CLARA: Somatic and Germline Mechanisms That Impact Renal Cancer Immunotherapy

NCT05215470 | Active Not Recruiting Phase 2 FDA Drug

• 3 other identifiers: CLARAU1111-1267-7778CA209-6E3
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Renal Cancer Metastatic

Keywords

Renal Cancer; Nivolumab; Ipilimumab; Immunotherapy; molecular profiling

Outcome Measures

Primary Outcomes (2)

• Overall Survival

  3 years

• Progression-free survival

  2 years

Secondary Outcomes (1)

• Overall Response Rate

  2 years

Study Arms (1)

Nivolumab+Ipilimumab

EXPERIMENTAL

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.

Drug: Nivolumab; Drug: Ipilimumab

Interventions

Nivolumab DRUG

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

Also known as: Opdivo

Nivolumab+Ipilimumab

Ipilimumab DRUG

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

Also known as: Yervoy

Nivolumab+Ipilimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital das Clínicas de Ribeirão Preto: lead
• Bristol-Myers Squibb: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

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

Ribeirão Preto, São Paulo, 14040-900, Brazil

Location

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Leandro Machado Colli, MD, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Oncology

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: January 31, 2022
• Study Start: January 18, 2022
• Primary Completion: November 30, 2024
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication.
• Access Criteria: Requests may be directed to PI.

Locations

BR (1)