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Cancer of Head and NeckPhase 2ELDORANDONCT03193931

Study Comparing Pembrolizumab With Methotrexate in Elderly, Frail or Cisplatin-ineligible Patients With Head and Neck Cancers

A Phase 2 study testing Pembrolizumab Injection and Methotrexate Injectable Solution in people with Cancer of Head and Neck, run by AIO-Studien-gGmbH at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The study is designed as an open-label, randomized, prospective, multicenter, phase II study comparing pembrolizumab with methotrexate in elderly, frail or cisplatin-ineligible patients with squamous carcinoma of the head and neck (HNSCC) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer of Head and Neck
What is being tested?
Pembrolizumab Injection and Methotrexate Injectable Solution
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteGermany
Study dates
2 Feb 2018to 23 Mar 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

  • Cooperation and willingness to complete all aspects of the study
  • Signed written informed consent must be given prior to study inclusion
  • Histological or cytological confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC) not amenable to local therapies
  • Progressive disease at study entry
  • At least 1 measurable lesion according to RECIST 1.1
  • No previous systemic treatment for metastatic disease
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  • Not eligible for cisplatin-based chemotherapy, defined as:
  • ECOG 2 [Eastern Cooperative Oncology Group] and/or
  • Calculated CrCl [Creatinine Clearance] <60 mL/min (measured by MDRD)
  • Age ≥ 18 years
  • ECOG performance status 0 - 2
  • Brain metastases require completion of local therapy with discontinuation of steroids prior to start of treatment
  • If of childbearing potential, willingness to use highly effective contraceptive method for the duration of the study and 120 days after last dose, such as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), vasectomized partner, bilateral tubal occlusion, sexual abstinence. If an oral contraception is used, a barrier method of contraception (e.g. male condom, female condom, cervical cap, diaphragm, contraceptive sponge) has to be applied additionally.
  • Adequate bone marrow function, liver and renal function:
  • Absolute neutrophil count ≥ 1.5 x 109/L
  • Thrombocytes ≥ 100 x 109/L
  • Hemoglobin ≥ 9 g/dL
  • INR [international normalized ratio] ≤ 1.5 and PPT [partial prothrombin time] ≤ 1.5 x lower limit during the last 7 days before therapy
  • Bilirubin < 1.5 x lower limit and
  • AST (GOT) [aspartate aminotransferase] and ALT (GPT) [alanine transaminase] < 3 x lower limit (5 x lower limit in case of liver metastases)
  • Tumor block or 20 slides must be available at study inclusion for central pathology testing

Who cannot join

  • Live expectancy less than 3 months
  • Nasopharynx carcinoma
  • Anticancer treatment during the last 30 days prior to start of treatment, including systemic therapy, radiotherapy or major surgery
  • Participation in a clinical trial within the last 30 days prior to study treatment
  • History of allogeneic tissue/solid organ transplant
  • History of pneumonitis that has required oral or i.v. steroids
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  • Evidence of interstitial lung disease
  • Minor surgery ≤ 24 hours prior first dose of study treatment
  • Symptomatic acute cardiovascular or cerebrovascular disease
  • Known active HBV [hepatitis B virus], HCV [hepatitis C virus] or HIV infection
  • Has any other active infection requiring systemic therapy.
  • Patients with active tuberculosis
  • 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)
  • A 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 trial treatment.
  • Patient has had a prior monoclonal antibody, which does significantly interfere with the immune system or which does have a systemic therapeutic effect on the tumor within 4 weeks prior to randomization.
  • Patient has not recovered (i.e., ≤ Grade 1 or at baseline) from any toxicity due to agents administered more than 4 weeks earlier. [Subjects with ≤ Grade 2 neuropathy or alopecia are an exception to this criterion and may qualify for the study.]
  • Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be 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.
  • Has received a live vaccine within 30 days prior to the first dose of trial treatment.
  • Has known hypersensitivity to methotrexate or pembrolizumab or any constituent of the products..
  • Other active malignancy requiring treatment
  • Lactating or pregnant women, women of child-bearing potential who do not agree to the usage of highly effective contraception methods (allowed methods of contraception, meaning methods with a rate of failure of less than 1% per year are combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), vasectomized partner, bilateral tubal occlusion, sexual abstinence. If an oral contraception is used, a barrier method of contraception (e.g. male condom, female condom, cervical cap, diaphragm, contraceptive sponge) has to be applied additionally). Women of childbearing potential must have a negative pregnancy test (serum β-hCG) at Screening.
  • Any psychiatric illness that would affect the patient's ability to understand the demands of the clinical trial
  • Patient has already been recruited in this trial (does not include screening failures)
  • 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

  • Medizinsche Hochschule Hannover

    Hanover, 30625

Other trials in Germany

About this study

Official title: A Randomized Phase II Study Comparing Pembrolizumab With Methotrexate in Elderly, Frail or Cisplatin-ineligible Patients With Head and Neck Cancers

The study is designed as an open-label, randomized, prospective, multicenter, phase II study comparing pembrolizumab with methotrexate in elderly, frail or cisplatin-ineligible patients with squamous carcinoma of the head and neck (HNSCC)

Being tested
Pembrolizumab Injection, Methotrexate Injectable Solution
Medical subject headings
Head and Neck Neoplasms

What participants receive

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

  • Pembrolizumab InjectionDrug

    Pembrolizumab 200 mg q3w i.v. until disease progression or non-tolerable toxicity (maximum 2 years)

  • Methotrexate Injectable SolutionDrug

    Methotrexate 40 mg/m2 weekly i.v. until disease progression or non-tolerable toxicity (maximum 2 years)

Study groups in NCT03193931
Study groupRoleWhat they receive
Arm AExperimentalPembrolizumab 200 mg q3w i.v. until disease progression or non-tolerable toxicity (maximum 2 years)
Receives: Drug: Pembrolizumab Injection
Arm BActive comparatorArm B: Methotrexate (MTX) 40 mg/m2 weekly i.v. until disease progression or non-tolerable toxicity (maximum 2 years)
Receives: Drug: Methotrexate Injectable Solution

What is being measured

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

  1. Antitumor activity of pembrolizumab in SCCHN

    Overall survival (OS) rate

    Measured: 1 year

Secondary outcomes (7)

  1. Quality of life QLQC30 [EORTC QLQ-C30]

    QLQC30

    Measured: through study completion, an average of 6 years

  2. Quality of life HN35 [EORTCQLQ-H&N35]

    HN35

    Measured: through study completion, an average of 6 years

  3. Predictive biomarkers

    molecular-genetic pro-inflammatory markers

    Measured: through study completion, an average of 6 years

  4. Predictive biomarkers

    PD-L1 expression

    Measured: through study completion, an average of 6 years

  5. Time to failure of strategy (TTFS)

    defined as death, progressive disease (PD), treatment discontinuation ( or deterioration of Instrumental Activities of Daily Living (IADL score) by 2 points.

    Measured: 1 year

  6. Efficacy of pembrolizumab in SCCHN

    Objective response rate (ORR) according to RECIST 1.1

    Measured: through study completion, an average of 6 years

  7. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Adverse event rates due to treatment with MTX and pembrolizumab in SCCHN measured according to CTCAE 4.03

    Measured: through study completion, an average of 6 years

Timeline

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

  1. First posted21 Jun 2017
  2. Study start2 Feb 2018
  3. Primary completion24 Nov 2021
  4. Study completion23 Mar 2022

Why it stopped: A very low recruitment rate made it impossible to reach the recruitment goal wthin an acceptable timeframe.

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
Model description
Patients recieve pembrolizumab or methotrexate
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03193931
Sponsor's protocol ID
AIO-KHT-0115
Acronym
ELDORANDO
Status last verified
Feb 2023
First submitted
31 May 2017
Last updated
6 Feb 2023
Results posted
No
Data monitoring committee
Yes
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 Pembrolizumab Injection and Methotrexate Injectable Solution in people with Cancer 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 21 inclusion and 25 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: stopped early, as of the sponsor's last update on 6 Feb 2023. 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 was stopped early (reason given: A very low recruitment rate made it impossible to reach the recruitment goal wthin an acceptable timeframe.). Results are not available in the source record.

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?

Antitumor activity of pembrolizumab in SCCHN (time frame: 1 year). 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 NCT03193931.

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 6 Feb 2023.

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