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

NCT ID: NCT04034225

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-11
• Study Completion Date: 2021-06-28

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SNS-301 added to pembrolizumab

• SNS-301
• Pembrolizumab

Group Type: EXPERIMENTAL

SNS-301

Intervention Type: 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.

Pembrolizumab

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Keytruda

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sensei Biotherapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ramzi Melhem, MD

Role: STUDY_DIRECTOR

Sensei Biotherapeutics

Locations

University of California - San Francisco

San Francisco, California, United States

Christiana Care

Newark, Delaware, United States

Georgetown University

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

Emory University

Atlanta, Georgia, United States

Rush University

Chicago, Illinois, United States

Alliance for Multispeciality Research

Kansas City, Missouri, United States

Mt. Sinai

New York, New York, United States

New Orleans Clinical Research

Knoxville, Tennessee, United States

Clear Lake Specialties

Webster, Texas, United States

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SNS-301-2-2

Identifier Type: -

Identifier Source: org_study_id