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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

Must not have

Major surgery within specific timeframes before first dose of study treatment

Subjects with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab or XL184 (cabozantinib)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am 18 years old or older.

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I have HIV and am receiving treatment for it.

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My cancer can be measured or observed.

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I am fully active or have some restrictions but can still take care of myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had major surgery recently.

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I have had allergic reactions to medications similar to nivolumab or cabozantinib.

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I am taking strong medication that affects liver enzyme CYP3A4.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of dose limiting toxicities (DLTs)

Secondary study objectives

Human immunodeficiency virus (HIV) viral loads

Immune status

Other study objectives

Change in angiogenesis markers

Change in immune checkpoint markers

Change in infiltrating immune cell markers

+1 more

Side effects data

From 2019 Phase 2 trial • 13 Patients • NCT02315430

85%

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%

Sore Throat

15%

Activated Partial Thromboplastin Time Prolonged

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

Allergic Rhinitis

Generalized Muscle Weakness

Creatinine Increased

Hyponatremia

Flank Pain

Bone Pain

Gastroesophageal Reflux Disease

Chest Pain - Cardiac

Vertigo

Neutrophil Count Decreased

Arthralgia

Syncope

Proteinuria

Pleural Effusion

Nasal Congestion

Pleuritic Pain

Hoarseness

Nail Discoloration

Ventricular Tachycardia

Tinnitus

Gastrointestinal Pain

Floaters

Dysphagia

Blood Bilirubin Increased

Lung Infection

Fever

Depression

Hypersomnia

Hypotension

Productive Cough

Memory Impairment

Anxiety

Cardiac Troponin I Increased

Urinary Incontinence

Pancreatitis

Upper Respiratory Infection

Bruising

Weight Gain

Skin Induration

100%

80%

60%

40%

20%

Study treatment Arm

Cabozantinib

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2790

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180