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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03084757
Recruitment Status : Active, not recruiting
First Posted : March 21, 2017
Last Update Posted : May 20, 2022
Sponsor:
Information provided by (Responsible Party):
Institut Curie

Tracking Information
First Submitted Date  ICMJE March 2, 2017
First Posted Date  ICMJE March 21, 2017
Last Update Posted Date May 20, 2022
Actual Study Start Date  ICMJE May 26, 2017
Estimated Primary Completion Date September 26, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2022)
  • 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.
  • 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.
  • 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
  • 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.
  • 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
  • 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.
  • Proportion of patients with a PFS2 to PFS1 ratio superior to 1.5, including patients who were treated with matched therapy based on a molecular alteration outside of RAF/MEK pathway [ 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2017)
  • 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.
  • 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.
  • 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
  • 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.
  • 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
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Cancer
  • Solid Tumor, Adult
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: research of druggable molecular alterations on tumor biopsy
Intervention: Diagnostic Test: research of druggable molecular alterations on tumor biopsy
Publications * 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, Bièche 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 30, 2022)
170
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2017)
370
Estimated Study Completion Date  ICMJE November 26, 2022
Estimated Primary Completion Date September 26, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03084757
Other Study ID Numbers  ICMJE IC 2016-06
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Institut Curie
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Institut Curie
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institut Curie
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP