Clinical Trials List
Protocol NumberCA017-063
NCT Number(ClinicalTrials.gov Identfier)NCT03386838
2018-02-08 - 2018-02-08
Phase III
Terminated3
ICD-10C44.42
Squamous cell carcinoma of skin of scalp and neck
A Randomized, Global, Open-label Study of Nivolumab in Combination With BMS-986205 vs Standard of Care EXTREME Regimen in First-line Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck
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Trial Applicant
BRISTOL-MYERS SQUIBB (TAIWAN) LTD.
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Sponsor
Bristol-Myers Squibb
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 林伯儒 Division of Radiation Therapy
- 陳建志 Division of Radiation Therapy
- YI-CHUN LIU Division of Radiation Therapy
- 李權 Division of Radiation Therapy
- 林敬薇 Division of Radiation Therapy
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Mu-Hsin Chang Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
- Hsiang-Fong Kao Division of Hematology & Oncology
- YA-FANG CHEN Division of Hematology & Oncology
- 廖斌志 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Condition/Disease
Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck
Objectives
Primary
To compare progression-free survival (PFS) as determined by Blinded
Independent Central Review (BICR) using RECIST 1.1 of nivolumab combined
with BMS-986205 vs the EXTREME regimen in R/M SCCHN participants with
PD-L1 expression 1% in the first-line setting
To compare overall survival (OS) of nivolumab combined with BMS-986205 vs
the EXTREME regimen in R/M SCCHN participants with PD-L1 expression
>=1% in the first-line setting
To evaluate the objective response rate (ORR) determined by BICR using
RECIST 1.1 of nivolumab combined with BMS-986205 vs the EXTREME
regimen in R/M SCCHN participants with PD-L1 expression 1% in the first-line
setting.
Test Drug
BMS-986205/Nivolumab
Active Ingredient
BMS-986205
Nivolumab
Nivolumab
Dosage Form
film-coated tablet
injection
injection
Dosage
100
100mg/10mL/vial
100mg/10mL/vial
Endpoints
Primary Outcome Measures :
Progression-free survival (PFS) as determined by Blinded Independent Central Review (BICR) using RECIST 1.1 [ Time Frame: Approximately 2 years ]
Overall survival (OS) [ Time Frame: Approximately 40 months ]
Objective response rate (ORR) determined by BICR using RECIST 1.1 [ Time Frame: Approximately 2 years ]
Secondary Outcome Measures :
Number of adverse events (AE) [ Time Frame: Approximately 2 years ]
Number of serious adverse events (SAE) [ Time Frame: Approximately 2 years ]
Time to meaningful symptomatic deterioration (TTSD) [ Time Frame: Approximately 2 years ]
Progression-free survival (PFS) as determined by Blinded Independent Central Review (BICR) using RECIST 1.1 [ Time Frame: Approximately 2 years ]
Overall survival (OS) [ Time Frame: Approximately 40 months ]
Objective response rate (ORR) determined by BICR using RECIST 1.1 [ Time Frame: Approximately 2 years ]
Secondary Outcome Measures :
Number of adverse events (AE) [ Time Frame: Approximately 2 years ]
Number of serious adverse events (SAE) [ Time Frame: Approximately 2 years ]
Time to meaningful symptomatic deterioration (TTSD) [ Time Frame: Approximately 2 years ]
Inclution Criteria
Key Inclusion Criteria:
a) Males and Females > ages 18 or age of majority
b) Histologically confirmed SCCHN, from any of the following primary sites only: oral
cavity, oropharynx, hypopharynx and larynx.
c) R/M disease that is not amenable to therapy with curative intent (surgery or radiation
therapy with or without chemotherapy). Participants that refuse potentially curative salvage
surgery for recurrent disease are ineligible.
d) No prior treatment with systemic anti-cancer therapy for SCCHN, unless the following
conditions are met:
i) Prior chemotherapy was given as adjuvant or neoadjuvant treatment or as part of
multimodal (chemotherapy + radiotherapy) treatment for locally advanced disease.
ii) Treatments must have been completed > 6 months prior to enrollment.
iii) No evidence of disease progression for at least 6 months after completion of systemic
therapy.
e) Availability of a suitable formulation and mode of administration for the participant’s
needs, as detailed in the IB and pharmacy manual at the time of enrollment
Note: at the time of original protocol finalization, BMS 986205 will be available in a tablet
formulation only and participants must be able to swallow intact tablets to enroll on the
study. Ongoing clinical pharmacology studies may expand the options available as detailed
in Section 5.4.2. Full details can be found in the IB and pharmacy manual, which will be
updated throughout the study. Please contact the Medical Monitor with any queries.
f) ECOG Performance Status of 0-1
g) Documentation of HPV p-16 status is required for SCCHN of the oropharynx. See
Section 9.8.6 for additional guidance.
h) Documentation of PD-L1 status by IHC performed by the central lab at randomization.
i) Prior palliative radiotherapy must have been completed at least 2 weeks prior to
randomization
a) Males and Females > ages 18 or age of majority
b) Histologically confirmed SCCHN, from any of the following primary sites only: oral
cavity, oropharynx, hypopharynx and larynx.
c) R/M disease that is not amenable to therapy with curative intent (surgery or radiation
therapy with or without chemotherapy). Participants that refuse potentially curative salvage
surgery for recurrent disease are ineligible.
d) No prior treatment with systemic anti-cancer therapy for SCCHN, unless the following
conditions are met:
i) Prior chemotherapy was given as adjuvant or neoadjuvant treatment or as part of
multimodal (chemotherapy + radiotherapy) treatment for locally advanced disease.
ii) Treatments must have been completed > 6 months prior to enrollment.
iii) No evidence of disease progression for at least 6 months after completion of systemic
therapy.
e) Availability of a suitable formulation and mode of administration for the participant’s
needs, as detailed in the IB and pharmacy manual at the time of enrollment
Note: at the time of original protocol finalization, BMS 986205 will be available in a tablet
formulation only and participants must be able to swallow intact tablets to enroll on the
study. Ongoing clinical pharmacology studies may expand the options available as detailed
in Section 5.4.2. Full details can be found in the IB and pharmacy manual, which will be
updated throughout the study. Please contact the Medical Monitor with any queries.
f) ECOG Performance Status of 0-1
g) Documentation of HPV p-16 status is required for SCCHN of the oropharynx. See
Section 9.8.6 for additional guidance.
h) Documentation of PD-L1 status by IHC performed by the central lab at randomization.
i) Prior palliative radiotherapy must have been completed at least 2 weeks prior to
randomization
Exclusion Criteria
Key Exclusion Criteria
a) Recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of
unknown primary, squamous cell carcinoma that originated from the skin and salivary
gland or paranasal sinus, non-squamous histologies (eg, mucosal melanoma).
b) Participants with untreated CNS metastases are excluded. Participants are eligible if CNS
metastases have been adequately treated and have neurologically returned to baseline
(except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks
prior to randomization. In addition, participants must be either off corticosteroids or on a
stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks
prior to randomization.
c) Participants with carcinomatous meningitis.
d) Participants with a personal or family (ie, in a first-degree relative) history or presence of
cytochrome b5 reductase deficiency (previously called methemoglobin reductase
deficiency) or other disease that puts them at risk of methemoglobinemia. All participants
will be screened for methemoglobin levels prior to randomization.
e) Participants with a history of glucose-6-phosphate dehydrogenase (G6PD) deficiency or
other congenital or autoimmune hemolytic disorders. All participants will be screened for
G6PD levels prior to randomization.
f) Participants with serious or uncontrolled medical disorders
g) Participants with active ILD / pneumonitis or with a history of ILD / pneumonitis requiring
steroids.
a) Recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of
unknown primary, squamous cell carcinoma that originated from the skin and salivary
gland or paranasal sinus, non-squamous histologies (eg, mucosal melanoma).
b) Participants with untreated CNS metastases are excluded. Participants are eligible if CNS
metastases have been adequately treated and have neurologically returned to baseline
(except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks
prior to randomization. In addition, participants must be either off corticosteroids or on a
stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks
prior to randomization.
c) Participants with carcinomatous meningitis.
d) Participants with a personal or family (ie, in a first-degree relative) history or presence of
cytochrome b5 reductase deficiency (previously called methemoglobin reductase
deficiency) or other disease that puts them at risk of methemoglobinemia. All participants
will be screened for methemoglobin levels prior to randomization.
e) Participants with a history of glucose-6-phosphate dehydrogenase (G6PD) deficiency or
other congenital or autoimmune hemolytic disorders. All participants will be screened for
G6PD levels prior to randomization.
f) Participants with serious or uncontrolled medical disorders
g) Participants with active ILD / pneumonitis or with a history of ILD / pneumonitis requiring
steroids.
The Estimated Number of Participants
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Taiwan
0 participants
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Global
0 participants
