Cabozantinib + Nivolumab for Cancer in HIV Patients

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byHaiying Cheng

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Haiying Cheng

Principal Investigator

Albert Einstein College of Medicine EDDOP

Eligibility Criteria

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.

Inclusion Criteria

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.

See 7 more

Exclusion Criteria

I have previously taken XL184, PD-1/PD-L1 inhibitors, or VEGFR inhibitors.

Subjects who are receiving any other investigational agents

I haven't had major surgery recently.

See 7 more

Treatment Details

Interventions

Cabozantinib (Tyrosine Kinase Inhibitor)
Nivolumab (Checkpoint Inhibitor)

Trial OverviewThe 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.

Participant Groups

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.

Cabozantinib is already approved in Canada, Japan for the following indications: