Recurrent Renal Cell CarcinomaNCT02170389

Vaccine Therapy Before Surgery in Treating Patients With Localized Kidney Cancer

A study testing Laboratory Biomarker Analysis, Nephrectomy and Renal Cell Carcinoma/CD40L RNA-Transfected Autologous Dendritic Cell Vaccine AGS-003 in people with Recurrent Renal Cell Carcinoma and Stage I Renal Cell Cancer, run by Roswell Park Cancer Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This pilot clinical trial studies vaccine therapy before surgery in treating patients with kidney cancer that has not spread to nearby lymph nodes or to other parts of the body. Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells when… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Recurrent Renal Cell Carcinoma, Stage I Renal Cell Cancer, Stage II Renal Cell Cancer
What is being tested?: Laboratory Biomarker Analysis, Nephrectomy and Renal Cell Carcinoma/CD40L RNA-Transfected Autologous Dendritic Cell Vaccine AGS-003
Type of treatment: Vaccines, Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 14 Oct 2014to 17 Mar 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have localized non-metastatic renal cell carcinoma (RCC) (< pT2, NO, MO), as per the American Joint Committee on Cancer (AJCC) seventh (7th) edition criteria
Must be surgical candidates as deemed fit by surgeon
Patients of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately
Willingness to undergo leukapheresis and biopsy procedures for the autologous components (peripheral blood mononuclear cells, plasma and fresh tumor specimen) required for manufacture of AGS-003
Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Who cannot join

Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (e.g., shortness of breath, fatigue, orthopnea, paroxysmal nocturnal dyspnea), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Radiation to primary tumor prior to enrollment in this study
Pregnant or nursing female patients
Unwilling or unable to follow protocol requirements
Active autoimmune disease or condition requiring chronic immunosuppressive therapy (e.g., rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, organ transplant recipient, etc.)

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NOTE: abnormal laboratory values for autoimmunity markers in the absence of other signs/symptoms of autoimmune disease are not exclusionary
Known clinically significant infections, including human immunodeficiency virus (HIV) and active hepatitis B or C
Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive treatment (i.e., any significant medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the subject's risk by participating in this study)
Chronic use of systemic corticosteroids (i.e., >= 10 mg/day prednisone or equivalent)
Received an investigational agent within 30 days prior to enrollment

Trial locations and contacts

1 site in 1 country.

United States1 site

Roswell Park Cancer Institute
Buffalo, New York, 14263

Other trials in United States

About this study

Official title: Neoadjuvant AGS-003 Immunotherapy in Patients With Localized Kidney Cancer <pT2

Read the detailed description

PRIMARY OBJECTIVES:

To assess the immune-modulatory systemic and intratumoral effects of AGS-003 (renal cell carcinoma/cluster of differentiation [CD]40L ribonucleic acid [RNA]-transfected autologous dendritic cell vaccine AGS-003) as neoadjuvant treatment in patients with localized renal cell carcinoma.

SECONDARY OBJECTIVES:

To assess the feasibility that total tumor RNA processing-related activities meet specifications for AGS-003 manufacturing utilizing a core needle biopsy procedure for tumor harvesting prior to nephrectomy.

OUTLINE:

Patients receive 3 injections of renal cell carcinoma/cluster of CD40L RNA-transfected autologous dendritic cell vaccine AGS-003 intradermally (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.

After completion of study treatment, patients are followed up at 1 month.

Conditions: Recurrent Renal Cell Carcinoma, Stage I Renal Cell Cancer, Stage II Renal Cell Cancer
Being tested: Laboratory Biomarker Analysis, Nephrectomy, Renal Cell Carcinoma/CD40L RNA-Transfected Autologous Dendritic Cell Vaccine AGS-003
Medical subject headings: Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Laboratory Biomarker AnalysisOther
Correlative studies
NephrectomyProcedure or surgery
Undergo partial or radical nephrectomy
Renal Cell Carcinoma/CD40L RNA-Transfected Autologous Dendritic Cell Vaccine AGS-003Biological
Also called AGS-003
Given ID

Study groups in NCT02170389
Study group	Role	What they receive
Treatment (AGS-003 immunotherapy, nephrectomy)	Experimental	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. Receives: Other: Laboratory Biomarker Analysis; Procedure: Nephrectomy; Biological: Renal Cell Carcinoma/CD40L RNA-Transfected Autologous Dendritic Cell Vaccine AGS-003

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Immune Marker Expression Levels
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.
Measured: Baseline to up to 30 days post-nephrectomy

Secondary outcomes (1)

Adverse Event Rates as Graded by the Common Terminology Criteria for Adverse Events Version 4.0
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.
Measured: Up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Oct 201417 Mar 2017

First posted23 Jun 2014 (estimated)
Study start14 Oct 2014
Primary completion17 Mar 2017
Study completion17 Mar 2017

Why it stopped: sponsor having financial difficulties

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Recurrent Renal Cell CarcinomaStudies of the same condition, open and under way.
More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02170389
Sponsor's protocol ID: I 250113
Other IDs: NCI-2014-01254, AGS-003-012, I 250113, P30CA016056
Status last verified: Jul 2020
First submitted: 19 Jun 2014
Last updated: 7 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
Metastatic Solid Tumor, Recurrent Solid Tumor
Active, not recruitingPhase 1/2
AB-2100, an Integrated Circuit T Cell Therapy in Patients With Recurrent Clear-cell Renal Cell Carcinoma (ccRCC)
Advanced/Metastatic Clear Cell Renal Cell Carcinoma, Recurrence
Active, not recruitingPhase 1/2
Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction
Advanced Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma
RecruitingPhase 1/2
Substudy 03C: A Study of Combination Therapies in Participants With Renal Cell Carcinoma With Recurrent Disease During or After Anti-PD-(L)1 Therapy (MK-3475-03C/KEYMAKER-U03)
Renal Cell Carcinoma
Active, not recruitingPhase 1
A Trial of Belzutifan (PT2977, MK-6482) Tablets In Patients With Advanced Solid Tumors (MK-6482-001)
Advanced Solid Tumors, Solid Tumor

All Recurrent Renal Cell Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neoadjuvant AGS-003 Immunotherapy in Patients With Localized Kidney Cancer <pT2
ClinicalTrials.gov ID: NCT02170389
Acronym / sponsor ID: I 250113
Conditions: Recurrent Renal Cell Carcinoma, Stage I Renal Cell Cancer, Stage II Renal Cell Cancer
Study type: Interventional
Recruitment status: TerminatedReason stopped: sponsor having financial difficulties
Enrolment: 5 participants (actual)
Lead sponsor: Roswell Park Cancer InstituteUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 14 Oct 2014 (actual)
Primary completion: 17 Mar 2017 (actual)
Study completion: 17 Mar 2017 (actual)
First posted: 23 Jun 2014 (estimated)
Results: Posted 6 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To assess the immune-modulatory systemic and intratumoral effects of AGS-003 (renal cell carcinoma/cluster of differentiation [CD]40L ribonucleic acid [RNA]-transfected autologous dendritic cell vaccine AGS-003) as neoadjuvant treatment in patients with localized renal cell carcinoma.

SECONDARY OBJECTIVES:

To assess the feasibility that total tumor RNA processing-related activities meet specifications for AGS-003 manufacturing utilizing a core needle biopsy procedure for tumor harvesting prior to nephrectomy.

OUTLINE:

After completion of study treatment, patients are followed up at 1 month.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (AGS-003 immunotherapy, nephrectomy)	Experimental	Other: Laboratory Biomarker Analysis, Procedure: Nephrectomy, Biological: Renal Cell Carcinoma/CD40L RNA-Transfected Autologous Dendritic Cell Vaccine AGS-003Patients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Have localized non-metastatic renal cell carcinoma (RCC) (< pT2, NO, MO), as per the American Joint Committee on Cancer (AJCC) seventh (7th) edition criteria
Must be surgical candidates as deemed fit by surgeon
Patients of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately
Willingness to undergo leukapheresis and biopsy procedures for the autologous components (peripheral blood mononuclear cells, plasma and fresh tumor specimen) required for manufacture of AGS-003
Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Key exclusion criteria (11 listed)

Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (e.g., shortness of breath, fatigue, orthopnea, paroxysmal nocturnal dyspnea), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Radiation to primary tumor prior to enrollment in this study
Pregnant or nursing female patients
Unwilling or unable to follow protocol requirements

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Laboratory Biomarker AnalysisCorrelative studies	Other	Treatment (AGS-003 immunotherapy, nephrectomy)
NephrectomyUndergo partial or radical nephrectomy	Procedure or surgery	Treatment (AGS-003 immunotherapy, nephrectomy)
Renal Cell Carcinoma/CD40L RNA-Transfected Autologous Dendritic Cell Vaccine AGS-003Also: AGS-003Given ID	Biological	Treatment (AGS-003 immunotherapy, nephrectomy)

Primary outcome

Change in Immune Marker Expression Levels
Time frame: Baseline to up to 30 days post-nephrectomy
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.

1 secondary outcome

Adverse Event Rates as Graded by the Common Terminology Criteria for Adverse Events Version 4.0
Time frame: Up to 30 days

Results and safety

Results posted to the registry on 6 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment (AGS-003 Immunotherapy, Nephrectomy)	5	4

Primary outcome: Change in Immune Marker Expression Levels

Time frame: Baseline to up to 30 days post-nephrectomy

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment (AGS-003 Immunotherapy, Nephrectomy)	0 of 4 (0%)	4 of 4 (100%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Recurrent Renal Cell Carcinoma

RecruitingPhase 1
A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
Metastatic Solid Tumor, Recurrent Solid Tumor
Active, not recruitingPhase 1/2
AB-2100, an Integrated Circuit T Cell Therapy in Patients With Recurrent Clear-cell Renal Cell Carcinoma (ccRCC)
Advanced/Metastatic Clear Cell Renal Cell Carcinoma, Recurrence
Active, not recruitingPhase 1/2
Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction
Advanced Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma
RecruitingPhase 1/2
Substudy 03C: A Study of Combination Therapies in Participants With Renal Cell Carcinoma With Recurrent Disease During or After Anti-PD-(L)1 Therapy (MK-3475-03C/KEYMAKER-U03)
Renal Cell Carcinoma
Active, not recruitingPhase 1
A Trial of Belzutifan (PT2977, MK-6482) Tablets In Patients With Advanced Solid Tumors (MK-6482-001)
Advanced Solid Tumors, Solid Tumor

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dr. med.Thomas Schwaab, MD principal investigator

Roswell Park Cancer Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Immune Marker Expression Levels (time frame: Baseline to up to 30 days post-nephrectomy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02170389.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.