Nivolumab + Ipilimumab for Cancer

Recruiting in Palo Alto (17 mi)

+34 other locations

Overseen byLakshmi Rajdev

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 studies the side effects and best dose of nivolumab when given with ipilimumab in treating patients with human immunodeficiency virus (HIV) associated classical Hodgkin lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory), or solid tumors that have spread from where it first started to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ipilimumab is an antibody that acts against a molecule called cytotoxic T-lymphocyte antigen 4 (CTLA-4). CTLA-4 controls a part of the immune system by shutting it down. Nivolumab is a type of antibody that is specific for human programmed cell death 1 (PD-1), a protein that is responsible for destruction of immune cells. Giving ipilimumab with nivolumab may work better in treating patients with HIV associated classical Hodgkin lymphoma or solid tumors compared to ipilimumab with nivolumab alone.

Research Team

Lakshmi Rajdev

Principal Investigator

AIDS Malignancy Consortium

Eligibility Criteria

Adults over 18 with HIV and relapsed/refractory classical Hodgkin lymphoma or metastatic/unresectable solid tumors. Must have completed certain treatments, have specific CD4 counts, not be pregnant/breastfeeding, use contraception, manage HIV effectively (including antiretrovirals), and meet blood count criteria. Excludes those previously treated with similar immunotherapies or having autoimmune diseases.

Inclusion Criteria

You have tested positive for HIV-1 infection using an approved test or have medical records confirming the presence of HIV.

Your hemoglobin level must be 9 grams per deciliter or higher within 2 weeks before joining the study, if you are not in the Hodgkin lymphoma expansion group.

I am mostly active and can care for myself.

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Exclusion Criteria

I do not have pancreatitis.

I haven't taken experimental drugs in the last 4 weeks and haven't had full-body radiation, but limited radiation might be okay if certain conditions are met. My brain cancer has been treated, with no signs of worsening in the last month.

I am not on high-dose steroids or other strong immune system drugs.

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Treatment Details

Interventions

Ipilimumab (Checkpoint Inhibitor)
Nivolumab (Checkpoint Inhibitor)

Trial OverviewThe trial is testing the combination of two immunotherapy drugs: Nivolumab and Ipilimumab. These drugs may help the immune system fight cancer by blocking proteins that control immune cell destruction. The study aims to find the best dose while observing side effects in patients with HIV-associated cancers.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (nivolumab, ipilimumab)Experimental Treatment6 Interventions

Patients receive nivolumab IV over 30 minutes on day 1. Patients in dose level 2 also receive ipilimumab IV over 90 minutes on day 1 of every third cycle of nivolumab, and patients in dose level -2 also receive ipilimumab IV over 90 minutes on day 1 of every sixth cycle of nivolumab. Treatment repeats every 14 days for up to 46 cycles of nivolumab (with ipilimumab if receiving dose level 2 or -2) in the absence of disease progression or unacceptable toxicity.Patients undergo blood sample collection throughout the study. Patients undergo PET and CT scan during screening and on study. Patients undergo bone marrow biopsy on screening and may undergo it during follow up.