Active — Not RecruitingPhase 1

Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV

United States8 participantsStarted 2021-11-22

Plain-language summary

This phase I trial investigates the side effects of cabozantinib and nivolumab in treating patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and who are undergoing treatment for human immunodeficiency virus (HIV). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and nivolumab may shrink or stabilize cancer in patients undergoing treatment for HIV.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \>= 18 years. Children are excluded from this study, but will be eligible for future pediatric trials * For the six-patient safety cohort, subjects must have histologically or cytologically confirmed advanced solid tumors that are metastatic or recurrent, and require palliative systemic treatment, for which there are either Food and Drug Administration (FDA) approved indications for XL184 (cabozantinib) or nivolumab or have at least phase 2 data clearly indicating activity (such as renal cell carcinoma \[RCC\], hepatocellular carcinoma \[HCC\], medullary thyroid carcinoma \[MTC\], melanoma, non-small cell lung cancer \[NSCLC\], head and neck cancer, urothelial carcinoma, small cell lung cancer \[SCLC\], radioiodine-refractory differentiated thyroid cancer, ovarian cancer, castration-resistant prostate carcinoma \[CRPC\], and triple-negative breast cancer \[TNBC\]). Subjects must have progressed, or are intolerant, or decline systemic therapy associated with clinically significant survival benefit if checkpoint blockade is not an approved or accepted treatment. The expansion cohort is limited to subjects with KS. Histologic, cytologic, and pathologic confirmation of KS is required * Any number of prior cancer therapies will be permitted, including treatment naive subjects. (Note: For KS, treatment naive asymptomatic subjects will be permitted. But treatment naive KS subjects with visceral symptomatic disease or complicated KS HHV 8 disease including …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this is a Phase 1 trial primarily measuring dose-limiting toxicities, what does that mean for what's currently known about safety and effectiveness of combining cabozantinib and nivolumab specifically in people with HIV — and how might that uncertainty affect my situation?
2Because this trial is active but no longer enrolling new patients, is there any way to access these two drugs together outside of a trial, or are there other open studies combining immunotherapy and targeted therapy that might be worth looking into for my specific cancer type?
3Nivolumab works by activating the immune system, and I already have HIV — how might my current CD4 count, viral load, and antiretroviral therapy interact with both drugs, and are there particular risks I should weigh more carefully than someone without HIV?
4Given that this trial covers a wide range of cancer types, is there data emerging from it that's specific to my cancer diagnosis that you've seen or that might guide whether this drug combination makes sense as a direction for my treatment?
5Before considering an experimental combination like this, should I explore whether standard approved treatments for my cancer type have been fully exhausted, and how would you weigh those options against pursuing a newer investigational approach?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Dose Limiting Toxicities (DLTs)

Timeframe: 28 days

Trial details

NCT IDNCT04514484

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2024-11-11

Results submitted2026-04-07

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