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Tyrosine Kinase Inhibitor
Cabozantinib + Nivolumab for Cancer in HIV Patients
Phase 1
Waitlist Available
Led By Haiying Cheng
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
Age >= 18 years. Children are excluded from this study, but will be eligible for future pediatric trials
Subjects must have known HIV infection and receive appropriate care and treatment for HIV infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
Study Summary
This trial is investigating the side effects of two drugs, cabozantinib and nivolumab, in treating patients with advanced cancer who are also undergoing treatment for HIV.
Who is the study for?
This trial is for adults with advanced cancers that have spread and are also undergoing treatment for HIV. They must meet certain lab criteria, not be pregnant or breastfeeding, use contraception, and have a life expectancy of at least 12 weeks. People with autoimmune diseases, recent chemotherapy or radiation therapy, allergies to similar drugs, or taking strong CYP3A4 inhibitors can't join.Check my eligibility
What is being tested?
The trial tests the combination of cabozantinib (which blocks enzymes needed for cancer cell growth) and nivolumab (an immunotherapy drug helping the immune system attack cancer). It aims to see if this combo can shrink or stabilize various advanced cancers in patients who are also being treated for HIV.See study design
What are the potential side effects?
Potential side effects include inflammation from immune reactions, liver issues due to enzyme inhibition by cabozantinib, fatigue from both drugs affecting energy levels, digestive problems as common reactions to chemotherapy agents like these two drugs.
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 have HIV and am receiving treatment for it.
Select...
My cancer can be measured or observed.
Select...
I am fully active or have some restrictions but can still take care of myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose limiting toxicities (DLTs)
Secondary outcome measures
Human immunodeficiency virus (HIV) viral loads
Immune status
Other outcome measures
Change in angiogenesis markers
Change in immune checkpoint markers
Change in infiltrating immune cell markers
+1 moreSide effects data
From 2019 Phase 2 trial • 13 Patients • NCT0231543085%
Fatigue
77%
Nausea
62%
Dysgeusia
62%
Vomiting
54%
Alkaline Phosphatase Increased
54%
Aspartate Aminotransferase Increased
54%
Mucositis Oral
54%
Abdominal Pain
46%
Hypertension
46%
Anorexia
38%
Alanine Aminotransferase Increased
38%
Thromboembolic Event
38%
Anemia
38%
Diarrhea
38%
Constipation
38%
Cough
38%
Weight Loss
38%
Dyspnea
31%
Hypomagnesemia
31%
Back Pain
31%
Lipase Increased
31%
Hypoalbuminemia
23%
Hypophosphatemia
23%
Hyperglycemia
23%
Dizziness
23%
Palmar-Plantar Erythrodysesthesia Syndrome
23%
Alopecia
23%
Hypothyroidism
23%
Pain In Extremity
23%
Oral Pain
23%
Pain
23%
Headache
15%
Activated Partial Thromboplastin Time Prolonged
15%
Sore Throat
15%
Myalgia
15%
Bloating
15%
White Blood Cell Decreased
15%
Insomnia
15%
Dry Mouth
15%
Dyspepsia
15%
Dehydration
15%
Hypocalcemia
15%
Dry Skin
15%
Flushing
15%
Peripheral Sensory Neuropathy
15%
Abdominal Distension
15%
Platelet Count Decreased
8%
Generalized Muscle Weakness
8%
Allergic Rhinitis
8%
Creatinine Increased
8%
Hyponatremia
8%
Flank Pain
8%
Bone Pain
8%
Gastroesophageal Reflux Disease
8%
Chest Pain - Cardiac
8%
Vertigo
8%
Neutrophil Count Decreased
8%
Arthralgia
8%
Syncope
8%
Proteinuria
8%
Pleural Effusion
8%
Nasal Congestion
8%
Pleuritic Pain
8%
Hoarseness
8%
Nail Discoloration
8%
Ventricular Tachycardia
8%
Tinnitus
8%
Gastrointestinal Pain
8%
Floaters
8%
Dysphagia
8%
Blood Bilirubin Increased
8%
Lung Infection
8%
Fever
8%
Depression
8%
Hypersomnia
8%
Hypotension
8%
Productive Cough
8%
Memory Impairment
8%
Anxiety
8%
Cardiac Troponin I Increased
8%
Urinary Incontinence
8%
Pancreatitis
8%
Upper Respiratory Infection
8%
Bruising
8%
Weight Gain
8%
Skin Induration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cabozantinib
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cabozantinib s-malate, nivolumab)Experimental Treatment5 Interventions
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Nivolumab
2014
Completed Phase 3
~4750
Biospecimen Collection
2004
Completed Phase 2
~1730
Cabozantinib S-malate
2013
Completed Phase 2
~470
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,135 Total Patients Enrolled
Haiying ChengPrincipal InvestigatorAlbert Einstein College of Medicine EDDOP
1 Previous Clinical Trials
3 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously taken XL184, PD-1/PD-L1 inhibitors, or VEGFR inhibitors.I haven't had major surgery recently.I have had radiation therapy recently before starting the study treatment.I am 18 years old or older.My advanced cancer has returned or spread and needs treatment that could include XL184 (cabozantinib) or nivolumab.I have HIV and am receiving treatment for it.You have a current autoimmune disease or a history of autoimmune disease that could come back.Your blood test results for certain things like white blood cells, platelets, liver function, kidney function, and immune system cells must meet certain levels.I haven't had chemotherapy or biologic treatments recently.You are expected to live for at least 12 more weeks.I have had allergic reactions to medications similar to nivolumab or cabozantinib.My cancer can be measured or observed.I am fully active or have some restrictions but can still take care of myself.I am taking strong medication that affects liver enzyme CYP3A4.My condition worsened or I can't tolerate the standard treatment, and I haven't used or can't use checkpoint inhibitors.I do not have serious heart, lung, stomach, or other related health issues.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cabozantinib s-malate, 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.
Are there any vacancies for participants in this research project?
"Affirmative. Clinicaltrials.gov's records indicate that this medical research, which was initially posted on November 4th 2020, is actively recruiting patients. Eighteen individuals need to be recruited from 2 distinct treatment sites."
Answered by AI
Have any other trials been conducted regarding the effectiveness of Cabozantinib S-malate?
"At the moment, Cabozantinib S-malate is being trialled in 793 different studies with 90 at Phase 3. Basel, BE hosts a majority of these trials but there are 43550 other locations around the world running cabozantinib s-malte clinical trials."
Answered by AI
How many individuals are partaking in the current research endeavor?
"Correct. Per the information on clinicialtrials.gov, this scientific research is still open for participation and was initially made public on November 4th 2020. Currently, 18 participants are needed between two different sites."
Answered by AI
Is this particular experiment unprecedented in nature?
"According to available records, 793 active clinical trials for Cabozantinib S-malate are being conducted across 53 countries and 2553 cities. This research began in 2012 when the drug's sponsor Exelixis ran a Phase 2 study with 86 participants; since then 397 other studies have concluded their investigations."
Answered by AI
Has Cabozantinib S-malate been endorsed by the FDA?
"Cabozantinib S-malate has limited evidence supporting its safety and efficacy, thus receiving a score of 1 on our team's scale."
Answered by AI
What medical issue is Cabozantinib S-malate typically employed to address?
"Cabozantinib S-malate is regularly employed to abate malignant neoplasms. Additionally, this drug has proven helpful in managing cases of metastatic esophageal adenocarcinoma, unresectable melanoma, and squamous cell carcinoma."
Answered by AI
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