Head and Neck CancerPhase 1NCT03818542
A Study to Assess the Effects of Multiple Study Drug Regimens in Subjects With Newly Diagnosed Locally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 1 study testing ABBV-181, ABBV-368 and ABBV-927 in people with Head and Neck Cancer, run by AbbVie at 3 sites in United States.
Trial summary
A study evaluating the safety, pharmacokinetics, and biomarker profiles of multiple study drugs as monotherapy in subjects with newly diagnosed, treatment-naïve locally advanced squamous cell carcinoma of the head and neck who are candidates for surgical resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- ABBV-181, ABBV-368 and ABBV-927
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Jan 2020to 23 Sep 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed stage 3 to 4B squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx who are candidates for surgical resection and are treatment-naïve. Participants must have been determined to be candidates for surgical resection by a multidisciplinary team including a surgeon, a medical oncologist, and a radiation oncologist.
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 and life expectancy of more than 3 months.
- Must consent to provide the tumor tissues for analyses as described in the protocol.
- Must have adequate bone marrow function (without any growth factors or transfusions within 2 weeks prior to the first dose), kidney and liver function, with all laboratory values criteria detailed in the protocol.
Who cannot join
- Has received live vaccine within 28 days prior to the first dose of study drug.
- Has a history of inflammatory bowel disease, a history of or ongoing pneumonitis or interstitial lung disease, had major surgery ≤ 28 days prior to the first dose of study drug and the surgical wound is not fully healed.
- Participants with hypopharyngeal or laryngeal tumors will not be candidates for Arm 4 of the study (IT injection of ABBV-927).
- Requires use of an immunosuppressive medication within 14 days prior to the first dose of the study drug; exceptions are described in the protocol.
- Has a confirmed positive test results for human immunodeficiency virus, or have active hepatitis A, B or C.
- Has a history of primary immunodeficiency, allogeneic bone marrow transplantation, solid organ transplantation, or previous clinical diagnosis of tuberculosis.
- Has a history of any other malignancy within the past 3 years except for successfully treated non-melanoma skin cancer or localized carcinoma in situ that is considered cured or adequately treated by the investigator.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan /ID# 210181
Ann Arbor, Michigan, 48109-5000
Massachusetts General Hospital /ID# 207392
Boston, Massachusetts, 02114
MD Anderson Cancer Center /ID# 208749
Houston, Texas, 77030
About this study
Official title: A Phase 1b Multi-Center Pharmacodynamic Study to Assess the Effects of Multiple Study Drug Regimens in Subjects With Newly Diagnosed Locally Advanced Head and Neck Squamous Cell Carcinoma
A study evaluating the safety, pharmacokinetics, and biomarker profiles of multiple study drugs as monotherapy in subjects with newly diagnosed, treatment-naïve locally advanced squamous cell carcinoma of the head and neck who are candidates for surgical resection.
- Conditions
- Head and Neck Cancer
- Being tested
- ABBV-181, ABBV-368, ABBV-927
- Keywords
- Head and Neck Squamous Cell Carcinoma, Cancer, ABBV-927, ABBV-368, ABBV-181, tumor resection, immunotherapeutic drug
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-181Drug
intravenous infusion
ABBV-368Drug
intravenous infusion
ABBV-927Drug
intravenous infusion
ABBV-927Drug
intratumoral injection
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: ABBV-181 IV | Experimental | A single dose of ABBV-181 administered via intravenous (IV) infusion on Day 1. Receives: Drug: ABBV-181 |
| Arm 2: ABBV-368 IV | Experimental | A single dose of ABBV-368 administered via intravenous (IV) infusion on Day 1. Receives: Drug: ABBV-368 |
| Arm 3: ABBV-927 IV | Experimental | A single dose of ABBV-927 administered via intravenous (IV) infusion on Day 1. Receives: Drug: ABBV-927 |
| Arm 4: ABBV-927 IT | Experimental | A single dose of ABBV-927 administered via intratumoral (IT) injection on Day 1. Receives: Drug: ABBV-927 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Gene Expression
The primary biomarker endpoint is to assess immune activation gene changes in the tumor microenvironment associated with T cell infiltration and activation, comparing baseline biopsy to surgical resection following drug treatment.
Measured: Baseline (before initiation of drug treatment) and after surgical resection (up to 120 days after study drug administration)
Secondary outcomes (3)
Maximum Serum Concentration (Cmax) of Study Drug
Maximum Serum Concentration (Cmax) of study drug
Measured: Up to approximately 120 days
Time to Maximum Plasma Concentration (Tmax) of Study Drug
Time to Maximum Plasma Concentration (Tmax) of study drug
Measured: Up to approximately 120 days
Area Under the Plasma Concentration-time Curve of Study Drug in Plasma
Area Under the Plasma Concentration-time Curve (AUC) of study drug in plasma
Measured: Up to approximately 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start22 Jan 2020
- Primary completion23 Sep 2020
- Study completion23 Sep 2020
Why it stopped: Strategic considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by AbbVieThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818542
- Sponsor's protocol ID
- M19-228
- Status last verified
- Dec 2020
- First submitted
- 24 Jan 2019
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Multi-Center Pharmacodynamic Study to Assess the Effects of Multiple Study Drug Regimens in Subjects With Newly Diagnosed Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03818542
- Acronym / sponsor ID
- M19-228
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Squamous Cell Carcinoma, Cancer, ABBV-927, ABBV-368, ABBV-181, tumor resection, immunotherapeutic drug
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic considerations
- Enrolment
- 3 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 23 Sep 2020 (actual)
- Study completion
- 23 Sep 2020 (actual)
- First posted
- 28 Jan 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.
A study evaluating the safety, pharmacokinetics, and biomarker profiles of multiple study drugs as monotherapy in subjects with newly diagnosed, treatment-naïve locally advanced squamous cell carcinoma of the head and neck who are candidates for surgical resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: ABBV-181 IV | Experimental | Drug: ABBV-181A single dose of ABBV-181 administered via intravenous (IV) infusion on Day 1. |
| Arm 2: ABBV-368 IV | Experimental | Drug: ABBV-368A single dose of ABBV-368 administered via intravenous (IV) infusion on Day 1. |
| Arm 3: ABBV-927 IV | Experimental | Drug: ABBV-927A single dose of ABBV-927 administered via intravenous (IV) infusion on Day 1. |
| Arm 4: ABBV-927 IT | Experimental | Drug: ABBV-927A single dose of ABBV-927 administered via intratumoral (IT) injection on Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Newly diagnosed stage 3 to 4B squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx who are candidates for surgical resection and are treatment-naïve. Participants must have been determined to be candidates for surgical resection by a multidisciplinary team including a surgeon, a medical oncologist, and a radiation oncologist.
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 and life expectancy of more than 3 months.
- Must consent to provide the tumor tissues for analyses as described in the protocol.
- Must have adequate bone marrow function (without any growth factors or transfusions within 2 weeks prior to the first dose), kidney and liver function, with all laboratory values criteria detailed in the protocol.
Key exclusion criteria (7 listed)
- Has received live vaccine within 28 days prior to the first dose of study drug.
- Has a history of inflammatory bowel disease, a history of or ongoing pneumonitis or interstitial lung disease, had major surgery ≤ 28 days prior to the first dose of study drug and the surgical wound is not fully healed.
- Participants with hypopharyngeal or laryngeal tumors will not be candidates for Arm 4 of the study (IT injection of ABBV-927).
- Requires use of an immunosuppressive medication within 14 days prior to the first dose of the study drug; exceptions are described in the protocol.
- Has a confirmed positive test results for human immunodeficiency virus, or have active hepatitis A, B or C.
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 |
|---|---|---|
| ABBV-181intravenous infusion | Drug | Arm 1: ABBV-181 IV |
| ABBV-368intravenous infusion | Drug | Arm 2: ABBV-368 IV |
| ABBV-927intravenous infusion | Drug | Arm 3: ABBV-927 IV |
| ABBV-927intratumoral injection | Drug | Arm 4: ABBV-927 IT |
Primary outcome
Changes in Gene Expression
Time frame: Baseline (before initiation of drug treatment) and after surgical resection (up to 120 days after study drug administration)
The primary biomarker endpoint is to assess immune activation gene changes in the tumor microenvironment associated with T cell infiltration and activation, comparing baseline biopsy to surgical resection following drug treatment.
3 secondary outcomes
Maximum Serum Concentration (Cmax) of Study Drug
Time frame: Up to approximately 120 days
Time to Maximum Plasma Concentration (Tmax) of Study Drug
Time frame: Up to approximately 120 days
Area Under the Plasma Concentration-time Curve of Study Drug in Plasma
Time frame: Up to approximately 120 days
Results and safety
The study was stopped early (reason given: Strategic considerations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Individual participant dataSharing planned: No
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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.
AbbVie Inc. study director
AbbVie
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-181, ABBV-368 and ABBV-927 in people with Head and Neck Cancer, run by AbbVie at 3 sites 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 4 inclusion and 7 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 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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: Strategic considerations). 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?
Changes in Gene Expression (time frame: Baseline (before initiation of drug treatment) and after surgical resection (up to 120 days after study drug administration)). 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 31 Dec 2020.