Clinical trial · Interventional
An Immuno-therapy Study of Nivolumab in Combination With Experimental Medication BMS-986205 Compared to Standard of Care EXTREME Regimen in First-line Recurrent/Metastatic Squamous Cell Carcinoma of Head 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
NCT03386838CI-TRIAL-00038225withdrawnPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business objectives have changed.
Summary
Brief summary (as posted)
This is a study of Nivolumab in combination with experimental medication BMS-986205 compared to the standard of care EXTREME regimen in head and neck cancer that has come back after initial treatment, or is widespread when first diagnosed.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-986205 | Drug | — | UNRESOLVED |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cetuximab | Biological | Cetuximab | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Fluorouracil | Drug | Fluorouracil | ALIAS |
| Nivolumab | Biological | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nivolumab and BMS-986205
- description
- Nivolumab administered in combination with BMS-986205
- interventionNames
- Biological: Nivolumab
- Drug: BMS-986205
- type
- ACTIVE_COMPARATOR
- label
- EXTREME study regimen
- description
- Cetuximab + Cisplatin/Carboplatin + Fluorouracil
- interventionNames
- Biological: Cetuximab
- Drug: Cisplatin
- Drug: Carboplatin
- Drug: Fluorouracil
Primary outcomes (3)
- measure
- Progression-free survival (PFS) as determined by Blinded Independent Central Review (BICR) using RECIST 1.1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN), from any of the following primary sites only: oral cavity, oropharynx, hypopharynx, and larynx. * Recurrent or metastatic disease that is not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy) * No prior treatment with systemic anti-cancer therapy for SCCHN, unless protocol specified criteria are met * ECOG Performance Status of 0-1 * Measurable disease by CT or MRI per RECIST 1.1 criteria Exclusion Criteria: * Women who are pregnant or breastfeeding * 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) * Participants with untreated CNS metastases are excluded * Participants with carcinomatous meningitis * Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast Other protocol defined inclusion/exclusion criteria could apply
References
Publications (0)
Data not yet available
No reference posted for this study.