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Tyrosine Kinase Inhibitor
Bempegaldesleukin + Nivolumab + TKI for Kidney Cancer (PIVOT IO 011 Trial)
Phase 1
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky Performance Status (KPS) of at least 70%
Advanced (not amenable to curative surgery or radiation therapy) or metastatic (American Joint Committee on Cancer (AJCC) Stage 4) RCC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2.5 years
Awards & highlights
PIVOT IO 011 Trial Summary
This trial is testing a combination of drugs to see if they are safe. One of the drugs is bempegaldesleukin (BEMPEG: NKTR-214).
Who is the study for?
This trial is for adults with advanced or metastatic kidney cancer who haven't had systemic therapy before, except possibly one VEGF-targeted adjuvant/neoadjuvant treatment. Participants must have a life expectancy of at least 12 weeks, be relatively active (KPS ≥ 70%), and have measurable disease. They should agree to use contraception if applicable and not have certain conditions like active brain metastases or autoimmune diseases.Check my eligibility
What is being tested?
The study is testing the safety of combining Bempegaldesleukin (BEMPEG: NKTR-214) with Nivolumab and a Tyrosine Kinase Inhibitor (TKI), compared to just Nivolumab and TKI in treating previously untreated advanced kidney cancer. The goal is to see if adding BEMPEG improves treatment outcomes.See study design
What are the potential side effects?
Possible side effects include those common to immunotherapies such as fatigue, skin reactions, inflammation in organs, potential immune system overactivity affecting healthy tissues, as well as side effects related to TKIs like high blood pressure, diarrhea, and hand-foot syndrome.
PIVOT IO 011 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You should have a good level of physical ability, with a score of at least 70% on the Karnofsky Performance Scale.
Select...
You have advanced or metastatic kidney cancer that cannot be treated with surgery or radiation therapy.
PIVOT IO 011 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of AEs leading to discontinuation (Part 1)
Incidence of adverse events (AEs) by severity (Part 1)
Incidence of changes in clinical laboratory results by severity: Clinical Chemistry tests (Part 1)
+5 moreSecondary outcome measures
Incidence of AEs by severity (Part 2)
Incidence of AEs leading to discontinuation (Part 2)
Incidence of SAEs (Part 2)
+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%
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%
Chills
7%
Hypertension
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Blood alkaline phosphatase increased
7%
Dehydration
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%
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%
Malignant pleural effusion
2%
Sepsis
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%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Pericardial effusion malignant
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
PIVOT IO 011 Trial Design
2Treatment groups
Experimental Treatment
Group I: Part 1B (Part 1): Nivolumab + CabozantinibExperimental Treatment2 Interventions
Group II: Part 1A (Part 1): Nivolumab + AxitinibExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
2020
Completed Phase 2
~1080
Nivolumab
2014
Completed Phase 3
~4750
Axitinib
2020
Completed Phase 2
~3050
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,484 Total Patients Enrolled
Nektar TherapeuticsIndustry Sponsor
58 Previous Clinical Trials
10,312 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have not received any previous treatments for kidney cancer, except for one specific type of treatment after surgery. If you did have this type of treatment, your cancer must have come back at least 6 months after you finished the treatment.You have cancer that has spread to your brain or the covering of your brain.You currently have or are suspected to have an autoimmune disease that is not controlled.You have not been properly treated for adrenal insufficiency.You are expected to live for at least 12 more weeks.You should have a good level of physical ability, with a score of at least 70% on the Karnofsky Performance Scale.You have a visible disease that can be seen on a CT scan or MRI according to specific guidelines.You have been diagnosed with a specific type of kidney cancer called renal cell carcinoma, which includes clear cell component and may have sarcomatoid features.You have advanced or metastatic kidney cancer that cannot be treated with surgery or radiation therapy.You have had a blood clot in your lungs or in your deep veins, or a significant blood clot in an artery within the 3 months before starting the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1A (Part 1): Nivolumab + Axitinib
- Group 2: Part 1B (Part 1): Nivolumab + Cabozantinib
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.
How has Bempegaldesleukin been evaluated for its safety profile?
"Our team at Power gave Bempegaldesleukin a score of 1 due to the limited data available from its first-phase clinical trials, indicating that efficacy and safety are still yet to be fully established."
Answered by AI
What other research endeavors have been done regarding Bempegaldesleukin?
"Bempegaldesleukin was initially studied at the University of Texas MD Anderson Cancer Center in 2011, and since then there have been a total 384 concluded studies. 836 active clinical trials are currently running, with many being performed within Houston, Texas."
Answered by AI
Is this research endeavor unique in its methodologies?
"At present, 836 clinical studies concerning Bempegaldesleukin are underway in 2627 cities and 54 countries. The inaugural research into this drug was conducted by Pfizer in 2011 which involved 39 participants and culminated with Phase 2 approval. Since then, 384 trials have been successfully concluded."
Answered by AI
How many participants are recruited for this research endeavor?
"At this time, recruitment for the study has been paused. The trial was initially listed on September 11th 2020 and revised most recently on November 22nd 2022. Alternatively, there are 2585 open trials recruiting patients with renal cell carcinoma and 836 studies seeking participants for Bempegaldesleukin treatment."
Answered by AI
Where are the current sites for this examination taking place?
"Numerous medical centres are currently enrolling patients in this clinical trial, including The University Of Texas MD Anderson Cancer Center (Houston and Springdale), Washington University School of Medicine (Stanford) and 24 other participating locations."
Answered by AI
What medical applications is Bempegaldesleukin most commonly leveraged for?
"Bempegaldesleukin is a common treatment for cases of unresectable melanoma. It can also be advantageous in situations such as squamous cell carcinoma, high risk recurrence, and similar maladies."
Answered by AI
Is there an opportunity for new participants to join this medical experiment?
"At this moment, recruitment for this trial has been paused. It was initially posted on the 11th of September 2020 and edited most recently on 22nd November 2022. For alternative trials, 2585 clinical studies are actively recruiting patients with renal cell carcinoma while 836 medical experiments seek participants to receive Bempegaldesleukin treatments."
Answered by AI
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