Cetuximab for Cancer of Colon

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cancer of Colon+22 More
Cetuximab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Cancer of Colon
  • Malignant Neoplasms
  • Stage IVC Colon Cancer AJCC v8
  • Rectal Carcinoma
  • Stage IIIC Colon Cancer AJCC v8
  • Stage IVB Rectal Cancer AJCC v8
  • Stage IVA Rectal Cancer AJCC v8
  • Unresectable Colon Adenocarcinoma
  • Adenocarcinoma
  • Metastatic Rectal Adenocarcinoma
  • Unresectable Rectal Adenocarcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Cancer of Colon

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 3 years

Year 3
Duration of response (DoR)
Year 3
Overall survival (OS)
Year 3
Progression-free survival (PFS)
Year 3
Immune related progression-free survival (irRC-PFS) in Arm I
Up to 3 years
Incidence of adverse events
Overall response rate (ORR)

Trial Safety

Safety Progress

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

Other trials for Cancer of Colon

Side Effects for

Cetuximab + Cisplatin + 5-FU : Treatment Emergent Phase
43%Leucopenia
43%Weight Decreased
40%Nausea
35%Rash
34%Hypomagnesaemia
32%Hypokalemia
31%Constipation
28%Neutropenia
28%Vomiting
26%Decreased Appetite
22%Pyrexia
19%Hemoglobin Decreased
19%Hyponatremia
19%Acne
18%Diarrhea
18%Stomatitis
15%Fatigue
15%Pruritus
13%Mucosal Inflammation
13%Neutrophil Count Decreased
12%Mouth Ulceration
10%Thrombocytopenia
10%Asthenia
10%Insomnia
9%Cough
9%White Blood Cell Count Decreased
9%Dizziness
7%Abdominal Pain Upper
7%Aspartate Aminotransferase Increased
7%Paronychia
7%Hypochloremia
7%Weight Increased
7%Hypocalcaemia
7%Dermatitis Acneiform
6%Oral Pain
6%Headache
6%Neck pain
6%Dyspnoea
3%Anaphylactic reaction
1%Pulmonary embolism
1%Toxic encephalopathy
1%Myocardial infarction
1%Staphylococcal skin infection
1%Microcytic anemia
1%Electrolyte imbalance
1%Tumor hemorrhage
1%Pneumonia
1%Mouth hemorrhage
1%Pneumonitis
1%Venous thrombosis
1%Respiratory alkalosis
This histogram enumerates side effects from a completed 2012 Phase 3 trial (NCT01177956) in the Cetuximab + Cisplatin + 5-FU : Treatment Emergent Phase ARM group. Side effects include: Leucopenia with 43%, Weight Decreased with 43%, Nausea with 40%, Rash with 35%, Hypomagnesaemia with 34%.

Trial Design

2 Treatment Groups

Arm II (encorafenib, cetuximab)
1 of 2
Arm I (encorafenib, cetuximab, nivolumab)
1 of 2
Active Control
Experimental Treatment

84 Total Participants · 2 Treatment Groups

Primary Treatment: Cetuximab · No Placebo Group · Phase 2

Arm I (encorafenib, cetuximab, nivolumab)Experimental Group · 3 Interventions: Nivolumab, Cetuximab, Encorafenib · Intervention Types: Biological, Biological, Drug
Arm II (encorafenib, cetuximab)ActiveComparator Group · 2 Interventions: Cetuximab, Encorafenib · Intervention Types: Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~5340
Cetuximab
2011
Completed Phase 3
~2470
Encorafenib
2021
Completed Phase 2
~230

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,990 Previous Clinical Trials
41,298,804 Total Patients Enrolled
1 Trials studying Cancer of Colon
500 Patients Enrolled for Cancer of Colon
Van K MorrisPrincipal InvestigatorSouthwest Oncology Group
3 Previous Clinical Trials
1,520 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must have unresectable and/or metastatic disease on CT or MRI imaging
Participants must have had one or two prior regimens of systemic chemotherapy for metastatic or locally advanced, unresectable disease.
You have a histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum
Participants must have proficient mismatch repair (pMMR) or microsatellite stable (MSS) status as tested in a CLIA-certified laboratory and documented by the treating clinician.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 26th, 2021

Last Reviewed: October 29th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.