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PD-1 Inhibitor

nivolumab for Liver Cancer

Phase 2

Waitlist Available

Led By Tim F Greten, M.D.

Research Sponsored by National Cancer Institute (NCI)

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 every 2 months and then every 6 months after discontinuation of treatment, for survival purposes, up to 3 years

Awards & highlights

Study Summary

This trial is investigating if a combination of nivolumab, tadalafil, and vancomycin helps people with hepatocellular carcinoma or metastases to the liver from colorectal or pancreatic cancer.

Eligible Conditions

Liver Cancer
Pancreatic Cancer
Colorectal Cancer
Liver Metastases

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 2 months and then every 6 months after discontinuation of treatment, for survival purposes, up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 2 months and then every 6 months after discontinuation of treatment, for survival purposes, up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 2 months and then every 6 months after discontinuation of treatment, for survival purposes, up to 3 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Best Overall Response (BOR)

Secondary outcome measures

Overall Survival (OS) of Nivolumab Combined With Oral Vancomycin and Tadalafil in Participants With Refractory Hepatocellular Carcinoma (HCC) or Liver Dominant Metastatic Cancer From Colorectal Cancer or Pancreatic Ductal Adenocarcinoma (PDAC)

Serious Adverse Events Possibly, Probably, and/or Definitely Related to Treatment

Other outcome measures

Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

Side effects data

From 2021 Phase 3 trial • 1844 Patients • NCT03068455

38%

Fatigue

37%

Diarrhoea

37%

Pruritus

29%

Headache

28%

Rash

24%

Hypothyroidism

24%

Nausea

20%

Hyperthyroidism

18%

Arthralgia

18%

Cough

18%

Asthenia

15%

Alanine aminotransferase increased

13%

Lipase increased

13%

Pyrexia

12%

Constipation

12%

Aspartate aminotransferase increased

12%

Decreased appetite

12%

Nasopharyngitis

11%

Abdominal pain

11%

Dry mouth

11%

Vomiting

11%

Myalgia

10%

Hypophysitis

10%

Back pain

10%

Insomnia

Amylase increased

Dyspnoea

Upper respiratory tract infection

Dizziness

Adrenal insufficiency

Abdominal pain upper

Infusion related reaction

Hyperglycaemia

Oropharyngeal pain

Blood creatine phosphokinase increased

Influenza like illness

Vitiligo

Hypertension

Pain in extremity

Colitis

Anxiety

Immune-mediated enterocolitis

Autoimmune hepatitis

Basal cell carcinoma

Malignant neoplasm progression

Autoimmune colitis

Squamous cell carcinoma

Hepatitis

Immune-mediated hepatitis

Erysipelas

Pneumonia

Melanoma recurrent

Pneumonitis

Sarcoidosis

100%

80%

60%

40%

20%

Study treatment Arm

Arm A: Nivo + Ipi

Arm B: Nivo

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1/Arm 1 - Nivolumab, Tadalafil and Oral VancomycinExperimental Treatment3 Interventions

Nivolumab, tadalafil and oral vancomycin

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

tadalafil

2010

Completed Phase 4

~12640

oral vancomycin

2019

Completed Phase 2

~30

nivolumab

2016

Completed Phase 3

~4960

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,651 Previous Clinical Trials

40,932,908 Total Patients Enrolled

104 Trials studying Liver Cancer

26,668 Patients Enrolled for Liver Cancer

Tim F Greten, M.D.Principal InvestigatorNational Cancer Institute (NCI)

20 Previous Clinical Trials

1,443 Total Patients Enrolled

5 Trials studying Liver Cancer

626 Patients Enrolled for Liver Cancer

Frequently Asked Questions

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

What conditions does nivolumab commonly treat?

"Nivolumab has been found to be a successful treatment for metastatic ureter urothelial carcinoma, hepatocellular carcinoma and malignant melanomas of the skin."

Answered by AI

Are there any recorded instances of nivolumab being tested in prior research projects?

"Presently, there are 784 ongoing studies examining the efficacy of nivolumab with 91 trials in their third phase. The majority of these research initiatives are being performed from Bern, BE but clinical trails for this drug can be found across 40782 locations worldwide."

Answered by AI

Are there still openings for participants in this clinical research project?

"As of 10/13/2022, this particular medical trial is not taking on any new patients. That said, 3894 cancer-related studies and 784 involving nivolumab are currently open for participation."

Answered by AI

How have studies indicated nivolumab impacts patient safety?

"The safety rating of nivolumab is a 2 since it has only undergone Phase 2 trials and there have been no studies which validate its efficacy."

Answered by AI

How many participants have enrolled in this experiment?

"Unfortunately, no additional participants are being admitted to this trial; the last update was made on October 13th 2022. Nevertheless, there is an abundance of other medical studies for those with carcinoma and nivolumab: 3894 trials recruiting patients and 784 actively admitting them respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nivolumab (Anti-PD1), Tadalafil and Oral Vancomycin in People With Refractory Primary Hepatocellular Carcinoma or Liver Dominant Metastatic Cancer From Colorectal or Pancreatic Cancers

Tim Greten, M.D. 2019. "Nivolumab (Anti-PD1), Tadalafil and Oral Vancomycin in People With Refractory Primary Hepatocellular Carcinoma or Liver Dominant Metastatic Cancer From Colorectal or Pancreatic Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03785210.