Squamous Cell Carcinoma of the Head and NeckPhase 3NCT03855384
Study of TQB2450 in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck（R/M SCCHN）
A Phase 3 study testing TQB2450+cisplatin or carboplatin + 5-Fluorouracil (5-FU) in people with Squamous Cell Carcinoma of the Head and Neck, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- TQB2450+cisplatin or carboplatin + 5-Fluorouracil (5-FU)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 334 participants
- Where
- 1 siteChina
- Study dates
- 11 Jun 2019to 30 May 2021
- Phase
- Phase 3
- 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
- Histologically or cytologically confirmed head and neck squamous cell carcinoma ，primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx.
- No indications of local radical therapy for recurrence/metastasis head and neck squamous cell carcinoma.
- At least one measurable lesion（ based on RECIST1.1）.
- Can provide tissue for PD-L1 biomarker analysis: A newly obtained biopsy is preferred but an archival sample is acceptable.
- Tumors express PD-L1,and PD-L1 expression on at least 1% of tumour cells .
- 18 years and older.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Life expectancy of at least 3 months.
- The main organs function are normally, the following criteria are met:
- routine blood tests：hemoglobin（Hb）≥90g/L（no blood transfusion and blood products within 14 days）；absolute neutrophil count（ANC）≥1.5×109/L； platelets（PLT）≥100×109/L.
- Blood biochemical examination: alanine transaminase（ALT）and aspartate aminotransferase（AST）≤2.5×upper limit of normal (ULN)（when the liver is invaded, ALT, and AST ≤5× upper limit of normal (ULN) ）； total bilirubin (TBIL)≤1.5×upper limit of normal (ULN)（Gilbert syndrome patients，≤3×upper limit of normal (ULN)）； calculated creatinine clearance（CrCl）≥60mL/min（Creatinine clearance criteria for subjects treated with cisplatin）or CrCl≥50mL/min（Creatinine clearance criteria for subjects treated with carboplatin）(Application of Standard Cockcroft-Gault Formula).
- Coagulation function: activated partial thromboplastin time (aPTT) 、 international normalized ratio (INR) 、prothrombin time（PT）≤ 1.5×upper limit of normal (ULN).
- left ventricular ejection fraction (LVEF) measured by the Cardiac echocardiography greater than or equal to 50%.
- Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study(Such as intrauterine devices , birth control pills or condoms) ；Not Pregnant or breastfeeding women,Pregnancy before pregnancy screening（Within 7 days before the start of the study）, the women who blood / urine results were positive.
- Understood and signed an informed consent form.
Who cannot join
- Received systemic chemotherapy, but not chemotherapy for locally advanced disease as part of multimodality therapy (this treatment must be completed more than 6 months after informed consent).
- Has progressive disease (PD) within six (6) months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.
- Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody ,or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Patients who have received cetuximab treatment within 6 moths before randomization.
- Diagnosed and/or treated additional malignancy within 5 years prior to randomization with the exception of cured carcinoma in situ of the cervix、intramucosal carcinoma of gastrointestinal tract、breast and non-melanoma skin cancers and superficial bladder tumors.
- Known untreated central nervous system (CNS) metastasis and/or carcinomatous meningitis. 7. Has neuropathy that is ≥ Grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) version 5 criteria.
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- 8. Previously had a severe hypersensitivity reaction to treatment with study drug or has a known sensitivity to any component of drug , including Severe hypersensitivity reaction≥3 grades (NCI CTCAEv5.0 )to monoclonal antibody 、fluorouracil、 carboplatin or cisplatin-related compounds.
- 9. Active autoimmune disease that may worsen with the administration of an immunostimulant. Patients with type 1 diabetes, vitiligo, psoriasis, or hypothyroidism or hyperthyroidism that do not require immunosuppression therapy are excluded.
- 10. Immunosuppressive drugs were used at randomization,except that:
- Intranasal, inhaled, topical steroid or topical steroid injection (e.g. intra-articular injection)
- Physiological doses of systemic corticosteroids (a dose of ≤ 10 mg daily prednisone (or equivalent) )
- Preadministration of steroids for hypersensitivity reactions (e.g., preadministration of CT scans)" 11. Interstitial lung disease or non-contagious pneumonia (including past history and current illness); uncontrolled systemic diseases including diabetes, hypertension,acute lung disease, etc. except for radiotherapy-induced interstitial pneumonitis.
- 12. Has any other active infection requiring systemic therapy,including patients with active tuberculosis.
- 13. Unstable pleural effusion, pericardial effusion or ascites. 14. Significant cardiovascular diseases such as heart failure of New York Heart Academy(NYHA) Class 2 and above, myocardial infarction within the past 3 months, unstable arrhythmias (including QT interval ≥480 ms) or unstable Angina.
- 15. Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history.
- 16. Virological examination of hepatitis B or hepatitis C during screening meets any of the following criteria:
- HBsAg positive and HBV DNA positive (≥1000 copies /mL); b. HCV antibody and HCV-RNA positive(The result is greater than the detection limit of the analytical method).
- 17. Major surgery, or unhealed wounds, ulcers or fractures within 4 weeks before randomization.
- 18.Has received a live-virus vaccination within 4 weeks before randomization ,allowing received seasonal flu vaccines without live viruses.
- 19. Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study intervention.
- 20. Investigator judges that the patient is not eligible to join the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality
Ye Guo, Doctor, 021-38804518, pattrickguo@gmail.com
Ye Guo
About this study
Official title: Multicenter, Randomized, Double-blind, Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of TQB2450 Plus Chemotherapy（Cisplatin or Carboplatin+ 5-Fluorouracil (5-FU) ） Versus Placebo Plus Chemotherapy as First-Line Treatment in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma（R/M SCCHN）
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
- Being tested
- TQB2450+cisplatin or carboplatin + 5-Fluorouracil (5-FU), placebo+cisplatin or carboplatin + 5-Fluorouracil (5-FU)
- 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.
TQB2450+cisplatin or carboplatin + 5-Fluorouracil (5-FU)Drug
TQB2450 1200mg IV ，cisplatin 75 mg/m^2 IV or carboplatin AUC 5 IV on Day 1 of each week in 3-week cycles (6 cycle maximum); plus 5-FU 750 mg/m^2/day IV continuous from Day 1-5 of each 3- week cycle (6 cycle maximum).
placebo+cisplatin or carboplatin + 5-Fluorouracil (5-FU)Drug
placebo 1200mg IV ，cisplatin 75 mg/m^2 IV or carboplatin AUC 5 IV on Day 1 of each week in 3-week cycles (6 cycle maximum); plus 5-FU 750 mg/m^2/day IV continuous from Day 1-5 of each 3- week cycle (6 cycle maximum).
| Study group | Role | What they receive |
|---|---|---|
| TQB2450+cisplatin or carboplatin + 5-Fluorouracil (5-FU) | Experimental | Not described Receives: Drug: TQB2450+cisplatin or carboplatin + 5-Fluorouracil (5-FU) |
| placebo+cisplatin or carboplatin + 5-Fluorouracil (5-FU) | Placebo comparator | Not described Receives: Drug: placebo+cisplatin or carboplatin + 5-Fluorouracil (5-FU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Overall survival
Measured: up to 72 weeks
Secondary outcomes (3)
DOR
Duration of Response
Measured: up to 72 weeks
PFS
Progression-free survival
Measured: up to 24 weeks
DCR
Disease Control Rate
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.
- First posted26 Feb 2019
- Study start11 Jun 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion30 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855384
- Sponsor's protocol ID
- TQB2450-II-03
- Status last verified
- Feb 2019
- First submitted
- 25 Feb 2019
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of TQB2450 Plus Chemotherapy（Cisplatin or Carboplatin+ 5-Fluorouracil (5-FU) ） Versus Placebo Plus Chemotherapy as First-Line Treatment in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma（R/M SCCHN）
- ClinicalTrials.gov ID
- NCT03855384
- Acronym / sponsor ID
- TQB2450-II-03
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQB2450+cisplatin or carboplatin + 5-Fluorouracil (5-FU) | Experimental | Drug: TQB2450+cisplatin or carboplatin + 5-Fluorouracil (5-FU) |
| placebo+cisplatin or carboplatin + 5-Fluorouracil (5-FU) | Placebo comparator | Drug: placebo+cisplatin or carboplatin + 5-Fluorouracil (5-FU) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically or cytologically confirmed head and neck squamous cell carcinoma ，primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx.
- No indications of local radical therapy for recurrence/metastasis head and neck squamous cell carcinoma.
- At least one measurable lesion（ based on RECIST1.1）.
- Can provide tissue for PD-L1 biomarker analysis: A newly obtained biopsy is preferred but an archival sample is acceptable.
- Tumors express PD-L1,and PD-L1 expression on at least 1% of tumour cells .
Key exclusion criteria (21 listed)
- Received systemic chemotherapy, but not chemotherapy for locally advanced disease as part of multimodality therapy (this treatment must be completed more than 6 months after informed consent).
- Has progressive disease (PD) within six (6) months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.
- Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody ,or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Patients who have received cetuximab treatment within 6 moths before randomization.
- Diagnosed and/or treated additional malignancy within 5 years prior to randomization with the exception of cured carcinoma in situ of the cervix、intramucosal carcinoma of gastrointestinal tract、breast and non-melanoma skin cancers and superficial bladder tumors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB2450+cisplatin or carboplatin + 5-Fluorouracil (5-FU)TQB2450 1200mg IV ，cisplatin 75 mg/m^2 IV or carboplatin AUC 5 IV on Day 1 of each week in 3-week cycles (6 cycle maximum); plus 5-FU 750 mg/m^2/day IV continuous from Day 1-5 of each 3- week cycle (6 cycle maximum). | Drug | TQB2450+cisplatin or carboplatin + 5-Fluorouracil (5-FU) |
| placebo+cisplatin or carboplatin + 5-Fluorouracil (5-FU)placebo 1200mg IV ，cisplatin 75 mg/m^2 IV or carboplatin AUC 5 IV on Day 1 of each week in 3-week cycles (6 cycle maximum); plus 5-FU 750 mg/m^2/day IV continuous from Day 1-5 of each 3- week cycle (6 cycle maximum). | Drug | placebo+cisplatin or carboplatin + 5-Fluorouracil (5-FU) |
Primary outcome
OS
Time frame: up to 72 weeks
Overall survival
3 secondary outcomes
DOR
Time frame: up to 72 weeks
PFS
Time frame: up to 24 weeks
DCR
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TQB2450+cisplatin or carboplatin + 5-Fluorouracil (5-FU) in people with Squamous Cell Carcinoma of the Head and Neck, run by Chia Tai Tianqing Pharmaceutical Group 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 15 inclusion and 21 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 30 Oct 2019. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Ye Guo, doctor (021-38804518, pattrickguo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: up to 72 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2019.