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Checkpoint Inhibitor
Nivolumab + Ipilimumab Timing for Kidney Cancer
Phase 2
Waitlist Available
Led By Toni K Choueiri, MD
Research Sponsored by Toni Choueiri, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Demonstrate adequate organ function as defined in the table below. All screening labs to be obtained within 28 days prior to first study treatment
Unresectable advanced or metastatic RCC to include both clear cell and non-clear histologies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for arm a, radiology imaging will be done every 8 weeks until disease progression. for arm b, radiology imaging will be done at 12 weeks and then every 8 weeks until disease progression
Awards & highlights
Study Summary
This trial is studying how well these drugs work when given at different times.
Who is the study for?
This trial is for adults with advanced kidney cancer, including those who haven't had their cancer surgically removed or have metastatic RCC. Participants can be new or previously treated but not with certain immune checkpoint inhibitors. They must have measurable disease, good organ function, and provide a tissue sample. Women of childbearing age need a negative pregnancy test and agree to use contraception.Check my eligibility
What is being tested?
The OMNIVORE Study is testing the timing and effectiveness of two drugs, Nivolumab and Ipilimumab, in treating advanced renal cell carcinoma (RCC). The study aims to optimize how these drugs are administered based on patient response to treatment.See study design
What are the potential side effects?
Potential side effects include immune-related reactions that may affect organs like the liver or lungs, skin rash, hormone gland problems (like thyroid), infusion reactions during drug administration, fatigue, and possible increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My recent tests show my organs are functioning well.
Select...
My kidney cancer cannot be removed by surgery and has spread.
Select...
My stored cancer tissue sample is good enough for testing.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after initiation of arm b treatment, patients underwent imaging at 12 weeks and then every 8 weeks, up to 22 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after initiation of arm b treatment, patients underwent imaging at 12 weeks and then every 8 weeks, up to 22 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Subjects With Persistent Partial Response (PR) or Complete Response (CR) at 1 Year Since Nivolumab Discontinuation (Arm A Only)
Percentage of Subjects With Stable or Progressive Disease (SD/PD) to Nivolumab Induction That Convert to Complete or Partial Response (CR/PR) Upon the Addition of Ipilimumab to Nivolumab (Arm B Only)
Secondary outcome measures
18-month Overall Survival Rate From Initiation of Nivolumab Induction (Overall Cohort)
Immune Related Objective Response Rate (irORR) in Arm A and Arm B
Median Progression Free Survival (Arm B)
+6 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%
Rash
14%
Hyponatraemia
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%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Hypertension
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%
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%
Femur fracture
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Neoplasm progression
1%
Atrial flutter
1%
Bronchial obstruction
1%
Hypercalcaemia
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
3Treatment groups
Experimental Treatment
Group I: Overall cohort: Initial Primary Treatment with Nivolumab (induction phase)Experimental Treatment1 Intervention
Therapy with nivolumab IV every 2 weeks
Serial imaging assessments every 8 weeks
After confirmatory scans, patients are assigned to Arm A or Arm B.
Group II: Arm B: Nivolumab+Ipilimumab then nivolumab alone (for patients with SD/PD to induction nivolumab)Experimental Treatment2 Interventions
Patients with confirmed SD/PD to induction nivolumab are allocated to Arm B (Combination Therapy Arm).
In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses.
After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression.
Arm B patients undergo imaging at 12 weeks and then every 8 weeks.
Group III: Arm A: Observation Arm (for patients with persistent response to induction nivolumab)Experimental Treatment2 Interventions
Patients with persistent response (complete or partial response) to induction nivolumab are assigned to Arm A (Observation Arm).
Patients discontinued nivolumab after allocation to Arm A.
Serial imaging assessments every 8 weeks.
If scans persistently show PR/CR, patients remained on observation.
If progressive disease develops, therapy with nivolumab (480 mg IV every 4 weeks) will be resumed.
If there is subsequent progression on nivolumab monotherapy, ipilimumab (1 mg/kg IV every 3 weeks x 2 doses) is added.
If progression after nivolumab + ipilimumab, therapy discontinued. If SD/PR/CR, nivolumab is continued until progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2670
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Toni Choueiri, MDLead Sponsor
2 Previous Clinical Trials
32 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,429 Total Patients Enrolled
Toni K Choueiri, MDPrincipal InvestigatorDana-Farber Cancer Institute
4 Previous Clinical Trials
132 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken steroids or immunosuppressants for an autoimmune disease in the last 6 months.I may or may not have had previous cancer treatments, including adjuvant therapy.My cancer can be measured by scans according to RECIST 1.1.My recent tests show my organs are functioning well.I have a serious wound or ulcer that is not healing.Your heart's electrical activity, as measured by a test, is too slow.I haven't had any serious GI issues or fistulas in the last 6 months.I am not pregnant and either cannot become pregnant or have been postmenopausal for at least a year.I have been mostly active in the last 28 days.I suspect I have kidney cancer that has spread, and I plan to have surgery or a biopsy soon.I haven't taken any cancer-targeting pills or any cancer treatment in the last 4 weeks.My brain or spinal cancer has been treated and stable for 4 weeks.You have had serious allergic reactions to certain types of medications made from proteins.All side effects from my previous cancer treatments have improved to mild or returned to normal.I can provide a tumor sample and am willing to have a biopsy before treatment, unless it's unsafe.My stored cancer tissue sample is good enough for testing.I have a history of lung scarring or inflammation but not from radiation.I have tested positive for HIV/AIDS.My kidney cancer cannot be removed by surgery and has spread.I have signs of a blocked gut or need nutrition through IV.You have air in your abdomen that isn't from a recent surgery or medical procedure.I haven't had cancer other than kidney cancer in the last 5 years, or if I did, it was not serious and was treated.I have not used checkpoint inhibitors for my kidney cancer but may have used IFN-α or IL-2.I haven't taken any immune-weakening drugs in the last 2 weeks, with some exceptions.I have received radiation for kidney cancer within the last 14 days, except for one dose for symptom relief.My adrenal gland disorder is not under control.I do not have active hepatitis B but had it in the past.You are allergic to any part of the nivolumab or ipilimumab product.I am 18 years old or older.I haven't had major surgery in the last 4 weeks.I agree to use two forms of birth control or abstain from sex during and 120 days after treatment.I have not received a live vaccine in the last 4 weeks.I have hepatitis C but my viral DNA test is negative.I haven't had severe infections or been hospitalized for them in the last 4 weeks.I have had a stem cell or organ transplant in the past.I do not have severe heart problems like recent heart attacks or unstable heart rhythms.I understand and can follow the study's procedures.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: Nivolumab+Ipilimumab then nivolumab alone (for patients with SD/PD to induction nivolumab)
- Group 2: Overall cohort: Initial Primary Treatment with Nivolumab (induction phase)
- Group 3: Arm A: Observation Arm (for patients with persistent response to induction nivolumab)
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.
Could you provide a synopsis of the earlier studies pertaining to Nivolumab?
"Nivolumab was initially tested in 2009 at Texas Children's Hospital and has since seen 365 trials to completion. Currently, 765 studies are actively recruiting participants, with numerous sites located around Boston."
Answered by AI
What conditions are commonly treated with Nivolumab?
"Nivolumab is often employed following anti-angiogenic therapy to treat serious illnesses like cancerous tumours, unresectable melanoma and squamous cell carcinoma."
Answered by AI
Has the Food and Drug Administration sanctioned Nivolumab for therapeutic use?
"Based on the information available, our team at Power has assigned Nivolumab a rating of 2 due to its Phase 2 trial status. At this stage, there is evidence for safety but not efficacy."
Answered by AI
What are the main aims of this clinical research?
"According to the Bristol-Myers Squibb trial sponsor, this study's primary outcome is the number of subjects who progress or remain stable but convert to complete/partial response after adding ipilimumab to nivolumab. This research will also be observing secondary outcomes such as 18 month Overall Survival Rate From Initiation of Nivolumab Induction (Overall Cohort), Percentage of Subjects Who Experienced Grade 3-4 Treatment Related Adverse Events (TRAE) During the Arm B Treatment (Arm B Only), and Percentage of Subjects Who Had Complete or Partial Response (CR/PR) to Nivol"
Answered by AI
In what areas can patients access this clinical trial?
"This clinical trial is currently enrolling patients at 8 different locations, including Beth Israel Deaconess Medical Center in Boston, Dana Farber Cancer Institute in Providence and Lifespan Comprehensve Cancer Center in Madison."
Answered by AI
Would participants be accepted at this point for the clinical trial?
"According to sources on clinicaltrials.gov, this project is not presently recruiting any study participants; the latest update was recorded on April 22nd 2022. Despite that fact, there are 1188 other trials seeking candidates at present time."
Answered by AI
How many participants have been enrolled in this experiment thus far?
"Unfortunately, this clinical trial is not currently accepting any new participants. The study was first uploaded on October 26th 2017 and the most recent changes were made April 22nd 2022. Should you seek other trials, there are 423 studies with kidney neoplasms actively recruiting patients as well as 765 Nivolumab trials looking for volunteers."
Answered by AI
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