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Tyrosine Kinase Inhibitor

Cabozantinib + Immunotherapy for Cancer

Phase 2

Waitlist Available

Led By Anteneh A Tesfaye

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

Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

HCV infection treated and cured or undetectable HCV viral load if currently on treatment

Must not have

Prior treatment with XL184 (cabozantinib), MET-targeting TKI, or MET-targeting monoclonal antibody (MetMAb)

Require concomitant treatment with strong CYP3A4 inducers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a combination of drugs to treat neuroendocrine tumors. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Nivolumab and ipilimumab are immunotherapy drugs that help the body's immune system attack the cancer.

Who is the study for?

This trial is for adults with poorly differentiated neuroendocrine tumors, excluding small cell lung cancer and merkel cell carcinoma. Participants must have only failed one prior treatment, have measurable disease, and be able to perform daily activities (ECOG <=2). They should not be pregnant or breastfeeding and must agree to use contraception. People who've had major surgery recently, those with active autoimmune diseases or a history of severe allergies to similar drugs are excluded.

What is being tested?

The study tests the effectiveness of combining XL184 (cabozantinib), nivolumab, and ipilimumab in treating certain neuroendocrine tumors. Cabozantinib may block enzymes needed for tumor growth while nivolumab and ipilimumab could help the immune system fight cancer by interfering with tumor growth.

What are the potential side effects?

Possible side effects include high blood pressure, tiredness, liver issues like hepatitis, diarrhea or colitis from inflammation in the intestines; skin problems such as rash; hormonal gland problems like thyroid disorders; kidney failure; infusion reactions during drug administration; muscle pain or weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but might not be able to do heavy physical work.

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My hepatitis C is either cured or undetectable.

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My lipase levels are normal and I don't have pancreatitis.

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My white blood cell count is healthy without needing medication to boost it.

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My alkaline phosphatase levels are within the normal range, even with bone metastases.

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I can swallow pills.

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I am willing to undergo biopsies before and during treatment.

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My hepatitis B virus load is undetectable with treatment.

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My kidney function, measured by creatinine levels or clearance, is within the normal range.

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I can take care of myself but may not be able to do active work.

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My cancer is a type of advanced neuroendocrine tumor, not including small cell lung cancer or Merkel cell carcinoma.

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My white blood cell count is healthy without needing medication.

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I am HIV-positive, on treatment, and my viral load is undetectable.

Exclusion Criteria

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

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I have previously been treated with cabozantinib or other MET-targeting therapies.

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I need treatment with strong medications that change how my body processes drugs.

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I have been treated with drugs targeting immune system checkpoints.

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I haven't had chemotherapy or certain drugs within the last 4 weeks.

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I need to take blood thinners or platelet inhibitors.

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I have an autoimmune disease that could come back or affects my organs.

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I do not have any severe, uncontrolled illnesses.

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I have not had major surgery in the last 4 weeks.

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I am experiencing side effects from previous radiation therapy.

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I still have side effects from cancer treatment that affect my daily activities.

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I have brain metastases that have not been treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall response rate (ORR)

Secondary study objectives

Disease control rate (DCR)

Duration of response (DOR)

Incidence of adverse events

+1 more

Other study objectives

CD8+ T lymphocytes

Myeloid-Derived Suppressor Cells

Tumor-associated macrophages

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, ipilimumab)Experimental Treatment3 Interventions

Patients receive cabozantinib s-malate PO QD on days 1-21 of cycles 1-4 and days 1-28 of subsequent cycles, nivolumab IV over 30 minutes on day 1, and ipilimumab IV over 90 minutes on day 1 of cycles 1-4 only. Treatment repeats every 21 for 4 cycles then every 28 days for subsequent cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cabozantinib S-malate

2013

Completed Phase 2

~590

Ipilimumab

2015

Completed Phase 3

~3420