Back to results

CLARA: Somatic and Germline Mechanisms That Impact Renal Cancer Immunotherapy

Primary Purpose

Renal Cancer Metastatic

Status

Recruiting

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

Nivolumab

Ipilimumab

About this trial

This is an interventional treatment trial for Renal Cancer Metastatic focused on measuring Renal Cancer, Nivolumab, Ipilimumab, Immunotherapy, molecular profiling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Renal cell carcinoma patient: histological confirmed clear cell tumor;
First-line metastatic treatment;
Stage IV with at least one measured lesion;
Fresh-frozen primary tumor tissue available;
No previous immunotherapy or tyrosine kinase inhibitor treatment;
All International Metastatic RCC Database Consortium (IMDC) Risk Score;
Karnofsky Performance Scale (KPS) >=70;
>=18 years old.

Exclusion Criteria:

History of a known or suspected autoimmune disease;
Any condition requiring systemic treatment with corticosteroids;
Creatinine clearance < 40mL/min;
Alanine aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) > 5 x ULN;
Pregnant women.

Sites / Locations

Hospital das Clínicas da Faculdade de Medicina de Ribeirao Preto - USPRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nivolumab+Ipilimumab

Arm Description

Nivolumab IV 3mg/kg 3/3w + Ipilimumab 1mg/kg 3/3w 4 doses, followed by Nivolumab IV 480mg 4/4w until progression, toxicity, or up to 2 years of use.

Outcomes

Primary Outcome Measures

Overall Survival

Progression-free survival

Secondary Outcome Measures

Overall Response Rate

Full Information

NCT ID

NCT05215470

First Posted

January 17, 2022

Last Updated

February 27, 2023

Sponsor

Hospital das Clínicas de Ribeirão Preto

Collaborators

Bristol-Myers Squibb, Fundação de Amparo à Pesquisa do Estado de São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT05215470

Brief Title

CLARA: Somatic and Germline Mechanisms That Impact Renal Cancer Immunotherapy

Official Title

CLARA: Characterization of Somatic and Germline Mechanisms That Impact the Immunotherapy Treatment and Prognosis of Patients With Renal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 18, 2022 (Actual)

Primary Completion Date

November 30, 2024 (Anticipated)

Study Completion Date

November 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital das Clínicas de Ribeirão Preto

Collaborators

Bristol-Myers Squibb, Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The study is studying the joint contribution and interactions of germline variants and somatic mutations and their impact on Renal Cell Carcinoma (RCC) development and treatment (immunotherapy).

Detailed Description

One hundred newly diagnosticated stage IV RCC patients will be recruited in the Ribeirao Preto Medical School. Patients will be treated with immune checkpoint inhibitors (ICI) combination: nivolumab (3 mg/kg of body weight) plus ipilimumab (1 mg/kg) intravenously every three weeks for four doses, followed by nivolumab 480mg every four weeks, until progression, toxicity or complete two years of treatment. Patients will be followed up for the clinical outcome (progression-free survival, best response, and overall survival). Fresh-frozen primary tumor tissue will be collected for somatic genomic characterization. Blood DNA will be genotyped for the identification of common germline variation, as well as ancestry determination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Cancer Metastatic

Keywords

Renal Cancer, Nivolumab, Ipilimumab, Immunotherapy, molecular profiling

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nivolumab+Ipilimumab

Arm Type

Experimental

Arm Description

Nivolumab IV 3mg/kg 3/3w + Ipilimumab 1mg/kg 3/3w 4 doses, followed by Nivolumab IV 480mg 4/4w until progression, toxicity, or up to 2 years of use.

Intervention Type

Drug

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

Opdivo

Intervention Description

Nivolumab is called an anti-PD-1 (Programmed Cell Death Ligand 1) or a checkpoint inhibitor and is an antibody (a type of human protein) designed to allow the body's own immune system to destroy tumors

Intervention Type

Drug

Intervention Name(s)

Ipilimumab

Other Intervention Name(s)

Yervoy

Intervention Description

Ipilimumab is called an anti-CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) and is a type of antibody that works to prevent the body's immune system from stopping to fight a specific cancer

Primary Outcome Measure Information:

Title

Overall Survival

Time Frame

3 years

Title

Progression-free survival

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Overall Response Rate

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Renal cell carcinoma patient: histological confirmed clear cell tumor; First-line metastatic treatment; Stage IV with at least one measured lesion; Fresh-frozen primary tumor tissue available; No previous immunotherapy or tyrosine kinase inhibitor treatment; All International Metastatic RCC Database Consortium (IMDC) Risk Score; Karnofsky Performance Scale (KPS) >=70; >=18 years old. Exclusion Criteria: History of a known or suspected autoimmune disease; Any condition requiring systemic treatment with corticosteroids; Creatinine clearance < 40mL/min; Alanine aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) > 5 x ULN; Pregnant women.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Leandro Machado Colli, MD, PhD

Phone

16991744260

leandroc@fmrp.usp.br

First Name & Middle Initial & Last Name or Official Title & Degree

Matheus Aquino Guimarães, MD, Msc

matheusamguimaraes@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leandro Machado Colli, MD, PhD

Organizational Affiliation

University of Sao Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital das Clínicas da Faculdade de Medicina de Ribeirao Preto - USP

City

Ribeirão Preto

State/Province

Sao Paulo

ZIP/Postal Code

14040-900

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Leandro Colli

Phone

16991744260

leandroc@fmrp.usp.br

First Name & Middle Initial & Last Name & Degree

Rodolfo Borges Reis, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The research team is committed to sharing data generated by this project with the research community. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication.

IPD Sharing Access Criteria

Requests may be directed to PI.

Learn more about this trial

CLARA: Somatic and Germline Mechanisms That Impact Renal Cancer Immunotherapy

We'll reach out to this number within 24 hrs