SHIVA02 - Evaluation of the Efficacy of Targeted Therapy Based on Tumor Molecular Profiling in Patients With Advanced Cancer Using Each Patient as Its Own Control (SHIVA02)

NCT03084757 | Completed

• 1 other identifier: IC 2016-06
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 4

Brief Summary

The study will evaluate the efficacy of targeted therapy based on tumor molecular profiling versus conventional chemotherapy in patients with advanced cancer using each patient as its own control. This study is a study involving patients with advanced cancer. All types of solid tumors will be allowed in the study.

Conditions

Cancer; Solid Tumor, Adult

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with a PFS2 to PFS1 ratio superior to 1.5.

  PFS1 is defined as the time to a documented progression under conventional therapy according to RECIST 1.1. PFS2 is defined as the time to a documented progression or death when patients are treated by targeted therapy according to RECIST 1.1

  3 years

Secondary Outcomes (7)

• Overall response rate (ORR) on both treatments

  3 years

• Overall survival (OS)

  3 years

• number of grade 3 or 4 adverse events and grade 1 or 2 adverse events that lead to dose modification or interruption

  3 years

• Ability of ctDNA to detect molecular alterations identified on tumor biopsies

  at baseline

• Ability of fine-needle aspiration cytology to detect molecular alterations identified on tumor biopsies

  at baseline

Study Arms (1)

research of druggable molecular alterations on tumor biopsy

EXPERIMENTAL

Diagnostic Test: research of druggable molecular alterations on tumor biopsy

Interventions

research of druggable molecular alterations on tumor biopsy DIAGNOSTIC_TEST

The study will run in 2 steps. Before starting a new treatment, patients with advanced cancer will undergo a tumor biopsy of a metastatic site in order to perform molecular analyses seeking for druggable molecular alterations

research of druggable molecular alterations on tumor biopsy

Eligibility Criteria

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

You may qualify if:

• Patient with recurrent/metastatic solid tumor who failed or are not candidate for treatments usually proposed in first intention and for whom a prospective clinical trial has been indicated in a tumor board
• Patient with a documented progression before the start of conventional therapy according to RECIST 1.1.
• Patient ≥18 years old
• \) Disease amenable to biopsy 5) ECOG performance status of 0 or 1 6) Measurable disease 7) Adequate renal function defined by a serum creatinine \<1.5xUNL (upper normal limit) 8) Adequate liver function test defined by SGOT \& SGPT \<3xUNL (5xUNL in case of liver metastases), and bilirubin level \<1.5xUNL 9) Adequate bone marrow function defined by platelets \>100,000/mm3, hemoglobin \>9 g/dL, and neutrophils \>1,000/mm3 10) Patient must be affiliated to the French Social Security System 11) Signed informed consent 12 For female of child-bearing potential: a negative pregnancy test \<72 hours before starting study treatment is required. If sexually active, female of childbearing potential must use "highly effective" methods of contraception for the study duration and for 3 months following the last treatment 13) For male of reproductive potential: any sexually active male patient must use a condom while on study treatment and for 3 months following the last treatment
• Patient for whom the Molecular Biology Board (MBB) has identified a druggable molecular alteration of the RAF/MEK signaling pathway and a treatment recommendation has been established by the MBB.
• Patient with a documented progression during the conventional therapy according to RECIST 1.1.
• Patient with imaging performed within 28 days prior to the planned start date of treatment

You may not qualify if:

• Patients below 18 years old
• Patients with CNS involvement that has not been controlled for \>3 months
• Patients planned to receive a molecularly targeted agent
• Patients who are candidate to receive a molecularly targeted agent that is approved for their disease
• Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, including uncontrolled diabetes, cardiac disease, uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infection within one year, chronic liver or renal disease, active gastrointestinal tract ulceration, severely impaired lung function
• Pregnant and/or breastfeeding women
• Patients individually deprived of liberty or placed under the authority of a tutor
• Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• Known HIV, HBV, or HCV infection

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (4)

Institut Bergonié

Bordeaux, 33076, France

Location

Centre LEON BERARD

Lyon, 69373, France

Location

Institut Curie

Paris, 75005, France

Location

Institut Curie Hôpital René Huguenin

Saint-Cloud, 92210, France

Location

Related Publications (1)

• Dupain C, Masliah-Planchon J, Gu C, Girard E, Gestraud P, Du Rusquec P, Borcoman E, Bello D, Ricci F, Hescot S, Sablin MP, Tresca P, de Moura A, Loirat D, Frelaut M, Vincent-Salomon A, Lecerf C, Callens C, Antonio S, Franck C, Mariani O, Bieche I, Kamal M, Le Tourneau C, Servois V. Fine-needle aspiration as an alternative to core needle biopsy for tumour molecular profiling in precision oncology: prospective comparative study of next-generation sequencing in cancer patients included in the SHIVA02 trial. Mol Oncol. 2021 Jan;15(1):104-115. doi: 10.1002/1878-0261.12776. Epub 2020 Sep 15.

  PMID: 32750212 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 21, 2017
• Study Start: May 26, 2017
• Primary Completion: October 20, 2022
• Study Completion: May 31, 2024
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data requests can be submitted starting 9 months after article publication and will be made accessible for up to 12 months.
• Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific reserach, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Locations

FR (4)