CP-675,206 (Tremelimumab) for Colorectal Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
Research Site, Newecastle Upon Tyne, United Kingdom
Colorectal Cancer+6 More
CP-675,206 (Tremelimumab) - Drug
Eligibility
18+
All Sexes
Eligible conditions
Colorectal Cancer

Study Summary

This study is evaluating whether a drug that has been used to treat cancer can be used to treat a different type of cancer.

See full description

Eligible Conditions

  • Colorectal Cancer
  • Colorectal Neoplasms
  • Cancer
  • Carcinoma, Renal Cell
  • Prostate Cancer
  • Melanoma
  • Neoplasms
  • Prostatic Neoplasms
  • Patients Who Have/Have Had Melanoma and Other Tumors
  • Renal Cell Adenocarcinoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether CP-675,206 (Tremelimumab) will improve 5 primary outcomes and 1 secondary outcome in patients with Colorectal Cancer. Measurement will happen over the course of Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years..

Year 2
Disease Free Survival
Efficacy Endpoints: Survival
Efficacy Endpoints: Tumor Status: Alive With Disease (AWD) or no Evidence of Disease (NED)
Safety Endpoints: Grade 3 or 4 Tremelimumab-related Adverse Events to Tremelimumab.
Safety Endpoints: Hypersensitivity Reactions to Tremelimumab.
Safety Endpoints: Serious Adverse Events to Tremelimumab.

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
1

This trial requires 37 total participants across 2 different treatment groups

This trial involves 2 different treatments. CP-675,206 (Tremelimumab) 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 and have already been tested with other people.

1
Drug
Drug: CP-675,206 (Tremelimumab)
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. actual median study duration was 2.2 years.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. actual median study duration was 2.2 years. for reporting.

Closest Location

Research Site - Little Rock, AR

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The subject must have already received tremelimumab in another protocol
Females of childbearing potential must agree to practice a form of effective contraception for 12 months following any dose of study drug. The definition of effective contraception will be based on the judgement of the investigator.
Subject must be willing and able to provide written informed consent and to comply with scheduled visits and other trial procedures

Patient Q&A Section

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

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

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Approximately 9,600 new cases of [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) are diagnosed a year in the United States. The mortality rate is much higher for colorectal cancer in this population than for other causes of cancer death.

Unverified Answer

What causes colorectal cancer?

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About 95% of colorectal cancers begin as colorectal polyps. Having multiple polyps, advanced age or family history are risk factors for developing colorectal cancer. People with colorectal cancer may be healthier, have more polyps or be screened regularly than others. This screening may help to identify and manage polyps. The risk of dying from colorectal cancer is greater if familial adenomatous polyposis (FAP), Von Hippel–Lindau syndrome, or Lynch syndrome is diagnosed before age 45. Smoking does not help to prevent colorectal cancer. Regular screening for colorectal cancer may be recommended.

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Can colorectal cancer be cured?

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The cure of colorectal cancer is possible. The cure depends on what is the tumoral site of resection (tumor size), how has and how has not the surgical margin been removed, which TNM stage has, and the age at which the patient has been diagnosed.

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What are the signs of colorectal cancer?

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Patients with colorectal cancer may complain of persistent or recurrent dyspepsia or other gastrointestinal symptom as well as non-specific symptoms such as fatigue, weight loss or rectal bleeding. Some patients have unexplained constipation. A high suspicion of colorectal cancer and colonoscopy can make the difference between life and death.

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What is colorectal cancer?

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Symptomatic colorectal cancer most commonly presents with dyspesia, anaemia, iron deficiency, iron deficiency anaemia and weight loss. The risk of lymph node involvement is increased and there are more tumours larger than 2 cm. Symptoms of advanced disease include diarrhoea, abdominal distension, constipation, weight loss and anemia.

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What are common treatments for colorectal cancer?

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Common treatment options involve surgery, chemotherapy, radiation, endoscopic treatment, palliative care, or a combination of these. The most common type of surgery is a curative procedure. For more advanced colorectal cancer, treatment with chemotherapy or targeted therapy may be preferable. A more aggressive approach, called radical surgery, may be appropriate in some cases.

Unverified Answer

Have there been other clinical trials involving cp-675,206 (tremelimumab)?

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This trial is designed to evaluate the long-term response in patients treated with CP 675,206 for treatment of advanced or metastatic clear-cell renal cell carcinoma (RCC). Patients randomized to CP 675,206 will have their disease assessed by an independent imaging committee to confirm or refute disease progression and RCC stage. If disease progression is confirmed based on imaging, patients will continue on the therapy in an experimental investigation of anti-tumor immune activity.

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How quickly does colorectal cancer spread?

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Patients with local or liver metastases from local colorectal carcinomas have a median survival of 12 months. Patients with extra-sarcomatous colorectal tumours usually develop liver metastases, and they have a median survival of only 10 to 14 months.

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Who should consider clinical trials for colorectal cancer?

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Patients' characteristics were similar in the GOC and the trial. Trial entry criteria were similar, indicating they could be used as criteria for consideration of clinical trials. Trials needed few participants to detect significant treatment effect in this disease.

Unverified Answer

What is cp-675,206 (tremelimumab)?

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Tremelimumab monotherapy as monotherapy or combination therapy with Cisplatin and oxaliplatin does not confer an indication of clinical benefit in patients with metastatic colorectal cancer.

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Does colorectal cancer run in families?

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The pattern of genetic markers in this study of families with [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) appears not to be different from that to be expected in colorectal cancer occurring in the general population. Although our study was not designed to search for a cause for colorectal cancer, its results do indicate the need for further research.

Unverified Answer

How does cp-675,206 (tremelimumab) work?

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Cp-675,206 was active in combination with radiotherapy in mice and in combination with standard of care chemotherapy in human CRC patients. However, the drug was generally well tolerated, without clinically relevant hepatotoxicity except in patients with high baseline grade of hepatic enzymes and no improvement was observable. Cp-675,206 may be a new therapeutic option for patients with CRC to warrant further investigation.

Unverified Answer
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