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Squamous Cell Carcinoma of Head and NeckPhase 1/2NCT05027204

A Study of Docetaxel for Injection (Albumin-bound) in Combination With Nivolumab in Patients With Head and Neck (SCCHN)

A Phase 1/2 study testing Docetaxel and Nivolumab in people with Squamous Cell Carcinoma of Head and Neck, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This trial is a single-arm, multicenter phase Ib/II clinical study to evaluate the efficacy and safety of Docetaxel for Injection (Albumin-bound) combined with Nivolumab and the pharmacokinetic characteristics of Docetaxel in patients with recurrent or metastatic SCCHN who are positive for PD-L1 expression and have… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Carcinoma of Head and Neck
What is being tested?
Docetaxel and Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteChina
Study dates
4 Mar 2022to 31 Dec 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

Who may be able to join

  • Age ≥ 18 years old and voluntarily signed the informed consent form.
  • Patients with histologically or cytologically confirmed SCCHN (primary tumor located in the oral cavity, oropharynx, larynx or hypopharynx), with positive PD-L1 expression, and who are not suitable for local radical therapy.
  • Patients with platinum-based regimen failure, defined as:
  • . Recurrent or metastatic SCCHN with disease progression during or after platinum-based therapy;
  • . Locally advanced head and neck carcinoma with recurrence or metastasis within 6 months after platinum-based therapy in previous multimodal therapy.
  • Previous or qualified tumor tissue samples are available for testing PD-L1.
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  • Patients with oropharyngeal carcinoma should provide previous HPVp16 immunohistochemical test results, or eligible tumor tissue samples for testing HPV status.
  • At least one measurable lesion confirmed by CT or MRI according to RECISTv1.1 (previously irradiated, progressive disease or tumor persistence ≥ 3 months after radiotherapy can be considered as measurable lesions).
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
  • Life expectancy ≥ 3 months.
  • Main organ function meets the following criteria within 7 days before treatment (no medical supportive treatments such as blood component transfusion, human granulocyte colony-stimulating factor (G-CSF), thrombopoietin (TPO), interleukin-11, and erythropoietin (EPO) within 2 weeks before administration of the investigational product).
  • Absolute neutrophil count ≥1.5×10^9/L Platelets ≥90×10^9/L Hb≥90 g/L or ≥5.6 mmol/L Serum creatinine ≤ 1.5×ULN or creatinine clearance rate ≥ 40 mL/min Total bilirubin ≤1.0×ULN (≤ 1.5 × ULN for patients with liver metastasis or liver cancer); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN ( ≤ 2.5 × ULN for patients with liver metastasis or liver cancer); Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN, International Normalized Ratio (INR) ≤ 1.5×ULN.
  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose of the investigational drug. The patient and his/her spouse must agree to take adequate contraception from signing of ICF through 6 months after last dose, during which time women should be nonlactating and men should refrain from donating sperm.

Who cannot join

  • Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma, SCCHN with unknown primary lesion, salivary gland carcinoma, or non-squamous tissue carcinoma (e.g., mucosal melanoma).
  • Patients with active brain metastasis and leptomeningeal metastasis. Patients with brain metastasis for whom there is no evidence of PD by MRI at least 8 weeks after treatment and within 28 days before the first dose of the investigational drug can be included; Those who do not require systemic cortisol therapy (prednisone > 10 mg/day or equivalent) at least 2 weeks before the first dose of the investigational drug can be included; Patients with skull base lesions without definite evidence of dural or parenchymal brain involvement can be considered to be included only after discussion with the sponsor's medical monitor.
  • History of other malignancies within 5 years prior to the first dose of the investigational drug, except for the following: a. Any other invasive malignancy (for which the patient has received adequate treatment) with disease free status lasting > 3 years, which will not affect the assessment of tumor efficacy as assessed by the investigator; b. Cured basal cell or squamous cell skin carcinoma, superficial bladder cancer, prostate cancer, cervical cancer, or breast cancer in situ, and other locally curable cancers.
  • Patients with known or suspected autoimmune disease within 2 years before the first dose of the investigational drug, except for the following: a. well-controlled type I diabetes; b. well-controlled hypothyroidism requiring only hormone replacement therapy; c. skin diseases (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment; d. patients who are not expected to relapse in the absence of external triggers.
  • Patients with an uncontrollable third space effusion (e.g. pleural effusion, ascites, or pericardial effusion), who, in the judgment of the investigator, are not suitable for the study.
  • Patients with a history of severe cardiovascular disease within 6 months before the first dose of the investigational drug, including but not limited to:
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  • . Severe heart rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention and third-degree atrioventricular block;
  • . History of myocardial infarction, angina pectoris, angioplasty and coronary artery bypass surgery;
  • . Heart failure with New York Heart Association (NYHA) Classification of Class III and above;
  • . Poorly controlled hypertension.
  • Patients with prolonged QT/QTc interval (QTcF > 480 ms, Fridericia's formula: QTcF = QT/RR^0.33, RR = 60/heart rate) by ECG during the screening period and/or with left ventricular ejection fraction (LVEF) ≤ 50% by echocardiography (ECHO) or multi-gated acquisition (MUGA) during the screening period;
  • Patients with positive HCV antibody (+) (patients with negative HCV RNA can be included, and anti-HCV treatment other than interferon is allowed), active hepatitis B (patients with HBV DNA ≤ 500 IU/mL can be included, and anti-HBV treatment other than interferon is allowed), known HIV positive or known acquired immunodeficiency syndrome (AIDS) during the screening period.
  • Patients who have undergone major organ surgery within 4 weeks before the first dose of the investigational drug, or who need to undergo elective surgery during the study.
  • Patients who fail to recover from the toxic responses caused by previous anti-tumor treatment to Grade 1 and below (CTCAE 5.0), except for the following: Grade 2 neuropathy, alopecia, hypothyroidism caused by previous anti-tumor treatment (including hormone replacement therapy) and toxicity without safety risks as judged by the investigator.
  • Patients who have previously received T cell costimulating drugs or drugs acting on immune checkpoint pathways (including PD-1, PD-L1/2, CTLA-4 inhibitors, etc.).
  • Patients who have previously received other immunotherapies and experienced ≥ Grade 3 irAE (immune-related adverse event).
  • Patients who have previously received taxanes (patients who previously received taxane-containing induction chemotherapy and progressed after 6 months can be included).
  • Patients who have received anti-tumor treatments such as chemotherapy, radiotherapy, targeted therapy, immunotherapy and other clinical study drugs within 4 weeks before the first dose of the investigational drug, and other conditions are as follows:
  • Local palliative radiotherapy within 2 weeks before the first dose of the investigational drug; oral fluoropyrimidines, small molecule targeted drugs, etc. within 2 weeks before the first dose of the investigational drug or within known 5 half-lives of the drug (whichever is longer); Traditional Chinese medicines with anti-tumor indications within 2 weeks before the first dose of the investigational drug.
  • Patients who have received corticosteroid (prednisone > 10 mg/day or equivalent) or other immunosuppressive therapies within 2 weeks before the first dose of the investigational drug, except for the following: a. use of topical, ocular, intra-articular, intranasal and inhaled glucocorticoids; b. short-term use of glucocorticoids for prophylaxis (such as prevention of contrast agent allergy).
  • Patients who have received live attenuated vaccine within 2 weeks before the first dose of the investigational drug or planned to receive live attenuated vaccine during the study period.
  • Patients who have used potent inhibitors or inducers of CYP3A4 within 2 weeks before the first dose of the investigational drug.
  • Patients with known ≥ Grade 3 hypersensitivity and/or contraindication to albumin or monoclonal antibodies.
  • Other situations that the investigator considers not suitable for participating in the clinical study, including but not limited to: the patient is complicated by severe or uncontrolled medical conditions, which interfere with the interpretation of study results and affect the study compliance.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Guo Ye

    Shanghai, Shanghai Municipality, 200031

    Guo Ye, Doctor, +86-028-61321610, pattrickguo@gmail.com

    Recruiting

Other trials in China

About this study

Official title: A Single-arm, Multicenter, Phase Ib/II Clinical Study of Docetaxel for Injection (Albumin-bound) in Combination With Nivolumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) Progressing on or After Platinum-based Therapy

This trial is a single-arm, multicenter phase Ib/II clinical study to evaluate the efficacy and safety of Docetaxel for Injection (Albumin-bound) combined with Nivolumab and the pharmacokinetic characteristics of Docetaxel in patients with recurrent or metastatic SCCHN who are positive for PD-L1 expression and have progressed on or after platinum-based therapy.

Read the detailed description

This study will be conducted in two stages (phase Ib and phase II). Phase Ib: To explore the safety and tolerability of Docetaxel for Injection (Albumin-bound) (75 mg/m^2 and 100 mg/m^2) combined with Nivolumab 360 mg. Dose exploration will be started at low dose and proceed in turn.

Phase II: According to the recommended phase II dose (RP2D) determined in the phase Ib study, a phase II study of Docetaxel for Injection (Albumin-bound) combined with Nivolumab will be conducted to observe the efficacy of the combination regimen, with ORR as the primary study endpoint. Simon's optimal 2-stage design will be adopted for phase II study.

All patients in Phase Ib and Phase II will be treated with Docetaxel for Injection (Albumin-bound) combined with Nivolumab until participants meet the criteria for termination or withdrawal criteria, for a maximum of 2 years

Being tested
Docetaxel, Nivolumab
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.

  • DocetaxelDrug

    Docetaxel for Injection (Albumin-bound), Q3W, i.v. 60 min

  • NivolumabDrug

    Nivolumab, Q3W, i.v. 30 min

Study groups in NCT05027204
Study groupRoleWhat they receive
Docetaxel combined with NivolumabExperimentalPhase Ib: The eligible patients with SCCHN will received Docetaxel for Injection (Albumin-bound) 75 mg/m^2 or 100 mg/m^2 sequentially in combination with Nivolumab 360 mg to evaluate safety and efficacy and explore RP2D. Phase II: According to the RP2D determined in the phase Ib study, patients will be treated with Docetaxel for Injection (Albumin-bound) combined with Nivolumab until participants meet the criteria for termination or withdrawal criteria, for a maximum of 2 years.
Receives: Drug: Docetaxel; Drug: Nivolumab

What is being measured

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

  1. Phase Ib: Incidence of adverse events and serious adverse events

    Incidence of adverse events and serious adverse events

    Measured: 6 weeks

  2. Phase II: Objective response rate (ORR)

    Objective response rate

    Measured: 2 years

Secondary outcomes (12)

  1. The pharmacokinetic parameters (free docetaxel and total docetaxel) : AUC0-last

    Area under the plasma concentration versus time curve (AUC)

    Measured: 24 hours

  2. The pharmacokinetic parameters (free docetaxel and total docetaxel) : AUC0-∞

    Area under the plasma concentration versus time curve (AUC)

    Measured: 24 hours

  3. The pharmacokinetic parameters (free docetaxel and total docetaxel) : Cmax

    The Cmax is the maximum observed serum concentration of Docetaxel

    Measured: 24 hours

  4. The pharmacokinetic parameters (free docetaxel and total docetaxel) : Tmax

    The Tmax is the time at which the maximum concentration of Docetaxel

    Measured: 24 hours

  5. The pharmacokinetic parameters (free docetaxel and total docetaxel) : t½

    Terminal elimination half-life (t1/2) of docetaxel

    Measured: 24 hours

  6. The pharmacokinetic parameters (free docetaxel and total docetaxel) : Vd

    Volume of distribtion of docetaxel

    Measured: 24 hours

  7. The pharmacokinetic parameters (free docetaxel and total docetaxel) : CL

    Clearance of Docetaxel

    Measured: 24 hours

  8. Phase II: Disease control rate (DCR)

    Disease control rate

    Measured: 2 years

  9. Phase II: Duration of response (DOR)

    Duration of response

    Measured: 2 years

  10. Phase II: Progression-free survival (PFS)

    Progression-free survival

    Measured: 2 years

  11. Phase II: Overall survival (OS)

    Overall survival

    Measured: 2 years

  12. Phase II: Incidence of adverse events and serious adverse events

    Incidence of adverse events and serious adverse events

    Measured: 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 posted30 Aug 2021
  2. Study start4 Mar 2022
  3. Primary completion31 Oct 2023 (estimated)
  4. Study completion31 Dec 2023 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
94 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05027204
Sponsor's protocol ID
HB1801-CSP-003
Status last verified
Jan 2022
First submitted
19 Aug 2021
Last updated
13 Oct 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 1/2 study testing Docetaxel and Nivolumab in people with Squamous Cell Carcinoma of Head and Neck, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

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 13 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 13 Oct 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 China. 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?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ib: Incidence of adverse events and serious adverse events (time frame: 6 weeks). 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 NCT05027204.

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 13 Oct 2022.

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