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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) (SHIVA02)

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ClinicalTrials.gov Identifier: NCT03084757
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Curie

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.

Condition or disease Intervention/treatment Phase
Cancer Solid Tumor, Adult Diagnostic Test: research of druggable molecular alterations on tumor biopsy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: 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
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: research of druggable molecular alterations on tumor biopsy Diagnostic Test: research of druggable molecular alterations on tumor biopsy
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




Primary Outcome Measures :
  1. Proportion of patients with a PFS2 to PFS1 ratio superior to 1.5. [ Time Frame: 3 years ]
    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


Secondary Outcome Measures :
  1. Overall response rate (ORR) on both treatments [ Time Frame: 3 years ]
    Evaluation of the best objective response rate (ORR) for each treatment according to RECIST 1.1 The best ORR is the best response reached during treatment according to RECIST 1.1 criteria.

  2. Overall survival (OS) [ Time Frame: 3 years ]
    Evaluation of overall survival (OS) defined as the time between inclusion and death, whatever the cause is. Alive patients will be censored at their last known contact date.

  3. number of grade 3 or 4 adverse events and grade 1 or 2 adverse events that lead to dose modification or interruption [ Time Frame: 3 years ]
    Evaluation of toxicities related to treatments according to CTCAE v4.03. Only grade 3 or 4 adverse events and grade 1 or 2 adverse events that lead to dose modification or interruption

  4. Ability of ctDNA to detect molecular alterations identified on tumor biopsies [ Time Frame: at baseline ]
    Percentage of patients for whom all druggable molecular alterations detected on the tumor biopsy are also detected on ctDNA.

  5. Ability of fine-needle aspiration cytology to detect molecular alterations identified on tumor biopsies [ Time Frame: at baseline ]
    Percentage of patients for whom all druggable molecular alterations detected on the tumor biopsy are also detected on fine-needle aspiration cytology

  6. Ability of sequential ctDNA sampling to predict response/resistance to treatment [ Time Frame: through study completion, every 2 months ]
    Changes in ctDNA levels and molecular alterations observed at different time points.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Inclusion will proceed in 2 steps. First step for molecular analyses and second step in order to be included in the efficacy analysis.

Inclusion criteria for Step 1:

  1. 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
  2. Patient with a documented progression before the start of conventional therapy according to RECIST 1.1.
  3. Patient ≥18 years old

3) 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

Inclusion criteria for Step 2:

  1. 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.
  2. Patient with a documented progression during the conventional therapy according to RECIST 1.1.
  3. Patient with imaging performed within 28 days prior to the planned start date of treatment

Exclusion criteria:

  1. Patients below 18 years old
  2. Patients with CNS involvement that has not been controlled for >3 months
  3. Patients planned to receive a molecularly targeted agent
  4. Patients who are candidate to receive a molecularly targeted agent that is approved for their disease
  5. 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
  6. Pregnant and/or breastfeeding women
  7. Patients individually deprived of liberty or placed under the authority of a tutor
  8. Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  9. Known HIV, HBV, or HCV infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084757


Locations
France
Institut Bergonié Not yet recruiting
Bordeaux, France, 33076
Contact: Antoine ITALIANO, MD         
Principal Investigator: Antoine ITALIANO, MD         
Centre LEON BERARD Recruiting
Lyon, France, 69373
Contact: Philippe CASSIER, MD       philippe.cassier@lyon.unicancer.fr   
Principal Investigator: Philippe CASSIER, MD         
Institut Curie Recruiting
Paris, France, 75005
Contact: Christophe LE TOURNEAU, MD       christophe.letourneau@curie.fr   
Sub-Investigator: Christophe LE TOURNEAU, MD         
Institut Curie Hôpital René Huguenin Recruiting
Saint-Cloud, France, 92210
Contact: Coraline DUBOT, MD       coraline.dubot@curie.fr   
Principal Investigator: Coraline DUBOT, MD         
Sponsors and Collaborators
Institut Curie

Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT03084757     History of Changes
Other Study ID Numbers: IC 2016-06
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No