Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Stage III-IVB Head and Neck Cancer with a Contraindication to Cisplatin

    Karmanos Trial ID
    • NRG-HN004
    NCT ID
    • NCT03258554
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase II
    Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
    • Phase II/III
    Principal Investigator

    Objective:

    Primary Objective:
    • Lead-In: To determine the safety of radiotherapy (RT) with concurrent and adjuvant anti-PD-L1 therapy [MEDI4736 (durvalumab)] is safe in patients with locoregionally advanced head and neck cancer (HNC) who have a contraindication to cisplatin.
    • Phase II: To test the hypothesis that concurrent RT and anti-PD-L1 therapy improves PFS compared to standard therapy (RT with concurrent cetuximab) in patients with locoregionally advanced HNC who have a contraindication to cisplatin.
    • Phase III: To test the hypothesis that concurrent RT and anti-PD-L1 therapy improves overall survival compared to standard therapy (RT with concurrent cetuximab) in patients with locoregionally advanced HNC who have a contraindication to cisplatin.
    Secondary Objective:
    • To compare toxicity using CTCAE and PRO-CTCAE between patients treated with RT + anti-PD-L1 therapy versus RT/cetuximab.
    • To test the effect of anti-PD-L1 therapy in the subpopulation of patients with tumors that overexpress PD-L1.
    • To compare overall survival, response (at 4-month FDG-PET-CT), locoregional failure, distant metastasis, and competing mortality in the two arms by known risk factors, including p16 status and ω score.
    • To test the hypothesis that MEDI4736 (durvalumab) therapy arm will have less decline in the physical function domain of European Organization for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30 Version 3.0) based on the change in score from baseline to 12 months from end of RT, compared to the cetuximab-RT arm in patients with locoregionally advanced HNC who have a contraindication to cisplatin.
    • To test the hypothesis that MEDI4736 (durvalumab) therapy arm at 1 year (from end of RT) will have less decline in swallowing related QOL using the MDADI total composite score, based on the change in score from baseline to 12 months from end of RT, compared to the cetuximab-RT arm in patients who are medically unfit for cisplatin.
    • To compare swallowing related performance and function short and long term using the PSS-HN
    • To evaluate gastrostomy tube retention rates between arms
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Karmanos Cancer Institute at Lawrence and Idell Weisberg Cancer Treatment Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Karmanos Cancer Institute at McLaren Bay Region

    3140 W Campus Dr.
    Bay City, MI 48706
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    Phone: 989-667-2370

    Karmanos Cancer Institute at McLaren Clarkston

    5680 Bow Pointe Dr
    Clarkston, MI 48346
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    Phone: 248-922-6650

    Karmanos Cancer Institute at McLaren Flint

    4100 Beecher Rd
    Flint, MI 48532
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    Phone: 810-342-3800

    Karmanos Cancer Institute at McLaren Flint - Singh and Arora

    4100 Beecher Road
    Flint, MI 48532
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    Karmanos Cancer Institute at McLaren Greater Lansing

    1540 Lake Lansing Rd.
    Lansing, MI 48912
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    Phone: 517-913-3890

    Karmanos Cancer Institute at McLaren Greater Lansing - Lake Lansing Road

    1540 Lake Lansing Rd.
    Lansing, MI 48912
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    Karmanos Cancer Institute at McLaren Lapeer Region

    1295 Barry Drive
    Lapeer, MI 48446
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    Karmanos Cancer Institute at McLaren Macomb

    1080 Harrington Blvd
    Mount Clemens, MI 48043
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    Phone: 586-493-7500

    Karmanos Cancer Institute at McLaren Northern Michigan, Petoskey

    560 W Mitchell St
    Petoskey, MI 49770
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    Phone: 231-487-3390

    Karmanos Cancer Institute at McLaren Port Huron

    1221 Pine Grove Ave
    Port Huron, MI 48060
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    Phone: 810-982-5200