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

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.

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors or Hematologic Malignancies

• Study Type: Observational
• Enrollment (Actual): 499

Contacts and Locations

Study Locations

• Germany
  • Aschaffenburg, Germany, 63739
    • Studienzentrum Aschaffenburg
  • Aschaffenburg, Germany, 63739
    • MVZ am Klinikum Aschaffenburg
  • Augsburg, Germany, 86152
    • Onkologische Schwerpunktpraxis
  • Bad Liebenwerda, Germany, 04924
    • Hämatologisch-Onkologische Schwerpunktpraxis Bad Liebenwerda
  • Bamberg, Germany, 96049
    • Sozialstiftung Bamberg Medizinisches Versorgungszentrum am Bruderwald gemeinnützige GmbH
  • Bamberg, Germany, 96052
    • Onkologische Schwerpunktpraxis Bamberg
  • Bayreuth, Germany, 95445
    • Klinikum Bayreuth; Klinik für Onkologie und Hämatologie
  • Berlin, Germany, 10707
    • Onkologische Schwerpunktpraxis Kurfürstendamm
  • Berlin, Germany, 14195
    • MVZ Onkologischer Schwerpunkt am Oskar-Helene-Heim
  • Berlin, Germany, 10407
    • Onkologisches Versorgungszentrum Friedrichshain
  • Berlin, Germany, 12627
    • Gemeinschaftspraxis für Onkologie und Hämatologie
  • Berlin, Germany, 13589
    • Evangelisches Waldkrankenhaus,Spandau,Innere Medizin I
  • Bremen, Germany, 28209
    • Onkologisch-Hämatologische Schwerpunktpraxis
  • Coburg, Germany, 96450
    • Klinikum Coburg Hämatologie, Onkologie
  • Coburg, Germany, 96450
    • Schwerpunktpraxis für Hämatologie und internistische Onkologie Coburg
  • Darmstadt, Germany, 64283
    • Klinikum Darmstadt, Onkologisches Studienzentrum
  • Deggendorf, Germany, 94469
    • Onkologisches Zentrum Deggendorf
  • Dresden, Germany, 01307
    • BAG / Onkologische Gemeinschaftspraxis
  • Dresden, Germany, 01127
    • Onkozentrum Dresden/Freiberg
  • Dresden, Germany, 01307
    • Onkologische Gemeinschaftspraxis
  • Düsseldorf, Germany, 40625
    • MVZ Onkologie und Hämatologie am Sana Krankenhaus Gerresheim
  • Ebersberg, Germany, 85560
    • Praxis und Tagesklinik für gynäkologische Onkologie
  • Frankfurt a.M., Germany, 60389
    • Studienbüro CHOP GmbH
  • Frankfurt a.M., Germany, 60431
    • Agaplesion Markus Krankenhaus
  • Frankfurt a.M., Germany, 60590
    • Universitätsklinikum Frankfurt; Medizinische Klinik 1: Pneumologie, Gastroenterologie, Hepatologie
  • Frankfurt a.M., Germany, 60590
    • Universitätsklinikum Frankfurt; Medizinische Klinik 2, Hämatologie, Onkologie
  • Freiburg, Germany, 79110
    • Praxis für interdisziplinäre Onkologie & Hämatologie
  • Garbsen, Germany, 30823
    • Gemeinschaftspraxis Panagiotou/Minaei (GbR)
  • Georgsmarienhütte, Germany, 49124
    • MVZ II der Niels Stensen Kliniken Onkologie u. Hämatologie
  • Gerlingen, Germany, 70839
    • Gemeinschaftspraxis Dres. Schmitt und Eulenbruch
  • Goslar, Germany, 38642
    • Überörtliche Berufsausübungsgemeinschaft, MVZ Onkologische Kooperation Harz
  • Göttingen, Germany, 37073
    • OSP Göttingen Dres. Meyer / Ammon / Metz
  • Halle (Saale), Germany, 06110
    • Gemeinschaftspraxis für Innere Medizin, Hämatologie, Onkologie, Gastroenterologie
  • Hamburg, Germany, 20249
    • Hamatologisch-Onkologische Praxis Eppendorf (HOPE)
  • Hamburg, Germany, 20251
    • Studiengesellschaft Hämato-Onkologie Hamburg Prof. Laack & Partner GbR
  • Hamburg, Germany, 22767
    • Hämatologisch-onkologische Praxis Altona (HOPA)
  • Hannover, Germany, 30171
    • MediProjekt GBR
  • Hannover, Germany, 30161
    • Onkologische Schwerpunktpraxis
  • Hannover, Germany, 30625
    • Gemeinschaftspraxis Dr. Haytham Kamal und Dr. David C. Dorn
  • Heidelberg, Germany, 69115
    • Onkologische Schwerpunktpraxis
  • Heilbronn, Germany, 74078
    • SLK Kliniken Heilbronn Klinik für Innere Medizin III
  • Herrsching, Germany, 82211
    • cancer Center Zweiseenland GbR
  • Hildesheim, Germany, 31135
    • Onkologische Schwerpunktpraxis im Medicinum
  • Kaiserslautern, Germany, 67655
    • Onkologische Schwerpunktpraxis Dres. Hansen & Reeb
  • Kassel, Germany, 34125
    • Klinikum Kassel, Klinik für Onkologie und Hämatologie
  • Krefeld, Germany, 47805
    • MVZ Hämatologie und Onkologie Dr. Michael Neise & Dr. André Lollert
  • Köln, Germany, 50674
    • PIOH - Praxis Internistische Onkologie und Hämatologie
  • Köln, Germany, 51103
    • Gemeinschaftspraxis für Hämatologie und Onkologie, München MVZ GmbH
  • Köthen, Germany, 06366
    • Internisten am Markt
  • Landshut, Germany, 84036
    • ÜBAG - MVZ Dr. Vehling-Kaiser GmbH
  • Lebach, Germany, 66822
    • Gemeinschaftspraxis für Hämatologie und Onkologie GbR
  • Leer, Germany, 26789
    • Onkologie UnterEms Leer-Emden-Papenburg
  • Leipzig, Germany, 04103
    • MVZ Mitte Am Johannisplatz
  • Mannheim, Germany, 68161
    • Mannheimer Onkologie Praxis
  • Moers, Germany, 47441
    • Gemeinschaftspraxis für Hämatologie & Onkologie
  • Mönchengladbach, Germany, 41061
    • Brustzentrum Niederrhein im evangelischen Krankenhaus Bethesda
  • Mönchengladbach, Germany, 41066
    • Praxis für Hämatologie, Onkologie & Palliativmedizin
  • Mönchengladbach, Germany, 41239
    • MVZ Onkologie GmbH am Elisabeth-Krankenhaus Rheydt
  • Mülheim an der Ruhr, Germany, 45468
    • Gemeinschaftspraxis für Hämatologie internistische Onkologie
  • München, Germany, 80639
    • Medizinisches Zentrum für Hämatologie und Onkologie
  • Münster, Germany, 48149
    • Hämatologisch-Onkologische Gemeinschaftspraxis
  • Neumünster, Germany, 24534
    • Friedrich-Ebert-Krankenhaus
  • Neuss, Germany, 41462
    • TZN - Tumorzentrum Niederrhein GmbH
  • Neustadt Am Rübenberge, Germany, 31535
    • MVZ Onko Medical GmbH Neustadt Innere, Med./Hämatologie-Onkologie
  • Neustadt i.S., Germany, 01844
    • Internistische Praxis und Tagesklinik
  • Offenburg, Germany, 77654
    • Onkologie Offenburg Ambulantes Therapiezentrum für Hämatologie und Onkologie
  • Oldenburg, Germany, 26121
    • Pius-Hospital Oldenburg Hämatologie, Onkologie
  • Passau, Germany, 94036
    • Onkologische Praxis Passau
  • Porta Westfalica, Germany, 32457
    • Zentrum für Hämatologie und Onkologie MVZ GmbH
  • Potsdam, Germany, 14467
    • MVZ für Blut- und Krebserkrankungen
  • Ratingen, Germany, 40883
    • Dr. Arnd Nusch
  • Ravensburg, Germany, 88212
    • Studienzentrum Onkologie Ravensburg
  • Recklinghausen, Germany, 45659
    • Praxis und Tagesklinik für Onkologie und Hämatologie
  • Regensburg, Germany, 93053
    • Schwerpunktpraxis und Tagesklinik für Hämatologie und Onkologie
  • Remscheid, Germany, 42853
    • Praxis und Tagesklinik für Onkologie und Hämatologie
  • Remscheid, Germany, 42859
    • Onkologische Praxis Remscheid
  • Rheinbach, Germany, 53359
    • Schwerpunktpraxis im Ärztehaus Rheinbach
  • Rheine, Germany, 48431
    • Gemeinschaftspraxis für internistische Hämatologie und Onkologie
  • Rostock, Germany, 18057
    • Praxis für Hämatologie und Internistische Onkologie
  • Rostock, Germany, 18059
    • Klinikum Südstadt Rostock Innere Medizin III
  • Rüsselsheim, Germany, 65428
    • GPR Gesundheits- und Pflegezentrum Rüsselsheim
  • Schorndorf, Germany, 73614
    • Zentrum Ambulante Onkologie
  • Singen (Hohentwiel), Germany, 78224
    • Schwerpunktpraxis für Hämatologie und Internistische Onkologie, Gastroenterologie
  • Soest, Germany, 59494
    • MVZ Kloster Paradiese GbR
  • Stolberg, Germany, 52222
    • Hämatologie - Onkologie - Stolberg
  • Stuttgart, Germany, 70174
    • Klinikum Stuttgart; Katharinenhospital Hämatologie, Onkologie und Palliativmedizin
  • Stuttgart, Germany, 70174
    • MVZ Leuschnerstr.
  • Traunstein, Germany, 83278
    • Kliniken Südostbayern - Klinikum Traunstein
  • Troisdorf, Germany, 53840
    • Praxisnetzwerk Hämatologie / internistische Onkologie
  • Villingen-Schwenningen, Germany, 78052
    • Onkologie Schwarzwald-Alb Dr. med. G. Köchling
  • Weinheim, Germany, 69469
    • Praxen MVZ für Innere Medizin
  • Westerstede, Germany, 26655
    • Gemeinschaftspraxis für Hämatologie und Onkologie
  • Wilhelmshaven, Germany, 26389
    • Praxisgemeinschaft für Onkologie und Urologie
  • Worms, Germany, 67547
    • Internistische Gemeinschaftspraxis,Hämatologie, Onkologie,Palliativmedizin
  • Würselen, Germany, 52146
    • MVZ West GmbH Würselen Hämatologie-Onkologie
  • Würzburg, Germany, 97080
    • Hämatologisch-Onkologische, Schwerpunktpraxis Würzburg GbR,Dres. med. R. Schlag & B. Schöttker
  • Zittau, Germany, 02763
    • Praxis und Tagesklinik für Hämatologie/Onkologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate	Proportion of patients with CR or PR as best response	Maximum 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient and Disease Characteristics	Describe demographics, comorbidities and tumor type of patients not eligible for standard therapies.	maximum 5 years
Details on molecular diagnostics	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	Maximum 5 years
Clinical decision making	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	Maximum 5 years (once per targeted therapy)
Evaluation of selected treatment approach assessed via project specific survey	Frequency of pre-defined answers on therapy duration, effectiveness and overall benefit	Maximum 5 years (once per completed targeted therapy)
Best overall response	Proportion of patients with complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD)	Maximum 5 years
Disease Control Rate	Proportion of patients with CR, PR or SD as best response	Maximum 5 years
Time to Response	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	Maximum 5 years
Duration of Response	Time from documentation of tumor response to disease progression or death from any cause	Maximum 5 years
Time to treatment failure	Time from start of therapy to discontinuation of treatment for any reason, including progression, toxicity, and death	Maximum 5 years
Progression-free survival	Time from start of treatment until disease progression or death	Maximum 5 years
PFS ratio	PFS ratio of targeted non-standard therapy and preceding treatment line	Maximum 5 years
Overall Survival	Time from start of treatment until death of any cause	Maximum 5 years

Collaborators and Investigators

• Sponsor: iOMEDICO AG
• Collaborators: Bristol-Myers Squibb; Roche Pharma AG
• Investigators: Principal Investigator: Norbert Marschner, MD, Outpatient center for hematology and oncology, Freiburg, Germany

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2020
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: April 17, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: IOM-050408

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No