AzTrials
AzTrials

Recurrent or Metastatic Squamous Cell Carcinoma of the Head and NeckPhase 2OPTIMNCT03620123

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

A Phase 2 study testing Nivolumab and Ipilimumab and Docetaxel in people with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck and Carcinoma, Squamous Cell of Head and Neck, run by AIO-Studien-gGmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nivolumab and Ipilimumab and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteGermany
Study dates
16 Jul 2018to 19 Jun 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 20Show fewer
  • 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
  • serum creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 40 mL/min
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
  • Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. [WOCBP should use an adequate method to avoid pregnancy for 5 months (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of nivolumab.] Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) do not require contraception.
  • 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 for a period of up to 7 months after the last dose of IMP.] Men who are not of childbearing potential (ie, surgically sterile or azoospermic ) do not require contraception
  • 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.

Who cannot join

  • 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
Show all 28Show fewer
  • 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
  • Exceptions are: Subjects who have completed local therapy and who meet both of the following criteria:
  • are asymptomatic and
  • have no requirement for steroids 6 weeks prior to start of nivolumab-monotherapy. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS metastases
  • Medication that is known to interfere with any of the agents applied in the trial.
  • Has known hypersensitivity to nivolumab or ipilimumab or docetaxel or any of the constituents of the products.
  • Any other efficacious cancer treatment except protocol specified treatment at study start.
  • Patient has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. [Subjects with ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study.]
  • Female subjects who are pregnant, breast-feeding or male/female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year). [Acceptable methods of contraception are: implants, injectable contraceptives, combined oral contraceptives, intrauterine pessars (only hormonal devices), sexual abstinence or vasectomy of the partner].
  • Prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-PD-L1, anti-Programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand,a member of the Tumor Necrosis Factor Receptor [TNFR] family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
  • Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lifes of previously used trial medication, whichever is longer
  • Previous treatment in the present study (does not include screening failure) [Criterion is not applicable during re-assessment of eligibility for randomization].
  • Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 AMG.
  • Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Essen University Hospital

    Essen, 45147

Other trials in Germany

About this study

Official title: A Randomized Phase II Study on the OPTimization of IMmunotherapy in Squamous Carcinoma of the Head and Neck

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.

Read the detailed description

This is a randomized, open-label, multicenter, phase II trial. Patients with recurrent or metastatic squamous cell carcinoma of the head and neck will be enrolled in this trial will initiate palliative systemic treatment with nivolumab monotherapy (240 mg fixed dose Q2W). Tumor response will be assessed after 4, 8, 12, 18 and 24 weeks to capture early progressors. Patients with (radiologic) tumor progression during the first 6 months of NIVO mono will be randomized (1:1) to receive either docetaxel (75 mg/m2 Q3W) or nivolumab+ipilimumab combination (Nivolumab 3mg/kg Q2W + Ipilimumab 1mg/kg Q6W) until progressive disease [PD] or death. Patients without PD within 6 months NIVO monotherapy continue treatment under study surveillance for a maximum of 12 months measured from first dose of NIVO or until documented disease progression.

Being tested
Nivolumab and Ipilimumab, Docetaxel
Keywords
SCCHN, Nivolumab, Ipilimumab
Medical subject headings
Recurrence, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nivolumab and IpilimumabDrug

    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

  • DocetaxelDrug

    docetaxel 75 mg/m² intravenous infusion every three weeks

Study groups in NCT03620123
Study groupRoleWhat they receive
Nivolumab and IpilimumabExperimentalNivolumab 3 mg/kg of body weight intravenous infusion every two weeks and ipilimumab 1 mg/kg of body weight intravenous infusion every six weeks
Receives: Drug: Nivolumab and Ipilimumab
DocetaxelOtherdocetaxel 75 mg/m² intravenous infusion every three weeks
Receives: Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. objective response rate in all randomized subjects

    Measured: approx. 48 months

Secondary outcomes (8)

  1. overall survival [OS]

    Measured: approx. 48 months

  2. Progression-free survival [PFS]

    Measured: approx. 42 months

  3. Best overall response [BOR]

    Measured: approx. 42 months

  4. Duration of Response [DOR]

    Measured: approx. 42 months

  5. Health related quality of life

    EORTC QLQ-C30

    Measured: approx. 42 months

  6. Health related quality of life: EORTC QLQ-H&N35

    EORTC QLQ-H\&N35

    Measured: approx. 42 months

  7. Health related quality of life: EQ-5D-5L

    EQ-5D-5L

    Measured: approx. 42 months

  8. Toxicity/Safety according to CTC-AE-criteria

    Measured: approx. 42 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2018
  2. Study start16 Jul 2018
  3. Primary completion20 Jun 2021
  4. Study completion19 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03620123
Sponsor's protocol ID
AIO-KHT-0117
Other IDs
2017-003349-14, CA209-998, 2017
Acronym
OPTIM
Status last verified
Nov 2022
First submitted
13 Jul 2018
Last updated
18 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab and Ipilimumab and Docetaxel in people with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck and Carcinoma, Squamous Cell of Head and Neck, run by AIO-Studien-gGmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

objective response rate in all randomized subjects (time frame: approx. 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03620123.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in