Neoadjuvant Nivolumab for Oral Cancer Combined With FDG and Anti-PD-L1 PET/CT Imaging for Response Prediction

NCT03843515 | Unknown Phase 1

• 1 other identifier: 2018-002643
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Safety and tolerability of neoadjuvant nivolumab for locally advanced resectable oral cancer, combined with \[18F\]BMS-986192 / \[18F\]-FDG PET imaging and immunomonitoring for response prediction

Conditions

Oral Cavity Squamous Cell Carcinoma

Keywords

head and neck squamous cell carcinoma; nivolumab; PD-L1; PET/CT; neoadjuvant

Outcome Measures

Primary Outcomes (2)

• (Serious) adverse events

  Adverse events

  untill 100 days after last study drug administration

• SUV values

  SUVpeak/mean/max of tumor lesions on FDG-PET/anti-PD-L1 PET

  2 years

Secondary Outcomes (1)

• Correlation between PET data and Blood/Tissue markers

  2 years

Study Arms (1)

Neoadjuvant nivolumab

EXPERIMENTAL

All subject will receive 400mg flat dose nivolumab in the neoadjuvant setting

Drug: Nivolumab

Interventions

Nivolumab DRUG

Neoadjuvant nivolumab flat dose 400mg

Also known as: Neoadjuvant nivolumab

Neoadjuvant nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a histologically confirmed diagnosis of locally advanced oral cancer (stage III/IV) which is planned for treatment with curative intent including surgical resection.
• Be willing and able to provide written informed consent/assent for the trial.
• Be more then 18 years of age on day of signing informed consent.
• Must agree to provide tissue from fresh tumor biopsy pretreatment and from the surgical resection material to determine the actual PD-L1 status and perform immunomonitoring/DNA/RNA profiling.
• Willing to allow up to two additional biopsies when baseline \[18F\]BMS-986192 PET /\[18F\]-FDG PET scans show heterogeneous and/or discrepant uptake.
• Have a performance status of 0-1 on the ECOG Performance Scale (Appendix 2).
• Demonstrate adequate organ function as defined in table 1. All screening labs should be performed within 2 weeks before any study imaging procedures are performed
• Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception during the study and for 23 weeks after the last dose of nivolumab. Women who are not of childbearing potential (i.e. who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception (Appendix 4)
• Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception during the study and for 31 weeks after the last dose of nivolumab (Appendix 4).

You may not qualify if:

• Is currently participating in or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
• Has had another known invasive malignancy within the previous 5 years and/or has had surgery, chemotherapy, targeted small molecule therapy or radiation therapy within 5 years for a known malignancy prior to study day 0.
• Has a known current additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
• If subject received major surgery for any other reason, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
• Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day -5. Inhaled or topical steroids, and adrenal replacement steroid \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
• Has an active autoimmune disease requiring systemic steroid treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids.
• Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
• Has an active infection requiring systemic therapy.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 23 weeks after the last dose of trial treatment.
• Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.
• Has a known history of Human Immunodeficiency Virus (HIV) infection (HIV 1/2 antibodies).
• Has known active Hepatitis B or C.

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

VU University medical center

Amsterdam, North Holland, 1081 HV, Netherlands

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• C. W. Menke, Phd, MD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

• C. R. Leemans, Phd, MD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Phase I safety and feasibility study with additional pilot biomarker assessments

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 18, 2019
• Study Start: April 11, 2019
• Primary Completion: November 30, 2021
• Study Completion: August 31, 2022
• Last Updated: October 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)