Pembrolizumab for Biliary Tract Carcinoma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
CHU Clermont-Ferrand - Site Estaing ( Site 0249), Clermont-Ferrand, France
Biliary Tract Carcinoma+1 More
Pembrolizumab - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called pembrolizumab can improve survival in people with biliary tract cancer.

See full description

Eligible Conditions

  • Biliary Tract Carcinoma

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Pembrolizumab will improve 1 primary outcome and 5 secondary outcomes in patients with Biliary Tract Carcinoma. Measurement will happen over the course of Up to approximately 26 months.

Month 26
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Progression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR
Month 38
Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
Number of Participants Who Experience One or More Adverse Events (AE)
Overall Survival (OS)

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Arm A (Pembrolizumab+Gemcitabine+Cisplatin)
1 of 2
Arm B (Placebo+Gemcitabine+Cisplatin)
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 1048 total participants across 2 different treatment groups

This trial involves 2 different treatments. Pembrolizumab is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Arm A (Pembrolizumab+Gemcitabine+Cisplatin)Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.
Arm B (Placebo+Gemcitabine+Cisplatin)Placebo to Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Gemcitabine
FDA approved
Cisplatin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 38 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to approximately 38 months for reporting.

Closest Location

University of California San Diego Moores Cancer Center ( Site 0008) - La Jolla, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Has a life expectancy of greater than 3 months
Has adequate organ function
Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer)
Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as determined by the site investigator Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria
Is able to provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion

Patient Q&A Section

Can carcinoma be cured?

"Cancers can be cured but these cures are rare. It is therefore important that each patient be assessed in their individual circumstances so that the best treatment is tailored to them. The cure rate in the treatment of solid tumours is estimated to be between 1 and 10%." - Anonymous Online Contributor

Unverified Answer

How many people get carcinoma a year in the United States?

"Approximately 25.4 million new cases of cancer will be diagnosed in 2019, and around 24.3 million will be patients with carcinoma. Over half of this new cancer burden will be attributed to cancer of the lung (5.2 million), breast (4.6 million) and colon (4.4 million). The proportion of lung cancer will be the highest in the United States. A recent study by the National Center for Health Statistics estimates 20,600 new cases of lung cancer per year. About 8,300 will be women and 12,200 will be men." - Anonymous Online Contributor

Unverified Answer

What are common treatments for carcinoma?

"Recent findings provides a comprehensive overview of clinical practice, which is consistent with previous reviews of cancer treatments. The authors found that the most common treatment for carcinoma included surgery, radiation therapy, chemotherapy, hormone therapy, and other medications. Most treatment options are generally used within a combination of several specific treatment modalities." - Anonymous Online Contributor

Unverified Answer

What is carcinoma?

"Carcinoma is an uncommon malignancy that occurs in the kidney, intestine, skin and respiratory tract. Carcinoma is characterized by growth and spread of malignant cells, which results in loss of functioning body parts. Most cases of carcinoma appear to occur because of an underlying hereditary or chromosomal ablation disorder of the carcinoma gene. There are approximately 15,000 new cases of carcinoma diagnosed every year in the USA." - Anonymous Online Contributor

Unverified Answer

What are the signs of carcinoma?

"Signs of carcinoma include unexplained, unexplained weight loss with no dietary change, excessive or frequent vomiting, and difficulty concentrating or sitting still. Painful or bloody urination, frequent urination at night, and an inability to urinate with full bladder or with a full strength bladder are also signs of carcinoma. It is difficult to understand how symptoms that are more typical of prostate cancer could be present without prostate cancer present." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma?

"Most cancer is caused by an environmental factor. Smoking, and alcohol, are the two main agents. When other risk factors such as alcohol consumption and diet are excluded, only environmental factors have a significant association with cancer. The environment plays a large role in cancer and we must explore the reasons that the environmental factor is a risk factor." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating carcinoma?

"Although the advances in research and technology have enabled physicians to treat the disease with more precision, the disease remains lethal for the majority of patients. A critical appraisal of current research is necessary to evaluate the need to continue to search for new therapeutic approaches for metastatic cancer." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing carcinoma?

"The 5-year cumulative risks of carcinoma in children and adolescents [for both skin and non-cutaneous cancers] are very low or non-existent at baseline [for skin, 0%, lower limit of (1×10[10]) [see (A9), also see (A10); non-cutaneous, 0%, lower limit of (1×10[10]) (see A11)]." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets carcinoma?

"If the average age at diagnosis is 70, then over a 5 year period about 90 patients need to be diagnosed to experience one new case of non-skin carcinoma. This suggests that even large scale carcinoma registries should consider including a minimum age of diagnosis to ensure that the majority of patients with a solid primary cancer diagnosis have been registered and can be used as a cancer registry control group." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for carcinoma?

"The survival curves for oral carcinoma were significantly shorter than those for other carcinomas. The survival rates for oral squamous cell carcinoma were the longest after 4 years; however, we should not forget that the survival of patients with oral carcinoma was still shorter than that of the general population despite good treatment. The prognosis of patients with oral carcinoma is poor except after 4 years. We consider oral cancers as very dangerous and, therefore, the treatment for oral carcinoma should be done as quickly as possible." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for carcinoma?

"Cancer patients were younger, healthier, and had less disease in the more advanced stages. Cancer patients with higher stages had lower performance levels but the majority performed functionally well. On the other hand, caregivers were not related to their performance levels, while they more heavily utilized clinical trials. This suggests the benefits of these trials to many persons, whereas the costs pose difficulty for caregivers to manage." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of carcinoma?

"[In the elderly group, the prevalence was more than 7.0% in women. In women, carcinoma was also more prevalent following surgeries such as hysterectomy, androphyxia/barriers, and endometrial ablation. A large percentage of carcinoma patients (22.0 % in women and 5.0 % in elderly men) suffered from diabetes mellitus and obesity. Diabetes mellitus, obesity, and liver dysfunction have more adverse effects on carcinoma patients." - Anonymous Online Contributor

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