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

Advanced Solid Tumors or Hematologic Malignancies Clinical Trial

— INFINITY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04389541
• Other study ID #: IOM-050408
• Status: Completed
• Start date: April 17, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• Source: iOMEDICO AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 499
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors or Hematologic Malignancies
• Hematologic Neoplasms

Locations

Country	Name	City	State
Germany	MVZ am Klinikum Aschaffenburg	Aschaffenburg
Germany	Studienzentrum Aschaffenburg	Aschaffenburg
Germany	Onkologische Schwerpunktpraxis	Augsburg
Germany	Hämatologisch-Onkologische Schwerpunktpraxis Bad Liebenwerda	Bad Liebenwerda
Germany	Onkologische Schwerpunktpraxis Bamberg	Bamberg
Germany	Sozialstiftung Bamberg Medizinisches Versorgungszentrum am Bruderwald gemeinnützige GmbH	Bamberg
Germany	Klinikum Bayreuth; Klinik für Onkologie und Hämatologie	Bayreuth
Germany	Evangelisches Waldkrankenhaus,Spandau,Innere Medizin I	Berlin
Germany	Gemeinschaftspraxis für Onkologie und Hämatologie	Berlin
Germany	MVZ Onkologischer Schwerpunkt am Oskar-Helene-Heim	Berlin
Germany	Onkologische Schwerpunktpraxis Kurfürstendamm	Berlin
Germany	Onkologisches Versorgungszentrum Friedrichshain	Berlin
Germany	Onkologisch-Hämatologische Schwerpunktpraxis	Bremen
Germany	Klinikum Coburg Hämatologie, Onkologie	Coburg
Germany	Schwerpunktpraxis für Hämatologie und internistische Onkologie Coburg	Coburg
Germany	Klinikum Darmstadt, Onkologisches Studienzentrum	Darmstadt
Germany	Onkologisches Zentrum Deggendorf	Deggendorf
Germany	BAG / Onkologische Gemeinschaftspraxis	Dresden
Germany	Onkologische Gemeinschaftspraxis	Dresden
Germany	Onkozentrum Dresden/Freiberg	Dresden
Germany	MVZ Onkologie und Hämatologie am Sana Krankenhaus Gerresheim	Düsseldorf
Germany	Praxis und Tagesklinik für gynäkologische Onkologie	Ebersberg
Germany	Agaplesion Markus Krankenhaus	Frankfurt a.M.
Germany	Studienbüro CHOP GmbH	Frankfurt a.M.
Germany	Universitätsklinikum Frankfurt; Medizinische Klinik 1: Pneumologie, Gastroenterologie, Hepatologie	Frankfurt a.M.
Germany	Universitätsklinikum Frankfurt; Medizinische Klinik 2, Hämatologie, Onkologie	Frankfurt a.M.
Germany	Praxis für interdisziplinäre Onkologie & Hämatologie	Freiburg
Germany	Gemeinschaftspraxis Panagiotou/Minaei (GbR)	Garbsen
Germany	MVZ II der Niels Stensen Kliniken Onkologie u. Hämatologie	Georgsmarienhütte
Germany	Gemeinschaftspraxis Dres. Schmitt und Eulenbruch	Gerlingen
Germany	Überörtliche Berufsausübungsgemeinschaft, MVZ Onkologische Kooperation Harz	Goslar
Germany	OSP Göttingen Dres. Meyer / Ammon / Metz	Göttingen
Germany	Gemeinschaftspraxis für Innere Medizin, Hämatologie, Onkologie, Gastroenterologie	Halle (Saale)
Germany	Hämatologisch-Onkologische Praxis Altona (HOPA)	Hamburg
Germany	Hämatologisch-Onkologische Praxis Eppendorf (HOPE)	Hamburg
Germany	Studiengesellschaft Hämato-Onkologie Hamburg Prof. Laack & Partner GbR	Hamburg
Germany	Gemeinschaftspraxis Dr. Haytham Kamal und Dr. David C. Dorn	Hannover
Germany	MediProjekt GbR	Hannover
Germany	Onkologische Schwerpunktpraxis	Hannover
Germany	Onkologische Schwerpunktpraxis	Heidelberg
Germany	SLK Kliniken Heilbronn Klinik für Innere Medizin III	Heilbronn
Germany	Cancer Center Zweiseenland GbR	Herrsching
Germany	Onkologische Schwerpunktpraxis im Medicinum	Hildesheim
Germany	Onkologische Schwerpunktpraxis Dres. Hansen & Reeb	Kaiserslautern
Germany	Klinikum Kassel, Klinik für Onkologie und Hämatologie	Kassel
Germany	Gemeinschaftspraxis für Hämatologie und Onkologie, München MVZ GmbH	Köln
Germany	PIOH - Praxis Internistische Onkologie und Hämatologie	Köln
Germany	Internisten am Markt	Köthen
Germany	MVZ Hämatologie und Onkologie Dr. Michael Neise & Dr. André Lollert	Krefeld
Germany	ÜBAG - MVZ Dr. Vehling-Kaiser GmbH	Landshut
Germany	Gemeinschaftspraxis für Hämatologie und Onkologie GbR	Lebach
Germany	Onkologie UnterEms Leer-Emden-Papenburg	Leer
Germany	MVZ Mitte am Johannisplatz	Leipzig
Germany	Mannheimer Onkologie Praxis	Mannheim
Germany	Gemeinschaftspraxis für Hämatologie & Onkologie	Moers
Germany	Brustzentrum Niederrhein im evangelischen Krankenhaus Bethesda	Mönchengladbach
Germany	MVZ Onkologie GmbH am Elisabeth-Krankenhaus Rheydt	Mönchengladbach
Germany	Praxis für Hämatologie, Onkologie & Palliativmedizin	Mönchengladbach
Germany	Gemeinschaftspraxis für Hämatologie internistische Onkologie	Mülheim an der Ruhr
Germany	Medizinisches Zentrum für Hämatologie und Onkologie	München
Germany	Hämatologisch-onkologische Gemeinschaftspraxis	Münster
Germany	Friedrich-Ebert-Krankenhaus	Neumünster
Germany	TZN - Tumorzentrum Niederrhein GmbH	Neuss
Germany	MVZ Onko Medical GmbH Neustadt Innere, Med./Hämatologie-Onkologie	Neustadt Am Rübenberge
Germany	Internistische Praxis und Tagesklinik	Neustadt i.S.
Germany	Onkologie Offenburg Ambulantes Therapiezentrum für Hämatologie und Onkologie	Offenburg
Germany	Pius-Hospital Oldenburg Hämatologie, Onkologie	Oldenburg
Germany	Onkologische Praxis Passau	Passau
Germany	Zentrum für Hämatologie und Onkologie MVZ GmbH	Porta Westfalica
Germany	MVZ für Blut- und Krebserkrankungen	Potsdam
Germany	Dr. Arnd Nusch	Ratingen
Germany	Studienzentrum Onkologie Ravensburg	Ravensburg
Germany	Praxis und Tagesklinik für Onkologie und Hämatologie	Recklinghausen
Germany	Schwerpunktpraxis und Tagesklinik für Hämatologie und Onkologie	Regensburg
Germany	Onkologische Praxis Remscheid	Remscheid
Germany	Praxis und Tagesklinik für Onkologie und Hämatologie	Remscheid
Germany	Schwerpunktpraxis im Ärztehaus Rheinbach	Rheinbach
Germany	Gemeinschaftspraxis für internistische Hämatologie und Onkologie	Rheine
Germany	Klinikum Südstadt Rostock Innere Medizin III	Rostock
Germany	Praxis für Hämatologie und Internistische Onkologie	Rostock
Germany	GPR Gesundheits- und Pflegezentrum Rüsselsheim	Rüsselsheim
Germany	Zentrum Ambulante Onkologie	Schorndorf
Germany	Schwerpunktpraxis für Hämatologie und Internistische Onkologie, Gastroenterologie	Singen (Hohentwiel)
Germany	MVZ Kloster Paradiese GbR	Soest
Germany	Hämatologie - Onkologie - Stolberg	Stolberg
Germany	Klinikum Stuttgart; Katharinenhospital Hämatologie, Onkologie und Palliativmedizin	Stuttgart
Germany	MVZ Leuschnerstr.	Stuttgart
Germany	Kliniken Südostbayern - Klinikum Traunstein	Traunstein
Germany	Praxisnetzwerk Hämatologie / internistische Onkologie	Troisdorf
Germany	Onkologie Schwarzwald-Alb Dr. med. G. Köchling	Villingen-Schwenningen
Germany	Praxen MVZ für Innere Medizin	Weinheim
Germany	Gemeinschaftspraxis für Hämatologie und Onkologie	Westerstede
Germany	Praxisgemeinschaft für Onkologie und Urologie	Wilhelmshaven
Germany	Internistische Gemeinschaftspraxis,Hämatologie, Onkologie,Palliativmedizin	Worms
Germany	MVZ West GmbH Würselen Hämatologie-Onkologie	Würselen
Germany	Hämatologisch-Onkologische, Schwerpunktpraxis Würzburg GbR,Dres. med. R. Schlag & B. Schöttker	Würzburg
Germany	Praxis und Tagesklinik für Hämatologie/Onkologie	Zittau

Sponsors (3)

Lead Sponsor	Collaborator
iOMEDICO AG	Bristol-Myers Squibb, Roche Pharma AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate	Proportion of patients with CR or PR as best response	Maximum 5 years
Secondary	Patient and Disease Characteristics	Describe demographics, comorbidities and tumor type of patients not eligible for standard therapies.	maximum 5 years
Secondary	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
Secondary	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)
Secondary	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)
Secondary	Best overall response	Proportion of patients with complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD)	Maximum 5 years
Secondary	Disease Control Rate	Proportion of patients with CR, PR or SD as best response	Maximum 5 years
Secondary	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
Secondary	Duration of Response	Time from documentation of tumor response to disease progression or death from any cause	Maximum 5 years
Secondary	Time to treatment failure	Time from start of therapy to discontinuation of treatment for any reason, including progression, toxicity, and death	Maximum 5 years
Secondary	Progression-free survival	Time from start of treatment until disease progression or death	Maximum 5 years
Secondary	PFS ratio	PFS ratio of targeted non-standard therapy and preceding treatment line	Maximum 5 years
Secondary	Overall Survival	Time from start of treatment until death of any cause	Maximum 5 years