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Monoclonal Antibodies

Nivolumab + Standard Treatment for Colorectal Cancer

Phase 2

Recruiting

Led By Van K Morris

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to registration

Participants must have documented unresectable and/or metastatic disease on CT or MRI imaging

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is testing whether adding nivolumab to the usual treatment of encorafenib and cetuximab works better at shrinking tumors in patients with colorectal cancer that has spread or cannot be removed by surgery.

Who is the study for?

This trial is for adults with metastatic or unresectable colorectal cancer that has a BRAF mutation. They should have had one or two prior chemotherapy treatments, no severe heart conditions, and be able to swallow pills. Excluded are those with recent heart issues, uncontrolled hypertension, active infections like HIV, certain immune diseases, or who've had specific past treatments like anti-EGFR therapies.Check my eligibility

What is being tested?

The study tests if adding Nivolumab (an immunotherapy drug) to the standard treatment of Encorafenib and Cetuximab improves outcomes in patients. It's a phase II trial aiming to see if this combination better shrinks tumors compared to the usual treatment alone.See study design

What are the potential side effects?

Possible side effects include allergic reactions related to monoclonal antibodies such as skin rashes or breathing difficulties; organ inflammation; increased risk of infection due to immune system changes; and potential gastrointestinal disturbances.

Eligibility Criteria

Inclusion Criteria

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

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I have chronic hepatitis B but it's under control with medication.

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My scans show cancer that cannot be removed or has spread.

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I can swallow and keep down pills.

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My heart is strong enough for daily activities without discomfort.

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My cancer is microsatellite stable or has proficient mismatch repair.

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My cancer is confirmed as colon or rectal adenocarcinoma.

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My colorectal cancer has a specific BRAF mutation.

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I have had 1 or 2 chemotherapy treatments for my advanced cancer that cannot be surgically removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Progression-free survival (PFS)

Secondary outcome measures

Duration of response (DoR)

Immune related progression-free survival (irRC-PFS) in Arm I

Incidence of adverse events

+2 more

Side effects data

From 2012 Phase 3 trial • 73 Patients • NCT01177956

43%

Leucopenia

43%

Weight Decreased

40%

Nausea

35%

Rash

34%

Hypomagnesaemia

32%

Hypokalemia

31%

Constipation

28%

Vomiting

28%

Neutropenia

26%

Decreased Appetite

22%

Pyrexia

19%

Acne

19%

Hyponatremia

19%

Hemoglobin Decreased

18%

Stomatitis

18%

Diarrhea

15%

Fatigue

15%

Pruritus

13%

Mucosal Inflammation

13%

Neutrophil Count Decreased

12%

Mouth Ulceration

10%

Insomnia

10%

Thrombocytopenia

10%

Asthenia

Cough

Dizziness

White Blood Cell Count Decreased

Dermatitis Acneiform

Hypocalcaemia

Hypochloremia

Abdominal Pain Upper

Paronychia

Aspartate Aminotransferase Increased

Weight Increased

Dyspnoea

Neck pain

Oral Pain

Headache

Anaphylactic reaction

Respiratory alkalosis

Pneumonia

Pulmonary embolism

Microcytic anemia

Myocardial infarction

Pneumonitis

Electrolyte imbalance

Mouth hemorrhage

Staphylococcal skin infection

Tumor hemorrhage

Toxic encephalopathy

Venous thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Cetuximab + Cisplatin + 5-FU : Treatment Emergent Phase

Cetuximab + Cisplatin + 5-FU : Late Phase

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (encorafenib, cetuximab, nivolumab)Experimental Treatment3 Interventions

Patients receive encorafenib PO QD on days 1-28, cetuximab IV on days 1 and 15, and nivolumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (encorafenib, cetuximab)Active Control2 Interventions

Patients receive encorafenib PO QD on days 1-28 and cetuximab IV on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetuximab

2011

Completed Phase 3

~2480

Nivolumab

2014

Completed Phase 3

~4750

Encorafenib

2021

Completed Phase 3

~960

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,655 Previous Clinical Trials

40,933,135 Total Patients Enrolled

Van K MorrisPrincipal InvestigatorSWOG Cancer Research Network

3 Previous Clinical Trials

1,520 Total Patients Enrolled

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05308446 — Phase 2

Colon Cancer Research Study Groups: Arm I (encorafenib, cetuximab, nivolumab), Arm II (encorafenib, cetuximab)

Colon Cancer Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT05308446 — Phase 2

Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05308446 — Phase 2

Frequently Asked Questions

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

What is the governmental authorization status of Cetuximab?

"Cetuximab's safety was given a score of 2 by our team at Power. This is because, although there is some data supporting its safety, none of it points to the medication being effective."

Answered by AI

Are you currently looking for participants in this experiment?

"The trial, which is still looking for participants, was first announced on June 6th, 2022 and has had one update on November 11st of the same year."

Answered by AI

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

"There are 100 sites enrolling patients in this trial. Major cities offering this medication include New york, Miami, and San Francisco."

Answered by AI

How many patients are being allowed to enroll in this clinical trial?

"That is correct. The online information portal clinicaltrials.gov has the latest update that this study is still looking for 84 people to participate at 100 different sites. The trial was first posted on 6/6/2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation

2022. "Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05308446.

All > Colorectal Cancer Glendale > Honolulu