Squamous Cell Carcinoma of the Head and NeckPhase 1NCT04659369
Study of Pharmacokinetic, Safety, Immunogenicity and Efficacy of CMAB819 and Nivolumab in R/M HNSCC
A Phase 1 study testing CMAB819 and Nivolumab in people with Squamous Cell Carcinoma of the Head and Neck, run by Taizhou Mabtech Pharmaceutical Co.,Ltd at 1 site in China.
Trial summary
The purpose of this study is to compare the pharmacokinetic, safety, immunogenicity and efficacy of CMAB819 and Nivolumab in subjects with recurrent or metastatic head and neck squamous cell carcinoma., after failure of prior platinum-based chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- CMAB819 and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 24 Sep 2020to 16 Oct 2023
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, Aged ≥18 years and ≤75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
- Life expectancy of at least 3 months.
- Histologically or cytologically confirmed recurrent or metastatic SCCHN (oropharynx, oral cavity, hypopharynx, larynx, etc.), Stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
- Tumor tissue (archival or fresh biopsy specimen wthin 3 years) must be available for PD-L1 expression analysis.
- Subjects must have experienced disease recurrence or progression during or after last dose of platinum therapy for advanced or metastatic disease.
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- (i)Subjects who received adjuvant or neoadjuvant platinum-based chemotherapy (after surgery and/or radiation therapy) and developed recurrent or metastatic disease within 3~6 months of completing therapy are eligible. (ii)Subjects with recurrent disease > 6 months after adjuvant or neoadjuvant platinum-based chemotherapy, who also subsequently progressed during or after a platinum- doublet regimen given to treat the recurrence, are eligible.
- Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria.
- All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to Grade 1 (NCI CTCAE version 5.0) or baseline before administration of study drug. Subjects with toxicities attributed to prior anti-cancer therapy which are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum based therapy, are permitted to enroll.
- Medically accepted effective contraception if procreative potential exists (applicable for both male and female subjects until at least 6 months after the last dose of trial treatment).
- All baseline laboratory requirements will be assessed and should be obtained within -14 days of randomization. Screening laboratory values must meet the following criteria： (i) Blood routine: (a) Neutrophils ≥ 1.5 x 10^9/L；(b) Platelets ≥ 75 x 10^9/L；(c) Hemoglobin ≥ 90 g/L.
- Liver function: (a) AST ≤ 1.5 x ULN (subjects with liver metastasis≤ 5 x ULN); (b) ALT ≤ 1.5 x ULN (subjects with liver metastasis≤ 5 x ULN); (c) Total bilirubin ≤ 1.5 ULN [except subjects with Gilbert Syndrome who must have total bilirubin < 2.5 x ULN（3.0 mg/dL)].
- Renal function: (a) Serum creatinine of ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/minute (using Cockcroft/Gault formula).
- Signed the informed consent form voluntarily.
Who cannot join
- Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal darcinoma, squamous carcinoma of unknown primary, salivary gland carcinoma, or cutaneous squamous cell carcinoma.
- Subjects with active CNS metastases and/or carcinomatous meningitis. Subjects are eligible if CNS metastases are adequately treated and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).
- Subjects with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) within the previous 3 years are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required during the study period.
- Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Subjects with immunodeficiency inculding testing positive for human immunodeficiency virus (HIV) , acquired or congenital immunodeficiency disease, or organ transplantation.
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 （such as ipilimumab）antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
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- Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.
- Subjects with significant cardiovascular or cerebrovascular disease, such as dysrhythmias, conduction block, QTc interval at rest > 480 ms, New York Heart Association cardiac disease Class II or greater, left ventricular ejection fraction (LVEF) <50％, uncontrollable high blood pressures, or the following within 6 months prior to the first dosing: acute coronary syndrome, congestive heart-failure, aoreic dissection, stroke or any other Grade 3 or 4 adverse events of cardia and cerebrovascular disorder.
- Treatment with Radical radiotherapy within 4 weeks prior to randomization; Treatment with palliative radiotherapy and anticancer effects of chinese herbal medicine within 2 weeks prior to randomization.
- Has not recovered from the effects of major surgery or significant traumatic injury within 4 weeks prior to randomization.
- Treatment with any investigational agent or devices within 4 weeks prior to randomization.
- Treatment with any live attenuated vaccine within 4 weeks prior to randomization; Treatment with transfusion, hemopoietin, granulocyte colony-stimulating factor (G-CSF) or granulocyte macrophage-colony stimulating factor within 2 weeks prior to randomization.
- Antitumor therapy except for study treatment are already ongoing or planned.
- Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive/immunoenhanced medications within 2 weeks prior to randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- Positive test for hepatitis B virus surface antigen (HBV sAg) and HBV-DNA ≥1×10^3 copies/mL; Positive test for hepatitis C virus antibody.
- History of allergy or intolerance (unacceptable adverse event) to study drug components, Polysorbate-80-containing infusions or other monoclonal antibodies.
- Subjects with any other serious or uncontrollable medical conditions, active infection, physical examination abnormality, laboratory examination abnormality, altered mental state or mental illness, which is believed by investigator may increase the risk to the subjects or affect the study results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Pharmacokinetic, Safety, Immunogenicity and Efficacy of CMAB819 and Nivolumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
The purpose of this study is to compare the pharmacokinetic, safety, immunogenicity and efficacy of CMAB819 and Nivolumab in subjects with recurrent or metastatic head and neck squamous cell carcinoma., after failure of prior platinum-based chemotherapy.
Read the detailed description
Patients were randomized to receive CMAB819 or Nivolumab 480 mg by intravenous infusion every 4 weeks until documented disease progression, discontinuation, withdrawal of consent, or up to 4 doses in subjects without disease progression, whichever occurs earlier. After completing 4 doses of therapy, administer of CMAB819 480 mg intravenous (IV) solution for injection every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends. Randomization was stratified by Eastern Cooperative Oncology Group (ECOG) performance status ECOG (0 versus 1), sex (male versus female), weight （≤60 kg versus >60kg）and clinical trial institution (up to 20 centers) .
- Being tested
- CMAB819, 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.
CMAB819Drug
for injection only
NivolumabDrug
Also called Opdivo
for injection only
| Study group | Role | What they receive |
|---|---|---|
| CMAB819 | Experimental | CMAB819 480 mg intravenous (IV) solution for Injection every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends. Receives: Drug: CMAB819 |
| Nivolumab | Active comparator | Nivolumab 480 mg intravenous (IV) solution for injection every 4 weeks until documented disease progression, discontinuation, withdrawal of consent, or the study ends or up to 4 doses in subjects without disease progression, whichever occurs earlier. After completing 4 doses of Nivolumab therapy, administer of CMAB819 480 mg intravenous (IV) solution for injection every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends. Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-4w,1
Area under the concentration-time curve (AUC) from time of the first dosing to time of 672 hours after the end of infusion.
Measured: Day 1 to Day 29
Secondary outcomes (13)
Cmax1
Maximum serum concentration from time of the first dosing to time of 672 hours after the end of infusion.
Measured: Day 1 to Day 29.
Cmin1
Minimum serum concentration from time of the first dosing to time of 672 hours after the end of infusion.
Measured: Day 1 to Day 29.
Tmax1
Time to maximum of blood concentration from time of the first dosing to time of 672 hours after the end of infusion.
Measured: Day 1 to Day 29
AUC0-4w,4
Area under the concentration-time curve (AUC) from time of the fourth dosing to time of 672 hours after the end of infusion .
Measured: From time of the fouth dosing to time of 672 hours after the end of infusion.
Cmax4
Maximum serum concentration from time of the fourth dosing to time of 672 hours after the end of infusion.
Measured: From time of the fourth dosing to time of 672 hours after the end of infusion.
Cmin4
Minimum serum concentration from time of the fourth dosing to time of 672 hours after the end of infusion.
Measured: From time of the fourth dosing to time of 672 hours after the end of infusion.
Tmax4
Time to maximum of blood concentration from time of the fourth dosing to time of 672 hours after the end of infusion.
Measured: From time of the fourth dosing to time of 672 hours after the end of infusion.
Adverse event frequencies
Number of Participants With Death, Study Drug-Related Death, Serious Adverse Events (SAEs), Drug-Related AEs, Deaths, Discontinuation of Study Drug Due to AE, and Immune-related AEs (irAEs) in Safety Population
Measured: Date of the first dosing of study drug to 28 days post last dose of study drug.
Incidence of anti-drug antibodies.
Incidence of anti-drug antibodies.
Measured: Date of first doing of study drug to 28 days post last dose of study drug.
Incidence of neutralizing antibody
Incidence of neutralizing antibody
Measured: Date of first dosing of study drug to 28 days post last dose of study drug.
ORR16w
ORR was defined as the proportion of randomized participants who achieved a best response of complete response (CR) or partial response (PR) using the RECIST1.1 criteria as per investigator assessment.
Measured: Randomization to disease progression, study drug is discontinued or 16 weeks after the end of infusion of the first dosing, whichever occurs first
DCR16w
DCR was defined as the proportion of randomized participants who achieved a best response of complete response (CR) , partial response (PR) or stable disease (SD) ≥6 weeks using the RECIST1.1 criteria as per investigator assessment.
Measured: Randomization to disease progression, study drug is discontinued or 16 weeks after the end of infusion of the first dosing, whichever occurs first
PFSR16w
PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator (as per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria), or death due to any cause, whichever occurs first.
Measured: Randomization to disease progression, study drug is discontinued or 16 weeks after the end of infusion of the first dosing, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start24 Sep 2020
- Primary completion16 Oct 2023
- Study completion16 Oct 2023
Why it stopped: Difficult to recruit subjects
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ye Guo, Ph.D, Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659369
- Sponsor's protocol ID
- CMAB819-001
- Status last verified
- May 2023
- First submitted
- 19 Nov 2020
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pharmacokinetic, Safety, Immunogenicity and Efficacy of CMAB819 and Nivolumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT04659369
- Acronym / sponsor ID
- CMAB819-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficult to recruit subjects
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Taizhou Mabtech Pharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 9 Dec 2020 (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.
The purpose of this study is to compare the pharmacokinetic, safety, immunogenicity and efficacy of CMAB819 and Nivolumab in subjects with recurrent or metastatic head and neck squamous cell carcinoma., after failure of prior platinum-based chemotherapy.
Detailed description
Patients were randomized to receive CMAB819 or Nivolumab 480 mg by intravenous infusion every 4 weeks until documented disease progression, discontinuation, withdrawal of consent, or up to 4 doses in subjects without disease progression, whichever occurs earlier. After completing 4 doses of therapy, administer of CMAB819 480 mg intravenous (IV) solution for injection every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends. Randomization was stratified by Eastern Cooperative Oncology Group (ECOG) performance status ECOG (0 versus 1), sex (male versus female), weight （≤60 kg versus >60kg）and clinical trial institution (up to 20 centers) .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CMAB819 | Experimental | Drug: CMAB819CMAB819 480 mg intravenous (IV) solution for Injection every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends. |
| Nivolumab | Active comparator | Drug: NivolumabNivolumab 480 mg intravenous (IV) solution for injection every 4 weeks until documented disease progression, discontinuation, withdrawal of consent, or the study ends or up to 4 doses in subjects without disease progression, whichever occurs earlier. After completing 4 doses of Nivolumab therapy, administer of CMAB819 480 mg intravenous (IV) solution for injection every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Males or females, Aged ≥18 years and ≤75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
- Life expectancy of at least 3 months.
- Histologically or cytologically confirmed recurrent or metastatic SCCHN (oropharynx, oral cavity, hypopharynx, larynx, etc.), Stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
- Tumor tissue (archival or fresh biopsy specimen wthin 3 years) must be available for PD-L1 expression analysis.
Key exclusion criteria (17 listed)
- Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal darcinoma, squamous carcinoma of unknown primary, salivary gland carcinoma, or cutaneous squamous cell carcinoma.
- Subjects with active CNS metastases and/or carcinomatous meningitis. Subjects are eligible if CNS metastases are adequately treated and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).
- Subjects with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) within the previous 3 years are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required during the study period.
- Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Subjects with immunodeficiency inculding testing positive for human immunodeficiency virus (HIV) , acquired or congenital immunodeficiency disease, or organ transplantation.
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 |
|---|---|---|
| CMAB819for injection only | Drug | CMAB819 |
| NivolumabAlso: Opdivofor injection only | Drug | Nivolumab |
Primary outcome
AUC0-4w,1
Time frame: Day 1 to Day 29
Area under the concentration-time curve (AUC) from time of the first dosing to time of 672 hours after the end of infusion.
13 secondary outcomes
Cmax1
Time frame: Day 1 to Day 29.
Cmin1
Time frame: Day 1 to Day 29.
Tmax1
Time frame: Day 1 to Day 29
AUC0-4w,4
Time frame: From time of the fouth dosing to time of 672 hours after the end of infusion.
Cmax4
Time frame: From time of the fourth dosing to time of 672 hours after the end of infusion.
Cmin4
Time frame: From time of the fourth dosing to time of 672 hours after the end of infusion.
Tmax4
Time frame: From time of the fourth dosing to time of 672 hours after the end of infusion.
Adverse event frequencies
Time frame: Date of the first dosing of study drug to 28 days post last dose of study drug.
Incidence of anti-drug antibodies.
Time frame: Date of first doing of study drug to 28 days post last dose of study drug.
Incidence of neutralizing antibody
Time frame: Date of first dosing of study drug to 28 days post last dose of study drug.
ORR16w
Time frame: Randomization to disease progression, study drug is discontinued or 16 weeks after the end of infusion of the first dosing, whichever occurs first
DCR16w
Time frame: Randomization to disease progression, study drug is discontinued or 16 weeks after the end of infusion of the first dosing, whichever occurs first
PFSR16w
Time frame: Randomization to disease progression, study drug is discontinued or 16 weeks after the end of infusion of the first dosing, whichever occurs first.
Results and safety
The study was stopped early (reason given: Difficult to recruit subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
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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.
Ye Guo, Ph.D principal investigator
Shanghai East Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CMAB819 and Nivolumab in people with Squamous Cell Carcinoma of the Head and Neck, run by Taizhou Mabtech Pharmaceutical 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 14 inclusion and 17 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: stopped early, as of the sponsor's last update on 9 Apr 2024. 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 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.
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 stopped early (reason given: Difficult to recruit subjects). Results are not available in the source record.
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?
AUC0-4w,1 (time frame: Day 1 to Day 29). 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 9 Apr 2024.