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Checkpoint Inhibitor

Nivolumab for Biliary Tract Cancer

Phase 2

Waitlist Available

Led By Richard Kim, M.D.

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

Study Summary

This trial will test whether the drug Nivolumab can shrink tumors in patients with advanced biliary tract cancer that has not responded to other treatments. Nivolumab is approved by the FDA for other types of cancer, but not yet for this one.

Eligible Conditions

Biliary Tract Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Response Rate (ORR) After 4 Cycles of Treatment

Secondary outcome measures

Overall Survival (OS)

Progression Free Survival (PFS)

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533

57%

Nausea

54%

Anaemia

51%

Fatigue

39%

Decreased appetite

36%

Malignant neoplasm progression

32%

Constipation

31%

Diarrhoea

30%

Cough

29%

Vomiting

29%

Dyspnoea

25%

Oedema peripheral

24%

Back pain

21%

Pyrexia

21%

Neutropenia

19%

Headache

19%

Hypomagnesaemia

18%

Arthralgia

16%

Asthenia

16%

Dizziness

16%

Neutrophil count decreased

15%

Thrombocytopenia

15%

Insomnia

14%

Hyponatraemia

14%

Rash

14%

Weight decreased

14%

Platelet count decreased

13%

Blood creatinine increased

13%

White blood cell count decreased

12%

Hypokalaemia

12%

Pruritus

12%

Abdominal pain

12%

Pain in extremity

11%

Myalgia

11%

Alanine aminotransferase increased

11%

Aspartate aminotransferase increased

10%

Alopecia

10%

Dry skin

10%

Hypoalbuminaemia

10%

Muscular weakness

10%

Chest pain

10%

Dysgeusia

10%

Pneumonia

10%

Productive cough

Abdominal pain upper

Upper respiratory tract infection

Hypothyroidism

Mucosal inflammation

Peripheral sensory neuropathy

Lacrimation increased

Nasopharyngitis

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Bronchitis

Chills

Hypertension

Hyperkalaemia

Hyperglycaemia

Dehydration

Blood alkaline phosphatase increased

Lymphocyte count decreased

Anxiety

Hypophosphataemia

Leukopenia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Rash maculo-papular

Hypotension

Musculoskeletal chest pain

Malaise

Pain

Dry mouth

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Fall

Pulmonary embolism

Metastases to central nervous system

Myocardial infarction

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Malignant pleural effusion

Sepsis

General physical health deterioration

Adrenal insufficiency

Atrial fibrillation

Cardiac failure

Embolism

Neoplasm progression

Small intestinal haemorrhage

Femur fracture

Cancer pain

Confusional state

Pneumothorax

Circulatory collapse

Bone pain

Hypercalcaemia

Pericardial effusion malignant

Atrial flutter

Bronchial obstruction

Superior vena cava syndrome

Syncope

Performance status decreased

Pancytopenia

Colitis

Pericardial effusion

Gastrointestinal haemorrhage

Ileus

Small intestinal obstruction

Lung cancer metastatic

Respiratory tract infection

Respiratory failure

Tumour pain

Appendicitis

Skin infection

Ataxia

Seizure

100%

80%

60%

40%

20%

Study treatment Arm

Investigator Choice of Chemotherapy

Post Chemotherapy Optional Nivolumab

Nivolumab

Trial Design

1Treatment groups

Experimental Treatment

Group I: Nivolumab TreatmentExperimental Treatment1 Intervention

This is a single arm study with two stage design using nivolumab in advanced biliary tract cancer (BTC), for participants who have failed or are intolerant to at least one line of therapy and no more than 2 lines of therapy. In the first stage, 18 participants will be accrued. If there is at least one response (or several participants with stable disease based on the study team's discretion), an additional 34 patients will be accrued for a total of 52 patients.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~4750

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,438 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,638 Previous Clinical Trials

4,128,460 Total Patients Enrolled

Richard Kim, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute

10 Previous Clinical Trials

263 Total Patients Enrolled

Frequently Asked Questions

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

What other scientific research has been conducted using Nivolumab?

"Nivolumab was first studied in 2010 at the H. Lee Moffitt Cancer Center and Research Institute. Since then, there have been a total of 249 completed studies on the medication. Because it is still an active area of research, there are currently 747 clinical trials underway--many of them out of Atlanta, Georgia."

Answered by AI

Do you have any data on Nivolumab's long-term safety effects?

"Nivolumab has received a score of 2 for safety. This is due to the fact that, while there have been Phase 2 trials conducted which support its safety, there is yet to be data affirming its efficacy."

Answered by AI

Are people currently signing up to participate in this experiment?

"Unfortunately, this trial is no longer recruiting patients. Although, it's worth mentioning that the study was last updated on August 15th, 2022 and was initially posted on October 5th, 2016. There are currently 105 trials actively recruiting patients with biliary tract cancer and 747 studies for Nivolumab searching for participants."

Answered by AI

Are there any other similar trials to this one?

"Nivolumab has been researched since 2010 when the first clinical study, sponsored by Medarex, was completed. After a Phase 1 drug trial in 2010 with 127 participants, Nivolumab received its approval. Now, there are over 700 active trials for this medication across 50 countries and 2347 cities."

Answered by AI

What are some common reasons that doctors prescribe Nivolumab?

"Nivolumab is a medication with many different potential applications, including the treatment of malignant neoplasms and unresectable melanoma."

Answered by AI

How many people are taking part in this clinical trial?

"This study is no longer admitting patients. The listing was first posted on October 5th, 2016 and was edited for the last time on August 15th, 2022. However, there are 105 other trials actively recruiting patients with biliary tract cancer and 747 trials for Nivolumab that are also looking for participants."

Answered by AI

Recent research and studies

JAMA OncologyJournal

A Phase 2 Multi-institutional Study of Nivolumab for Patients with Advanced Refractory Biliary Tract Cancer

Kim, Richard D., Vincent Chung, Olatunji B. Alese, Bassell F. El-Rayes, Daneng Li, Taymeyah E. Al-Toubah, Michael J. Schell, et al.. 2020. “A Phase 2 Multi-institutional Study of Nivolumab for Patients with Advanced Refractory Biliary Tract Cancer”. JAMA Oncology. American Medical Association (AMA). doi:10.1001/jamaoncol.2020.0930.

clinicaltrials.govStudy

Study of Nivolumab in Patients With Advanced Refractory Biliary Tract Cancers

2016. "Study of Nivolumab in Patients With Advanced Refractory Biliary Tract Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02829918.