Actively Recruiting
Randomized Phase 2 Study of Nivolumab and Ipilimumab With or Without Cabozantinib in Advanced Nasopharyngeal Cancer After Platinum and Immunotherapy
Led by National Cancer Institute (NCI) · Updated on 2026-05-18
50
Participants Needed
92
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how well a combination of immunotherapy drugs nivolumab and ipilimumab, with or without the targeted drug cabozantinib, works in treating patients with nasopharyngeal cancer that has returned, spread, or cannot be cured. This phase II trial aims to compare progression-free survival between the combination therapies and also assess safety, overall response, overall survival, and molecular predictors of response. Participants are randomly assigned to one of two groups. One group receives nivolumab and ipilimumab intravenously every 28 days for up to 2 years, while the other group receives the same immunotherapy plus daily oral cabozantinib for 28 days per cycle, also for up to 2 years. Imaging scans (CT or MRI) and blood samples are collected throughout the trial to monitor disease and treatment effects. After treatment ends, patients are followed every 8 to 12 weeks until disease progression or new therapy starts, then every 6 months for up to 2 years. During the study, patients undergo regular assessments including imaging scans and blood tests to track tumor changes and immune response. Researchers measure progression-free survival as the main outcome, along with overall survival and treatment safety. The study also monitors adverse events and evaluates response in specific patient subgroups. The total involvement may last several years including treatment and follow-up periods to gather comprehensive data on how the treatments affect nasopharyngeal cancer.
CONDITIONS
Brief Title
Testing Nivolumab and Ipilimumab Immunotherapy With or Without the Targeted Drug Cabozantinib in Recurrent, Metastatic, or Incurable Nasopharyngeal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed nasopharyngeal carcinoma regardless of subtype or viral association
- Recurrent, metastatic, or incurable disease after platinum-gemcitabine and prior PD-1/L1 immunotherapy
- At least one measurable lesion not previously irradiated
- No more than 2 prior systemic therapy lines for recurrent or metastatic disease
- No prior VEGFR targeted therapy
- Age 18 years or older
- ECOG performance status 0 to 2
- Adequate blood counts and organ function as specified
- Negative pregnancy test for women of childbearing potential
- No active tumor bleeding or major blood vessel infiltration
- Recovered from prior therapy side effects except alopecia
- No recent chemotherapy or radiotherapy within specified timeframes
- No interfering prior malignancy
- Treated brain metastases allowed with stable imaging
- Controlled HIV, hepatitis B or C allowed under specific conditions
- Solid organ transplant allowed with transplant team monitoring
- No active autoimmune disease requiring immunosuppression
- Able to swallow oral medication
- No systemic corticosteroids or immunosuppressive drugs within 14 days except permitted uses
- No prohibited anticoagulants; some anticoagulants allowed
- Avoid strong CYP3A4 inhibitors or inducers during study
You will not qualify if you...
- Pregnant or nursing women
- Active tumor bleeding or major blood vessel invasion
- Life-threatening immune-related adverse events from prior immunotherapy
- Active brain metastases requiring immediate treatment
- Active autoimmune diseases affecting vital organs or requiring immunosuppression
- Known inability to swallow oral medication
- Use of systemic corticosteroids or immunosuppressive drugs within 14 days except allowed exceptions
- Use of prohibited anticoagulant medications
- Concurrent use of strong CYP3A4 inhibitors or inducers unless adjusted
- Prior VEGFR targeted therapy
- More than 2 prior systemic therapies for recurrent/metastatic disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive nivolumab and ipilimumab intravenously on day 1 of each 28-day cycle. Some participants also take cabozantinib orally daily during each cycle. Treatment continues for up to 2 years unless disease progression or unacceptable side effects occur. CT or MRI scans and blood sample collections are performed throughout treatment.
Visits every 28 days for drug administration and assessments
Duration - Up to 2 years after treatment
After treatment ends, participants are monitored every 8 to 12 weeks until disease progresses or new therapy starts, then every 6 months for up to 2 years to assess long-term outcomes.
Visits every 8 to 12 weeks initially, then every 6 months
Trial Site Locations
Total: 92 locations
1
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States, 92612
Actively Recruiting
2
Keck Medicine of USC Koreatown
Los Angeles, California, United States, 90020
Actively Recruiting
3
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
4
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
5
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, United States, 92663
Actively Recruiting
6
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
7
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States, 94304
Actively Recruiting
8
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
9
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
Suspended
10
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, United States, 83605
Suspended
11
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States, 83814
Actively Recruiting
12
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, United States, 83687
Suspended
13
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States, 83854
Actively Recruiting
14
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States, 83864
Actively Recruiting
15
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
16
University of Illinois
Chicago, Illinois, United States, 60612
Actively Recruiting
17
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
18
Carle at The Riverfront
Danville, Illinois, United States, 61832
Actively Recruiting
19
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States, 60115
Actively Recruiting
20
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Actively Recruiting
21
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States, 60201
Actively Recruiting
22
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States, 60134
Actively Recruiting
23
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, United States, 60026
Actively Recruiting
24
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, United States, 60026
Actively Recruiting
25
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, United States, 60030
Actively Recruiting
26
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Actively Recruiting
27
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, United States, 60035
Actively Recruiting
28
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, United States, 60045
Actively Recruiting
29
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Actively Recruiting
30
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States, 60451
Actively Recruiting
31
Northwestern Medicine Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
32
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
33
Carle Cancer Center
Urbana, Illinois, United States, 61801
Actively Recruiting
34
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States, 60555
Actively Recruiting
35
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States, 50023
Actively Recruiting
36
Mercy Cancer Center-West Lakes
Clive, Iowa, United States, 50325
Actively Recruiting
37
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, United States, 50325
Actively Recruiting
38
Heartland Oncology and Hematology LLP
Council Bluffs, Iowa, United States, 51503
Suspended
39
Methodist Jennie Edmundson Hospital
Council Bluffs, Iowa, United States, 51503
Actively Recruiting
40
Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ
Council Bluffs, Iowa, United States, 51503
Suspended
41
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Actively Recruiting
42
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States, 50309
Actively Recruiting
43
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Actively Recruiting
44
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, United States, 50314
Actively Recruiting
45
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, United States, 50263
Actively Recruiting
46
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
47
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States, 56601
Actively Recruiting
48
Mercy Hospital South
St Louis, Missouri, United States, 63128
Actively Recruiting
49
Community Hospital of Anaconda
Anaconda, Montana, United States, 59711
Actively Recruiting
50
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Actively Recruiting
51
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States, 59715
Actively Recruiting
52
Benefis Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Actively Recruiting
53
Logan Health Medical Center
Kalispell, Montana, United States, 59901
Actively Recruiting
54
Community Medical Center
Missoula, Montana, United States, 59804
Actively Recruiting
55
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
Omaha, Nebraska, United States, 68114
Actively Recruiting
56
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
Actively Recruiting
57
Oncology Associates PC
Omaha, Nebraska, United States, 68114
Suspended
58
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
59
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
60
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
61
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Actively Recruiting
62
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
63
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
64
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
65
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
66
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204
Actively Recruiting
67
Novant Health Cancer Institute - Huntersville
Huntersville, North Carolina, United States, 28078
Actively Recruiting
68
Novant Health Cancer Institute - Matthews
Matthews, North Carolina, United States, 28105
Actively Recruiting
69
Novant Health Cancer Institute - Mooresville
Mooresville, North Carolina, United States, 28117
Actively Recruiting
70
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
Actively Recruiting
71
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
72
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
73
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, United States, 45220
Suspended
74
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, United States, 73505
Actively Recruiting
75
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
76
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States, 74146
Suspended
77
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, United States, 97914
Suspended
78
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
79
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
80
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Actively Recruiting
81
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
Actively Recruiting
82
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
83
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, United States, 23235
Actively Recruiting
84
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
85
West Virginia University Healthcare
Morgantown, West Virginia, United States, 26506
Actively Recruiting
86
Camden Clark Medical Center
Parkersburg, West Virginia, United States, 26101
Actively Recruiting
87
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, United States, 54701
Actively Recruiting
88
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States, 54449
Actively Recruiting
89
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, United States, 54548
Actively Recruiting
90
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, United States, 54868
Actively Recruiting
91
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, United States, 54482
Actively Recruiting
92
Marshfield Medical Center - Weston
Weston, Wisconsin, United States, 54476
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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