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Spots Global Cancer Trial Database for Study of NIS793 and Other Novel Investigational Combinations With SOC Anti-cancer Therapy for the 2L Treatment of mCRC

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Trial Identification

Brief Title: Study of NIS793 and Other Novel Investigational Combinations With SOC Anti-cancer Therapy for the 2L Treatment of mCRC

Official Title: An Open-label, Multi-center, ph II Platform Study Evaluating the Efficacy and Safety of NIS793 and Other New Investigational Drug Combinations With SOC Anti-cancer Therapy for the 2L Treatment of Metastatic Colorectal Cancer (mCRC)

Study ID: NCT04952753

Study Description

Brief Summary: The purpose of this study is to evaluate the preliminary efficacy and safety of NIS793 and other novel investigational combinations with standard of care (SOC) anti-cancer therapy vs SOC anti-cancer therapy for the second line treatment of mCRC. This study aims to explore whether different mechanisms of action may reverse resistance and improve responsiveness to the currently considered SOC anti-cancer therapy in the second line metastatic colorectal cancer (mCRC) setting.

Detailed Description: This is an open-label, multi-center, phase II, 2-part platform study with Safety run-in and Expansion parts. The platform design of this study is adaptive to allow flexibility in the introduction of additional treatment arms with new investigational drugs in combination with SOC anti-cancer therapy for the second line treatment of mCRC. The study will include a control arm that will enroll participants treated with SOC anti-cancer therapy (bevacizumab with mFOLFOX6 or FOLFIRI) for the second line treatment of mCRC. The choice of the chemotherapy medications (mFOLFOX6 or FOLFIRI) will be determined by the Investigator based on prior exposure to oxaliplatin or irinotecan. Each investigational arm will include a combination of an investigational drug and the SOC anti-cancer therapy. The first investigational arm of the study will explore the combination of anti-transforming growth factor β (TGF-β) monoclonal antibody, NIS793 with SOC anti-cancer therapy. The second investigational arm of the study will explore the combination of anti-transforming growth factor β (TGF-β) monoclonal antibody, NIS793 with Tislelizumab, which is an anti-PD1 monoclonal antibody, and SOC anti-cancer therapy. Combination of other investigational drugs with SOC anti-cancer therapy may be added by protocol amendments an additional investigational arms. In each investigational arm, a Safety run-in part will be conducted before opening the expansion part to confirm the recommended phase 2 dose (RP2D) for a combination of any investigational drug with SOC anti-cancer therapy unless the dose has been confirmed externally to this trial. The decision to open the Expansion part of the study will be based on dose confirmation of investigational drug with available safety, relevant PK and other relevant data from Safety run-in part. Participants in the expansion part will be randomized in 1:2 ratio to the control arm or investigational arm.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

The Angeles Clinic and Research Institute ., Los Angeles, California, United States

University of Michigan Medical ., Ann Arbor, Michigan, United States

WA Uni School Of Med ., Saint Louis, Missouri, United States

Astera Cancer Center, East Brunswick, New Jersey, United States

Sarah Cannon Research Institute DeptofSarahCannonRes Inst 2, Nashville, Tennessee, United States

Uni of TX MD Anderson Cancer Cntr, Houston, Texas, United States

Mays Cancer Center, San Antonio, Texas, United States

Novartis Investigative Site, Adelaide, South Australia, Australia

Novartis Investigative Site, Bendigo, Victoria, Australia

Novartis Investigative Site, Perth, Western Australia, Australia

Novartis Investigative Site, Bruxelles, , Belgium

Novartis Investigative Site, Bruxelles, , Belgium

Novartis Investigative Site, Leuven, , Belgium

Novartis Investigative Site, Brampton, Ontario, Canada

Novartis Investigative Site, Cambridge, Ontario, Canada

Novartis Investigative Site, Montreal, Quebec, Canada

Novartis Investigative Site, Montreal, Quebec, Canada

Novartis Investigative Site, Brno, Czech Republic, Czechia

Novartis Investigative Site, Hradec Kralove, CZE, Czechia

Novartis Investigative Site, Praha 4, , Czechia

Novartis Investigative Site, Avignon, , France

Novartis Investigative Site, Creteil, , France

Novartis Investigative Site, Nantes Cedex 1, , France

Novartis Investigative Site, Berlin, , Germany

Novartis Investigative Site, Bochum, , Germany

Novartis Investigative Site, Dresden, , Germany

Novartis Investigative Site, Essen, , Germany

Novartis Investigative Site, Frankfurt, , Germany

Novartis Investigative Site, Hamburg, , Germany

Novartis Investigative Site, Ulm, , Germany

Novartis Investigative Site, Pokfulam, , Hong Kong

Novartis Investigative Site, Shatin New Territories, , Hong Kong

Novartis Investigative Site, Haifa, , Israel

Novartis Investigative Site, Petach Tikva, , Israel

Novartis Investigative Site, Milano, MI, Italy

Novartis Investigative Site, Milano, MI, Italy

Novartis Investigative Site, Rozzano, MI, Italy

Novartis Investigative Site, Nagoya, Aichi, Japan

Novartis Investigative Site, Kashiwa, Chiba, Japan

Novartis Investigative Site, Kawasaki-city, Kanagawa, Japan

Novartis Investigative Site, Osaka-city, Osaka, Japan

Novartis Investigative Site, Toyama-city, Toyama, Japan

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Singapore, , Singapore

Novartis Investigative Site, Sabadell, Barcelona, Spain

Novartis Investigative Site, Santander, Cantabria, Spain

Novartis Investigative Site, Barcelona, Catalunya, Spain

Novartis Investigative Site, Barcelona, Catalunya, Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, St. Gallen, , Switzerland

Novartis Investigative Site, Tainan, , Taiwan

Novartis Investigative Site, Taipei, , Taiwan

Novartis Investigative Site, Aberdeen, Scotland, United Kingdom

Novartis Investigative Site, Cambridge, , United Kingdom

Novartis Investigative Site, Oxford, , United Kingdom

Contact Details

Name: Novartis Pharmaceuticals

Affiliation: Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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