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NCT01935921

Ipilimumab, Cetuximab, and Intensity-Modulated Radiation Therapy in Treating Patients With Previously Untreated Stage III-IVB Head and Neck Cancer

Completed Phase 1 Last updated 15 June 2023
What this trial tests

Phase 1 trial testing Cetuximab in Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7 in 19 participants. Completed in 6 July 2018.

Timeline
9 April 2013
Primary endpoint
29 October 2016
6 July 2018

Quick facts

Lead sponsorNational Cancer Institute (NCI)
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment19
Start date9 April 2013
Primary completion29 October 2016
Estimated completion6 July 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7 or Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase Ib trial studies the side effects and best dose of ipilimumab when given together with cetuximab and intensity-modulated radiation therapy (IMRT) in treating patients with previously untreated stage III-IVB head and neck cancer. Monoclonal antibodies, such as ipilimumab and cetuximab, may block tumor growth in different ways by targeting certain cells. Specialized radiation therapy, such as IMRT, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving ipilimumab together with cetuximab and IMRT may kill more tumor cells.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Myeloid-derived suppressor cells as immunosuppressive regulators and therapeutic targets in cancer.
    Li K, Shi H, Zhang B, Ou X, et al · · 2021 · cited 687× · PMID 34620838 · DOI 10.1038/s41392-021-00670-9
  2. Immunology and Immunotherapy of Head and Neck Cancer.
    Ferris RL. · · 2015 · cited 515× · PMID 26351330 · DOI 10.1200/jco.2015.61.1509
  3. Current clinical trials testing the combination of immunotherapy with radiotherapy.
    Kang J, Demaria S, Formenti S. · · 2016 · cited 293× · PMID 27660705 · DOI 10.1186/s40425-016-0156-7
  4. Combinations of immunotherapy and radiation in cancer therapy.
    Vatner RE, Cooper BT, Vanpouille-Box C, Demaria S, et al · · 2014 · cited 189× · PMID 25506582 · DOI 10.3389/fonc.2014.00325
  5. The intersection of radiotherapy and immunotherapy: mechanisms and clinical implications.
    Spiotto M, Fu YX, Weichselbaum RR. · · 2016 · cited 177× · PMID 28018989 · DOI 10.1126/sciimmunol.aag1266
  6. Rationale for combination of therapeutic antibodies targeting tumor cells and immune checkpoint receptors: Harnessing innate and adaptive immunity through IgG1 isotype immune effector stimulation.
    Ferris RL, Lenz HJ, Trotta AM, García-Foncillas J, et al · · 2018 · cited 143× · PMID 29223828 · DOI 10.1016/j.ctrv.2017.11.008
  7. In situ vaccination by radiotherapy to improve responses to anti-CTLA-4 treatment.
    Vanpouille-Box C, Pilones KA, Wennerberg E, Formenti SC, et al · · 2015 · cited 138× · PMID 26148880 · DOI 10.1016/j.vaccine.2015.05.105
  8. Circulating exosomes measure responses to therapy in head and neck cancer patients treated with cetuximab, ipilimumab, and IMRT.
    Theodoraki MN, Yerneni S, Gooding WE, Ohr J, et al · · 2019 · cited 128× · PMID 31143513 · DOI 10.1080/2162402x.2019.1593805

Verify or expand the search:

Other trials of Cetuximab

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Other recruiting trials for Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7

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Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

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Data sources for this page

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