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

NCT04034225 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: SNS-301-2-2
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 10

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.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Outcome Measures

Primary Outcomes (6)

• 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

  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.

  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.

  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.

  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.

  12 weeks

• Overall Survival

  Overall survival calculated from date of treatment to date of death.

  36 months

Secondary Outcomes (4)

• Antigen-specific Response

  12 weeks

• TCR Sequencing

  12 weeks

• Immune Gene Transcript Profiling

  12 weeks

• Profiling of Pro-inflammatory/Immunosuppressive Molecules

  12 weeks

Other Outcomes (5)

• Immune Related Expression

  12 weeks

• Tumor Specific Oncoproteins

  12 weeks

• ASPH Expression

  12 weeks

Study Arms (1)

SNS-301 added to pembrolizumab

EXPERIMENTAL

* SNS-301 * Pembrolizumab

Drug: SNS-301; Drug: Pembrolizumab

Interventions

SNS-301 DRUG

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.

SNS-301 added to pembrolizumab

Pembrolizumab DRUG

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.

Also known as: Keytruda

SNS-301 added to pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sensei Biotherapeutics, Inc.: lead

Study Sites (10)

University of California - San Francisco

San Francisco, California, 94143, United States

Location

Christiana Care

Newark, Delaware, 19713, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Rush University

Chicago, Illinois, 60612, United States

Location

Alliance for Multispeciality Research

Kansas City, Missouri, 64114, United States

Location

Mt. Sinai

New York, New York, 10029, United States

Location

New Orleans Clinical Research

Knoxville, Tennessee, 37920, United States

Location

Clear Lake Specialties

Webster, Texas, 77598, United States

Location

University of Wisconsin

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Limitations and Caveats

The study stopped prematurely for lack of efficacy 25 patients were enrolled. Lab analyzes were not performed.

Results Point of Contact

• Title: Alice Drumheller
• Organization: Sensei Bio

adrumheller@senseibio.com

2404548027

Study Officials

• Ramzi Melhem, MD

  Sensei Biotherapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 26, 2019
• Study Start: November 11, 2019
• Primary Completion: June 28, 2021
• Study Completion: June 28, 2021
• Last Updated: March 24, 2023
• Results First Posted: December 30, 2022

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (10)