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CLARA: Somatic and Germline Mechanisms That Impact Renal Cancer Immunotherapy

NCT05215470 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-07-03

No results posted yet for this study

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).

Conditions

  • Renal Cancer Metastatic

Interventions

DRUG

Nivolumab

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

DRUG

Ipilimumab

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

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • Hospital das Clínicas de Ribeirão Preto

    lead OTHER

Principal Investigators

  • Leandro Machado Colli, MD, PhD · University of Sao Paulo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-18
Primary Completion
2024-11-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05215470 on ClinicalTrials.gov