Safety Testing of Adding Nivolumab to Chemotherapy in Patients With Intermediate and High-Risk Local-Regionally Advanced Head and Neck Cancer

Part of paid clinical trials in Palo Alto, California.

Sponsor
RTOG Foundation, Inc.
Study ID
NCT02764593
Phase
PHASE1
Status
Completed

Conditions

  • Head and Neck Squamous Cell Carcinoma (HNSCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Anti-PD-1 targeted immunotherapy
  • Cisplatin — DRUG
    Anti-cancer alkylating agent
  • Cetuximab — DRUG
    Epidermal Growth Factor Receptor (EGFR) antagonist
  • IMRT — RADIATION
    High-precision radiotherapy

Study Details

This study will evaluate the safety of adding nivolumab to several chemotherapy platforms with weekly cisplatin, high-dose cisplatin, cetuximab or radiation therapy alone.

Key Dates

Start date
Jun 30, 2016
Status verified
Nov 2022
Primary completion
Sep 25, 2018
Completion
Feb 21, 2022

Study Design

Enrollment
40 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 (Nivolumab + Cisplatin)
    Patients will receive Nivolumab via IV administration every 14 days for 10 doses starting 14 days prior to IMRT. Cisplatin will be given weekly. IMRT will be given at 5 fractions per week for 7 weeks for a dose of 70 Gy. Adjuvant nivolumab every 28 days for 7 doses will be administered starting 3 months after end of chemoradiation. Adjuvant administration of nivolumab may be discontinued if more than 4 of first 8 patients receive less than 7 doses.
  • Experimental: Arm 2 (Nivolumab + High-dose Cisplatin)
    Patients will receive Nivolumab via IV administration starting 14 days prior to IMRT, then Day 1 of IMRT and then every 21 days for 6 doses. Cisplatin will be given every 21 days for 3 doses. IMRT will be given at 5 fractions per week for 7 weeks for a dose of 70 Gy. Adjuvant nivolumab every 28 days for 7 doses will be administered starting 3 months after end of chemoradiation. Adjuvant administration of nivolumab may be discontinued if more than 4 of first 8 patients receive less than 7 doses.
  • Experimental: Arm 3 (Nivolumab + Cetuximab)
    Patients will receive Nivolumab via IV administration every 14 days for 10 doses starting 14 days prior to IMRT. Cetuximab will be given for 7 doses. IMRT will be given at 5 fractions per week for 7 weeks for a dose of 70 Gy. Adjuvant nivolumab every 28 days for 7 doses will be administered starting 3 months after end of chemoradiation. Adjuvant administration of nivolumab may be discontinued if more than 4 of first 8 patients receive less than 7 doses.
  • Experimental: Arm 4 (Nivolumab + IMRT)
    Patients will receive Nivolumab via IV administration every 14 days for 10 doses starting 14 days prior to IMRT. IMRT will be given at 5 fractions per week for 7 weeks for a dose of 70 Gy. Adjuvant nivolumab every 28 days for 7 doses will be administered starting 3 months after end of chemoradiation. Adjuvant administration of nivolumab may be discontinued if more than 4 of first 8 patients receive less than 7 doses.

Primary Outcome Measure

Dose Limiting Toxicity (DLT) [ Time Frame: From the first dose of nivolumab to 28 days after the completion of radiation therapy. ]

Locations (11)

FacilityCityStateZIPSite coordinators
Stanford Cancer InstitutePalo AltoCalifornia94304-
University of Florida Cancer Center at Orlando HealthOrlandoFlorida32806-
Emory University/Winship Cancer InstituteAtlantaGeorgia30322-
University of LouisvilleLouisvilleKentucky40202-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Ohio State UniversityColumbusOhio43210-
Providence Portland Medical CenterPortlandOregon97213-
UPMC - Shadyside HospitalPittsburghPennsylvania15232-
MD Anderson Cancer CenterHoustonTexas77030-
Inova Fairfax HospitalFalls ChurchVirginia22042-
University of Wisconsin Hospital and ClinicsMadisonWisconsin53792-

Find similar trials in Palo Alto, CA

By research site
Stanford Cancer Institute· Palo Alto, CAUniversity of Florida Cancer Center at Orlando Health· Orlando, FLEmory University/Winship Cancer Institute· Atlanta, GAUniversity of Louisville· Louisville, KYUniversity Hospitals Cleveland Medical Center· Cleveland, OHOhio State University· Columbus, OH

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