Neoplasms

All Conditions

Infections

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Papilloma

Communicable Diseases

Virus Diseases

Papillomavirus Infections

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

Oral Squamous Cell Carcinoma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Durvalumab

Immunoglobulins

Immunoglobulin G

Immunoglobulins, Intravenous

Antibodies, Monoclonal

Antineoplastic Agents, Immunological

Immunologic Factors

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.

Laboratory Biomarker Analysis

Therapeutic Conventional Surgery

Mercedes Porosnicu

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.

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.

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

Pilot Study to Evaluate the Anti-Tumor Effect of Durvalumab (Medi4736) in Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN), Human Papilloma Virus (HPV) Positive Versus Negative, When Treated Before Surgery

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 Tes

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).

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-

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

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

SUV activity as measured by PET scans will also be compared between groups at each time point and descriptive statistics, confidence intervals will be calculated and 2-sample t-tests will be performed.

Tumor volumes will be compared between groups (HPV +/-) pre- and post- treatment. Descriptive statistics, confidence intervals will be calculated and 2-sample t-tests will be performed

National Cancer Institute (NCI)

Wake Forest University Health Sciences

Docetaxel

Fluorouracil

Cisplatin

Induction chemotherapy before surgery: docetaxel, cisplatin, and 5-fluorouracil.

Docetaxel (at a dose of 75mg/m2 of body surface area) was administered as a 2-hour intravenous infusion, followed by intravenous cisplatin (75 mg/m2), administered during a period of 2 to 3 hours. After completion of the cisplatin infusion, 5-Fu (750 mg/m2/day) was administered during a period at least 8 hours for 5 days. Induction chemotherapy was given every 3 weeks for 2 cycles, unless there was disease progression, unacceptable toxic effects, or withdrawal of consent by the patient.

TPF induction chemotherapy

Zhi-yuan Zhang, MD, PhD

Induction chemotherapy is regarded as an effective way to reduce or downgrade the locally advanced or aggressive cancers, and to improve the chance of eradication of the locoregional lesions by radical surgery and/or radiotherapy. However, there are still debates on the clinical value of induction chemotherapy for patients with advanced and resectable oral squamous cell carcinoma. The hypothesis of this study is that the induction chemotherapy of TPF (docetaxel, cisplatin, and 5-fluorouracil) protocol could benefit the patients with locally advanced oral squamous cell carcinoma. The endpoints of this study are the survival rate, local control, and safety.

The primary endpoint of this study is the survival rate (2, 3, 5 years) after induction chemotherapy followed by surgery and radiotherapy. The second endpoint of this study is locoregional control rates (1, 2 years), and the safety.

TPF Induction Chemotherapy for Locally Advanced and Resectable Oral Squamous Cell Carcinoma

Study of TPF (Docetaxel, Cisplatin, 5-fluorouracil) Induction Chemotherapy Followed by Surgery and Radiotherapy in Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma

To evaluate the survival rate after TPF induction chemotherapy followed by surgery and radiotherapy.

To evaluate the 1, 2, 3, 5-year local and regional control rate and distant metastasis rate after TPF indcution chemotherapy followed by surgery and radiotherapy

All adverse events, including serious adverse events, exposure of all study drugs and radiation.

Shanghai Jiao Tong University School of Medicine

Ninth People's Hospital, School of Medicine

Nivolumab

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Tubulin Modulators

Antimitotic Agents

Immune Checkpoint Inhibitors

Patients receive nivolumab IV over at least 30 minutes on day 1, paclitaxel IV on days 1 and 8, and carboplatin IV on days 1 and 8. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Jennifer Johnson, MD, PhD

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.

PRIMARY OBJECTIVES:

I. To estimate pathologic complete response (pCR) at the primary site in patients with newly diagnosed and untreated stage III-IVA squamous cell carcinoma of the head and neck (SCCHN) of the oral cavity, oropharynx, larynx, and hypopharynx with nivolumab, paclitaxel and carboplatin in addition to standard chemotherapy.

SECONDARY OBJECTIVES:

I. Safety. II. Complete pathologic response at all sites of disease. III. Major pathologic response rate at primary site. IV. Overall clinical response rate. V. Clinical complete response rate. VI. 1 year progression-free survival (PFS). VII. Overall survival.

TERTIARY OBJECTIVES:

I. To explore whether PDL1 expression is associated with treatment response. II. To explore whether there is a net change in the Th1/Th2 ratio (IFN-gamma, IL-4, IL10, etc.) or cell subset frequencies (M2 monocytes, myeloid-derived suppressor cells, etc.) within a patient's peripheral blood either at baseline or in response to treatment is associated with treatment response.

III. To explore whether exosomes or other immune related serum biomarkers change after combination therapy.

IV. To explore the predictive value of serial cell free deoxyribonucleic acid (DNA) levels and response.

Nivolumab, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma That Can Be Removed by Surgery

Nivolumab Plus Weekly Carboplatin and Paclitaxel as Induction in Resectable Locally Advanced Head and Neck Cancer

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.

patients achieved the major pathologic response (i.e., \<10% viable tumor) or pathologic complete response

Bristol-Myers Squibb

Sidney Kimmel Cancer Center at Thomas Jefferson University

An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.

Patients receive nivolumab IV over at least 30 minutes on day 1, paclitaxel IV on days 1 and 8, and carboplatin IV on days 1 and 8. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Paclitaxel: Given IV

Carboplatin: Given IV

Nivolumab: Given IV

Treatment (Nivolumab, Paclitaxel, Carboplatin)

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Jennifer Johnson

The complete pathologic response rate was 45.45% (15/33) with a 95% Confidence Interval of 28.5% to 63.4%.

Pathologic Complete Response Rate

number of patients with Major response (Major or complete) was 72.73% (24/33) with a 95% Confidence Interval of 54.2% to 86.1%.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Durvalumab Before Surgery in Treating Patients With Oral Cavity or Oropharynx Cancer	NCT02827838	Human Papilloma... Stage I Oral Ca... Stage I Orophar... Stage II Oral C... Stage II Oropha... Stage III Oral ... Stage III Oroph... Stage IVA Oral ... Stage IVA Oroph... Stage IVB Oral ... Stage IVB Oroph... Stage IVC Oroph...	Durvalumab Laboratory Biom... Therapeutic Con...	18 Years -	Wake Forest University Health Sciences
TPF Induction Chemotherapy for Locally Advanced and Resectable Oral Squamous Cell Carcinoma	NCT01542931	Stage III Oral ... Stage IVA Oral ...	TPF induction c...	18 Years - 75 Years	Shanghai Jiao Tong University School of Medicine
Durvalumab Before Surgery in Treating Patients With Oral Cavity or Oropharynx Cancer	NCT02827838	Human Papilloma... Stage I Oral Ca... Stage I Orophar... Stage II Oral C... Stage II Oropha... Stage III Oral ... Stage III Oroph... Stage IVA Oral ... Stage IVA Oroph... Stage IVB Oral ... Stage IVB Oroph... Stage IVC Oroph...	Durvalumab Laboratory Biom... Therapeutic Con...	18 Years -	Wake Forest University Health Sciences
Nivolumab, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma That Can Be Removed by Surgery	NCT03342911	Name Human Papi... Stage II Oropha... Stage III Hypop... Stage III Laryn... Stage III Oral ... Stage III Oroph... Stage IV Hypoph... Stage IV Laryng... Stage IV Oral C... Stage IV Oropha... Stage IVA Hypop... Stage IVA Laryn... Stage IVA Oral ... Stage IVA Oroph... Stage IVB Hypop... Stage IVB Laryn... Stage IVB Oral ... Stage IVB Oroph... Stage IVC Hypop... Stage IVC Laryn... Stage IVC Oral ... Stage IVC Oroph...	Paclitaxel Carboplatin Nivolumab	18 Years -	Thomas Jefferson University
Durvalumab Before Surgery in Treating Patients With Oral Cavity or Oropharynx Cancer	NCT02827838	Human Papilloma... Stage I Oral Ca... Stage I Orophar... Stage II Oral C... Stage II Oropha... Stage III Oral ... Stage III Oroph... Stage IVA Oral ... Stage IVA Oroph... Stage IVB Oral ... Stage IVB Oroph... Stage IVC Oroph...	Durvalumab Laboratory Biom... Therapeutic Con...	18 Years -	Wake Forest University Health Sciences

Spots Global Cancer Trial Database for stage iii oral cavity squamous cell carcinoma