total, other adverse events | Arm 1- Safety Run-in Dose Level 1 | 2 | 2 |
| Total, serious adverse events | Arm 1- Safety Run-in Dose Level 1 | 1 | 2 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32508818 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04150562
GET https://conductscience.org/api/trials/v1/NCT04150562/events?page=2