* daNIS-3
Research type
Research Study
Full title
daNIS-3: An open-label, multi-center, phase II platform study evaluating the efficacy and safety of NIS793 and other new investigational drug combinations with standard of care (SOC) anti-cancer therapy for the second line treatment of metastatic colorectal cancer (mCRC)
IRAS ID
1004890
Contact name
Agnieszka Krystyniak
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2021-000553-40
Clinicaltrials.gov Identifier
Research summary
A study evaluating how well NIS793 works (‘efficacy’) and how safe it is in combination with another investigational drug- Tislelizumab- and standard of care (SoC) anti-cancer therapy for the second\nline treatment of metastatic colorectal cancer.\nNIS793 is a monoclonal antibody which should help boost the body’s immune response against cancer cells, and also increase the effectiveness of Bevacizumab and Tislelizumab. Tislelizumab is a monoclonal antibody which should help boost the body’s immune response against cancer cells. Bevacizumab is an antibody which targets a cancer cell protein called VEGF. This protein helps cancers to grow blood vessels so blocking it should reduce tumour growth. Other chemotherapies given will be either modified FOLFOX6 (mFOLFOX6) or FOLFIRI chemotherapy regimens, depending what patients have received previously. \nThe primary objective is to evaluate efficacy of NIS793 or NIS793+tislelizumab in combination with SOC anti-cancer therapy versus SOC anti-cancer therapy in terms of progression-free survival (PFS). \nDosing will be on Day 1, 8 and 15 of each cycle. Patients can remain on trial until the point of disease progression.\nIn each investigational arm, a Safety run-in part will be conducted before opening the expansion part to confirm the recommended dose. \nThe study will include adult participants with metastatic colorectal cancer treated with second line treatment, who have measurable disease and a sufficient level of health. \nStudy procedures will be disease assessment (by scan), ECG, vital signs, physical exam, weight, height, safety and research bloods, pregnancy testing (where applicable) and review of adverse events and medications.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
22/WM/0195
Date of REC Opinion
26 May 2022
REC opinion
Further Information Favourable Opinion