Bevacizumab for Metastatic Colorectal Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Metastatic Colorectal CancerBevacizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Metastatic Colorectal Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 26 Secondary · Reporting Duration: Upto approximately 12 months

Baseline
Antidrug antibodies (ADA) at baseline
Month 12
Safety run-in part: Overall Survival (OS)
Month 12
Safety run-in: PFS by investigator assessment per RECIST 1.1
Month 12
Expansion: Time to response (TTR) by investigator assessment per RECIST 1.1
Safety run-in: Time to response (TTR) by investigator assessment per RECIST 1.1
Month 12
Safety run-in: Duration of response (DOR) by investigator assessment per RECIST 1.1
Month 12
Expansion part: Overall Survival (OS)
Month 12
Expansion: Progression-free survival (PFS) by investigator assessment per RECIST 1.1
Month 12
ADA incidence on treatment
Maximum concentration (Cmax) of NIS793
Maximum concentration (Cmax) of bevacizumab
Maximum concentration (Cmax) of irinotecan and its metabolite (SN38)
Maximum concentration (Cmax) of tislelizumab
Trough Concentration (Ctrough) of NIS793
Trough Concentration (Ctrough) tislelizumab
Month 12
Trough Concentration (Ctrough) of irinotecan and its metabolite (SN38)
Month 12
Trough Concentration (Ctrough) of bevacizumab
Up to 4 weeks
Safety run-in: Percentage of participants with dose limiting toxicities (DLTs) during the first cycle (4 weeks) of treatment.
Month 12
Expansion part: Percentage of participants with dose interruptions and dose reductions of investigational drug
Expansion: Disease control rate (DCR) by investigator assessment per RECIST 1.1
Expansion: Dose intensity of investigational drug
Expansion: Overall response rate (ORR) by investigator assessment per RECIST 1.1
Expansion: Percentage of participants with Adverse Events (AEs)
Safety run-in: Disease control rate (DCR) by investigator assessment per RECIST 1.1
Safety run-in: Dose intensity of investigational drug
Safety run-in: Overall response rate (ORR) by investigator assessment per RECIST 1.1
Safety run-in: Percentage of participants with Adverse Events (AEs)
Upto approximately 12 months
Safety run-in: Percentage of participants with dose interruptions and dose reductions of investigational drug

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Bevacizumab
22%vitreous hemorrhage
17%worsening of cataract
9%vitreous syneresis
9%posterior capsule opacification
4%pyelonephritis
4%pneumonia
4%colon cancer
4%cranial nerve VI palsy
4%bradycardia
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT02036424) in the Bevacizumab ARM group. Side effects include: vitreous hemorrhage with 22%, worsening of cataract with 17%, vitreous syneresis with 9%, posterior capsule opacification with 9%, pyelonephritis with 4%.

Trial Design

5 Treatment Groups

Expansion: SOC (control arm)
1 of 5
Safety run-in: NIS793+Tislelizumab+SOC (Investigational arm 2)
1 of 5
Safety run-in: NIS793+SOC (Investigational arm 1)
1 of 5
Expansion: NIS793+SOC (Investigational arm 1)
1 of 5
Expansion: NIS793+Tislelizumab+SOC (Investigational arm 2)
1 of 5

Active Control

Experimental Treatment

266 Total Participants · 5 Treatment Groups

Primary Treatment: Bevacizumab · No Placebo Group · Phase 2

Safety run-in: NIS793+Tislelizumab+SOC (Investigational arm 2)Experimental Group · 5 Interventions: NIS793, Tislelizumab, Modified FOLFOX6, FOLFIRI, Bevacizumab · Intervention Types: Drug, Drug, Drug, Drug, Drug
Safety run-in: NIS793+SOC (Investigational arm 1)Experimental Group · 4 Interventions: NIS793, Modified FOLFOX6, FOLFIRI, Bevacizumab · Intervention Types: Drug, Drug, Drug, Drug
Expansion: NIS793+SOC (Investigational arm 1)Experimental Group · 4 Interventions: NIS793, Modified FOLFOX6, FOLFIRI, Bevacizumab · Intervention Types: Drug, Drug, Drug, Drug
Expansion: NIS793+Tislelizumab+SOC (Investigational arm 2)Experimental Group · 5 Interventions: NIS793, Tislelizumab, Modified FOLFOX6, FOLFIRI, Bevacizumab · Intervention Types: Drug, Drug, Drug, Drug, Drug
Expansion: SOC (control arm)ActiveComparator Group · 3 Interventions: Modified FOLFOX6, FOLFIRI, Bevacizumab · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NIS793
2017
Completed Phase 1
~120
Tislelizumab
2018
Completed Phase 3
~1710
Leucovorin
FDA approved
Leucovorin
FDA approved
Bevacizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: upto approximately 12 months

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,717 Previous Clinical Trials
3,524,589 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have at least one measurable lesion assessed by CT and/or MRI according to RECIST 1.1.1.
You have a performance status of 0 or 1.
You have an adequate organ function.