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CTLA-4 Inhibitor
NeoVax + Ipilimumab for Kidney Cancer
Phase 1
Waitlist Available
Led By Toni Choueiri, MD
Research Sponsored by Patrick Ott, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years.
Patients should have suspected stage III or stage IV clear cell renal cell carcinoma (ccRCC), with anticipation that all disease can be surgically resected. Confirmation of clear cell histology, final stage (III or IV), and removal of all disease will be done after the surgery, and will be required for further participation of the trial.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new cancer vaccine for kidney cancer. The vaccine is personalized, meaning it is made from each patient's own tumor. The study will also test two other drugs, Poly-ICLC and Ipilimumab, in combination with the vaccine.
Who is the study for?
This trial is for adults over 18 with stage III or IV clear cell renal cell carcinoma (ccRCC) that can be surgically removed. Participants must understand and sign a consent form, agree to provide tissue samples, have an ECOG performance status ≤1, and meet certain blood test criteria.Check my eligibility
What is being tested?
The study tests a new vaccine called 'Personalized NeoAntigen Cancer Vaccine' alongside Poly-ICLC (Hiltonol) and Ipilimumab as potential treatments for kidney cancer. The aim is to see if this combination helps in treating ccRCC after surgery.See study design
What are the potential side effects?
Potential side effects may include typical reactions to vaccines such as soreness at the injection site, fever, fatigue; Ipilimumab might cause immune-related issues like rash, diarrhea, liver inflammation or endocrine problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am suspected to have advanced kidney cancer that can be entirely removed by surgery.
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with dose-limiting toxicity (DLT) experienced within 49 days (7 weeks) of treatment initiation as assessed by CTCAE v4.0
Secondary outcome measures
Number of participants alive at 2 years
Number of participants with NeoVax induced IFN γ (interferon γ) T-cell Response against neoepitopes measured by ELISPOT at week 16
Side effects data
From 2017 Phase 3 trial • 1289 Patients • NCT0128560938%
Alopecia
36%
Anaemia
32%
Nausea
31%
Decreased appetite
31%
Diarrhoea
30%
Fatigue
25%
Constipation
23%
Neutropenia
20%
Dyspnoea
19%
Vomiting
19%
Pyrexia
18%
Rash
17%
Asthenia
17%
Cough
16%
Pruritus
16%
Thrombocytopenia
16%
Arthralgia
15%
Peripheral sensory neuropathy
14%
Myalgia
13%
Insomnia
13%
Neuropathy peripheral
11%
Hypokalaemia
10%
Platelet count decreased
9%
Pain in extremity
9%
Weight decreased
9%
Leukopenia
8%
Alanine aminotransferase increased
8%
Hyponatraemia
8%
Pneumonia
8%
Haemoglobin decreased
7%
Neutrophil count decreased
7%
Dizziness
7%
Malignant neoplasm progression
7%
Aspartate aminotransferase increased
7%
Bone pain
7%
Haemoptysis
7%
Back pain
6%
Headache
6%
Hypomagnesaemia
6%
Stomatitis
5%
Abdominal pain upper
5%
Oedema peripheral
5%
White blood cell count decreased
5%
Chest pain
5%
Dehydration
5%
Abdominal pain
4%
Febrile neutropenia
4%
Paraesthesia
4%
Musculoskeletal pain
3%
Colitis
2%
Death
2%
Lung infection
2%
Pulmonary embolism
2%
Mucosal inflammation
1%
Multi-organ failure
1%
Cerebrovascular accident
1%
Lung neoplasm malignant
1%
Lung abscess
1%
General physical health deterioration
1%
Interstitial lung disease
1%
Liver function test abnormal
1%
Sudden death
1%
Chronic obstructive pulmonary disease
1%
Metastases to central nervous system
1%
Blood creatinine increased
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Confusional state
1%
Intestinal perforation
1%
Pulmonary haemorrhage
1%
Drug hypersensitivity
1%
Infection
1%
Pneumothorax
1%
Renal failure
1%
Lower respiratory tract infection
1%
Pain
1%
Respiratory failure
1%
Syncope
1%
Hyperglycaemia
1%
Sepsis
1%
Acute kidney injury
1%
Hypersensitivity
1%
Urinary tract infection
1%
Disease progression
1%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
Placebo + Paclitaxel/ Carboplatin
Trial Design
2Treatment groups
Experimental Treatment
Group I: Neovax in Combination with IpilimumabExperimental Treatment2 Interventions
Patients will undergo surgery with the intent to resect the primary kidney tumor
Neovax is a combination of Poly-ICLC and Neoantigen Peptides
Priming doses of NeoVax will be administered on days 1, 4, 8, 15, and 22
In the boost phase, vaccine will be administered on days 78 (week 12) and 134 (week 20
Ipilimumab will be injected within 1 cm of each NeoVax administration
Group II: NeoVax aloneExperimental Treatment1 Intervention
Patients will undergo surgery with the intent to resect the primary kidney tumor
Neovax is a combination of Poly-ICLC and Neoantigen Peptides
Priming doses of NeoVax will be administered on days 1, 4, 8, 15, and 22
In the boost phase, vaccine will be administered on days 78 (week 12) and 134 (week 20)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2620
Find a Location
Who is running the clinical trial?
Patrick Ott, MDLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
Patrick Ott, MD, PhDLead Sponsor
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,495 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am suspected to have advanced kidney cancer that can be entirely removed by surgery.I am having surgery to remove cancer spread, and there's enough tissue for a vaccine.I agree to provide samples for genetic testing.I am fully active and can carry on all pre-disease activities without restriction.
Research Study Groups:
This trial has the following groups:- Group 1: NeoVax alone
- Group 2: Neovax in Combination with 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.
Are there any vacancies left in this research endeavor?
"Affirmative. Information on clinicaltrials.gov asserts that this experiment, which was first posted March 3rd 2019, is in the process of enlisting volunteers. Nineteen participants must be enrolled at 1 site."
Answered by AI
What have been some of the most successful applications for ipilimumab?
"Ipilimumab is usually prescribed to treat cutaneous melanoma. It has also been anecdotally successful in treating conditions such as complete resection, liver carcinoma and metastatic melanoma."
Answered by AI
Has Ipilimumab been tested in other clinical experiments?
"Presently, there are 318 clinical trials researching Ipilimumab with 38 at the Phase 3 stage. Of those studies, a significant portion take place in Pittsburgh, Pennsylvania; nevertheless, 20370 medical sites globally have launched research into this treatment modality."
Answered by AI
How many participants can partake in this research at any one time?
"Affirmative. Clinicaltrials.gov shows that this clinical trial, initially posted on March 3rd 2019, is still recruiting patients. 19 participants are required to be found from one medical site."
Answered by AI
To what extent may Ipilimumab put individuals at risk?
"The safety assessment conducted by our team at Power yielded a score of 1 for Ipilimumab, as this is currently in the early stages of clinical trials and has yet to produce substantial evidence on its efficacy or safety."
Answered by AI
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