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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ upto approximately 12 months

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

vitreous syneresis

posterior capsule opacification

cranial nerve VI palsy

pneumonia

pyelonephritis

colon cancer

bradycardia

100%

80%

60%

40%

20%

Study treatment Arm

Bevacizumab

Ozurdex

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~590

FOLFIRI

2005

Completed Phase 3

~5860