Clinical trial · Observational
Immunologic Responses in HPV-Associated Carcinoma for Patients Receiving Chemoradiation
Evaluation of Immunologic Responses in HPV-Associated Oropharyngeal Carcinoma Patients Receiving Chemoradiation Therapy
- 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 primary purpose of this research is to investigate anti-tumor immune responses in patients undergoing chemotherapy and radiation for Head and Neck Cancers. Hypothesis: Treatment of HPV-associated OPSCC with concurrent chemoradiation results in changes in the tumor microenvironment. We hypothesize that these changes during daily fractionated chemoradiotherapy can lead to detectable changes in HPV-specific tumor immune responses. Hypothesis: HPV-specific cellular immune responses can still be detected during radiotherapy in the presence or absence of lymphopenia. * This study will determine whether specific anti-tumor immune responses (Specific Antibodies and Specific T-cells) can be detected in patients undergoing chemoradiation treatment for Head and Neck Cancers. * This study will evaluate the presence or absence of HPV (human papillomavirus) specific immune responses before, during, and after treatment for Head and Neck Cancers. * This study will also evaluate whether decreased white blood cell counts may affect development of immune responses in Head and Neck cancer patients undergoing treatment. Any head and neck cancer patient undergoing concurrent chemoradiotherapy is eligible if: you are older than 18 years of age, capable of providing informed consent, have a life expectancy of greater than 4 months, and have a good performance status. You are eligible irregardless of your HPV positive or negative status. People with HPV positive (human papillomavirus associated) head and neck cancer may join. People with HPV negative head and neck cancer may also join.
Conditions
Conditions (3)
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 |
| HPV (Human Papillomavirus)-Associated Carcinoma | — | UNRESOLVED | — |
| Oropharyngeal | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| research blood draw and tissue biopsy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Chemoradiation with Research Samples
- description
- Standard of care chemoradiation therapy will be given as clinically indicated by the treating physicians. 4 research blood and tissue samples will be obtained. One before treatment starts, 2 while treatments are being received and finally one after treatments are completed.
- interventionNames
- Other: research blood draw and tissue biopsy
Primary outcomes (1)
- measure
- Compare Systemic and Local Immunologic Changes During Chemoradiation
- timeFrame
- Baseline within 1-3 weeks of start of radiation, week 2 between radiation fractions 10-12, week 4 between radiation fractions 20-22, 4-6 weeks after chemoradiation completion
- description
- Primary objective: To evaluate the systemic and local immunologic changes which may occur during a standard treatment course of combined chemoradiation for HPV-associated oropharyngeal squamous cell carcinoma (OPSCC) and non-HPV associated head and neck squamous cell carcinomas (HNSCC).
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * patients must have head and neck cancer and be receiving concurrent chemotherapy and radiation * patients greater than or equal to 18 years of age * patients must be capable of providing informed consent * patients must have a life expectancy of greater than 4 months * patients must have an adequate performance status Exclusion Criteria: * Patients must not have had surgery for their head and neck cancer * Patients must not have a diagnosis of an immunosuppressant disease * Patients must not have certain uncontrolled concurrent illnesses * Patients must not a history of autoimmune disease * Patients must not be pregnant, become pregnant or breast feeding * Patients must not have a history of certain prior malignancies
References
Publications (0)
Data not yet available