Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05904080

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

Led by National Cancer Institute (NCI) · Updated on 2026-05-13

50

Participants Needed

92

Research Sites

225 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed nasopharyngeal carcinoma of any WHO type
  • Recurrent, metastatic, or incurable disease previously treated with platinum-gemcitabine and PD-1/L1 blockade
  • At least one measurable lesion not previously irradiated
  • No more than 2 prior systemic therapy lines for recurrent/metastatic disease
  • No prior VEGFR targeted therapy
  • Age 18 years or older
  • ECOG performance status 0 to 2
  • Absolute neutrophil count ≥ 1,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 30 MDRD
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN), except Gilbert syndrome allowed up to <3 mg/dL
  • AST/ALT ≤ 3 times ULN (up to 5 times with liver metastases)
  • Negative pregnancy test for women of childbearing potential
  • No active tumor bleeding or major blood vessel infiltration
  • Recovery from prior anti-cancer therapy toxicities except alopecia
  • No chemotherapy or radiotherapy within 3 weeks (6 weeks for certain agents) before registration
  • No interfering prior malignancies
  • Brain metastases allowed if stable or not requiring immediate treatment
  • HIV infection controlled with undetectable viral load
  • Controlled or cured hepatitis B or C infection
  • Solid organ or tissue transplant allowed with close monitoring
  • No active autoimmune disease requiring immunosuppressive therapy
  • Able to swallow oral medication
  • No systemic corticosteroids >10 mg prednisone equivalent within 14 days
  • No prohibited anticoagulants
  • Avoid strong CYP3A4 inhibitors or inducers during study
Not Eligible

You will not qualify if you...

  • Pregnant or nursing women
  • Life-threatening immune-related adverse events from prior immunotherapy
  • Active brain metastases requiring immediate treatment
  • Active autoimmune diseases affecting vital organs or requiring systemic treatment
  • Current use of prohibited anticoagulants
  • Use of complementary medications intended to treat the cancer under study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

Actively Recruiting

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

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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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