Squamous Cell Carcinoma of the Head and NeckPhase 1/2NCT04034225

Addition of SNS-301 to Checkpoint Inhibitor Treatment in Metastatic/Recurrent SCCHN

A Phase 1/2 study testing SNS-301 and Pembrolizumab in people with Squamous Cell Carcinoma of the Head and Neck, run by Sensei Biotherapeutics, Inc. at 10 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

To evaluate safety, immunogenicity and anti-tumor responses of intradermally delivered SNS-301 added to checkpoint inhibitor therapy in locally advanced unresectable or metastatic/recurrent squamous cell carcinoma of the head and neck (SCCHN) patients. 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?: SNS-301 and Pembrolizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 10 sitesUnited States
Study dates: 11 Nov 2019to 28 Jun 2021
Phase: Phase 1/2
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

Signed informed consent.
Be 18 years of age or older.
Have histologically or cytologically documented locally advanced unresectable or metastatic/recurrent SCCHN and meet the criteria of either Cohort A or B.
Cohort A: Patients with Ongoing CPI Therapy
Patients currently receiving a checkpoint inhibitor (CPI: anti-PD-1 and anti-PD-L1 agents).
Patients currently receiving a CPI must be considered by Investigator to have the potential to derive clinical benefit from continued treatment with pembrolizumab.

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Based on RECIST 1.1/iRECIST criteria on current CPI treatment (prior to initiation of this study), patients must have a best response of stable disease (SD) or first evidence of progressive disease (PD) after a minimum of 12 weeks of a CPI.
Patients on other CPI therapy than pembrolizumab must be willing to switch over to pembrolizumab therapy.
Cohort B: Patients without Previous CPI Therapy
Patients must be checkpoint inhibitor naïve (anti-PD-1 and anti-PD-L1 agents)
Patients should receive study treatment as first line (PD-L1 positive) or as second line (PD-L1 negative) systemic therapy in the advanced/metastatic setting.
Have measurable disease by RECIST 1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Scale 0-1.
Have a life expectancy of ≥ 3 months.
Be willing to provide a pre-treatment tissue sample (archived or fresh).
Demonstrate adequate organ function: hematological, renal, hepatic, coagulation parameters.
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use two highly effective contraceptive methods during the treatment period and for at least 180 days after the last dose of study treatment. For male patients: Agree that during the period specified above, men will not father a child. Male patients must remain abstinent, must be surgically sterile during the treatment period and for at least 180 days after the last dose of study treatment.

Who cannot join

Any approved anti-cancer therapy including chemotherapy, targeted small molecule therapy or radiation therapy within 2 weeks prior to trial Day 0.
Participated on a clinical trial of an investigational agent and/or investigational device within 28 days prior to Day 0.
Uncontrolled tumor-related pain.
Malignancies other than indications open for enrollment within 3 years prior to Day 0.
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
Known hypersensitivity allergy or contraindication to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the PD-1/PD-L1 inhibitor formulation.

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Active autoimmune disease that has required systemic treatment in the past 2 years
History or any evidence of interstitial lung disease.
History of HIV. HIV antibody testing recommended per investigator's clinical suspicion.
Active hepatitis B (hepatitis B surface antigen reactive) or active hepatitis C (HCV qualitative RNA detected); testing recommended per investigator's clinical suspicion.
Severe infections within 4 weeks prior to enrollment.
Received therapeutic oral or IV antibiotics within 2 weeks prior to Day 0.
History or current evidence of any condition, therapy or laboratory abnormality that in the opinion of the treating investigator might confound the results of the trial.
Prior allogeneic stem cell or solid organ transplant.
Known previous or ongoing, active psychiatric or substance abuse disorders that would interfere with the requirements of the trial.
Treatment with systemic immunomodulating agents (including but not limited to IFNs, IL-2, ipilimumab) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to first dose.
Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Emory University
Atlanta, Georgia, 30322
Rush University
Chicago, Illinois, 60612
Alliance for Multispeciality Research
Kansas City, Missouri, 64114
New Orleans Clinical Research
Knoxville, Tennessee, 37920
University of Wisconsin
Madison, Wisconsin, 53715
Mt. Sinai
New York, New York, 10029
Christiana Care
Newark, Delaware, 19713
University of California - San Francisco
San Francisco, California, 94143
Georgetown University
Washington D.C., District of Columbia, 20057
Clear Lake Specialties
Webster, Texas, 77598

Other trials in United States

About this study

Official title: An Open-Label, Multi-Center Trial of SNS-301 Added to Pembrolizumab in Patients With Locally Advanced Unresectable or Metastatic/Recurrent Squamous Cell Carcinoma of the Head and Neck

Read the detailed description

This is a Phase 1/2, open-label, multi-center trial to evaluate the safety, immunogenicity and preliminary clinical efficacy of SNS-301 delivered intradermally in addition to pembrolizumab in patients with locally advanced unresectable or metastatic/recurrent SCCHN. The trial population consists of patients with locally advanced unresectable or metastatic/recurrent SCCHN who are currently receiving checkpoint inhibitor (CPI) therapy (Cohort A) or are naïve to CPI therapy (Cohort B). Patients who are currently receiving CPI therapy must have a best response of stable disease (SD) or first evidence of progressive disease (PD) after a minimum of 12 weeks of treatment with a CPI. Patients receiving a CPI other than pembrolizumab will be switched over to pembrolizumab at the time of entering this study. Patients receiving pembrolizumab in the first line setting must be PD-L1 positive.

Conditions: Squamous Cell Carcinoma of the Head and Neck
Being tested: SNS-301, Pembrolizumab
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.

SNS-301Drug
Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months.
PembrolizumabDrug
Also called Keytruda
Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months.

Study groups in NCT04034225
Study group	Role	What they receive
SNS-301 added to pembrolizumab	Experimental	* SNS-301 * Pembrolizumab Receives: Drug: SNS-301; Drug: Pembrolizumab

What is being measured

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

Number of Participants With Adverse Events of SNS-301 in Addition to Pembrolizumab
Number of adverse events including adverse events of special interest as assessed by CTCAE v5.0
Measured: 12 weeks
Objective Response Rate by RECIST and iRECIST
Objective response rate based on best objective response during the study. Objective tumor response definitions included: Complete response (CR): Disappearance of all target lesions, Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters, Progressive disease (PD): At least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study.
Measured: 12 weeks
Duration of Response by RECIST 1.1 and iRECIST
Duration of response calculated from date of first response to date of progression. Objective tumor response definitions included: Complete response (CR): Disappearance of all target lesions, Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters, Progressive disease (PD): At least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study.
Measured: 12 weeks
Disease Control Rate by RECIST 1.1 and iRECIST
Disease control rate calculated as the proportion of patients with stable disease or better. Objective tumor response definitions included: Complete response (CR): Disappearance of all target lesions, Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters, Progressive disease (PD): At least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study.
Measured: 12 weeks
Progression Free Survival by RECIST 1.1 and iRECIST
Progression free survival calculated from the date of start of treatment to date of progression. Objective tumor response definitions included: Complete response (CR): Disappearance of all target lesions, Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters, Progressive disease (PD): At least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study.
Measured: 12 weeks
Overall Survival
Overall survival calculated from date of treatment to date of death.
Measured: 36 months

Secondary outcomes (4)

Antigen-specific Response
Measure levels at pretreatment, changes during treatment and at progression or end of study
Measured: 12 weeks
TCR Sequencing
Determine TCR diversity pretreatment, changes during treatment and at progression or end of study
Measured: 12 weeks
Immune Gene Transcript Profiling
Determine gene signature pretreatment, during treatment and at progression
Measured: 12 weeks
Profiling of Pro-inflammatory/Immunosuppressive Molecules
Measure levels at pretreatment, changes during treatment and at progression or end of study
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Nov 201928 Jun 2021

First posted26 Jul 2019
Study start11 Nov 2019
Primary completion28 Jun 2021
Study completion28 Jun 2021

Why it stopped: Terminated by the sponsor

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.
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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Open label
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04034225
Sponsor's protocol ID: SNS-301-2-2
Status last verified: Mar 2023
First submitted: 16 Jul 2019
Last updated: 24 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data that underline the results reported in the article, after deidentification (text, tables, figures and appendices) will be shared to researchers who have provide a methodologically sound proposal and sign a data access agreement.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma

All Squamous Cell Carcinoma of the Head and Neck trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multi-Center Trial of SNS-301 Added to Pembrolizumab in Patients With Locally Advanced Unresectable or Metastatic/Recurrent Squamous Cell Carcinoma of the Head and Neck
ClinicalTrials.gov ID: NCT04034225
Acronym / sponsor ID: SNS-301-2-2
Conditions: Squamous Cell Carcinoma of the Head and Neck
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated by the sponsor
Enrolment: 25 participants (actual)
Lead sponsor: Sensei Biotherapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 11 Nov 2019 (actual)
Primary completion: 28 Jun 2021 (actual)
Study completion: 28 Jun 2021 (actual)
First posted: 26 Jul 2019 (actual)
Results: Posted 30 Dec 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Open label

Arm	Type	Receives
SNS-301 added to pembrolizumab	Experimental	Drug: SNS-301, Drug: Pembrolizumab* SNS-301 * Pembrolizumab

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Signed informed consent.
Be 18 years of age or older.
Have histologically or cytologically documented locally advanced unresectable or metastatic/recurrent SCCHN and meet the criteria of either Cohort A or B.
Cohort A: Patients with Ongoing CPI Therapy
Cohort B: Patients without Previous CPI Therapy

Key exclusion criteria (17 listed)

Any approved anti-cancer therapy including chemotherapy, targeted small molecule therapy or radiation therapy within 2 weeks prior to trial Day 0.
Participated on a clinical trial of an investigational agent and/or investigational device within 28 days prior to Day 0.
Uncontrolled tumor-related pain.
Malignancies other than indications open for enrollment within 3 years prior to Day 0.
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.

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
SNS-301Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months.	Drug	SNS-301 added to pembrolizumab
PembrolizumabAlso: KeytrudaPembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months.	Drug	SNS-301 added to pembrolizumab

Primary outcome

Number of Participants With Adverse Events of SNS-301 in Addition to Pembrolizumab
Time frame: 12 weeks
Number of adverse events including adverse events of special interest as assessed by CTCAE v5.0
Objective Response Rate by RECIST and iRECIST
Time frame: 12 weeks
Objective response rate based on best objective response during the study. Objective tumor response definitions included: Complete response (CR): Disappearance of all target lesions, Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters, Progressive disease (PD): At least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study.
Duration of Response by RECIST 1.1 and iRECIST
Time frame: 12 weeks
Duration of response calculated from date of first response to date of progression. Objective tumor response definitions included: Complete response (CR): Disappearance of all target lesions, Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters, Progressive disease (PD): At least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study.
Disease Control Rate by RECIST 1.1 and iRECIST
Time frame: 12 weeks
Disease control rate calculated as the proportion of patients with stable disease or better. Objective tumor response definitions included: Complete response (CR): Disappearance of all target lesions, Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters, Progressive disease (PD): At least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study.
Progression Free Survival by RECIST 1.1 and iRECIST
Time frame: 12 weeks
Progression free survival calculated from the date of start of treatment to date of progression. Objective tumor response definitions included: Complete response (CR): Disappearance of all target lesions, Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters, Progressive disease (PD): At least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study.
Overall Survival
Time frame: 36 months
Overall survival calculated from date of treatment to date of death.

4 secondary outcomes

Antigen-specific Response
Time frame: 12 weeks
TCR Sequencing
Time frame: 12 weeks
Immune Gene Transcript Profiling
Time frame: 12 weeks
Profiling of Pro-inflammatory/Immunosuppressive Molecules
Time frame: 12 weeks

Results and safety

Results posted to the registry on 30 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SNS-301 Added to Pembrolizumab	25	0

Primary outcome: Number of Participants With Adverse Events of SNS-301 in Addition to Pembrolizumab

Time frame: 12 weeks. Count of participants. Unit: Participants

Measure	SNS-301 Added to Pembrolizumab in Participants on a CPI >12 Weeks With a BOR SD/uPD n = 21	SNS-301 Added to Pembrolizumab in Participants CPI Naive/ First Line Systemic Therapy n = 4
Value	16	3

Primary outcome: Objective Response Rate by RECIST and iRECIST

Time frame: 12 weeks. Count of participants. Unit: Participants

Measure	SNS-301 Added to Pembrolizumab in Participants on a CPI >12 Weeks With a BOR SD/uPD n = 18	SNS-301 Added to Pembrolizumab in Participants CPI Naive/ First Line Systemic Therapy n = 1
Partial Response	1	0
Stable Disease	8	1
Progressive Disease	9	0

Primary outcome: Duration of Response by RECIST 1.1 and iRECIST

Time frame: 12 weeks. Median (95% Confidence Interval). Unit: weeks

Measure	SNS-301 Added to Pembrolizumab in Participants on a CPI >12 Weeks With a BOR SD/uPD n = 18	SNS-301 Added to Pembrolizumab in Participants CPI Naive/ First Line Systemic Therapy n = 1
Value	48.3 (NA to NA)	0 (NA to NA)

Population analysed: A total of 18 patients were evaluable in patients who had previous pembrolizumab group and 1 patient was evaluable in the CPI naive group. One patient had a partial response with a DOR of 48.3 weeks. All other patients had stable disease or has progressive disease at the 12 week timeframe.

Primary outcome: Disease Control Rate by RECIST 1.1 and iRECIST

Time frame: 12 weeks. Number. Unit: participants

Measure	SNS-301 Added to Pembrolizumab in Participants on a CPI >12 Weeks With a BOR SD/uPD n = 18	SNS-301 Added to Pembrolizumab in Participants CPI Naive/ First Line Systemic Therapy n = 1
Value	9	1

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SNS-301 Added to Pembrolizumab in Participants on a CPI >12 Weeks With a BOR SD/uPD	5 of 21 (23.8%)	16 of 21 (76.2%)	3 of 21
SNS-301 Added to Pembrolizumab in Participants CPI Naive/ First Line Systemic Therapy	1 of 4 (25%)	2 of 4 (50%)	0 of 4

Limitations and caveats (from the sponsor): The study stopped prematurely for lack of efficacy 25 patients were enrolled. Lab analyzes were not performed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Individual participant data that underline the results reported in the article, after deidentification (text, tables, figures and appendices) will be shared to researchers who have provide a methodologically sound proposal and sign a data access agreement.

Related trials for Squamous Cell Carcinoma of the Head and Neck

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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.

Ramzi Melhem, MD study director

Sensei Biotherapeutics

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SNS-301 and Pembrolizumab in people with Squamous Cell Carcinoma of the Head and Neck, run by Sensei Biotherapeutics, Inc. at 10 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 17 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 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 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?

Yes. Results are posted in the registry (first posted 30 Dec 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?

Number of Participants With Adverse Events of SNS-301 in Addition to Pembrolizumab (time frame: 12 weeks). The study lists 6 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 NCT04034225.

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 24 Mar 2023.