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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up upto approximately 12 months

Awards & highlights

daNIS-3 Trial 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.Check my eligibility

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.See study design

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.

daNIS-3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a tumor that can be measured by a scan.

Select...

I am fully active or can carry out light work.

daNIS-3 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

ADA incidence on treatment

Antidrug antibodies (ADA) at baseline

Expansion part: Overall Survival (OS)

+23 more

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424

22%

vitreous hemorrhage

17%

worsening of cataract

posterior capsule opacification

vitreous syneresis

cranial nerve VI palsy

bradycardia

pneumonia

pyelonephritis

colon cancer

100%

80%

60%

40%

20%

Study treatment Arm

Bevacizumab

Ozurdex

daNIS-3 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

FOLFIRI

2005

Completed Phase 3

~5860

Tislelizumab

2018

Completed Phase 3

~4260

Modified FOLFOX6

2018

Completed Phase 2

~390

NIS793

2017

Completed Phase 1

~120

Bevacizumab

2013

Completed Phase 4

~5280

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,197,148 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What diseases or conditions is Bevacizumab commonly used as a treatment for?

"Bevacizumab is most frequently used to treat rectal carcinoma, but it has also shown efficacy in the treatment of colorectal carcinoma, sarcoma, and locally advanced nonsquamous non-small cell lung cancer."

Answered by AI

What are the main goals that we hope to achieve with this clinical trial?

"The primary objective of this clinical trial, as measured over a 12-month period, is to assess the safety of the investigational drug. Secondary outcomes include the prevalence of antidrug antibodies at baseline and the dose intensity of the investigational drug. Blood samples will also be collected for analysis of bevacizumab concentration."

Answered by AI

Could you please describe the risks associated with Bevacizumab?

"Bevacizumab has only been tested in Phase 2 trials, so there is some data supporting safety, but it received a score of 2 because there is no evidence yet of efficacy."

Answered by AI

What findings have been made in other research involving Bevacizumab?

"As of now, there are 967 open clinical trials for Bevacizumab with 280 in Phase 3. Many of the Guangzhou, Guangdong based trials for Bevacizumab are ongoing, however, there are a total of 42259 locations running clinical trials for Bevacizumab globally."

Answered by AI

How many study volunteers are currently enrolled?

"A total of 266 patients that meet the specific inclusion criteria are required to enroll in this clinical trial. Patients can go to multiple sites such as Astera Cancer Center in East Brunswick, New jersey and University of Texas MD Anderson Cancer Center in Houston, Texas to participate in the trial."

Answered by AI

In how many different geographical areas is this trial being conducted?

"This research is being conducted at 4 principle locations, with the option to enroll at a site nearest you to reduce travel burden. The sites are in East Brunswick, Houston, and Cambridge; there are also 4 other potential sites."

Answered by AI

Are patients being enrolled in this experiment at the current time?

"Yes, currently this study is recruiting patients as indicated on the website clinicaltrials.gov. This research was first posted on November 15th, 2021 and has had one edit since then which occurred on September 30th, 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Study of NIS793 and Other Novel Investigational Combinations With SOC Anti-cancer Therapy for the 2L Treatment of mCRC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04952753.

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