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Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Phase 2NCT04862650

Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

A Phase 2 study testing Carboplatin, Cemiplimab and Paclitaxel in people with Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Metastatic Head and Neck Squamous Cell Carcinoma, run by Marcelo Bonomi at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase II trial studies the effect of cemiplimab in combination with low-dose paclitaxel and carboplatin in treating patients with squamous cell carcinoma of the head and neck that has come back (recurrent) or spread to other places in the body (metastatic). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Carboplatin, Cemiplimab and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteUnited States
Study dates
30 Nov 2021to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Recurrent/metastatic (R/M) SCCHN of the oral cavity, oropharynx, larynx and hypopharynx
  • No prior systemic therapy for treatment of R/M disease
  • Patients with squamous cell carcinoma of an unknown primary are eligible provided their tumor tested positive for p-16 and they have previously received treatment for locoregional head and neck cancer
  • Must be at least four weeks since prior radiation and/or surgery
  • Must be at least four weeks from curative intent systemic therapy. Of note: patients who have received up to two courses of chemoradiotherapy (CRT) for locoregionally advanced disease are eligible. Induction chemotherapy will not be considered a separate line of therapy
  • At least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 on screening computed tomography (CT) or magnetic resonance imaging (MRI)
Show all 19Show fewer
  • 18 years of age and older
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • White blood cell (WBC) count > 2,500 cells/uL
  • Absolute neutrophil count (ANC) >1,500 cells/uL
  • Platelet count >= 100,000 cells/uL
  • Hemoglobin >= 9 g/dL
  • Creatinine =< 1.6 mg/dL
  • Total bilirubin =< 1.6 mg/dL
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate transaminase [AST]), serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x upper limit of normal (ULN)
  • Potassium >= lower limit of normal (LLN)
  • Willingness to use medically acceptable contraception throughout the study period and four months after the final administration of treatment
  • For female subjects with reproductive potential: a negative serum pregnancy test at baseline
  • Ability and willingness to provide written informed consent and to comply with the study visits and assessment schedule

Who cannot join

  • Disease amenable to curative local therapy
  • Nasopharyngeal, salivary gland, lip, or sinonasal carcinoma
  • Disease that requires corticosteroids or other ongoing immunosuppressive treatment
  • Previous treatment with mAb-based immunotherapy for treatment of prior oncologic treatment
  • Previous treatment with PI3K inhibitors
  • Known brain metastases, unless stable for at least 21 days prior to registration
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  • Known infection human immunodeficiency virus (HIV), hepatitis B or C
  • Clinically significant cardiac disease (e.g., congestive heart failure, unstable or uncontrolled angina, myocardial infarction) within the past six months
  • History of pneumonitis within the past five years
  • Recipient of live vaccines (including attenuated) within 30 days of planned study treatment
  • Female patients who are pregnant or breast-feeding
  • Any other condition or circumstance that could interfere with adherence to the study's procedures or requirements or otherwise compromise the study's objectives in the opinion of the Principal Investigator

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: A Phase II Trial of the Efficacy and Safety of the Combination of Cemiplimab and Low-Dose Paclitaxel and Carboplatin in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

This phase II trial studies the effect of cemiplimab in combination with low-dose paclitaxel and carboplatin in treating patients with squamous cell carcinoma of the head and neck that has come back (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as cemiplimab , may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, like paclitaxel and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cemiplimab in combination with paclitaxel and carboplatin may work better in treating recurrent or metastatic squamous cell carcinoma of the head and neck.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess the overall response rate (ORR) at 12 weeks of treatment with the treatment combination cemiplimab, paclitaxel, and carboplatin.

SECONDARY OBJECTIVES:

  1. To assess toxicity/tolerance to the proposed treatment combination (a safety run-in phase of ten patients will be performed initially).

II. To assess progression-free survival (PFS) and overall survival (OS) at one and two years.

EXPLORATORY OBJECTIVES:

  1. Prospectively test the ability of our clinical nomogram to predict median OS in squamous cell carcinoma of the head and neck (SCCHN) patients planning to receive first-line cemiplimab in combination with low-dose weekly paclitaxel and carboplatin.

II. To assess the PFS and OS of patients with combined positive score (CPS) <1%, >1%, and > 20%.

III. Compare the predictive power of our nomogram to that of CPS in the prospective cohort, as well as evaluate the combined correlation of nomogram and CPS to median OS.

IV. Perform comprehensive immune analysis including phenotypic analysis of immune cell subsets using high dimensional spectral flow cytometry. T cell functionality and ability to produce cytokines after ex vivo stimulation for all T cells and E6/E7-reactive T cells (P16+ subset patients) and TCR sequencing to determine if clonal T cell populations emerge from the tumor of responding patients in comparison with non-responders.

OUTLINE:

Patients receive cemiplimab intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 104 weeks, and paclitaxel IV over 60 minutes and carboplatin IV over 30 minutes once weekly (QW) for up to 24 weeks. Treatment continuous in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 14 days and then every 12 weeks.

Being tested
Carboplatin, Cemiplimab, Paclitaxel
Medical subject headings
Oropharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck, Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Mouth Neoplasms

What participants receive

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

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • CemiplimabBiological

    Also called Cemiplimab RWLC, Cemiplimab-rwlc, Libtayo, REGN2810

    Given IV

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

Study groups in NCT04862650
Study groupRoleWhat they receive
Treatment (cemiplimab, paclitaxel, carboplatin)ExperimentalPatients will be treated with a combination of cemiplimab 350 mg every three weeks, with weekly combination of paclitaxel 25 mg/m2 and carboplatin AUC 1. Treatment will continue for a total of 24 months or until disease progression or unacceptable toxicity. Weekly chemotherapy will stop after six months of treatment (24 weeks). A ten patient safety run-in phase will be initially performed.
Receives: Drug: Carboplatin; Biological: Cemiplimab; Drug: Paclitaxel

What is being measured

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

  1. Overall response rate (ORR)

    ORR defined as the proportion of patients with a documented complete response (CR) + partial response (PR) at week 12 of treatment based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. An ORR of 40% (percent) or higher will be consider a positive result. Simon two-stage optimal design will be used.

    Measured: 12 weeks

Secondary outcomes (3)

  1. Progression-free survival (PFS)

    PFS will be calculated based on RECIST criteria.

    Measured: From the date of enrollment until documented disease progression, assessed up to 2 years

  2. Overall survival (OS)

    Measured: From the date of patient enrollment into the trial until death, assessed up to 2 years

  3. Incidence of adverse events

    Toxicity will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

    Measured: Up to 24 weeks

Timeline

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

  1. First posted28 Apr 2021
  2. Study start30 Nov 2021
  3. Primary completion12 Jun 2026
  4. Study completion31 Dec 2026 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04862650
Sponsor's protocol ID
OSU-20258
Other IDs
NCI-2021-02081
Status last verified
Jun 2026
First submitted
26 Mar 2021
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin, Cemiplimab and Paclitaxel in people with Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Metastatic Head and Neck Squamous Cell Carcinoma, run by Marcelo Bonomi at 1 site in United States.

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 19 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. 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 United States. 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?

This study is still under way. Results are not available in the source record yet.

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?

Overall response rate (ORR) (time frame: 12 weeks). 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 NCT04862650.

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 25 Jun 2026.

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