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Head and Neck NeoplasmsPhase 1/2NCT02643550

Study of Monalizumab and Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

A Phase 1/2 study testing Monalizumab, Cetuximab and Anti-PD(L)1 in people with Head and Neck Neoplasms, run by Innate Pharma at 18 sites in 2 countries.

Completed

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

Official record
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Trial summary

The objective of this study is to evaluate in a 3 +3 design, the safety of escalating doses of Monalizumab given IV in combination with cetuximab in patients who have received prior systemic regimen(s) for recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Neoplasms
What is being tested?
Monalizumab, Cetuximab and Anti-PD(L)1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
143 participants
Where
18 sitesin 2 countries
Study dates
Dec 2015to 28 Mar 2023
Phase
Phase 1/2
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

Main Inclusion Criteria:

  1. Age ≥ 18 years
  2. Histologically or cytologically-confirmed, HPV (+) or HPV (-) squamous cell carcinoma of the nasopharynx (WHO Type 1), oropharynx, hypopharynx, larynx (supraglottis, glottis, subglottis) or oral cavity.
  3. Recurrent or metastatic disease, documented by imaging (CT scan, MRI, X-ray) and/or physical examination with measurable disease as per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1

For phase II cohorts:

  • Cohort #1: Patients who received a maximum of two prior systemic regimens for recurrent and/or metastatic disease and not amenable to further therapy with curative intent
  • Cohort #2: Patients with R/M SCCHN not amenable to therapy of curative intent, who have received a maximum of two prior systemic regimens in the R/M setting and who have received prior PD-(L)1 blockers
  • Cohort #3: Patients with R/M SCCHN who have not received prior systemic regimens in the R/M setting and who have not received prior PD-(L)1 inhibitors

Main Exclusion Criteria:

  1. For phase II cohort #1 and cohort #2: Patients who received more than 2 prior systemic regimens for recurrent and/or metastatic disease (no restriction in the phase Ib part of the trial).
  2. For phase II cohort #1 and cohort #2: Patients who received cetuximab or another inhibitor of epidermal growth factor receptor are excluded from the phase II of the trial, except if cetuximab was given as part of a primary treatment approach, with no progressive disease for at least 4 months following the end of prior cetuximab treatment.

Trial locations and contacts

18 sites in 2 countries.

18 sites in 2 countries

United States9 sites

  • University of Maryland, Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland

  • University of Chicago

    Chicago, Illinois, 60637

  • University of California, Moores Cancer Center

    La Jolla, California

  • Vanderbilt University Medical Center

    Nashville, Tennessee

  • Icahn School of Medicine at Mount Sinaï

    New York, New York, 10029

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Washington University School of Medicine

    St Louis, Missouri

  • Stanford Cancer Center

    Stanford, California, 94305

Other trials in United States

France9 sites

  • Centre Jean Perrin

    Clermont-Ferrand

  • Centre Oscar Lambret

    Lille

  • Centre Leon Berard

    Lyon

  • Hopital La Timone

    Marseille

  • Institut Regional du Cancer de Montpellier

    Montpellier

  • Centre Antoine Lacassagne

    Nice

  • Centre Eugene Marquis

    Rennes

  • ICO Rene Gauducheau

    Saint-Herblain

  • Institut Gustave Roussy

    Villejuif

Other trials in France

About this study

Official title: Phase 1b/2 Trial of IPH2201 And Cetuximab in Patients With Human Papillomavirus (HPV) (+) and HPV (-) Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

The objective of this study is to evaluate in a 3 +3 design, the safety of escalating doses of Monalizumab given IV in combination with cetuximab in patients who have received prior systemic regimen(s) for recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).

Cohorts expansion will evaluate antitumor activity of monalizumab and cetuximab with or without anti-PD(L)1

Being tested
Monalizumab, Cetuximab, Anti-PD(L)1
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.

  • MonalizumabBiological

    Also called IPH2201

  • CetuximabBiological

  • Anti-PD(L)1Biological

Study groups in NCT02643550
Study groupRoleWhat they receive
Dose escalationExperimentalDose escalation of monalizumab in combination with cetuximab
Receives: Biological: Monalizumab; Biological: Cetuximab
Expansion cohort 1Experimentalmonalizumab + cetuximab expansion cohort
Receives: Biological: Monalizumab; Biological: Cetuximab
Expansion cohort 2Experimentalmonalizumab + cetuximab expansion cohort in patients with prior exposure to PD-(L)1 blockers
Receives: Biological: Monalizumab; Biological: Cetuximab
Expansion cohort 3Experimentalmonalizumab + cetuximab + anti-PD(L)1
Receives: Biological: Monalizumab; Biological: Cetuximab; Biological: Anti-PD(L)1

What is being measured

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

  1. Occurrence of Dose Limiting Toxicities (DLT) in the dose escalation part of the study

    To assess the occurrence of Drug Limited Toxicities (DLTs)

    Measured: within 4 weeks after first administration

  2. Objective Response Rate for expansion cohorts

    rate of patients in complete or partial response according to RECIST 1.1.

    Measured: up to 12 months

Secondary outcomes (4)

  1. Objective Response Rate for dose escalation part of the study

    rate of patients in complete or partial response according to RECIST 1.1

    Measured: up to 12 months

  2. Duration of Response for expansion cohorts

    Duration of complete and partial response

    Measured: From confirmed response until disease progression, up to 12 months

  3. Progression Free Survival for expansion cohorts

    time between the start of treatment and the first documented progression or death

    Measured: Until disease progression or death, up to 2 years

  4. Overall Survival for expansion cohorts

    time between the start of treatment and death

    Measured: Until death, up to 2 years

Timeline

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

  1. First posted31 Dec 2015 (estimated)
  2. Study startDec 2015
  3. Primary completion28 Mar 2023
  4. Study completion28 Mar 2023

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02643550
Sponsor's protocol ID
IPH2201-203
Status last verified
May 2023
First submitted
17 Dec 2015
Last updated
12 May 2023
Results posted
No
Data monitoring committee
No

Publications

  • Hwang M, Fan C, Yue MS, Zhou D, Paturel C, Andre P, Cheng LY, Mitchell P, Kourtesis P, Ruscica D, Das M, Morsli N, Ren S, Gibbs M, Phipps A, Song X. Population Pharmacokinetics of Monalizumab in Patients With Advanced Solid Tumors. J Clin Pharmacol. 2023 Jul;63(7):817-829. doi: 10.1002/jcph.2220. Epub 2023 Apr 10.

    PubMed 36852723

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Monalizumab, Cetuximab and Anti-PD(L)1 in people with Head and Neck Neoplasms, run by Innate Pharma at 18 sites in 2 countries.

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

Who may be eligible to take part?

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 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, France. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Occurrence of Dose Limiting Toxicities (DLT) in the dose escalation part of the study (time frame: within 4 weeks after first administration). The study lists 2 primary outcomes in all. 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 NCT02643550, which also lists 1 linked publication.

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 12 May 2023.

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