← Back to Search

Monoclonal Antibodies

Nivolumab + Standard Treatment for Colorectal Cancer

Phase 2

Waitlist Available

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

Must not have

Participants must not have certain conditions requiring systemic treatment with corticosteroids or immunosuppressive medications

Participants must not have had prior treatment with specific inhibitors or antibodies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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

Select...

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

Select...

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

Select...

I am 18 years old or older.

Select...

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

Select...

I can swallow and keep down pills.

Select...

My heart is strong enough for daily activities without discomfort.

Select...

My cancer is microsatellite stable or has proficient mismatch repair.

Select...

My cancer is confirmed as colon or rectal adenocarcinoma.

Select...

My colorectal cancer has a specific BRAF mutation.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not on steroids or immunosuppressants for any condition.

Select...

I have not been treated with specific inhibitors or antibodies.

Select...

I have never had a bad reaction to antibody therapy or an organ transplant.

Select...

I do not have HIV and am not on medications that are not allowed in the study.

Select...

I am not planning to use other cancer treatments or experimental drugs.

Select...

I do not have another cancer that could affect this treatment's safety or results.

Select...

My digestive system works well and doesn't affect how my body absorbs medication.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS)

Secondary study objectives

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%

Hyponatremia

19%

Acne

19%

Hemoglobin Decreased

18%

Stomatitis

18%

Diarrhea

15%

Pruritus

15%

Fatigue

13%

Mucosal Inflammation

13%

Neutrophil Count Decreased

12%

Mouth Ulceration

10%

Insomnia

10%

Thrombocytopenia

10%

Asthenia

Dizziness

Cough

White Blood Cell Count Decreased

Hypocalcaemia

Dermatitis Acneiform

Hypochloremia

Abdominal Pain Upper

Paronychia

Aspartate Aminotransferase Increased

Weight Increased

Dyspnoea

Neck pain

Oral Pain

Headache

Anaphylactic reaction

Pneumonitis

Mouth hemorrhage

Pneumonia

Electrolyte imbalance

Microcytic anemia

Myocardial infarction

Staphylococcal skin infection

Tumor hemorrhage

Pulmonary embolism

Respiratory alkalosis

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

Awards & Highlights

No Placebo-Only Group

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

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

2015

Completed Phase 3

~4010