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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04952753
Phase
PHASE2
Status
Terminated

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jul 7, 2021
Start date
Nov 15, 2021
Status verified
Mar 2025
Primary completion
Jan 20, 2025
Completion
Jan 20, 2025

Study Design

Enrollment
204 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety run-in: NIS793+SOC (Investigational arm 1)
    In the safety run-in part for investigational arm 1, participants will be treated with a combination of SOC anti-cancer therapy (bevacizumab with either modified FOLFOX6 or FOLFIRI) and NIS793 to confirm the RP2D of the NIS793
  • Experimental: Expansion: NIS793+SOC (Investigational arm 1)
    In the expansion part, participants in the investigational arm 1 will be treated with a combination of SOC anti-cancer therapy (bevacizumab with either modified FOLFOX6 or FOLFIRI) and NIS793 at the RP2D defined in the safety run-in
  • Active Comparator: Expansion: SOC (control arm)
    In the expansion part, participants in the control arm will be treated with a combination of SOC anti-cancer therapy (bevacizumab with either modified FOLFOX6 or FOLFIRI)
  • Experimental: Safety run-in: NIS793+Tislelizumab+SOC (Investigational arm 2)
    In the safety run-in part for investigational arm 2, participants will be treated with a combination of SOC anti-cancer therapy (bevacizumab with either modified FOLFOX6 or FOLFIRI), NIS793 and tislelizumab to confirm the RP2D of NIS793.
  • Experimental: Expansion: NIS793+Tislelizumab+SOC (Investigational arm 2)
    In the expansion part, participants in the investigational arm 2 will be treated with a combination of SOC anti-cancer therapy (bevacizumab with either modified FLOFOX6 or FOLFIRI) with NIS793 and tislelizumab at the RP2D for NIS793 defined in the safety run-in

Primary Outcome Measure

Safety run-in: Percentage of participants with dose limiting toxicities (DLTs) during the first cycle (4 weeks) of treatment. [ Time Frame: Up to 4 weeks ]

Locations (7)

FacilityCityStateZIPSite coordinators
The Angeles Clinic and Research InstituteLos AngelesCalifornia90025-
University of Michigan MedicalAnn ArborMichigan48109-0331-
WA Uni School Of MedSt LouisMissouri63110-
Astera Cancer CenterEast BrunswickNew Jersey08816-
Sarah Cannon Research InstituteNashvilleTennessee37203-
Uni Of TX MD Anderson Cancer CntrHoustonTexas77030-
Mays Cancer CenterSan AntonioTexas78229-

Find similar trials in Los Angeles, CA

By research site
The Angeles Clinic and Research Institute· Los Angeles, CAUniversity of Michigan Medical· Ann Arbor, MIWA Uni School Of Med· St Louis, MOAstera Cancer Center· East Brunswick, NJSarah Cannon Research Institute· Nashville, TNUni Of TX MD Anderson Cancer Cntr· Houston, TX

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