CClinicalTrials.gg
Sign In
TerminatedNCT02827838Updated Mar 17, 2025Results posted

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

An Early Phase 1 interventional study of Durvalumab and Laboratory Biomarker Analysis in Human Papillomavirus Infection, Stage I Oral Cavity Squamous Cell Carcinoma and Stage I Oropharyngeal Squamous Cell Carcinoma, sponsored by Wake Forest University Health Sciences. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-17.

Sponsored by Wake Forest University Health Sciences · Early Phase 1, Interventional, and Treatment

Why this study was terminated
Study closed prior to meeting enrollment goal and funding issues
Phase
Early Phase 1
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

PRIMARY OBJECTIVES:

I. To investigate the effect of durvalumab on local and systemic immune activation by HPV status in patients with oral cavity and oropharynx head and neck squamous cell carcinoma (HNSCC).

II. To examine the effects of durvalumab on systemic immune response to HPV and tumor associated antigens.

III. To examine the effects of durvalumab on immune regulatory mechanisms. IV. To explore the association between levels of immune-regulatory micro-ribonucleic acid (miR) in plasma and saliva and immune response.

SECONDARY OBJECTIVES:

I. Investigate the effect of the treatment with durvalumab on the computed tomography (CT) scan and positron emission tomography (PET) scan response.

II. Evaluate the safety of a short induction treatment with durvalumab.

OUTLINE:

Patients receive durvalumab intravenously (IV) over approximately 60 minutes on day 1. Treatment repeats every 2 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 3-17 days after last dose administration of durvalumab, patients undergo surgery. Patients may receive an additional dose of durvalumab if time to surgery is longer than 30 days.

After completion of study treatment, patients are followed up for 90 days.

02

Conditions studied

  • Human Papillomavirus Infection
  • Stage I Oral Cavity Squamous Cell Carcinoma
  • Stage I Oropharyngeal Squamous Cell Carcinoma
  • Stage II Oral Cavity Squamous Cell Carcinoma
  • Stage II Oropharyngeal Squamous Cell Carcinoma
  • Stage III Oral Cavity Squamous Cell Carcinoma
  • Stage III Oropharyngeal Squamous Cell Carcinoma
  • Stage IVA Oral Cavity Squamous Cell Carcinoma
  • Stage IVA Oropharyngeal Squamous Cell Carcinoma
  • Stage IVB Oral Cavity Squamous Cell Carcinoma
  • Stage IVB Oropharyngeal Squamous Cell Carcinoma
  • Stage IVC Oropharyngeal Squamous Cell Carcinoma
03

In context

Papillomavirus Infections

495 studies on the registry are indexed under Papillomavirus Infections; 125 are open to participants now.

This study's enrollment of 17 is below the median of 202 across 332 interventional studies indexed under Papillomavirus Infections.

Browse Papillomavirus Infections studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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 axis > or = 15 mm) with CT or magnetic resonance imaging (MRI) or clinical measurement and that is suitable for accurate repeated measurements as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines
  • Previous surgery is permitted provided that a minimum of 28 days (4 weeks) have elapsed between any major surgery and date of registration, and that wound healing has occurred
  • Absolute neutrophil count (ANC) >= 1.5 x 10\^9/L
  • Platelet count >= 100 x 10\^9/L
  • Hemoglobin >= 9.0 g/dL
  • Serum bilirubin =\< 1.5 x upper limit of normal (ULN) (institutional upper limit of normal)
  • Total bilirubin is less than or equal to ULN, except the case in which the elevated total bilirubin is not a sign of liver disease, such as the Gilbert Syndrome, in which case a Total Bilirubin less than or equal to 2X ULN is acceptable.
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN
  • Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
  • Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: >= 60 years old and no menses for >= 1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry
  • In accordance with National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) policy, protocol treatment is to begin within 2 working days of patient registration
  • Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of American [USA], European Union [EU] Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
  • Age 18 years or older at time of study entry.
  • Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up

Exclusion criteria

Exclusion Criteria:

  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). Previous enrollment in the present study
  • Participation in another clinical study with an investigational product during the last 6 months (mo)
  • Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab
  • Receipt of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) within the last 6 mo (before the first dose of Durvalumab).
  • Mean QT interval corrected for heart rate (corrected QT [QTc]) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's correction
  • Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
  • Any unresolved toxicity (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2) from previous anti-cancer therapy; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy)
  • Any prior grade >= 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE > grade 1
  • Active or prior documented autoimmune disease within the past 2 years; NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
  • Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
  • History of primary immunodeficiency
  • History of allogeneic organ transplant
  • History of hypersensitivity to durvalumab or any excipient
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
  • Known history of previous clinical diagnosis of tuberculosis
  • Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab
  • Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
  • Patients with body weight \<= 30 kg
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    Treatment (durvalumab, surgery)

    Patients receive durvalumab IV over approximately 60 minutes on day 1. Treatment repeats every 2 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 3-17 days after last dose administration of durvalumab, patients undergo surgery. Patients may receive an additional dose of durvalumab if time to surgery is longer than 30 days.

    Biological: Durvalumab · Other: Laboratory Biomarker Analysis · Procedure: Therapeutic Conventional Surgery

Interventions

  • BiologicalDurvalumab

    Given IV

    Also known as: Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI-4736, MEDI4736

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • ProcedureTherapeutic Conventional Surgery

    Undergo surgery

06

What researchers measure

Primary outcomes

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

    Concentration of certain immune effector will be assessed in blood pre- and post- treatment. Descriptive statistics, confidence intervals will be calculated and 2-sample t-tests will be performed. Tumor-infiltrating immune-regulator and effector cells will be quantified (0 to 3+) using standing immunofluorescence techniques. Counts and percents will be calculated for these measures overall and by HPV (+/-) groups pre- and post-treatment. Fisher exact tests will be used to compare groups at pre- and post- treatment. Stuart-Maxwell tests (generalizations of the McNemar's Test

    Time frame: Up to 18 months

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

    Percent change of levels of immune-regulatory miRs assessed in plasma assessed pre-treatment and one week post-treatment.

    Time frame: At baseline and at one week post treatment start

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

    Lab results will be compared between patients who are HPV+ and HPV- using 2 sample t-tests. These measures will be compared in several ways. First, baseline, pre-treatment levels will be examined using descriptive statistics (n, mean, standard deviations, range). These measures will be examined overall and by HPV (+/-) groups. For each measure, and time point, 95% confidence intervals will be estimated. Next, two sample t-tests will be performed to compare levels of the measures at baseline. Next, measures taken post-treatment will be examined in a similar manner (descriptive statistics and 2-

    Time frame: Up to 18 months

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

    Concentration of certain regulatory cells will be assessed in blood pre- and post- treatment. Descriptive statistics, confidence intervals will be calculated and 2-sample t-tests will be performed. Tumor-infiltrating immune-regulator and effector cells will be quantified (0 to 3+) using standing immunofluorescence techniques. Counts and percents will be calculated for these measures overall and by HPV (+/-) groups pre- and post-treatment. Fisher exact tests will be used to compare groups at pre- and post- treatment. Stuart-Maxwell tests (generalizations of the McNemar's Tes

    Time frame: Up to 18 months

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

    Percent change of levels of immune-regulatory miRs assessed in saliva assessed pre-treatment and one week post-treatment.

    Time frame: Baseline and one week post treatment start

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

    Levels of immune-regulatory miRs assessed in blood, saliva and tumor tissue will be assessed pre- and post- treatments. Descriptive statistics, confidence intervals will be calculated and 2-sample t-tests will be performed. In addition, correlations between the different methods will be examined (i.e., correlation between saliva and blood measures, saliva and tumor measures, and blood and tumor measures).

    Time frame: Up to 18 months

  7. Systemic Immune Response to Tumor Associated Antigens Assessed by Enzyme-linked Immunosorbent Assay (ELISA)

    Lab results will be compared between patients who are HPV+ and HPV- using 2 sample t-tests. These measures will be compared in several ways. First, baseline, pre-treatment levels will be examined using descriptive statistics (n, mean, standard deviations, range). These measures will be examined overall and by HPV (+/-) groups. For each measure, and time point, 95% confidence intervals will be estimated. Next, two sample t-tests will be performed to compare levels of the measures at baseline. Next, measures taken post-treatment will be examined in a similar manner (descriptive statistics and 2-

    Time frame: Up to 18 months

Secondary outcomes

  1. Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03

    AEs will be coded using the Medical Dictionary for Regulatory Activities to their organ class by preferred term. Coded AEs will be displayed by frequency, severity, and relationship to treatment (durvalumab) in the safety population. In addition, summary tables will be generated for the following situations: 1) fatigue, diarrhea, nausea and skin rash; 2) Immune-mediated reactions of any grade; 3) other adverse events graded as 3 or more by CTCAE Version 4.03; 4) Durvalumab dose reductions; 5) discontinuations of treatment with durvalumab, with specification of reason for discontinuation; and 6) changes in the surgical treatment schedule. Toxicity grades Grade I (mild), Grade II (moderate), Grade III (severe), Grade IV (life threatening) and Grade V (fatal). Toxicities of greater than or equal to Grade III (except infusion reaction) are considered worse outcomes.

    Time frame: At baseline (pre-treatment), during scheduled treatment and up to the 90-day follow up period after the last dose of study drug administered, with a median of 1 month and maximum of 13 months

  2. Standardized Uptake Value (SUV) as Measured by PET Scans

    Change in SUV activity as measured by PET scans from baseline to post-treatment not specific to HPV status.

    Time frame: Up to 18 months

  3. Tumor Diameter Assessed Using RECIST Version 1.1 Criteria

    Change in tumor diameters will be compared between groups (HPV +/-) pre- and post- treatment.

    Time frame: Up to 18 months

07

Results

Posted Mar 17, 2025

Participant flow

Participant flow — Overall Study
MilestoneTreatment (Durvalumab, Surgery) HPV NegativeTreatment (Durvalumab, Surgery) HPV Positive
Started116
Completed116
Not completed00

Outcome measures

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

Concentration of certain immune effector will be assessed in blood pre- and post- treatment. Descriptive statistics, confidence intervals will be calculated and 2-sample t-tests will be performed. Tumor-infiltrating immune-regulator and effector cells will be quantified (0 to 3+) using standing immunofluorescence techniques. Counts and percents will be calculated for these measures overall and by HPV (+/-) groups pre- and post-treatment. Fisher exact tests will be used to compare groups at pre- and post- treatment. Stuart-Maxwell tests (generalizations of the McNemar's Test

Time frame:
Up to 18 months

No measurements were reported for this outcome.

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

Percent change of levels of immune-regulatory miRs assessed in plasma assessed pre-treatment and one week post-treatment.

Time frame:
At baseline and at one week post treatment start
Reported as:
Median · percent change from baseline
Immune-regulatory miR Responses as Measured in Plasma Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR)
percent change from baselineTreatment (Durvalumab, Surgery) - HPV NegativeTreatment (Durvalumab, Surgery) - HPV Positive
miR 14627.5 (-24.5 to 124.2)1251.6 (116.6 to 6039.3)
miR 15519.7 (-24.2 to 364.3)814 (100.7 to 2154.9)
miR 18125.7 (1.7 to 189.8)893.2 (107.8 to 3880.8)
miR 20a-15.6 (-55.2 to 6.4)520.6 (43.4 to 1226.9)
miR 22313.7 (-61.3 to 51.0)1031.2 (43.9 to 3034.1)
miR 33512.5 (-44.9 to 142.8)1166.0 (336.2 to 2070.6)
miR 12543.4 (-9.2 to 79.6)194.5 (4.2 to 1789.6)
PrimarySystemic Immune Response to HPV Assessed by Enzyme-linked Immunosorbent Assay (ELISA)

Lab results will be compared between patients who are HPV+ and HPV- using 2 sample t-tests. These measures will be compared in several ways. First, baseline, pre-treatment levels will be examined using descriptive statistics (n, mean, standard deviations, range). These measures will be examined overall and by HPV (+/-) groups. For each measure, and time point, 95% confidence intervals will be estimated. Next, two sample t-tests will be performed to compare levels of the measures at baseline. Next, measures taken post-treatment will be examined in a similar manner (descriptive statistics and 2-

Time frame:
Up to 18 months

No measurements were reported for this outcome.

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

Concentration of certain regulatory cells will be assessed in blood pre- and post- treatment. Descriptive statistics, confidence intervals will be calculated and 2-sample t-tests will be performed. Tumor-infiltrating immune-regulator and effector cells will be quantified (0 to 3+) using standing immunofluorescence techniques. Counts and percents will be calculated for these measures overall and by HPV (+/-) groups pre- and post-treatment. Fisher exact tests will be used to compare groups at pre- and post- treatment. Stuart-Maxwell tests (generalizations of the McNemar's Tes

Time frame:
Up to 18 months

No measurements were reported for this outcome.

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

Percent change of levels of immune-regulatory miRs assessed in saliva assessed pre-treatment and one week post-treatment.

Time frame:
Baseline and one week post treatment start
Reported as:
Median · percent change from baseline
Immune-regulatory miR Responses as Measured in Saliva Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR)
percent change from baselineTreatment (Durvalumab, Surgery) - HPV NegativeTreatment (Durvalumab, Surgery) - HPV Positive
miR 146251.3 (-12.3 to 497.9)105.3 (-16.2 to 362.7)
miR 155141.2 (4.6 to 970.3)255.0 (0.0 to 367.5)
miR 181114.4 (-35.6 to 864.6)232.5 (77.8 to 558.9)
miR 20a163.9 (-63.1 to 1312.3)113.1 (58.6 to 500.0)
miR 22366.4 (-47.0 to 502.1)199.2 (0.0 to 465.7)
miR 335249.4 (20.2 to 628.5)150.2 (0.0 to 397.6)
miR 125351.6 (-34.9 to 471.6)64.9 (-10.8 to 457.9)
PrimaryImmune-regulatory miR Responses as Measured in Tumor Tissue Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR)

Levels of immune-regulatory miRs assessed in blood, saliva and tumor tissue will be assessed pre- and post- treatments. Descriptive statistics, confidence intervals will be calculated and 2-sample t-tests will be performed. In addition, correlations between the different methods will be examined (i.e., correlation between saliva and blood measures, saliva and tumor measures, and blood and tumor measures).

Time frame:
Up to 18 months

No measurements were reported for this outcome.

PrimarySystemic Immune Response to Tumor Associated Antigens Assessed by Enzyme-linked Immunosorbent Assay (ELISA)

Lab results will be compared between patients who are HPV+ and HPV- using 2 sample t-tests. These measures will be compared in several ways. First, baseline, pre-treatment levels will be examined using descriptive statistics (n, mean, standard deviations, range). These measures will be examined overall and by HPV (+/-) groups. For each measure, and time point, 95% confidence intervals will be estimated. Next, two sample t-tests will be performed to compare levels of the measures at baseline. Next, measures taken post-treatment will be examined in a similar manner (descriptive statistics and 2-

Time frame:
Up to 18 months

No measurements were reported for this outcome.

SecondaryIncidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03

AEs will be coded using the Medical Dictionary for Regulatory Activities to their organ class by preferred term. Coded AEs will be displayed by frequency, severity, and relationship to treatment (durvalumab) in the safety population. In addition, summary tables will be generated for the following situations: 1) fatigue, diarrhea, nausea and skin rash; 2) Immune-mediated reactions of any grade; 3) other adverse events graded as 3 or more by CTCAE Version 4.03; 4) Durvalumab dose reductions; 5) discontinuations of treatment with durvalumab, with specification of reason for discontinuation; and 6) changes in the surgical treatment schedule. Toxicity grades Grade I (mild), Grade II (moderate), Grade III (severe), Grade IV (life threatening) and Grade V (fatal). Toxicities of greater than or equal to Grade III (except infusion reaction) are considered worse outcomes.

Time frame:
At baseline (pre-treatment), during scheduled treatment and up to the 90-day follow up period after the last dose of study drug administered, with a median of 1 month and maximum of 13 months
Reported as:
Number · events
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
eventsHPV -HPV +
Acute kidney injury - Unrelated or Unlikely related - Grade 310
Alanine aminotransferase increased - Possible to Definitely related - Grade 210
Alanine aminotransferase increased - Possible to Definitely related - Grade 310
Alkaline phosphatase increased - Possible to Definitely related - Grade 120
Alkaline phosphatase increased - Possible to Definitely related - Grade 210
Anemia - Unrelated or Unlikely related - Grade 320
Anorexia - Possible to Definitely relate - Grade 111
Aspartate aminotransferase increased - Possible to Definitely related - Grade 120
Aspartate aminotransferase increased - Possible to Definitely related - Grade 220
Aspartate aminotransferase increased - Possible to Definitely related - Grade 410
Blood bilirubin increased - Possible to Definitely related - Grade 120
Blood bilirubin increased - Possible to Definitely relate - Grade 210
Bullous dermatitis - Possible to Definitely relate - Grade 110
Constipation - Possible to Definitely relate - Grade 111
Constipation - Possible to Definitely relate - Grade 210
Device related infection - Unrelated or Unlikely related - Grade 310
Diarrhea - Possible to Definitely relate - Grade 130
Diarrhea - Possible to Definitely relate - Grade 310
Diarrhea - Unrelated or Unlikely related - Grade 141
Fatigue - Possible to Definitely relate - Grade 163
Fatigue - Possible to Definitely relate - Grade 210
Fatigue - Unrelated or Unlikely related - Grade 111
Fatigue - Unrelated or Unlikely related - Grade 210
Head soft tissue necrosis - Unrelated or Unlikely related - Grade 310
Hyperglycemia - Unrelated or Unlikely related - Grade 301
Hyperglycemia - Unrelated or Unlikely related - Grade 410
Hypermagnesemia - Unrelated or Unlikely related - Grade 310
Hypertension - Unrelated or Unlikely related - Grade 301
Hypoalbuminemia - Unrelated or Unlikely related - Grade 320
Hypocalcemia - Unrelated or Unlikely related - Grade 340
Hypocalcemia - Unrelated or Unlikely related - Grade 410
Hypokalemia - Unrelated or Unlikely related - Grade 330
Hyponatremia - Unrelated or Unlikely related - Grade 340
Hypophosphatemia - Unrelated or Unlikely related - Grade 340
Hypotension - Unrelated or Unlikely related - Grade 320
Hypothyroidism - Possible to Definitely relate - Grade 201
Leukocytosis - Unrelated or Unlikely related - Grade 311
Lipase increased - Possible to Definitely relate - Grade 301
Malaise - Possible to Definitely relate - Grade 110
Nausea - Possible to Definitely relate - Grade 110
Nausea - Unrelated or Unlikely related - Grade 130
Neck soft tissue necrosis - Unrelated or Unlikely related - Grade 310
Neutrophil count decreased - Unrelated or Unlikely related - Grade 310
Pruritus - Possible to Definitely relate - Grade 101
Rash maculo-papular - Possible to Definitely relate - Grade 110
Rash pustular - Possible to Definitely relate - Grade 110
Serum amylase increased - Possible to Definitely relate - Grade 101
Skin ulceration - Unrelated or Unlikely related - Grade 310
Skin ulceration - Unrelated or Unlikely related - Grade 410
Taste alteration (dysgeusia) - Possible to Definitely relate - Grade 101
Urine output decreased - Unrelated or Unlikely related - Grade 310
Urticaria - Possible to Definitely relate - Grade 101
Weight loss - Possible to Definitely relate - Grade 111
Wound complication - Unrelated or Unlikely related - Grade 310
Wound infection - Unrelated or Unlikely related - Grade 310
Discontinuation of Durvalumab due to immune-related hepatitis10
SecondaryStandardized Uptake Value (SUV) as Measured by PET Scans

Change in SUV activity as measured by PET scans from baseline to post-treatment not specific to HPV status.

Time frame:
Up to 18 months
Reported as:
Mean · change in SUV
Standardized Uptake Value (SUV) as Measured by PET Scans
change in SUVTreatment (Durvalumab, Surgery) - HPV NegativeTreatment (Durvalumab, Surgery) - HPV Positive
Standardized Uptake Value (SUV) as Measured by PET Scans-0.15 ± 1.200 ± 0
SecondaryTumor Diameter Assessed Using RECIST Version 1.1 Criteria

Change in tumor diameters will be compared between groups (HPV +/-) pre- and post- treatment.

Time frame:
Up to 18 months
Reported as:
Median · mm
Tumor Diameter Assessed Using RECIST Version 1.1 Criteria
mmTreatment (Durvalumab, Surgery) - HPV NegativeTreatment (Durvalumab, Surgery) - HPV Positive
Tumor Diameter Assessed Using RECIST Version 1.1 Criteria1.0 (0.0 to 4.0)-2.0 (-2.0 to 2.0)

Adverse events

Collected over Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment (Durvalumab, Surgery) - HPV Negative1/11 (9.1%)5/11 (45.5%)11/11 (100%)
Treatment (Durvalumab, Surgery) - HPV Positive0/6 (0%)0/6 (0%)6/6 (100%)
Most frequent serious events
Most frequent serious events
EventTreatment (Durvalumab, Surgery) - HPV NegativeTreatment (Durvalumab, Surgery) - HPV Positive
DiarrheaGastrointestinal disorders1/110/6
Alanine aminotransferase increasedInvestigations1/110/6
Aspartate aminotransferase increasedInvestigations1/110/6
HyperglycemiaMetabolism and nutrition disorders1/110/6
HypocalcemiaMetabolism and nutrition disorders1/110/6
Acute kidney injuryRenal and urinary disorders1/110/6
Skin ulcerationSkin and subcutaneous tissue disorders1/110/6
HypotensionVascular disorders1/110/6
Most frequent other events
Showing 10 of 110
Most frequent other events
EventTreatment (Durvalumab, Surgery) - HPV NegativeTreatment (Durvalumab, Surgery) - HPV Positive
AnemiaBlood and lymphatic system disorders6/115/6
HyperglycemiaMetabolism and nutrition disorders4/115/6
HypomagnesemiaMetabolism and nutrition disorders8/110/6
FatigueGeneral disorders7/114/6
HypoalbuminemiaMetabolism and nutrition disorders7/112/6
HyponatremiaMetabolism and nutrition disorders7/111/6
HypocalcemiaMetabolism and nutrition disorders6/113/6
ConstipationGastrointestinal disorders5/112/6
DiarrheaGastrointestinal disorders5/111/6
NauseaGastrointestinal disorders4/110/6

Baseline characteristics

Age, Continuous
Age, Continuous(years)Treatment (Durvalumab, Surgery) - HPV NegativeTreatment (Durvalumab, Surgery) - HPV PositiveTotal
Mean58.5 ± 9.258.0 ± 6.558.3 ± 8.1
Sex: Female, Male
Sex: Female, Male(Participants)Treatment (Durvalumab, Surgery) - HPV NegativeTreatment (Durvalumab, Surgery) - HPV PositiveTotal
Female516
Male6511
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment (Durvalumab, Surgery) - HPV NegativeTreatment (Durvalumab, Surgery) - HPV PositiveTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American011
White11516
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Treatment (Durvalumab, Surgery) - HPV NegativeTreatment (Durvalumab, Surgery) - HPV PositiveTotal
United States11617
08

Study locations

1 site
  • Comprehensive Cancer Center of Wake Forest University
    Winston-Salem, North Carolina 27157, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · May 18, 2021
  • Informed consent form · Jun 28, 2021

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02827838
Lead sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jul 11, 2016
Start date
Jan 2017
Primary completion
Apr 22, 2022
Completion
Apr 22, 2022
Results posted
Mar 17, 2025
Last update
Mar 17, 2025

Study contacts

Mercedes Porosnicu
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Papillomavirus Infections→

Other studies from this sponsor

Wake Forest University Health Sciences

Start the discussion