Clinical trial · Interventional
First Line Weekly Chemo/Immunotherapy for Metastatic Head/Neck Squamous Cell Carcinoma Patients
Phase II Study of First Line Weekly Chemo/Immunotherapy for Metastatic Head/Neck Squamous Cell Carcinoma Patients
NCT04858269CI-TRIAL-00117790active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this research is to see what effects the treatment regimen chemotherapy (carboplatin and paclitaxel) plus immunotherapy (pembrolizumab), has on patients who have been diagnosed with head/neck squamous cell carcinoma and are unable to take the drug 5-fluorouracil
Conditions
Conditions (6)
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 Neck Cancer | — | UNRESOLVED | — |
| Hypopharynx Squamous Cell Carcinoma | Hypopharyngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
| Larynx Squamous Cell Carcinoma | Laryngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
| Metastatic Squamous Cell Carcinoma | Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Oral Cavity Squamous Cell Carcinoma | Oral Cavity Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Oropharynx Squamous Cell Carcinoma | Oropharynx Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combination of Chemotherapy and Immunotherapy
- description
- The intervention will be administered on an outpatient basis. The treatment regimen will consist of combination chemotherapy and immunotherapy administered as: Pembrolizumab PLUS Carboplatin PLUS Paclitaxel.
- interventionNames
- Drug: Pembrolizumab
- Drug: Carboplatin
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- At 18 weeks on study
- description
- Using RECIST 1.1 will be defined as the percentage of analyzed participants with a complete response (defined as disappearance of all target lesions) or partial response (defined as decrease by ≥ 30% in sum of longest diameter of target lesions) as compared to the historical objective response rate (19%) reported for pembrolizumab alone.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Recurrent or metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx or neck node with occult primary but suspected to be non-cutaneous head/neck that is incurable by local therapies (i.e. radiation or surgery) and either locoregionally advanced or with at least one distant metastasis. * Histologic or cytologic confirmation of malignancy by pathology report. * Not a candidate for infusional 5FU (mucositis, 5-day infusional pump not feasible, patient refusal, other). * 18 years old or greater. * ECOG performance status of 0-2. * Life expectancy of greater than 3 months. * Patients must have normal organ and marrow function as defined: Absolute neutrophil count greater than or equal to 1,000/mcL, platelets greater than or equal to 75,000/mcL, total bilirubin less than or equal to 2 mg/dL * Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative). Exclusion Criteria: * No prior systemic cancer-directed therapy administered in the recurrent or metastatic setting. Prior treatments are allowed if they were administered with curative intent prior to incurable progression of disease. Prior treatments for other cancers are also allowed. * Untreated, symptomatic central nervous system (CNS) metastases. * Active autoimmune disease requiring systemic immunosuppression. * History of autoimmune pneumonitis requiring high-dose systemic steroids (equivalent prednisone \>20 mg/day for \>1 week). * History of greater than or equal to Grade 3 hypersensitivity reaction to carboplatin or paclitaxel. * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study because paclitaxel and carboplatin are Class D agents with significant potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these drugs, breastfeeding should be discontinued during the study.
References
Publications (0)
Data not yet available
No reference posted for this study.