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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
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

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not on steroids or immunosuppressants for any condition.
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I have not been treated with specific inhibitors or antibodies.
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I have never had a bad reaction to antibody therapy or an organ transplant.
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I do not have HIV and am not on medications that are not allowed in the study.
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I am not planning to use other cancer treatments or experimental drugs.
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I do not have another cancer that could affect this treatment's safety or results.
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My digestive system works well and doesn't affect how my body absorbs medication.

Timeline

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
9%
Dizziness
9%
Cough
9%
White Blood Cell Count Decreased
7%
Hypochloremia
7%
Dermatitis Acneiform
7%
Hypocalcaemia
7%
Abdominal Pain Upper
7%
Paronychia
7%
Aspartate Aminotransferase Increased
7%
Weight Increased
6%
Dyspnoea
6%
Neck pain
6%
Oral Pain
6%
Headache
3%
Anaphylactic reaction
1%
Pneumonitis
1%
Tumor hemorrhage
1%
Microcytic anemia
1%
Respiratory alkalosis
1%
Pulmonary embolism
1%
Pneumonia
1%
Staphylococcal skin infection
1%
Electrolyte imbalance
1%
Mouth hemorrhage
1%
Myocardial infarction
1%
Toxic encephalopathy
1%
Venous thrombosis
100%
80%
60%
40%
20%
0%
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
~4740
Encorafenib
2022
Completed Phase 3
~970

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,959,317 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 II (encorafenib, cetuximab), Arm I (encorafenib, cetuximab, nivolumab)
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
~3 spots leftby Aug 2024
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