A phase II single arm clinical trial of a Tailored ImmunoTherapy Approach with Nivolumab in subjects with metastatic or advanced Renal Cell Carcinoma - TITAN RCC

AIO-Studien-gGmbH0 sites200 target enrollmentFebruary 2, 2017

ConditionsSubjects with previously untreated (1st line) or pretreated (2nd line), intermediate or high risk, advanced or metastatic renal cell carcinoma MedDRA version: 20.0Level: LLTClassification code 10038400Term: Renal carcinoma stage IVSystem Organ Class: 100000004864 MedDRA version: 20.0Level: LLTClassification code 10038399Term: Renal carcinoma stage IIISystem Organ Class: 100000004864 MedDRA version: 20.0Level: LLTClassification code 10050076Term: Metastatic renal carcinomaSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

DrugsOPDIVO Yervoy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Subjects with previously untreated (1st line) or pretreated (2nd line), intermediate or high risk, advanced or metastatic renal cell carcinoma
Sponsor: AIO-Studien-gGmbH
Enrollment: 200
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 2, 2017

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

AIO-Studien-gGmbH

Eligibility Criteria

Inclusion Criteria

•1\. Signed Written Informed Consent
•\- Subjects or legally acceptable representatives must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.
•\- Subjects or legally acceptable representatives must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.
•2\. Target Population
•\- Histological confirmation of RCC with a clear\-cell component.
•\- Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
•\- One (antioangiogenic or temsirolimus) or no prior systemic therapy for RCC with the following exception:
•One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors as well as CTLA\-4\- or PD\-1/PD\-L1 immune checkpoint inhibitors, respectively, and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy.
•\- KPS of at least 70% (See Appendix 2\)
•\- Measurable disease as per RECIST v1\.1

Exclusion Criteria

•1\.Target Disease Exceptions
•\- Any history of or current CNS metastases. Baseline imaging of the brain by MRI (preferred) or CT scan is required within 28 days prior to registration.
•2\. Medical History and Concurrent Diseases
•\- Prior systemic treatment with more than one of the following drugs: mTOR, VEGF or VEGF receptor targeted therapy (including, but not limited to, temsirolimus, everolinus, sunitinib, pazopanib, axitinib, tivozanib, and bevacizumab).
•\- Prior treatment with an anti\-PD\-1, anti\-PD\-L1, anti\-PD\-L2, anti\-CD137, or anti CTLA 4 antibody, or any other antibody or drug specifically targeting T\-cell co\-stimulation or checkpoint pathways.
•\- Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (\> 10 mg daily prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger. Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll.
•\- Any condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
•\- Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
•\- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection.
•Known medical condition (eg, a condition associated with diarrhea or acute diverticulitis) that, in the investigator’s opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results.