Metastatic Head and Neck CancerPhase 2NCT03937141
Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Head and Neck Cancer
A Phase 2 study testing ADU-S100 in people with Metastatic Head and Neck Cancer and Recurrent Head and Neck Cancer, run by Chinook Therapeutics, Inc. (formerly Aduro) at 17 sites in United States.
Trial summary
ADU-CL-20 is an open-label, multicenter Phase 2 clinical trial to evaluate the efficacy and safety of intratumoral ADU-S100 (also referred to as MIW815) administered with pembrolizumab in the first-line setting. The population will consist of adults with PD-L1 positive recurrent or metastatic HNSCC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer
- What is being tested?
- ADU-S100
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 17 sitesUnited States
- Study dates
- 26 Aug 2019to 10 Jun 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 or cytological confirmation of recurrent or metastatic HNSCC
- Measurable disease as defined by RECIST v1.1
- PD-L1 positive
Who cannot join
- Diagnosis of recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary histology; or salivary gland or non-squamous histologies (e.g. mucosal melanoma)
- Disease amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy)
- Prior systemic anti-cancer therapy (use of chemotherapeutic agents, targeted small molecules, immunotherapy, or monoclonal antibodies) for the treatment of recurrent or metastatic HNSCC
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Emory University Hospital
Atlanta, Georgia, 30308
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
MUSC Hollings Cancer Center
Charleston, South Carolina, 29425
Baylor University Medical Center
Dallas, Texas, 75246
Karmanos Cancer Institute
Detroit, Michigan, 48201
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
UC San Diego Moores Cancer Center
La Jolla, California, 92093
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Yale University Cancer Center
New Haven, Connecticut, 06520
University Pittsburgh Medical Center Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Regions Cancer Care Center
Saint Paul, Minnesota, 55101
Washington University School of Medicine
St Louis, Missouri, 63110
Moffitt Cancer Center
Tampa, Florida, 33612
University of Arizona Cancer Center
Tucson, Arizona, 85724
University of Kansas
Westwood, Kansas, 66205
About this study
Official title: A Phase 2 Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Adults With Head and Neck Cancer
ADU-CL-20 is an open-label, multicenter Phase 2 clinical trial to evaluate the efficacy and safety of intratumoral ADU-S100 (also referred to as MIW815) administered with pembrolizumab in the first-line setting. The population will consist of adults with PD-L1 positive recurrent or metastatic HNSCC.
- Being tested
- ADU-S100
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADU-S100Drug
Also called MIW815
intratumoral
| Study group | Role | What they receive |
|---|---|---|
| ADU-S100 and pembrolizumab | Experimental | All eligible subjects will receive intravenous (IV) infusions of pembrolizumab and intratumoral injections of ADU-S100. Receives: Drug: ADU-S100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Clinical Activity by the Objective Response Rate (ORR; Complete Response [CR] and Partial Response [PR]) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
To determine ORR of ADU-S100 in combination with pembrolizumab in subjects with recurrent or metastatic head and neck squamous cell cancer (HNSCC). ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 and as assessed by the investigator.
Measured: Up to 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start26 Aug 2019
- Primary completion10 May 2021
- Study completion10 Jun 2021
Why it stopped: No substantial anti-tumor activity was observed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Head and Neck CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinook Therapeutics, Inc. (formerly Aduro)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937141
- Sponsor's protocol ID
- ADU-CL-20
- Status last verified
- Dec 2021
- First submitted
- 29 Apr 2019
- Last updated
- 3 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Gogoi H, Mansouri S, Jin L. The Age of Cyclic Dinucleotide Vaccine Adjuvants. Vaccines (Basel). 2020 Aug 13;8(3):453. doi: 10.3390/vaccines8030453.
PubMed 32823563
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Adults With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT03937141
- Acronym / sponsor ID
- ADU-CL-20
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No substantial anti-tumor activity was observed.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Chinook Therapeutics, Inc. (formerly Aduro)Industry (pharma, biotech, devices)
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 3 May 2019 (actual)
- Results
- Posted 3 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ADU-CL-20 is an open-label, multicenter Phase 2 clinical trial to evaluate the efficacy and safety of intratumoral ADU-S100 (also referred to as MIW815) administered with pembrolizumab in the first-line setting. The population will consist of adults with PD-L1 positive recurrent or metastatic HNSCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADU-S100 and pembrolizumab | Experimental | Drug: ADU-S100All eligible subjects will receive intravenous (IV) infusions of pembrolizumab and intratumoral injections of ADU-S100. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histological or cytological confirmation of recurrent or metastatic HNSCC
- Measurable disease as defined by RECIST v1.1
- PD-L1 positive
Key exclusion criteria (3 listed)
- Diagnosis of recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary histology; or salivary gland or non-squamous histologies (e.g. mucosal melanoma)
- Disease amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy)
- Prior systemic anti-cancer therapy (use of chemotherapeutic agents, targeted small molecules, immunotherapy, or monoclonal antibodies) for the treatment of recurrent or metastatic HNSCC
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 |
|---|---|---|
| ADU-S100Also: MIW815intratumoral | Drug | ADU-S100 and pembrolizumab |
Primary outcome
Evaluation of Clinical Activity by the Objective Response Rate (ORR; Complete Response [CR] and Partial Response [PR]) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to 25 months
To determine ORR of ADU-S100 in combination with pembrolizumab in subjects with recurrent or metastatic head and neck squamous cell cancer (HNSCC). ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 and as assessed by the investigator.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32823563Gogoi H, Mansouri S, Jin L. The Age of Cyclic Dinucleotide Vaccine Adjuvants. Vaccines (Basel). 2020 Aug 13;8(3):453. doi: 10.3390/vaccines8030453.
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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.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADU-S100 in people with Metastatic Head and Neck Cancer and Recurrent Head and Neck Cancer, run by Chinook Therapeutics, Inc. (formerly Aduro) at 17 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 3 inclusion and 3 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 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 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?
Yes. Results are posted in the registry (first posted 3 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evaluation of Clinical Activity by the Objective Response Rate (ORR; Complete Response [CR] and Partial Response [PR]) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (time frame: Up to 25 months). 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 NCT03937141, which also lists 1 linked publication.
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 3 Jan 2022.