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Trial record 1 of 1 for:    NCT04034225
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Addition of SNS-301 to Checkpoint Inhibitor Treatment in Metastatic/Recurrent SCCHN

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04034225
Recruitment Status : Terminated (Terminated by the sponsor)
First Posted : July 26, 2019
Results First Posted : December 30, 2022
Last Update Posted : March 24, 2023
Sponsor:
Information provided by (Responsible Party):
Sensei Biotherapeutics, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Drug: SNS-301 Drug: Pembrolizumab Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 11, 2019
Actual Primary Completion Date : June 28, 2021
Actual Study Completion Date : June 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SNS-301 added to pembrolizumab
  • SNS-301
  • Pembrolizumab
Drug: SNS-301
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.

Drug: Pembrolizumab
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.
Other Name: Keytruda




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Overall Survival [ Time Frame: 36 months ]
    Overall survival calculated from date of treatment to date of death.


Secondary Outcome Measures :
  1. Antigen-specific Response [ Time Frame: 12 weeks ]
    Measure levels at pretreatment, changes during treatment and at progression or end of study

  2. TCR Sequencing [ Time Frame: 12 weeks ]
    Determine TCR diversity pretreatment, changes during treatment and at progression or end of study

  3. Immune Gene Transcript Profiling [ Time Frame: 12 weeks ]
    Determine gene signature pretreatment, during treatment and at progression

  4. Profiling of Pro-inflammatory/Immunosuppressive Molecules [ Time Frame: 12 weeks ]
    Measure levels at pretreatment, changes during treatment and at progression or end of study


Other Outcome Measures:
  1. Immune Related Expression [ Time Frame: 12 weeks ]
    Determine immune expression pretreatment, changes during treatment and at progression

  2. Tumor Specific Oncoproteins [ Time Frame: 12 weeks ]
    Determine expression pretreatment, during treatment and at progression

  3. ASPH Expression [ Time Frame: 12 weeks ]
    Determine pretreatment expression, changes during treatment and at progression

  4. Cytokine/Chemokine Profiling [ Time Frame: 12 weeks ]
    Determine cytokine/chemokine profile pretreatment, changes during treatment and at progression

  5. ctDNA [ Time Frame: 12 weeks ]
    Determine ctDNA profile pretreatment, changes during treatment and at progression



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent.
  2. Be 18 years of age or older.
  3. 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

    1. Patients currently receiving a checkpoint inhibitor (CPI: anti-PD-1 and anti-PD-L1 agents).
    2. Patients currently receiving a CPI must be considered by Investigator to have the potential to derive clinical benefit from continued treatment with pembrolizumab.
    3. 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.
    4. Patients on other CPI therapy than pembrolizumab must be willing to switch over to pembrolizumab therapy.

    Cohort B: Patients without Previous CPI Therapy

    1. Patients must be checkpoint inhibitor naïve (anti-PD-1 and anti-PD-L1 agents)
    2. 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.
  4. Have measurable disease by RECIST 1.1.
  5. Eastern Cooperative Oncology Group (ECOG) Performance Scale 0-1.
  6. Have a life expectancy of ≥ 3 months.
  7. Be willing to provide a pre-treatment tissue sample (archived or fresh).
  8. Demonstrate adequate organ function: hematological, renal, hepatic, coagulation parameters.
  9. 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.

Exclusion Criteria:

  1. Any approved anti-cancer therapy including chemotherapy, targeted small molecule therapy or radiation therapy within 2 weeks prior to trial Day 0.
  2. Participated on a clinical trial of an investigational agent and/or investigational device within 28 days prior to Day 0.
  3. Uncontrolled tumor-related pain.
  4. Malignancies other than indications open for enrollment within 3 years prior to Day 0.
  5. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
  6. Known hypersensitivity allergy or contraindication to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the PD-1/PD-L1 inhibitor formulation.
  7. Active autoimmune disease that has required systemic treatment in the past 2 years
  8. History or any evidence of interstitial lung disease.
  9. History of HIV. HIV antibody testing recommended per investigator's clinical suspicion.
  10. Active hepatitis B (hepatitis B surface antigen reactive) or active hepatitis C (HCV qualitative RNA detected); testing recommended per investigator's clinical suspicion.
  11. Severe infections within 4 weeks prior to enrollment.
  12. Received therapeutic oral or IV antibiotics within 2 weeks prior to Day 0.
  13. 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.
  14. Prior allogeneic stem cell or solid organ transplant.
  15. Known previous or ongoing, active psychiatric or substance abuse disorders that would interfere with the requirements of the trial.
  16. 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.
  17. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04034225


Locations
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United States, California
University of California - San Francisco
San Francisco, California, United States, 94143
United States, Delaware
Christiana Care
Newark, Delaware, United States, 19713
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20057
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Rush University
Chicago, Illinois, United States, 60612
United States, Missouri
Alliance for Multispeciality Research
Kansas City, Missouri, United States, 64114
United States, New York
Mt. Sinai
New York, New York, United States, 10029
United States, Tennessee
New Orleans Clinical Research
Knoxville, Tennessee, United States, 37920
United States, Texas
Clear Lake Specialties
Webster, Texas, United States, 77598
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
Sensei Biotherapeutics, Inc.
Investigators
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Study Director: Ramzi Melhem, MD Sensei Biotherapeutics
  Study Documents (Full-Text)

Documents provided by Sensei Biotherapeutics, Inc.:
Study Protocol  [PDF] November 6, 2020
Statistical Analysis Plan  [PDF] May 5, 2021

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Responsible Party: Sensei Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04034225    
Other Study ID Numbers: SNS-301-2-2
First Posted: July 26, 2019    Key Record Dates
Results First Posted: December 30, 2022
Last Update Posted: March 24, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Time Frame: Beginning 9 months and ending 36 months following article publication.
Access Criteria: Access will be considered to researchers who provide a methodologically sound proposal. Analysis must achieve the aims outlined in the approved proposal Proposals should be directed to info@senseibio.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 36 months following article publication.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action