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Chemotherapy

NIS793 + Standard Therapy for Colorectal Cancer (daNIS-3 Trial)

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
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
Previously administered TGF-β targeted therapies or anti-cancer immunotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upto approximately 12 months
Awards & highlights

Summary

This trial will compare the standard of care for second line treatment of metastatic colorectal cancer (mCRC) against different combinations of NIS793 and other investigational drugs. The goal is to see if this new approach is more effective and has fewer side effects.

Who is the study for?
This trial is for adults over 18 with metastatic colorectal adenocarcinoma that's worsened after one systemic anti-cancer therapy. They must have at least one measurable tumor and be in good physical condition (ECOG 0 or 1). People can't join if they're at high risk of bleeding, had recent strokes or blood clots, are pregnant/breastfeeding without using effective contraception, have certain genetic mutations or deficiencies, haven't recovered from major surgery, or previously received TGF-β therapies.
What is being tested?
The study tests the effectiveness and safety of NIS793 combined with standard cancer treatments like Bevacizumab and chemotherapy (Modified FOLFOX6/FOLFIRI) versus standard treatments alone for second-line treatment of mCRC. It explores whether combining different action mechanisms improves response to current standard care.
What are the potential side effects?
Potential side effects may include typical reactions to immunotherapy such as fatigue, skin reactions, digestive issues; risks associated with chemotherapy like nausea and low blood counts; plus specific concerns related to NIS793 which will be monitored during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a tumor that can be measured by a scan.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a condition that increases my risk of serious bleeding.
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I have received treatments targeting TGF-β or immunotherapies for cancer.
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My colorectal cancer is MSI-H/dMMR or has a BRAFV600 mutation.
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I have heart problems or significant heart disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upto approximately 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and upto approximately 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Expansion: Progression-free survival (PFS) by investigator assessment per RECIST 1.1
Safety run-in: Percentage of participants with dose limiting toxicities (DLTs) during the first cycle (4 weeks) of treatment.
Secondary study objectives
ADA incidence on treatment
Antidrug antibodies (ADA) at baseline
Expansion part: Overall Survival (OS)
+20 more

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424
22%
vitreous hemorrhage
17%
worsening of cataract
9%
posterior capsule opacification
9%
vitreous syneresis
4%
pneumonia
4%
cranial nerve VI palsy
4%
pyelonephritis
4%
colon cancer
4%
bradycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Safety run-in: NIS793+Tislelizumab+SOC (Investigational arm 2)Experimental Treatment5 Interventions
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.
Group II: Safety run-in: NIS793+SOC (Investigational arm 1)Experimental Treatment4 Interventions
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
Group III: Expansion: NIS793+Tislelizumab+SOC (Investigational arm 2)Experimental Treatment5 Interventions
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
Group IV: Expansion: NIS793+SOC (Investigational arm 1)Experimental Treatment4 Interventions
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
Group V: Expansion: SOC (control arm)Active Control3 Interventions
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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Modified FOLFOX6
2018
Completed Phase 2
~390
FOLFIRI
2005
Completed Phase 3
~5860
Tislelizumab
2018
Completed Phase 3
~4560
NIS793
2017
Completed Phase 1
~120
Bevacizumab
2013
Completed Phase 4
~5540

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,889 Previous Clinical Trials
4,201,800 Total Patients Enrolled

Media Library

FOLFIRI (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04952753 — Phase 2
Colorectal Cancer Research Study Groups: Safety run-in: NIS793+Tislelizumab+SOC (Investigational arm 2), Expansion: NIS793+Tislelizumab+SOC (Investigational arm 2), Safety run-in: NIS793+SOC (Investigational arm 1), Expansion: NIS793+SOC (Investigational arm 1), Expansion: SOC (control arm)
Colorectal Cancer Clinical Trial 2023: FOLFIRI Highlights & Side Effects. Trial Name: NCT04952753 — Phase 2
FOLFIRI (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04952753 — Phase 2
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