A Randomized Phase II Study on the Optimization of Immunotherapy in Squamous Carcinoma of the Head and Neck

NCT03620123 | Completed Phase 2

• 3 other identifiers: AIO-KHT-01172017-003349-14CA209-998
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

AIO-KHT-0117 (OPTIM) is a phase II, open-label randomized, multicenter study of nivolumab and ipilimumab on the optimization of immunotherapy in squamous carcinoma of the head and neck after prior platinum-based therapy.

Conditions

Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck; Carcinoma, Squamous Cell of Head and Neck

Keywords

SCCHN; Nivolumab; Ipilimumab

Outcome Measures

Primary Outcomes (1)

• objective response rate in all randomized subjects

  approx. 48 months

Secondary Outcomes (8)

• overall survival [OS]

  approx. 48 months

• Progression-free survival [PFS]

  approx. 42 months

• Best overall response [BOR]

  approx. 42 months

• Duration of Response [DOR]

  approx. 42 months

• Health related quality of life

  approx. 42 months

Other Outcomes (1)

• Tumor tissue analysis

  approx. 42 months

Study Arms (2)

Nivolumab and Ipilimumab

EXPERIMENTAL

Nivolumab 3 mg/kg of body weight intravenous infusion every two weeks and ipilimumab 1 mg/kg of body weight intravenous infusion every six weeks

Drug: Nivolumab and Ipilimumab

Docetaxel

OTHER

docetaxel 75 mg/m² intravenous infusion every three weeks

Drug: Docetaxel

Interventions

Nivolumab and Ipilimumab DRUG

Nivolumab 3 mg/kg of body weight intravenous infusion every two weeks and ipilimumab 1 mg/kg of body weight intravenous infusion every six weeks

Nivolumab and Ipilimumab

Docetaxel DRUG

docetaxel 75 mg/m² intravenous infusion every three weeks

Docetaxel

Eligibility Criteria

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

You may qualify if:

• Written informed consent including participation in translational research and any locally required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
• Age ≥ 18 years at time of study entry
• Histological or cytological confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC) or nasal sinus not amenable to local therapies
• Availability of tumor tissue from biopsy for determination of PD-L1 and HPV status according to the following priority ranking: i) recent biopsy (≤3 months old) without intervening therapy; ii) any recent biopsy (≤3 months old); iii) any archival tumor tissue (\> 3 months old) \[Biopsy should be excisional, incisional or core biopsy. Fine needle aspiration is not allowed.\]
• Progression or recurrence during or after platinum-based palliative chemotherapy for relapsed or metastatic disease OR Progression within 6 months after completion of definitive platinum-containing radiochemotherapy for locally advanced disease
• At least 1 measurable lesion according to RECIST 1.1
• ECOG performance status 0-1
• Completion of local therapy for brain metastases with discontinuation of steroids prior to start of study treatment
• Adequate blood count, liver enzymes, and renal function
• neutrophil count \> 1.5 x 10\^6/mL
• platelet count ≥ 100 x 10\^9/L (\>100,000 per mm³)
• hemoglobin ≥ 9 g/dL
• INR ≤ 1.5 and PTT ≤ 1.5 x lower limit during the last 7 days before therapy
• AST (SGOT)/ALT (SGPT) \< 3 x institutional upper limit of normal (5 x lower limit in case of liver metastases)
• bilirubin \< 1.5 x ULN

You may not qualify if:

• Nasopharynx carcinoma or carcinoma of salivary glands
• Life expectancy less than 3 months
• Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results, including but not limited to:
• Minor surgery ≤ 24 hours prior first dose of nivolumab monotherapy
• Anticancer treatment during the last 30 days prior to start of nivolumab monotherapy, including systemic therapy, or major surgery \[palliative radiotherapy has to be completed at least 2 weeks prior to start of nivolumab monotherapy\]
• Known active HBV, HCV or HIV infection
• Active tuberculosis
• Any other active infection requiring systemic therapy
• History of allogeneic tissue/solid organ transplant (including hematopoietic stem cell transplantation)
• Diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of nivolumab-monotherapy or randomization.
• Has an active autoimmune disease requiring systemic treatment within the past 3 months before enrolment or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo, hypothyroidism, diabetes mellitus type I or resolved childhood asthma/atopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study. Psoriasis not requiring treatment is not excluded from the study.
• Live vaccine within 30 days prior to the first dose of nivolumab-monotherapy or during study treatment.
• Other active malignancy requiring treatment
• Clinically significant or symptomatic cardiovascular/cerebrovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 6 months before enrollment
• History or clinical evidence of CNS metastases

Sponsors & Collaborators

• AIO-Studien-gGmbH: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Essen University Hospital

Essen, 45147, Germany

Location

Related Links

• AIO - Working Group for Medical Oncology from the German Cancer Society
• AIO-Studien-gGmbH

MeSH Terms

Conditions

Recurrence; Squamous Cell Carcinoma of Head and Neck

Interventions

Nivolumab; Ipilimumab; Docetaxel

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Viktor Grünwald, Prof. Dr.

  Essen University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: August 8, 2018
• Study Start: July 16, 2018
• Primary Completion: June 20, 2021
• Study Completion: June 19, 2022
• Last Updated: November 18, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)