TerminatedEarly Phase 1

Durvalumab Before Surgery in Treating Patients With Oral Cavity or Oropharynx Cancer

Stopped: Study closed prior to meeting enrollment goal and funding issues

United States17 participantsStarted 2017-01

Plain-language summary

This pilot clinical trial studies how well durvalumab before surgery works in treating patients with oral cavity or oropharynx cancer. Monoclonal antibodies, such as durvalumab, may interfere with the ability of tumor cells to grow and spread.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologically or cytologically confirmed HNSCC of the oral cavity (OC; more than 90% patients have HPV negative cancer) or oropharynx (about 60-80% of patient have HPV positive cancer) * Presence of radiologically of clinically documented disease. All radiology studies must be performed within 28 days prior to registration * Any stage, considered candidates for surgery and planned for surgery either by robotic or by standard surgical technique * Documentation of HPV tested by polymerase chain reaction (PCR) (resulted or pending) * Willing to provide consent for an additional tissue biopsy for research purposes, to allow a part of their surgical tumor tissue to be utilized for research (in case tumor tissue has not already been saved in the tumor tissue bank), and to donate samples of blood and saliva collected weekly through the treatment * All patients must have provided informed consent for correlative studies * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 * Patients must have no prior exposure to immune-mediated therapy, including anti- cytotoxic T-lymphocyte protein 4 (CTLA-4), anti-programmed cell death 1, anti-programmed cell death 1 ligand 1 (PD-L1), or anti-programmed cell death ligand 2 antibodies, excluding therapeutic anticancer vaccines * At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as \> or = 10 mm in the longest diameter (except lymph nodes, which must have a short …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Immune Effector Assessed in Blood by Flow Cytometry and in Tissue by Immunohistochemistry

Timeframe: Up to 18 months

Immune-regulatory miR Responses as Measured in Plasma Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR)

Timeframe: At baseline and at one week post treatment start

Systemic Immune Response to HPV Assessed by Enzyme-linked Immunosorbent Assay (ELISA)

Timeframe: Up to 18 months

Regulatory Responses Assessed in Blood by Flow Cytometry and in Tissue by Immunohistochemistry

Timeframe: Up to 18 months

Immune-regulatory miR Responses as Measured in Saliva Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR)

Timeframe: Baseline and one week post treatment start

Immune-regulatory miR Responses as Measured in Tumor Tissue Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR)

Timeframe: Up to 18 months

Trial details

NCT IDNCT02827838

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-22

Results submitted2024-06-18

View on ClinicalTrials.gov More Human Papillomavirus Infection trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Immune Effector Assessed in Blood by Flow Cytometry and in Tissue by Immunohistochemistry

Timeframe: Up to 18 months

Immune-regulatory miR Responses as Measured in Plasma Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR)

Timeframe: At baseline and at one week post treatment start

Systemic Immune Response to HPV Assessed by Enzyme-linked Immunosorbent Assay (ELISA)

Timeframe: Up to 18 months

Regulatory Responses Assessed in Blood by Flow Cytometry and in Tissue by Immunohistochemistry

Timeframe: Up to 18 months

Immune-regulatory miR Responses as Measured in Saliva Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR)

Timeframe: Baseline and one week post treatment start

Immune-regulatory miR Responses as Measured in Tumor Tissue Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR)

Timeframe: Up to 18 months