← Back to Search

Checkpoint Inhibitor

Immunotherapy + Tacrolimus for Cancer in Kidney Transplant Recipients

Phase 1
Waitlist Available
Led By Evan J Lipson
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
Patients must be kidney transplant recipients with a functioning allograft who do not currently require dialysis
Patients must have Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Must not have
Patients must not have known central nervous system (CNS) metastases or leptomeningeal metastases
Patients must not have uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Summary

This trialstudies a combo of drugs to treat kidney transplant recipients' cancer that can't be surgically removed or has spread. Immunotherapy & tacrolimus may help attack the cancer & stop tumor growth. It may work better than surgery, chemo, radiation or targeted therapies.

Who is the study for?
This trial is for kidney transplant recipients with certain advanced cancers (melanoma, basal cell carcinoma, Merkel cell carcinoma, squamous cell carcinoma) that can't be removed or have spread. Participants must be in fair health based on ECOG status, meet specific blood test criteria, use contraception if applicable, and may include HIV-positive patients under effective treatment.
What is being tested?
The study tests tacrolimus combined with the monoclonal antibodies nivolumab and ipilimumab to see if they're more effective than traditional treatments for cancer in kidney transplant recipients. The goal is to harness the body's immune system to fight cancer while considering the unique circumstances of organ transplant patients.
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs like the liver or intestines, infusion reactions from antibody treatment which could cause fever or chills, increased risk of infection due to immune system changes, and possible interference with transplanted organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a working kidney transplant and don't need dialysis.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I have a skin cancer or MSI-high cancer that cannot be treated with standard surgery or therapies.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer has not spread to my brain or spinal cord.
Select...
I do not have any severe illnesses or mental health issues that would stop me from following the study's requirements.
Select...
I have no current or recent severe gut issues or abdominal cancer spread.
Select...
I haven't received treatments targeting the immune system for my current cancer.
Select...
I do not have an active autoimmune disease or a history of one that could come back and affect my organs.
Select...
I have not had a transplant of the liver, lung, heart, pancreas, or any bone marrow.
Select...
I am willing and able to undergo dialysis if needed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number (and Percentage) of Outcome Responses After Receiving Nivolumab, Tacrolimus, and Prednisone
Secondary study objectives
Duration of Overall Survival After Receiving Nivolumab, Tacrolimus, and Prednisone
Duration of Progression-free Survival After Receiving Nivolumab, Tacrolimus, and Prednisone
Objective Response (CR or PR) Rate (ORR) After Receiving Nivolumab, Tacrolimus, and Prednisone
+3 more

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Cushingoid
10%
Tinnitus
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (tacrolimus, prednisone, nivolumab, ipilimumab)Experimental Treatment4 Interventions
Patients receive tacrolimus PO BID and prednisone PO QD. Within 28 days, patients then receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 4 weeks for up to 24 cycles (96 weeks) in the absence of disease progression or unacceptable toxicity. Patients who experience PD or patients who have experienced allograft loss at 16 weeks receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1. Patients also receive tacrolimus PO BID and prednisone PO QD. Cycles repeat every 3 weeks for 4 cycles (12 weeks) in the absence of disease progression or unacceptable toxicity. Starting 6 weeks later, patients receive nivolumab IV over 30 minutes every 4 weeks for up to 21 cycles (84 weeks) in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~5220
Prednisone
2014
Completed Phase 4
~2500
Tacrolimus
2019
Completed Phase 4
~5510
Ipilimumab
2014
Completed Phase 3
~3140

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,988 Total Patients Enrolled
4 Trials studying Cutaneous Melanoma
198 Patients Enrolled for Cutaneous Melanoma
Evan J LipsonPrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO
1 Previous Clinical Trials
16 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03816332 — Phase 1
Cutaneous Melanoma Research Study Groups: Treatment (tacrolimus, prednisone, nivolumab, ipilimumab)
Cutaneous Melanoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT03816332 — Phase 1
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03816332 — Phase 1
~2 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top