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Clinical Research Platform on Decision Making and Clinical Impact of Biomarker-Driven Precision Oncology (INFINITY)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04389541
Recruitment Status : Recruiting
First Posted : May 15, 2020
Last Update Posted : August 1, 2022
Sponsor:
Collaborators:
Bristol-Myers Squibb
Roche Pharma AG
Information provided by (Responsible Party):
iOMEDICO AG

Brief Summary:
The retrospective cohort study INFINITY will be an instrument to analyze the current practice of precision oncology in the real-world setting. It will provide insight into real-world biomarker-directed treatment of cancer patients not eligible for standard therapies. The study will retrospectively collect medical records' data of patients who received a targeted treatment based on a potentially actionable alteration or biomarker identified by molecular diagnostics. Data of deceased patients will be included. The study will analyze how molecular test results guided clinical decision making. The compiled treatment and outcome data will be a valuable resource to analyze the use and effectiveness of targeted therapy approaches in biomarker-defined and entity-defined subpopulations of cancer patients. These signals might generate new insights and foster progress of targeted cancer treatment. The associated biomarker profiling module aims to set up a decentral biobank for future research on molecular alterations or central re-testing.

Condition or disease
Advanced Solid Tumors or Hematologic Malignancies

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: Clinical Research Platform on Decision Making and Clinical Impact of Biomarker-Driven Precision Oncology
Actual Study Start Date : April 17, 2020
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023



Primary Outcome Measures :
  1. Overall response rate [ Time Frame: Maximum 5 years ]
    Proportion of patients with CR or PR as best response


Secondary Outcome Measures :
  1. Patient and Disease Characteristics [ Time Frame: maximum 5 years ]
    Describe demographics, comorbidities and tumor type of patients not eligible for standard therapies.

  2. Details on molecular diagnostics [ Time Frame: Maximum 5 years ]
    Frequency of type of molecular diagnostic testing performed, of single gene/protein tests, multigene panels or NGS in molecular diagnostics, of type (by panel size) of NGS library sequenced, of proteins and genes tested, of altered proteins and genes, if tested, of treatment recommendations given in molecular diagnostic reports, of implemented treatment recommendations given in molecular diagnostic reports, of the use of a molecular tumor board (MTB), of implementation of the treatment recommendation given by MTB and duration from molecular testing result to start of non-standard targeted treatment

  3. Clinical decision making [ Time Frame: Maximum 5 years (once per targeted therapy) ]
    Frequency of answers rated with a Likert scale on patient's non-suitability for standard therapy options / choice of performed molecular diagnostics / choice of selected molecular target and targeted non-standard therapy / reasons for the selection of targeted non-standard therapy / primary goal of the non-standard targeted therapy / expected advantages of the non-standard targeted therapy and frequency of ESMO Scale of Clinical Actionability for molecular Targets (ESCAT) evidence levels

  4. Evaluation of selected treatment approach assessed via project specific survey [ Time Frame: Maximum 5 years (once per completed targeted therapy) ]
    Frequency of pre-defined answers on therapy duration, effectiveness and overall benefit

  5. Best overall response [ Time Frame: Maximum 5 years ]
    Proportion of patients with complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD)

  6. Disease Control Rate [ Time Frame: Maximum 5 years ]
    Proportion of patients with CR, PR or SD as best response

  7. Time to Response [ Time Frame: Maximum 5 years ]
    Time from start of treatment to the first objective tumor response (e.g., tumor shrinkage of ≥30%) observed for patients who achieved a CR or PR

  8. Duration of Response [ Time Frame: Maximum 5 years ]
    Time from documentation of tumor response to disease progression or death from any cause

  9. Time to treatment failure [ Time Frame: Maximum 5 years ]
    Time from start of therapy to discontinuation of treatment for any reason, including progression, toxicity, and death

  10. Progression-free survival [ Time Frame: Maximum 5 years ]
    Time from start of treatment until disease progression or death

  11. PFS ratio [ Time Frame: Maximum 5 years ]
    PFS ratio of targeted non-standard therapy and preceding treatment line

  12. Overall Survival [ Time Frame: Maximum 5 years ]
    Time from start of treatment until death of any cause


Biospecimen Retention:   Samples With DNA
Tissue samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with advanced solid tumors or hematologic malignancies not eligible for standard therapies who received a targeted therapy based on an actionable alteration or biomarker identified by molecular diagnostics
Criteria

Inclusion Criteria:

  • Advanced solid tumors (i.e. locally advanced, inoperable and/or metastatic) or hematologic malignancies not eligible for standard therapy options (i.e. without further treatment options with drugs approved for the specific indication based on the judgement of the treating physician)
  • Started or completed at the documenting study site a non-standard targeted therapy based on an actionable alteration or biomarker identified by molecular diagnostics
  • Results on molecular diagnostics (e.g. tumor genomic or protein expression test) must be available; based on these results the therapy decision was taken
  • Targeted therapy (given as monotherapy or as part of a therapy regimen) must be non-standard at time point of patient registration in the eCRF
  • Age ≥ 18 years
  • Signed and dated informed consent form (only if patient is alive at time of data entry into the project; not applicable for inclusion of deceased patients' data)

Exclusion Criteria:

  • Non-standard targeted therapy was given within a clinical trial
  • The targeted therapy was given in a line of treatment for which it is non-standard (e.g. treatment in first line instead of second line where it is approved); the targeted therapy is however in principle approved for the given entity
  • The targeted therapy was non-standard because a certain prior treatment has not been applied (e.g. targeted therapy is only approved after platin-based treatment but has been given without prior platin-based treatment); the targeted therapy is however in principle approved for the given entity
  • The targeted therapy was non-standard because a different or no chemotherapy back-bone has been applied (e.g. targeted therapy is approved in combination with cisplatin but has been given with oxaliplatin or without chemotherapy backbone); the targeted therapy is however in principle approved for the given entity

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): NCT04389541


Contacts
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Contact: Sina Grebhardt, PhD +49 761 15242 ext 0 sina.grebhardt@iomedico.com

Locations
Show Show 97 study locations
Sponsors and Collaborators
iOMEDICO AG
Bristol-Myers Squibb
Roche Pharma AG
Investigators
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Principal Investigator: Norbert Marschner, MD Outpatient center for hematology and oncology, Freiburg, Germany
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Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT04389541    
Other Study ID Numbers: IOM-050408
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: August 1, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases