RecruitingPhase 2NCT05904080

Testing Nivolumab and Ipilimumab Immunotherapy With or Without the Targeted Drug Cabozantinib in Recurrent, Metastatic, or Incurable Nasopharyngeal Cancer

Randomized Phase 2 Study of Nivolumab and Ipilimumab With or Without Cabozantinib in Patients With Advanced Nasopharyngeal Carcinoma That Have Progressed After Platinum Treatment and Immunotherapy


Sponsor

National Cancer Institute (NCI)

Enrollment

50 participants

Start Date

Feb 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests how well nivolumab and ipilimumab immunotherapy with or without cabozantinib works in treating patients with nasopharyngeal cancer that has come back (after a period of improvement) (recurrent), has spread from where it first started (primary site) to other places in the body (metastatic), or for which no treatment is currently available (incurable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving immunotherapy with nivolumab and ipilimumab and targeted therapy with cabozantinib may help shrink and stabilize nasopharyngeal cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing two immunotherapy drugs (nivolumab and ipilimumab) with or without a targeted drug (cabozantinib) in people whose nasopharyngeal cancer (a cancer at the back of the nose/throat) has come back or spread and no longer responds to standard treatments. **You may be eligible if...** - You are 18 or older with confirmed nasopharyngeal cancer that has returned or spread - You have already been treated with platinum-based chemotherapy and an immunotherapy drug - You have had no more than 2 prior treatment regimens for advanced disease - You have measurable cancer on a scan - You are able to carry out basic daily activities (ECOG 0–2) - Your blood, liver, and kidney lab values are within acceptable ranges **You may NOT be eligible if...** - You have previously received anti-VEGF/VEGFR-targeted therapy - You have an active autoimmune disease (such as lupus, multiple sclerosis, or inflammatory bowel disease) - You are pregnant or breastfeeding - You are on high-dose steroids or immune-suppressing medications - You had a severe, life-threatening reaction to prior immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

DRUGCabozantinib S-malate

Given PO

PROCEDUREComputed Tomography

Undergo CT scan

BIOLOGICALIpilimumab

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

BIOLOGICALNivolumab

Given IV


Locations(92)

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

Keck Medicine of USC Koreatown

Los Angeles, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, United States

Northwestern University

Chicago, Illinois, United States

University of Illinois

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Carle at The Riverfront

Danville, Illinois, United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, United States

Carle Physician Group-Effingham

Effingham, Illinois, United States

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, United States

Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois, United States

Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, United States

Ingalls Memorial Hospital

Harvey, Illinois, United States

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States

Northwestern Medicine Orland Park

Orland Park, Illinois, United States

University of Chicago Medicine-Orland Park

Orland Park, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, United States

Mercy Cancer Center-West Lakes

Clive, Iowa, United States

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, United States

Heartland Oncology and Hematology LLP

Council Bluffs, Iowa, United States

Methodist Jennie Edmundson Hospital

Council Bluffs, Iowa, United States

Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ

Council Bluffs, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, United States

Tufts Medical Center

Boston, Massachusetts, United States

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States

Mercy Hospital South

St Louis, Missouri, United States

Community Hospital of Anaconda

Anaconda, Montana, United States

Billings Clinic Cancer Center

Billings, Montana, United States

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Logan Health Medical Center

Kalispell, Montana, United States

Community Medical Center

Missoula, Montana, United States

Nebraska Cancer Specialists/Oncology Hematology West PC - MECC

Omaha, Nebraska, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Oncology Associates PC

Omaha, Nebraska, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, United States

Novant Health Cancer Institute - Huntersville

Huntersville, North Carolina, United States

Novant Health Cancer Institute - Matthews

Matthews, North Carolina, United States

Novant Health Cancer Institute - Mooresville

Mooresville, North Carolina, United States

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Good Samaritan Hospital - Cincinnati

Cincinnati, Ohio, United States

Cancer Centers of Southwest Oklahoma Research

Lawton, Oklahoma, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Oklahoma Cancer Specialists and Research Institute-Tulsa

Tulsa, Oklahoma, United States

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, United States

Oregon Health and Science University

Portland, Oregon, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

West Virginia University Healthcare

Morgantown, West Virginia, United States

Camden Clark Medical Center

Parkersburg, West Virginia, United States

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, United States

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, United States

Marshfield Medical Center - Weston

Weston, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT05904080


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