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Trial record 1 of 1 for:    CA209-9TM
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Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT03349710
Recruitment Status : Active, not recruiting
First Posted : November 21, 2017
Last Update Posted : February 4, 2019
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
This study has two, independent, cohorts, both in locally advanced squamous cell head and neck cancer. The purpose of the first cohort is to determine whether nivolumab in combination with radiotherapy is more effective than cetuximab in combination with radiotherapy, in subjects who are ineligible for cisplatin. The purpose of the second cohort is to determine whether nivolumab, cisplatin, and radiotherapy is more effective than cisplatin and radiotherapy in subjects who are eligible to receive cisplatin

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Biological: Nivolumab Drug: Cetuximab Drug: Cisplatin Radiation: Radiotherapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1046 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Participants With Cisplatin Ineligible and Cisplatin Eligible Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : October 6, 2019
Estimated Study Completion Date : October 6, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A
Cohort 1
Biological: Nivolumab
Specified dose on specified day
Other Names:
  • BMS-936558
  • Opdivo

Radiation: Radiotherapy
Specified dose on specified day

Experimental: Arm B
Cohort 1
Drug: Cetuximab
Specified dose on specified day
Other Name: Erbitux

Radiation: Radiotherapy
Specified dose on specified day

Experimental: Arm C
Cohort 2
Biological: Nivolumab
Specified dose on specified day
Other Names:
  • BMS-936558
  • Opdivo

Drug: Cisplatin
Specified dose on specified day

Radiation: Radiotherapy
Specified dose on specified day

Experimental: Arm D
Cohort 2
Drug: Cisplatin
Specified dose on specified day

Radiation: Radiotherapy
Specified dose on specified day




Primary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: Up to 12 months ]
  2. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Histologically proven squamous cell carcinoma of the head and neck (SCCHN) from one of the following primary sites: oral cavity, oropharynx, hypopharynx, and larynx
  • Locally advanced disease which is unresectable, or resectable but suitable for an organ sparing approach
  • No previous radiotherapy or systemic treatment for SCCHN

Exclusion Criteria:

  • Carcinoma originating in the nasopharynx or paranasal sinus, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histology (e.g., mucosal melanoma), squamous cell carcinoma of unknown primary
  • Clinical or radiological evidence of metastatic disease
  • Prior radiotherapy that overlaps with radiation fields

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349710


  Show 97 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03349710     History of Changes
Other Study ID Numbers: CA209-9TM
2017-002676-87 ( EudraCT Number )
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Cisplatin
Nivolumab
Cetuximab
Antineoplastic Agents
Antineoplastic Agents, Immunological