CLINICAL TRIAL

Nivolumab for Colorectal Cancer

Metastatic
Waitlist Available · 18+ · All Sexes · New York, NY

This study is evaluating whether a new drug called nivolumab can be used to treat metastatic colorectal cancer.

See full description

About the trial for Colorectal Cancer

Eligible Conditions
Colorectal Neoplasms · Colorectal Carcinoma (CRC)

Treatment Groups

This trial involves 2 different treatments. Nivolumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Nivolumab
BIOLOGICAL
Oxaliplatin
DRUG
Fluorouracil
DRUG
Bevacizumab
DRUG
Leucovorin
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Oxaliplatin
DRUG
Fluorouracil
DRUG
Bevacizumab
DRUG
Leucovorin
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Oxaliplatin
FDA approved
Fluorouracil
FDA approved
Bevacizumab
FDA approved
Leucovorin
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Histologically confirmed metastatic colorectal cancer, not amenable to curative resection
No prior chemotherapy for metastatic colorectal cancer
ECOG Performance Status of 0-1
You have the ability to provide adequate tissue sample. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: From the date of first confirmed response (CR or PR) up to the date of the first documented progression (per RECIST 1.1) or death due to any cause, whichever occurs first (up to 15 months)
Screening: ~3 weeks
Treatment: Varies
Reporting: From the date of first confirmed response (CR or PR) up to the date of the first documented progression (per RECIST 1.1) or death due to any cause, whichever occurs first (up to 15 months)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From the date of first confirmed response (CR or PR) up to the date of the first documented progression (per RECIST 1.1) or death due to any cause, whichever occurs first (up to 15 months).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Nivolumab will improve 2 primary outcomes and 29 secondary outcomes in patients with Colorectal Cancer. Measurement will happen over the course of From first dose up to 30 days post last dose (up to 35 months).

Abnormalities in Specific Thyroid Tests
FROM FIRST DOSE UP TO 30 DAYS POST LAST DOSE (UP TO 35 MONTHS)
Laboratory test results of laboratory abnormalities in specific thyroid tests during the treatment period per CTCAE (Version 4) in SI units.
FROM FIRST DOSE UP TO 30 DAYS POST LAST DOSE (UP TO 35 MONTHS)
Abnormalities in Specific Liver Tests
FROM FIRST DOSE UP TO 30 DAYS POST LAST DOSE (UP TO 35 MONTHS)
Laboratory test results of laboratory abnormalities in hepatic parameters during the treatment period per CTCAE (Version 4) in SI units.
FROM FIRST DOSE UP TO 30 DAYS POST LAST DOSE (UP TO 35 MONTHS)
Number of Participants With Serious Adverse Events (SAEs)
FROM FIRST DOSE TO 30 DAYS POST LAST DOSE (UP TO 35 MONTHS)
Number of participants with any grade of serious adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine safety and tolerability
FROM FIRST DOSE TO 30 DAYS POST LAST DOSE (UP TO 35 MONTHS)
Number of Participants With Adverse Events (AEs)
FROM FIRST DOSE TO 30 DAYS POST LAST DOSE (UP TO 35 MONTHS)
Number of participants with any grade of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine safety and tolerability
FROM FIRST DOSE TO 30 DAYS POST LAST DOSE (UP TO 35 MONTHS)
Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR)
FROM RANDOMIZATION TO UP TO THE DATE OF THE FIRST DOCUMENTED PROGRESSION (UP TO 16 MONTHS)
PFS is defined as the time from randomization to the date of the first documented progression, as determined by BICR (per RECIST 1.1), or death due to any cause, whichever occurs first.
FROM RANDOMIZATION TO UP TO THE DATE OF THE FIRST DOCUMENTED PROGRESSION (UP TO 16 MONTHS)
Progression Free Survival (PFS) Per Investigator Assessment
FROM RANDOMIZATION UP TO THE DATE OF THE FIRST DOCUMENTED PROGRESSION (UP TO 16 MONTHS)
PFS is defined as the time from randomization to the date of the first documented progression, as determined by tumor assessments by the Investigator, or death due to any cause, whichever occurs first.
FROM RANDOMIZATION UP TO THE DATE OF THE FIRST DOCUMENTED PROGRESSION (UP TO 16 MONTHS)
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Patient Q & A Section

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

What causes colorectal cancer?

Many factors contribute to colorectal cancer and its precursors; nevertheless, a range of genes may be particularly important in colorectal cancer. The risk of developing colorectal cancer depends heavily on inherited factors. Genetic predisposition is not the only important contributor to colorectal cancer and it seems likely that other environmental influences are less important.

Anonymous Patient Answer

How many people get colorectal cancer a year in the United States?

About 3 million Americans are diagnosed each year with colorectal cancer. In those with advanced disease, about 70% die within 12 to 15 years following a diagnosis of colorectal cancer.

Anonymous Patient Answer

What are common treatments for colorectal cancer?

For stage I to II colorectal cancer, common treatments involve surgical resection, chemotherapy and radiation therapy. For stages III and IV colorectal cancer, common treatments are curative.

Anonymous Patient Answer

What is colorectal cancer?

Colorectal cancer is a disease characterized by a malignant growth that forms in the colon or rectum and can spread to other parts of the body via the bloodstream, lymph node, or direct contact with tumour cells.\n

Anonymous Patient Answer

What are the signs of colorectal cancer?

It is necessary for the examination to be done with a complete medical history and physical examination in order to identify signs of colorectal cancer. Abnormal symptoms may be suggestive of colon cancer. A CT scan is considered to be the most useful investigation for predicting the development of colon cancer in asymptomatic patients.

Anonymous Patient Answer

Can colorectal cancer be cured?

There is no cure for colorectal cancer. The 5-year survival rate for patients with Stage III disease is 49%, which is a long way from cure. More than 10% of patients with Stage IV colorectal cancer will die during the first year after diagnosis, and most of these will die within the first month.

Anonymous Patient Answer

Is nivolumab safe for people?

Nivolumab is well tolerated and effective in patients with metastatic squamous non-small cell [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) and metastatic urothelial carcinoma. The rate of severe skin reactions with this monoclonal antibody is comparable to earlier monoclonal antibody-based cancer therapies. The toxicity and the antitumor responses are generally higher than those of checkpoint ligand inhibitors used in other indications, such as the antibody-based drug ipilimumab. Results from a recent paper of the phase II study showed that patients treated with nivolumab have a better response rate but the overall survival and progression-free survival have not yet been determined.

Anonymous Patient Answer

What is the latest research for colorectal cancer?

There is still much progress and information is being published every couple of months. This is an exciting area and it will continue to look for the cause. A little hope is now on. Please see the site with links. Screening the elderly with colonoscopy every twenty years or more is thought to reduce the growth of [colon cancer](https://www.withpower.com/clinical-trials/colon-cancer). In the United States, colorectal cancer mortality is significantly lower in women than it is in men. Women are also more likely to receive screenings.\n\n- Cancer.Net - Colorectal Cancers\n- Cancer.

Anonymous Patient Answer

Have there been any new discoveries for treating colorectal cancer?

Our knowledge increased by two decades, but our understanding of how colorectal cancer develops and spreads has not improved much. We still do not know the true magnitude of the problem of colorectal cancer; we know that one in six people in the developed world will have to face the decision to undergo surgery for diagnosing, or treatment. This does appear to get worse.

Anonymous Patient Answer

Have there been other clinical trials involving nivolumab?

Nivolumab has been investigated in more than a dozen different tumor types and indications, and no convincing case of safety or efficacy could be presented for its use in colorectal cancer. Given the significant financial investments necessary in order to develop and market anti-PD-1 immun agents, we would recommend caution before incorporating these agents into clinical practice in patients with CRC or other solid tumors.

Anonymous Patient Answer

Does nivolumab improve quality of life for those with colorectal cancer?

Nivolumab enhances the QoL for patients with metastatic CD20+ mCRC while increasing overall survival, delaying the need for treatment. In addition, it is associated with a reduction in serious non-fatal toxicity associated with chemotherapy.

Anonymous Patient Answer

What is the survival rate for colorectal cancer?

Survival rate depends heavily on the type of colorectal cancer as noted above at the time of diagnosis. After a colorectal cancer diagnosis the cure rate depends significantly on the age of the patient. Most colorectal cancers were curable for patients 55 years and younger with surgical resection or for patients older than 80 years of age when surgery was not possible the disease would be monitored or adjuvant chemotherapy might be prescribed.

Anonymous Patient Answer
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