AzTrials
AzTrials

Head and Neck Squamous Cell CarcinomaPhase 2NCT04831450

Phase 2 Trial of Maintenance Cemiplimab for Head and Neck Squamous Cell Carcinoma (HNSCC)

A Phase 2 study testing Cemiplimab-Rwlc in people with Head and Neck Squamous Cell Carcinoma and HNSCC, run by University of Miami.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the experimental immunotherapy agent cemiplimab-rwlc when given after completion of chemotherapy and radiation treatment and determine if it will improve progression free survival and cure rates in patients with PD-L1 positive locally advanced head and neck cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cemiplimab-Rwlc
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jul 2022to 15 Jul 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

  • Histological diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
  • Intermediate or high-risk disease defined by the following:
  • Squamous Cell Carcinoma of the oral cavity, larynx or hypopharynx American Joint Committee on Cancer (AJCC) 8th Stage III-IVB
  • p16-Negative oropharynx SCC, AJCC 8th Stage III-IVB
  • p16--positive oropharyngeal SCC, AJCC 8th stage II-III
  • Tumor must have documented Programmed Death (PD) Ligand (L) -1 Combined Positive Score (CPS) PD-L1 CPS ≥ 1 by immunohistochemistry (IHC).
Show all 20Show fewer
  • Prior therapy for advanced stage HNSCC with definitive Standard of Care (SoC) CRT Intensity Modulated Radiation Therapy (IMRT (66-70 Gy) with concurrent Cisplatin with curative intent. Patients must have received a total cumulative dose of cisplatin of ≥ 200 mg/m2 or equivalent carboplatin plus taxanes combination per investigator criteria during concurrent treatment.
  • No clinical or radiographic evidence of progressive disease at the time of enrollment.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.
  • Adequate bone marrow function, including:
  • Absolute Neutrophil Count (ANC) ≥ 1,000/µL or ≥ 1.0 x 10^9/L.
  • Platelets ≥ 75,000/µL or ≥ 100 x 10^9/L.
  • Hemoglobin ≥ 8 g/dL (may have been transfused).
  • Adequate renal function, as determined by an estimated creatinine clearance ≥ 30 mL/min as calculated using the Cockcroft- Gault.
  • Adequate liver function, including:
  • Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • Aspartate and alanine aminotransferase (AST and ALT) < 2.5 x ULN.
  • Pregnancy test (for patients of childbearing potential) negative at screening.
  • Male patients able to father children and female patients of childbearing potential and at risk for pregnancy must agree to use two methods of contraception (at least one of which is considered to be highly effective throughout the study and for at least 3 months after the last dose of cemiplimab-rwlc.
  • Evidence of a signed and dated informed consent document indicating that the patient (or a legally acceptable representative, as allowed by local guideline/practice) has been informed of all pertinent aspects of the study.

Who cannot join

  • Prior immunotherapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T lymphocyte Associated (CTLA)-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways.
  • Major surgery ≤ 4 weeks prior to enrollment.
  • Prior malignancy (other than the current Head and Neck cancer or in situ disease) requiring tumor-directed therapy within the last 2 years prior to enrollment, or concurrent malignancy associated with clinical instability. Exceptions for disease within the 2 years are superficial esophageal cancer (TIS or T1a) fully resected by endoscopy, prostate cancer (Gleason score ≤6) either curatively treated or deemed to not require treatment, ductal in situ carcinoma of the breast that has completed curative treatment, adequately treated basal cell or squamous cell skin cancer.
  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
  • Active infection requiring systemic therapy.
  • Use of immunosuppressive medication at time of enrollment, except the following:
Show all 13Show fewer
  • Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤10 mg/day of prednisone or equivalent
  • Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).
  • Prior organ transplantation including allogenic stem-cell transplantation.
  • Diagnosis of prior immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness.
  • Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA [ribonucleic acid] if anti-HCV antibody screening test positive).
  • Pregnant female patients, breastfeeding female patients, and male patients able to father children and female patients of childbearing potential who are unwilling or unable to use 2 methods of contraception (at least one of which is considered to be highly effective) for at least 3 months after the last dose of cemiplimab-rwlc.
  • Patients with impaired decision-making capacity.

About this study

Official title: Phase II Trial of Maintenance Cemiplimab-rwlc After Concurrent Chemoradiotherapy (CRT) in Intermediate and High-Risk Head and Neck Squamous Cell Carcinoma (HNSCC)

The purpose of this study is to evaluate the experimental immunotherapy agent cemiplimab-rwlc when given after completion of chemotherapy and radiation treatment and determine if it will improve progression free survival and cure rates in patients with PD-L1 positive locally advanced head and neck cancer.

Being tested
Cemiplimab-Rwlc
Medical subject headings
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.

  • Cemiplimab-RwlcDrug

    Also called REGN2810

    350 mg Cemiplimab administered via intravenous infusion over 30 minutes on Day 1 of a 21-day cycle.

Study groups in NCT04831450
Study groupRoleWhat they receive
Cemiplimab After CRT in HNSCCExperimentalParticipants will receive Cemiplimab for 6 consecutive months (a total of 8 cycles) 14-42 days after completion of standard of care CRT.
Receives: Drug: Cemiplimab-Rwlc

What is being measured

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

  1. Progression-Free Survival (PFS)

    Progression-Free Survival (PFS) is defined as the elapsed time from the date of starting maintenance treatment until disease progression or death (whichever occurs first). Patients who have not had an event will be censored at the date of last disease assessment documenting the patient was free of progression. Progression will be assessed using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.

    Measured: Up to 2 years

Secondary outcomes (3)

  1. PFS Rate

    PFS is defined as the elapsed time from the date of starting maintenance treatment until disease progression or death (whichever occurs first). Patients who have not had an event will be censored at the date of last disease assessment documenting the patient was free of progression. Progression will be assessed using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.

    Measured: Up to 1 year

  2. Overall Survival (OS)

    Overall survival (OS) will be defined as the elapsed time from the date of starting maintenance treatment (Cycle 1 Day 1) until death. Alive patients will be censored at the date of last known to be alive.

    Measured: Up to 2 years

  3. Incidence of Treatment-Related Toxicity and Adverse Events

    Safety of the intervention will be reported as the incidence of treatment-related toxicity, including serious adverse events (SAEs) and adverse events (AEs), in study participants using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.

    Measured: Up to 9 months

Timeline

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

  1. First posted5 Apr 2021
  2. Study startJul 2022 (estimated)
  3. Primary completion15 Jul 2022
  4. Study completion15 Jul 2022

Why it stopped: Investigator Decision

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04831450
Sponsor's protocol ID
20200543
Status last verified
Aug 2022
First submitted
1 Apr 2021
Last updated
4 Aug 2022
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 Cemiplimab-Rwlc in people with Head and Neck Squamous Cell Carcinoma and HNSCC, run by University of Miami.

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 13 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: withdrawn, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

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 withdrawn before enrolling participants, so there are no results.

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?

Progression-Free Survival (PFS) (time frame: Up to 2 years). 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 NCT04831450.

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 4 Aug 2022.

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

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in