Vaccination with dendritic cells pulsed with autologous tumorhomogenate in combination with HD-IL2 and immunomodulating radiotherapy in metastatic RCC: a phase II trial (RENALVax-2)

Phase 1

• Conditions: metastatic renal cancer; MedDRA version: 20.0Level: PTClassification code 10050513Term: Metastatic renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-000556-14-IT
• Lead Sponsor: ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-15
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

1. Signed Written Informed Consent: patients must be willing and able to give written informed consent, that has to be given before starting of screening procedures.
2. Availability of autologous tumor tissue fulfilling acceptance criteria prescribed by the Product Specification File”.
3. Patients must have histologically or cytologically confirmed RCC (all histology types except for urothelial cancer);
4. Patients must have stage IV disease in progression after at least 1 TKI and/or antiangiogenetic and/or mTOR inhibitors therapy
(patients must have finished prior treatments at least 4 weeks before the first IL2 dose)
5. Patients must have at least one measurable lesion, according to the irRC response criteria (see section 8 ), after asportation of tumor tissue for vaccine preparation. The tumor lesions that will be irradiated are excluded for response evaluation.
6. Life expectancy of greater than 3 months.
7. ECOG performance status 0-1
8. Patients must have organ and marrow function as defined below:
-leukocytes >4000/L
-absolute neutrophil count>1,500/L
-platelets >100,000/L
-total bilirubin within normal institutional limits (nil)
- AST(SGOT)/ALT(SGPT)<2.5 X institutional upper limit of normal
-creatinine< 1.5 mg/dl
- haemoglobin >8.0 gm/dl
- hematocrit <30%
9. ECG and echocardiography within normal institutional limits
10. Pulmonary function tests within normal institutional limits
11. No contraindication for the use of vasopressor agents
12. Negative screening tests for HIV, HBV HCV and syphilis not older than 30 days before performing any of the GMP-regulated activities required
13. Men and women aged > 18 years.
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

1.Patients who have positive tests to HCV, HBV, HIV, or syphilis (specific blood testing must be performed within 30 days before
any GMP-regulated activity).
2.Patients who did not have prior lines of systemic therapy for advanced disease.
3.Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
4.Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure,
unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study
requirements (on physician’s judgment).
5.Other known malignant neoplastic diseases in the patient’s medical history with a disease-free interval of less than 3 years
(except for previously treated basal cell carcinoma and in situ carcinoma of the uterine cervix);
6.Patients who have had chemotherapy or radiotherapy or immunotherapy 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.
7.Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because
they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
8.History of allergic reactions attributed to compounds of similar chemical or biologic composition to IL-2 or other agents used in
the study.
9.Any autoimmune disease which could be exacerbated by IL-2
10.A medical illness requiring chronic treatments with corticosteroids or other immunosuppressive agents
11.A history of significant cardiovascular disease, including myocardial infarction, congestive heart failure, primary cardiac
arrhythmias, angina pectoris or cerebrovascular accident
12.HIV-positivity, whether or not symptomatic
13.Any contraindication to undergo leukapheresis as evaluated by transfusionist (e.g. severe anemia, piastrinopenia, oral
anticoagulant therapy) or to undergo surgery.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Overal Response Rate by irRC ;Secondary Objective: Toxicity, Overall Survival, Duration of response, PFS, ORR by RECIST 1.1, Prognostic and predictive marker response, Immunological response;Primary end point(s): Overal Response Rate by IrRC;Timepoint(s) of evaluation of this end point: 36 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Prognostic and predictive marker response;Timepoint(s) of evaluation of this end point: 36 months