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

Recruiting in Palo Alto (17 mi)

+52 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

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.

Inclusion Criteria

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

I am fully active or can carry out light work.

I am 18 or older with advanced colorectal cancer that cannot be surgically removed and has worsened after one treatment.

See 1 more

Exclusion Criteria

Pregnant or breast-feeding women

I have a condition that increases my risk of serious bleeding.

I have a history or signs of low UGT1A1 activity, relevant for my irinotecan treatment.

See 7 more

Treatment Details

Interventions

Bevacizumab (Monoclonal Antibodies)
FOLFIRI (Chemotherapy)
Modified FOLFOX6 (Chemotherapy)
NIS793 (Monoclonal Antibodies)
Tislelizumab (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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)

FOLFIRI is already approved in Canada, Japan for the following indications: