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Tyrosine Kinase Inhibitor

Cabozantinib + Immunotherapy for Cancer

Q: How does this research compare to other work on Cabozantinib S-malate?

There are 879 clinical trials for Cabozantinib S-malate that have not yet concluded, with 96 of those being in Phase 3. Some of the ongoing research for this medication is based out of Pittsburgh, but there are 46890 total locations running these studies.

Q: How many individuals are being given this medication as part of the trial?

This particular clinical trial is no longer recruiting patients. It was originally posted on January 14th, 2020 but the last update to the study was on October 4th, 2022. However, there are presently 2736 other trials for carcinoma and neuroendocrine searching for participants as well 879 studies for Cabozantinib S-malate admitting patients.

Q: Are researchers actively looking for participants for this experiment?

Unfortunately, the latest information from clinicaltrials.gov shows that this study has stopped recruiting patients as of October 4th, 2022. This was first posted on January 14th, 2020. Although this particular trial is not enrolling new participants, there are 3,615 other trials that are currently looking for candidates.

Q: Are there any safety concerns associated with Cabozantinib S-malate?

Because there is only preliminary data supporting cabozantinib s-malate's safety, it received a score of 2.

Q: In how many different medical clinics is this clinical trial being run?

Enrollment for this trial is happening at 42 different locations, some of which are in Lee's Summit, Clemmons and <a href="https://www.withpower.com/clinical-trials/kansas">Kansas</a> City. If you enroll in the study, try to pick a site that is close to your residence to avoid travel complications.

Q: For what purpose is Cabozantinib S-malate most commonly prescribed?

Cabozantinib S-malate is most frequently used to treat unresectable <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>. However, it has also been taken to address multiple other conditions like <a href="https://www.withpower.com/clinical-trials/squamous-cell-carcinoma">squamous cell carcinoma</a> and high risk of recurrence disease.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall response rate (ORR)

Secondary outcome measures

Disease control rate (DCR)

Duration of response (DOR)

Incidence of adverse events

+1 more

Other outcome measures

CD8+ T lymphocytes

Myeloid-Derived Suppressor Cells

Tumor-associated macrophages

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

Ipilimumab

2014

Completed Phase 3

~2620

Cabozantinib S-malate

2013

Completed Phase 2

~470

Nivolumab

2014

Completed Phase 3

~4750

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,657 Previous Clinical Trials

40,933,637 Total Patients Enrolled

Anteneh A TesfayePrincipal InvestigatorYale University Cancer Center LAO

Media Library

Cabozantinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04079712 — Phase 2

Neuroendocrine Carcinoma Research Study Groups: Treatment (cabozantinib s-malate, nivolumab, ipilimumab)

Neuroendocrine Carcinoma Clinical Trial 2023: Cabozantinib Highlights & Side Effects. Trial Name: NCT04079712 — Phase 2

Cabozantinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04079712 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How does this research compare to other work on Cabozantinib S-malate?

"There are 879 clinical trials for Cabozantinib S-malate that have not yet concluded, with 96 of those being in Phase 3. Some of the ongoing research for this medication is based out of Pittsburgh, but there are 46890 total locations running these studies."

Answered by AI

How many individuals are being given this medication as part of the trial?

"This particular clinical trial is no longer recruiting patients. It was originally posted on January 14th, 2020 but the last update to the study was on October 4th, 2022. However, there are presently 2736 other trials for carcinoma and neuroendocrine searching for participants as well 879 studies for Cabozantinib S-malate admitting patients."

Answered by AI

Are researchers actively looking for participants for this experiment?

"Unfortunately, the latest information from clinicaltrials.gov shows that this study has stopped recruiting patients as of October 4th, 2022. This was first posted on January 14th, 2020. Although this particular trial is not enrolling new participants, there are 3,615 other trials that are currently looking for candidates."

Answered by AI

Are there any safety concerns associated with Cabozantinib S-malate?

"Because there is only preliminary data supporting cabozantinib s-malate's safety, it received a score of 2."

Answered by AI

In how many different medical clinics is this clinical trial being run?

"Enrollment for this trial is happening at 42 different locations, some of which are in Lee's Summit, Clemmons and Kansas City. If you enroll in the study, try to pick a site that is close to your residence to avoid travel complications."

Answered by AI

For what purpose is Cabozantinib S-malate most commonly prescribed?

"Cabozantinib S-malate is most frequently used to treat unresectable melanoma. However, it has also been taken to address multiple other conditions like squamous cell carcinoma and high risk of recurrence disease."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Combination of XL184 (Cabozantinib), Nivolumab, and Ipilimumab for Poorly Differentiated Neuroendocrine Tumors

2020. "Testing the Combination of XL184 (Cabozantinib), Nivolumab, and Ipilimumab for Poorly Differentiated Neuroendocrine Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04079712.

All > Neuroendocrine Tumor