Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03854032 · ClinicalTrials.gov registry record · Phase 2
Nivolumab and BMS986205 in Treating Patients With Stage II-IV Squamous Cell Cancer of the Head and Neck
A Phase 2 study of Squamous Cell Carcinoma and Oral Cavity Squamous Cell Carcinoma, sponsored by Thomas Jefferson University.
- Active
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 2
- Study locations
NCT03854032: Active Phase 2 study of Squamous Cell Carcinoma and Oral Cavity Squamous Cell Carcinoma, sponsored by Thomas Jefferson University.
NCT03854032 is a Phase 2 study of Squamous Cell Carcinoma and Oral Cavity Squamous Cell Carcinoma that is active but no longer recruiting, run by Thomas Jefferson University. The registered enrollment target is 45 participants, below the 103-participant average among 47 other Squamous Cell Carcinoma trials with a reported enrollment target (56% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03854032, a Phase 2 study of Squamous Cell Carcinoma and Oral Cavity Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by Thomas Jefferson University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II trial studies how well nivolumab works, with or without BMS986205, in treating patients with stage II-IV squamous cell cancer of the head and neck. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. BMS986205 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving nivolumab with BMS986205 may work better than nivolumab alone in treating patients with squamous cell cancer of the head and neck.
Primary Outcome
Will be assessed by computed tomography (CT) or magnetic resonance imaging (MRI) scans. The proportions of the primary endpoint in the two treatment groups will be compared at 25% significance level using a two-sided test in proportions. Will re-analyze the primary endpoints using a combined patients collection. Historical controls of patients who received nivolumab alone for 4 weeks in previous window of opportunity trial (CA209-9A7) will be included in the control group. Patients' demographic
Conditions Studied
Interventions
- OTHER Questionnaire Administration
- BIOLOGICAL Nivolumab
- PROCEDURE Therapeutic Conventional Surgery
- BIOLOGICAL IDO1 Inhibitor BMS-986205
Study Locations (2)
Ohio
- Ohio State University - Columbus
Pennsylvania
- Sidney Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2019-04-09 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
What the registry record for NCT03854032 still lists
NCT03854032 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 103-participant average among 47 other Squamous Cell Carcinoma trials with a reported enrollment target (56% lower).
The record links to 5 conditions, with Squamous Cell Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Questionnaire Administration is the first listed.
NCT03854032 reports a single indexed study location in Ohio, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03854032 about?
NCT03854032 is a clinical study titled "Nivolumab and BMS986205 in Treating Patients With Stage II-IV Squamous Cell Cancer of the Head and Neck". This phase II trial studies how well nivolumab works, with or without BMS986205, in treating patients with stage II-IV squamous cell cancer of the head and neck. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with t...
What is the current status of trial NCT03854032?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2019-04-09. Estimated completion is 2025-12-31.
What conditions does trial NCT03854032 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma, Lip, Larynx, Pharynx.
What interventions are being tested in trial NCT03854032?
The interventions under investigation include: Questionnaire Administration (OTHER), Nivolumab (BIOLOGICAL), Therapeutic Conventional Surgery (PROCEDURE), IDO1 Inhibitor BMS-986205 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03854032?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03854032 being conducted?
This trial has 2 study locations across Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Squamous Cell Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03854032's enrollment target sits among peer trials
45 23rd of 47 higher than 24 of 47 other Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of Afatinib in Advanced Cutaneous Squamous Cell Carcinoma
RECRUITING · Phase 2
-
Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin
RECRUITING · Phase 2
-
Toripalimab With Chemotherapy for Sinus Cancer
RECRUITING · Phase 2
-
Radiotherapy With Cisplatin vs. Docetaxel-cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design
RECRUITING · Phase 2
-
Preoperative Immunotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck
RECRUITING · Phase 2
-
Immunotherapy With Chemotherapy and Chemoradiation for Advanced Squamous Cancer of Nasal Cavity / Paranasal Sinuses (I-NAPA)
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00804154 · 45 participants · Phase 1
Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer
- NCT01851694 · 45 participants · NA
Beta-cell Response to Incretin Hormones in Cystic Fibrosis
- NCT02896335 · 45 participants · Phase 2
Palbociclib and Pembrolizumab In Central Nervous System Metastases
- NCT03454035 · 45 participants · Phase 1
Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI