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Checkpoint Inhibitor
Intermittent Nivolumab + Ipilimumab for Kidney Cancer
Phase 2
Waitlist Available
Led By Moshe C. Ornstein, MD, MA
Research Sponsored by Case Comprehensive Cancer Center
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 expected duration 5.5 months
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of nivolumab in patients with advanced renal cell carcinoma when given intermittently.
Who is the study for?
This trial is for adults with advanced kidney cancer who have either responded well to initial treatment with Ipi/Nivo followed by Nivo maintenance, or have had up to three prior treatments but not certain immune therapies. Participants need a good performance status and must meet specific lab criteria.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of an FDA-approved drug called Nivolumab (Opdivo®) when given intermittently to patients with advanced renal cell carcinoma. It investigates how well this anti-PD-1 antibody works in controlling cancer after various front-line treatments.See study design
What are the potential side effects?
Nivolumab may cause immune system-related side effects such as inflammation in organs, skin reactions, hormone gland problems, infusion reactions, fatigue, and can increase the risk of infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ expected duration 5.5 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~expected duration 5.5 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of participants who maintain CR/PR off therapy for at least 9 months
the proportion of patients who receive intermittent therapy
Secondary outcome measures
Change in tumor burden
Length of Progression Free Survival
Objective Response
+1 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%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Chills
7%
Hypertension
7%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Musculoskeletal chest pain
5%
Malaise
5%
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%
Hypercalcaemia
1%
Neoplasm progression
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Atrial flutter
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
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
2Treatment groups
Experimental Treatment
Group I: Cohort II: combination ipilimumab/nivolumabExperimental Treatment2 Interventions
Combination of ipilimumab/nivolumab for previously untreated intermediate and poor risk mRCC
Includes participants treated front-line ipilimumab/nivolumab. Participants with treatment-naïve mRCC who receive up to four doses of induction ipilimumab/nivolumab and 24 weeks (+/- 8 weeks; minimum 3 infusions) of maintenance nivolumab and achieve stable disease (SD), complete response (CR), or partial response (PR) will be eligible for inclusion. Participants who achieve SD will continue with nivolumab maintenance per standard of care while those who achieve a PR or CR will enter an observation period off therapy. Upon disease progression, participants will be re-challenged with combination ipilimumab/nivolumab.
Group II: Cohort I: Intermittent NivolumabExperimental Treatment1 Intervention
Nivolumab monotherapy. Participants who have initial 10% or greater tumor burden reduction will discontinue nivolumab until they experience a pre-specified disease progression at which time nivolumab will be restarted
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,884 Total Patients Enrolled
Moshe C. Ornstein, MD, MAPrincipal InvestigatorCleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Criterion: For the first group of participants: You have received certain treatments in the past, have had recent major surgery, or have specific medical conditions.I have had 1-2 treatments targeting blood vessel growth in my advanced kidney cancer.You have shown a certain level of response to a specific treatment for kidney cancer, and you meet certain health and testing requirements.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort II: combination ipilimumab/nivolumab
- Group 2: Cohort I: Intermittent Nivolumab
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What prior experimentation has been conducted involving Nivolumab?
"Presently, there are 765 investigations concerning Nivolumab across a staggering 42755 locations. Out of these clinical trials, 86 have progressed to the third phase. Of significance is that many experiments for this treatment are in Pittsburgh, Pennsylvania."
Answered by AI
Has the US Food and Drug Administration given clearance to Nivolumab?
"There is evidence of Nivolumab's safety from the Phase 2 trial, so it obtained a score of 2."
Answered by AI
Are recruitment efforts underway for this experiment?
"Checking the clinicaltrials.gov website confirms that this medical study is not currently recruiting patients, having first been posted on August 3rd 2017 and last updated October 10th 2022. Luckily, there are 3349 alternative trials actively taking partcipants at present."
Answered by AI
How many people is the trial recruiting?
"Currently, this trial is not accepting any further participants. This clinical study was originally posted on August 3rd 2017 and most recently updated on October 10th 2022. If you are seeking alternative trials, there are 2584 studies concerning carcinoma with 765 pertaining to Nivolumab that remain open for enrolment."
Answered by AI
In what medical contexts is Nivolumab routinely prescribed?
"Nivolumab is typically utilized to treat prior anti-angiogenic therapy yet this medication can also be administered for the management of malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."
Answered by AI
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