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Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Renal Cell Carcinoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Renal Cell Carcinoma

A Phase II Single Arm Clinical Trial of a Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Renal Cell Carcinoma

NCT02917772•AIO-Studien-gGmbH

View on ClinicalTrials.gov

Summary

TITAN RCC (0216-ASG) is a Phase 2, open-label study of nivolumab monotherapy with additional nivolumab/ipilimumab "boost" cycles in previously untreated and pretreated (2nd line), advanced or metastatic renal cell carcinoma (mRCC) subjects with intermediate and high risk disease according to IMDC.

Detailed Description

The primary object is to estimate the Objective response rate (ORR) based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of the TITAN regimen in untreated (1st line) and pretreated (2nd line) subjects with International Metastatic RCC Database Consortium (IMDC) intermediate and high risk, advanced Renal cell carcinoma (RCC) with clear cell component

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed Written Informed Consent
•* Subjects 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 must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.
•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 (anti-angiogenic or temsirolimus) \[to be eligible for 2nd line tier\] or no prior systemic therapy for RCC \[to be eligible for 1st line tier\] 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%
•* Measurable disease as per RECIST v1.1
+9 more criteria

Exclusion Criteria

•Age and Reproductive Status
•* Males and Females, ≥ 18 years of age
•* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
•* Women must not be breastfeeding
•* Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for a period of 30 days (duration of ovulatory cycle) plus the time required for the investigational drug to undergo five half-lives. The terminal half lives of nivolumab and ipilimumab are up to 25 days and 18 days, respectively. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug.
•* Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for a period of 90 days (duration of sperm turnover) plus the time required for the investigational drug to undergo five half-lives. The terminal half lives of nivolumab and ipilimumab are up to 25 days and 18 days, respectively. Males who receive nivolumab combined with ipilimumab who are sexually active with WOCBP must continue contraception for 31 weeks (90 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug.
•* Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, WOCBP must still undergo pregnancy testing as described in this section.
•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.
•Medical History and Concurrent Diseases
+23 more criteria

Locations (35)

Ordensklinikum Linz Barmherzige Schwestern

Linz, Austria

AKH Wien Universitätsklinik für Innere Medizin I

Vienna, Austria

ZNA Middelheim

Antwerp, Belgium

CHR Verviers

Verviers, Belgium

Fakultní nemocnice Hradec Králové

Hradec Králové, Czechia

Fakultní nemocnice Olomouc

Olomouc, Czechia

FN Motol

Prague, Czechia

Všeobecné fakultní nemocnice

Prague, Czechia

CHD Vendée

La Roche-sur-Yon, France

Centre Hôpitalier Lyon Sud

Lyon, France

Key Dates

Start Date

October 1, 2016

Primary Completion Date

October 1, 2021

Completion Date

October 1, 2022

Last Updated

October 6, 2022

Enrollment

200

ACTUAL participants

Conditions

Carcinoma, Renal CellClear-cell Metastatic Renal Cell Carcinoma

Interventions

Nivolumab/Ipilimumab

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 6, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Renal Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

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