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

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)

ClinicalTrials.gov Identifier: NCT04952753

Novartis Reference Number: CNIS793E12201

Last Update: May 03, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Metastatic Colorectal Cancer
Phase 
Phase 2
Overall status 
Recruiting
Start date 
Nov 15, 2021
Completion date 
Feb 17, 2025
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
NIS793
Investigational drug NIS793 will be administered intravenously (IV) at the dose and schedule determined in the safety run-in part.
Drug
Bevacizumab
Bevacizumab will be administered IV
Drug
Modified FOLFOX6
5-fluorouracil [continuous infusion], leucovorin [administered IV] (or levoleucovorin [administered IV]), and oxaliplatin [administered IV]
Drug
FOLFIRI
5-fluorouracil [continuous infusion], leucovorin [administered IV] (or levoleucovorin [administered IV]), and irinotecan [administered IV]
Drug
Tislelizumab
Investigational drug tislelizumab will be administered intravenously (IV).

Eligibility Criteria

Key Inclusion Criteria:

Participants age 18 or older with histologically or cytologically confirmed (by local laboratory and local clinical guidelines) metastatic colorectal adenocarcinoma that is not amenable to potentially curative surgery in the opinion of the investigator and progressed on or within 6 months after the last dose of one prior line of systemic anti-cancer therapy administered for metastatic disease.
Presence of at least one measurable lesion assessed by CT and/or MRI according to RECIST 1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
Adequate organ function (assessed by central laboratory for eligibility).

Key Exclusion Criteria:

Previously administered TGF-β targeted therapies or anti-cancer immunotherapy.
Microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR) and/or BRAFV600 mutation positive colorectal cancer.
Known complete or partial dipyrimidine dehydrogenase (DPD) enzyme deficiency (testing for DPD enzyme deficiency is not mandatory unless required by local regulations and can be conducted at a local laboratory).
For participants treated with irinotecan: Known history or clinical evidence of reduced UGT1A1 activity (testing for UGT1A1 status is not mandatory unless required by local regulations and can be conducted at a local laboratory).
Participants who have not recovered from a major surgery performed prior to start of study treatment or have had a major surgery within 4 weeks prior to start of study treatment.
Impaired cardiac function or clinically significant cardio-vascular disease.
Participants with conditions that are considered to have a high risk of clinically significant gastrointestinal tract bleeding or any other condition associated with or history of significant bleeding.
Stroke or transient ischemic attack, or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 3 months before start of study treatment.
Pregnant or breast-feeding women.
Women of childbearing potential, unless willing to use highly effective contraception methods during treatment and after stopping study treatments as required.

Other inclusion/exclusion criteria may apply

Study Locations

United States
Astera Cancer Center
Recruiting
East Brunswick, 08816 - New Jersey
Contact: (732-390-7750) Bruno Fang
United States
University of Texas MD Anderson Cancer Center
Recruiting
Houston, 77030 - Texas
Contact: Lori Manson (713-792-2921) - [email protected] - Van Karlyle Morris
United States
Australia
Novartis Investigative Site
Recruiting
Perth,
Western Australia
Australia
Czech Republic
Novartis Investigative Site
Recruiting
Brno, 656 53
Czech Republic
Czech Republic
Novartis Investigative Site
Recruiting
Hradec Kralove, 500 05
CZE
Czech Republic
France
Novartis Investigative Site
Recruiting
Avignon Cedex, 84082
-
France
Novartis Investigative Site
Recruiting
Creteil, 94010
-
France
Novartis Investigative Site
Recruiting
Reims, 51092
-
France
Germany
Novartis Investigative Site
Recruiting
Essen, 45147
-
Germany
Novartis Investigative Site
Recruiting
Frankfurt, 60488
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 20249
-
Germany
Israel
Novartis Investigative Site
Recruiting
Haifa, 3109601
-
Israel
Novartis Investigative Site
Recruiting
Petach Tikva, 4941492
-
Israel
Japan
Novartis Investigative Site
Recruiting
Nagoya, 464 8681
Aichi
Japan
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 05505
-
Korea, Republic of
Singapore
Novartis Investigative Site
Recruiting
Singapore, 119074
-
Singapore
Spain
Novartis Investigative Site
Recruiting
Sabadell, 08208
Barcelona
Spain
Novartis Investigative Site
Recruiting
Santander, 39008
Cantabria
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08036
Catalunya
Spain
Novartis Investigative Site
Recruiting
Madrid, 28040
-
Spain
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 10002
-
Taiwan

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

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Call 1-888-669-6682 or email [email protected]