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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%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number (and Percentage) of Outcome Responses After Receiving Nivolumab, Tacrolimus, and Prednisone
Secondary outcome measures
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 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
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
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Hyperkalaemia
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Hyperglycaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Cancer pain
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Circulatory collapse
1%
Confusional state
1%
Pericardial effusion malignant
1%
Syncope
1%
Hypercalcaemia
1%
Femur fracture
1%
Superior vena cava syndrome
1%
Bronchial obstruction
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
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
Tacrolimus
2011
Completed Phase 4
~4740
Prednisone
2014
Completed Phase 4
~2370
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2620
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,687 Previous Clinical Trials
40,930,359 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have records showing I've considered or been deemed ineligible for certain cancer treatments.I have a working kidney transplant and don't need dialysis.My cancer has not spread to my brain or spinal cord.I have no prior evidence of specific immune system antibodies against a transplant.I do not have any severe illnesses or mental health issues that would stop me from following the study's requirements.I can take care of myself but might not be able to do heavy physical work.I have no current or recent severe gut issues or abdominal cancer spread.I haven't received treatments targeting the immune system for my current cancer.Your blood test results for white blood cells, neutrophils, platelets, liver function, and kidney function need to be within certain ranges.I haven't had chemotherapy or radiotherapy in the last 4 weeks and have recovered from any side effects.I have at least one tumor that can be measured.I do not have an active autoimmune disease or a history of one that could come back and affect my organs.I have a skin cancer or MSI-high cancer that cannot be treated with standard surgery or therapies.I have not had a transplant of the liver, lung, heart, pancreas, or any bone marrow.I am HIV positive with an undetectable viral load or have chronic hepatitis but meet specific criteria.I am willing and able to undergo dialysis if needed.I haven't had a transplant rejection in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (tacrolimus, prednisone, nivolumab, ipilimumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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 is most commonly used as an intervention for squamous cell carcinoma. It can also be administered to treat multiple other conditions including ulcerative colitis, varicella-zoster virus acute retinal necrosis, and other diseases."
Answered by AI
What is the United States federal government's stance on Nivolumab?
"Nivolumab's safety is based on limited data from Phase 1 trials, which means it received a score of 1."
Answered by AI
What other medical studies have included Nivolumab as a treatment?
"Nivolumab was first trialled in 2001 at Hulston Cancer Center. Since that initial study, there have been a total of 1639 completed clinical trials. At present, there are 1347 active studies taking place, a significant number of which are based in Pittsburgh, Pennsylvania."
Answered by AI
Are numerous hospitals throughout the U.S. conducting this research?
"8 sites are presently enrolling for this clinical trial, with locations in Pittsburgh, Tampa, Boston and 8 other cities. If you choose to enroll, selecting the location closest to you will help minimize travel demands."
Answered by AI
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