Nivolumab, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma That Can Be Removed by Surgery
CompletedPhase 2Results postedLast updated 24 April 2025
What this trial tests
Phase 2 trial testing Paclitaxel in Name Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma in 34 participants. Completed in 6 October 2020.
Timeline
13 November 2017
Primary endpoint 6 October 2020
6 October 2020
Quick facts
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Who can join
18 and older, any sex, with Name Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma or Stage II Oropharyngeal Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pathologic Complete Response RatePrimary· Up to 26 months
The primary objective of the study is to estimate the rate of pathologic complete response (pCR) at the primary site, defined as the absence of any residual invasive cancer on H\&E evaluation of the resected specimen and all sampled ipsilateral lymph nodes, in patients with newly diagnosed and untreated Stage III-IVA SCCHN of the oral cavity, Oropharynx, Larynx, and Hypopharynx treated with standard neoadjuvant chemotherapy plus Nivolumab, paclitaxel, and carboplatin. Pathologic complete response rate and its associated score 95% confidence interval will be estimated.
Group
Value
95% CI
Treatment (Nivolumab, Paclitaxel, Carboplatin)
45.5
28.5 – 63.4
Number of Patients Who Achieved Major Pathologic Response (Defined as 10% or Less Residual Viable Tumor)Secondary· Up to 26 months
patients achieved the major pathologic response (i.e., \<10% viable tumor) or pathologic complete response
Group
Value
95% CI
Treatment (Nivolumab, Paclitaxel, Carboplatin)
72.73
54.2 – 86.1
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment (Nivolumab, Paclitaxel, Carboplatin)
Serious: 14/34 (41%)
Deaths: 5/34
Serious adverse events (24 terms)
Reaction
System
Treatment (Nivolumab, Pacl…
Aspiration
Respiratory, thoracic and mediastinal disorders
—
low absolute neutrophil count grade 4
Blood and lymphatic system disorders
—
Chest pain - Cardiac
Cardiac disorders
—
Feeding tube dependency
Gastrointestinal disorders
—
Muscle weakness - lower limbs
Musculoskeletal and connective tissue disorders
—
Anemia
Blood and lymphatic system disorders
—
Hypotension
Vascular disorders
—
Dehydration
Metabolism and nutrition disorders
—
Diarrhea
Gastrointestinal disorders
—
Gastric Ulcer
Gastrointestinal disorders
—
lightheaded and anxious
General disorders
—
Hyperglycemia
Metabolism and nutrition disorders
—
Hypoxia
Respiratory, thoracic and mediastinal disorders
—
Cellulitis
Infections and infestations
—
Anorexia
Metabolism and nutrition disorders
—
Stupor
Respiratory, thoracic and mediastinal disorders
—
Sepsis
Blood and lymphatic system disorders
—
Seroma
Blood and lymphatic system disorders
—
Edema
Skin and subcutaneous tissue disorders
—
Hospitalization - Failure to thrive
General disorders
—
Generalized weakness
General disorders
—
Urinary retention
Renal and urinary disorders
—
Tracheal Hemorrhage
Skin and subcutaneous tissue disorders
—
Wound complication
Surgical and medical procedures
—
Other adverse events (155 terms — click to expand)
This phase II trial studies how well nivolumab, carboplatin, and paclitaxel work in treating patients with stage III-IV head and neck squamous cell carcinoma that can be removed by surgery. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab, carboplatin, and paclitaxel may work better in treating patients with head and neck squamous cell carcinoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07346196 — A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck
· Phase 2
· not yet recruiting
NCT07441681 — Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Head and Neck Cancer Who Cannot Receive
· Phase 3
· not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa
· Phase 2
· recruiting
NCT07195734 — Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
· Phase 2
· recruiting
NCT07465757 — A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC)
· Phase 2
· not yet recruiting
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NCT03807492 — Evaluation and Management for Prostate Oncology, Wellness, and Risk (EMPOWeR)
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NCT03477864 — Stereotactic Body Radiation Therapy With REGN2810 and/or Ipilimumab Before Surgery in Treating Participants With Progres
· Phase 1
· withdrawn
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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Sponsor: as reported to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Last refreshed: 24 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03342911.