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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

No Placebo-Only Group

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

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I have a working kidney transplant and don't need dialysis.

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I can take care of myself but might not be able to do heavy physical work.

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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:

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My cancer has not spread to my brain or spinal cord.

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I do not have any severe illnesses or mental health issues that would stop me from following the study's requirements.

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I have no current or recent severe gut issues or abdominal cancer spread.

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I haven't received treatments targeting the immune system for my current cancer.

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I do not have an active autoimmune disease or a history of one that could come back and affect my organs.

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I have not had a transplant of the liver, lung, heart, pancreas, or any bone marrow.

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I am willing and able to undergo dialysis if needed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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%

Tinnitus

10%

Cushingoid

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%

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2015

Completed Phase 3

~4010

Prednisone

2014

Completed Phase 4

~2500