Trial Outcomes & Findings for Vaccine Therapy Before Surgery in Treating Patients With Localized Kidney Cancer (NCT NCT02170389)

Last Updated: 2020-07-07

Results Overview

The time component will be modeled as a three-level classification factor. The full model for the effects of time will be fit using linear mixed model methods. The model will include a random patient effect and 5 fixed effects for time and the interactions. The presence of any time effect will be assessed with full-reduced model type 3 test. If the omnibus test is statistically significant at the p \< 0.05 level, then three pairwise time-point comparisons will be conducted. Expression measurements may be transformed to satisfy modeling assumptions.

Recruitment status

TERMINATED

Study phase

Target enrollment

5 participants

Primary outcome timeframe

Baseline to up to 30 days post-nephrectomy

Results posted on

2020-07-07

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (AGS-003 Immunotherapy, Nephrectomy) Patients receive 3 injections of renal cell carcinoma/cluster of CD40L RNA-transfected autologous dendritic cell vaccine AGS-003 ID once every 7 days during weeks 6-8 in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy on week 10. Laboratory Biomarker Analysis: Correlative studies Nephrectomy: Undergo partial or radical nephrectomy Renal Cell Carcinoma/CD40L RNA-Transfected Autologous Dendritic Cell Vaccine AGS-003: Given ID
Overall Study STARTED	5
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (AGS-003 Immunotherapy, Nephrectomy) Patients receive 3 injections of renal cell carcinoma/cluster of CD40L RNA-transfected autologous dendritic cell vaccine AGS-003 ID once every 7 days during weeks 6-8 in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy on week 10. Laboratory Biomarker Analysis: Correlative studies Nephrectomy: Undergo partial or radical nephrectomy Renal Cell Carcinoma/CD40L RNA-Transfected Autologous Dendritic Cell Vaccine AGS-003: Given ID
Overall Study Study terminated prior to start of treat	1

Baseline Characteristics

Pre and post treatment samples were to be analyzed in batch. The study was terminated early due and samples were not analyzed.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (AGS-003 Immunotherapy, Nephrectomy) n=5 Participants Patients receive 3 injections of renal cell carcinoma/cluster of CD40L RNA-transfected autologous dendritic cell vaccine AGS-003 ID once every 7 days during weeks 6-8 in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy on week 10. Laboratory Biomarker Analysis: Correlative studies Nephrectomy: Undergo partial or radical nephrectomy Renal Cell Carcinoma/CD40L RNA-Transfected Autologous Dendritic Cell Vaccine AGS-003: Given ID
Age, Continuous	63.4 years STANDARD_DEVIATION 19.4 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to up to 30 days post-nephrectomy

Population: The clinical trial was terminated due to lack of funding before data were collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 30 days

Population: Only patients who received any injections were included.

Summarized in all patients who received AGS-003. These rates will be described as the proportion of patients with the event, by grade, and supported with exact 95% confidence intervals.

Outcome measures

Outcome measures
Measure	Treatment (AGS-003 Immunotherapy, Nephrectomy) n=4 Participants Patients receive 3 injections of renal cell carcinoma/cluster of CD40L RNA-transfected autologous dendritic cell vaccine AGS-003 ID once every 7 days during weeks 6-8 in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy on week 10. Laboratory Biomarker Analysis: Correlative studies Nephrectomy: Undergo partial or radical nephrectomy Renal Cell Carcinoma/CD40L RNA-Transfected Autologous Dendritic Cell Vaccine AGS-003: Given ID
Adverse Event Rates as Graded by the Common Terminology Criteria for Adverse Events Version 4.0 Any Grade AE	100 percentage of subjects Interval 40.0 to 100.0
Adverse Event Rates as Graded by the Common Terminology Criteria for Adverse Events Version 4.0 Any Grade 1	100 percentage of subjects Interval 40.0 to 100.0
Adverse Event Rates as Graded by the Common Terminology Criteria for Adverse Events Version 4.0 Any Grade 2	50 percentage of subjects Interval 7.0 to 93.0
Adverse Event Rates as Graded by the Common Terminology Criteria for Adverse Events Version 4.0 Any Grade 3	25 percentage of subjects Interval 5.0 to 70.0
Adverse Event Rates as Graded by the Common Terminology Criteria for Adverse Events Version 4.0 Any Grade 4	0 percentage of subjects Interval 0.0 to 49.0
Adverse Event Rates as Graded by the Common Terminology Criteria for Adverse Events Version 4.0 Any Grade 5	0 percentage of subjects Interval 0.0 to 49.0

Adverse Events

Treatment (AGS-003 Immunotherapy, Nephrectomy)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (AGS-003 Immunotherapy, Nephrectomy) n=4 participants at risk Patients receive 3 injections of renal cell carcinoma/cluster of CD40L RNA-transfected autologous dendritic cell vaccine AGS-003 ID once every 7 days during weeks 6-8 in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy on week 10. Laboratory Biomarker Analysis: Correlative studies Nephrectomy: Undergo partial or radical nephrectomy Renal Cell Carcinoma/CD40L RNA-Transfected Autologous Dendritic Cell Vaccine AGS-003: Given ID
Cardiac disorders Bundle branch block	25.0% 1/4 • Number of events 1 • All deaths and new AEs occurring from the date of signed consent until 30-days after the administration of the last study treatment or a new treatment is started, are reported.
General disorders Fatigue	25.0% 1/4 • Number of events 1 • All deaths and new AEs occurring from the date of signed consent until 30-days after the administration of the last study treatment or a new treatment is started, are reported.
General disorders Inflammation	25.0% 1/4 • Number of events 2 • All deaths and new AEs occurring from the date of signed consent until 30-days after the administration of the last study treatment or a new treatment is started, are reported.
General disorders Influenza like illness	25.0% 1/4 • Number of events 1 • All deaths and new AEs occurring from the date of signed consent until 30-days after the administration of the last study treatment or a new treatment is started, are reported.
General disorders Injection site inflammation	25.0% 1/4 • Number of events 1 • All deaths and new AEs occurring from the date of signed consent until 30-days after the administration of the last study treatment or a new treatment is started, are reported.
General disorders Injection site pain	25.0% 1/4 • Number of events 1 • All deaths and new AEs occurring from the date of signed consent until 30-days after the administration of the last study treatment or a new treatment is started, are reported.
General disorders Injection site pruritus	25.0% 1/4 • Number of events 1 • All deaths and new AEs occurring from the date of signed consent until 30-days after the administration of the last study treatment or a new treatment is started, are reported.
General disorders Injection site reaction	50.0% 2/4 • Number of events 2 • All deaths and new AEs occurring from the date of signed consent until 30-days after the administration of the last study treatment or a new treatment is started, are reported.
General disorders Injection site swelling	25.0% 1/4 • Number of events 1 • All deaths and new AEs occurring from the date of signed consent until 30-days after the administration of the last study treatment or a new treatment is started, are reported.
Infections and infestations Nasopharyngitis	25.0% 1/4 • Number of events 2 • All deaths and new AEs occurring from the date of signed consent until 30-days after the administration of the last study treatment or a new treatment is started, are reported.
Injury, poisoning and procedural complications Procedural pain	25.0% 1/4 • Number of events 2 • All deaths and new AEs occurring from the date of signed consent until 30-days after the administration of the last study treatment or a new treatment is started, are reported.
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 1/4 • Number of events 1 • All deaths and new AEs occurring from the date of signed consent until 30-days after the administration of the last study treatment or a new treatment is started, are reported.
Musculoskeletal and connective tissue disorders Pain in extremity	25.0% 1/4 • Number of events 1 • All deaths and new AEs occurring from the date of signed consent until 30-days after the administration of the last study treatment or a new treatment is started, are reported.
Respiratory, thoracic and mediastinal disorders Epistaxis	25.0% 1/4 • Number of events 1 • All deaths and new AEs occurring from the date of signed consent until 30-days after the administration of the last study treatment or a new treatment is started, are reported.
Skin and subcutaneous tissue disorders Rash	25.0% 1/4 • Number of events 2 • All deaths and new AEs occurring from the date of signed consent until 30-days after the administration of the last study treatment or a new treatment is started, are reported.

Additional Information

Senior Administrator, Compliance - Clinical Research Services

Roswell Park Cancer Institute

Phone: 716-845-2300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place