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A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy (TdVax)

Primary Purpose

Melanoma

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Tetanus Diptheria Vaccine

Polio Boost Immunization

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically confirmed advanced metastatic melanoma
Male or female participants who are at least 18 years of age on the day of signing informed consent
Participants must be planned or scheduled by their treating physician to receive PD-1 therapy or PD-1 plus anti CTLA-4 therapy as standard of care
Participant (or legally acceptable representative if applicable) provides written informed consent for the trial
Participant must have at least 1 lesion that is at least 8 mm in size and is cutaneous, subcutaneous, palpable, or amenable to ultrasound guided core biopsy. The lesion chosen for biopsy can also be a target lesion but does not have to be a target lesion
Adequate organ function as defined below. Standard of care labs drawn within 45 days prior to consent may be used for the purposes of determining eligibility
1. ANC >/= 1500/uL
2. platelets >/=100,000/uL
3. Hemoglobin >/= 9.0 g/dL

Exclusion Criteria:

Uveal or mucosal melanoma
Any women known to be pregnant or breastfeeding
Any prior systemic therapy for metastatic melanoma (prior surgery is allowed)
Known diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone or equivalent), or any other form of immunosuppressive therapy within 7 days prior to first research biopsy
Patients with symptomatic CNS metastases and/or carcinomatous meningitis
a) Patients with asymptomatic, stable CNS metastases are allowed provided that they are not on >10mg prednisone daily
History of or active (non-infectious) pneumonitis that required steroids
Active infection requiring systemic therapy
Known history of Human Immunodeficiency Virus (HIV) infection
Known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. NOTE: no testing for Hepatitis B or Hepatitis C is required
Known history of active TB (Bacillus Tuberculosis)
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with subject's participation for the full duration of the study, or make it not in the best interest of the subject to participate, in the opinion of the treating physician
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
History of allogenic tissue or solid organ transplant
History of allergic reaction to IPOL or Td vaccine
Receipt of Td vaccine within 30 days prior to starting IO therapy

Sites / Locations

Duke University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Td Vaccine

IPOL Vaccine

Arm Description

The first 15 subjects enrolled will receive the Td (tetanus diphtheria) vaccine at cycle 4 of IO therapy. The Td vaccine is administered as 0.5 mL intramuscular injection in the extremity (thigh or upper arm) in closest proximity to the largest tumor.

Subjects 16 through 25 will receive the IPOL (polio booster) vaccine at cycle 4 of IO therapy. The IPOL vaccine is administered as 0.5 mL intramuscular or subcutaneous injection in the extremity (thigh or upper arm) in closest proximity to the largest tumor

Outcomes

Primary Outcome Measures

Number of subjects out of the proposed 25 that successfully receive the vaccine after 4 cycles of IO therapy

Evaluable patients are defined as those who receive four cycles of IO therapy and then receive a Td or IPOL vaccine

Safety, as measured by the change in the number and severity of adverse events deemed related to the vaccine or study procedures (blood draw and biopsies)

Adverse events will only include those that are determined to be related to the study vaccine or study procedures (blood draw and biopsies)

Secondary Outcome Measures

Preliminary efficacy, as measured by objective response rate

Number of patients that experience tumor response vs. stable disease vs. progression as determined by PI assessment of standard of care scans

Full Information

NCT ID

NCT05077137

First Posted

September 13, 2021

Last Updated

September 8, 2022

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT05077137

Brief Title

A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy

Acronym

TdVax

Official Title

A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 7, 2021 (Actual)

Primary Completion Date

September 1, 2023 (Anticipated)

Study Completion Date

September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine the safety and feasibility of administering the Tetanus Diptheria Vaccine (Td) or Polio Boost Immunization (IPOL) to patients with metastatic melanoma who are receiving immune checkpoint inhibitor (IO) therapy per standard of care. Subjects will have the vaccine at cycle 4 of IO therapy and will have research blood and tissue samples collected prior to starting IO therapy, at cycle 4 prior to vaccine administration, and at 12-17 days post vaccine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Td Vaccine

Arm Type

Experimental

Arm Description

Arm Title

IPOL Vaccine

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Tetanus Diptheria Vaccine

Other Intervention Name(s)

Tenivac

Intervention Description

tetanus and diphtheria toxoids

Intervention Type

Biological

Intervention Name(s)

Polio Boost Immunization

Other Intervention Name(s)

IPOL

Intervention Description

trivalent inactivated polio vaccine

Primary Outcome Measure Information:

Title

Number of subjects out of the proposed 25 that successfully receive the vaccine after 4 cycles of IO therapy

Description

Evaluable patients are defined as those who receive four cycles of IO therapy and then receive a Td or IPOL vaccine

Time Frame

informed consent through date of vaccine (est apx 4-5 months)

Title

Safety, as measured by the change in the number and severity of adverse events deemed related to the vaccine or study procedures (blood draw and biopsies)

Description

Adverse events will only include those that are determined to be related to the study vaccine or study procedures (blood draw and biopsies)

Time Frame

Baseline, cycle 4 of IO therapy (apx 12-16 weeks), 12-17 days post vaccine, SOC scan following vaccine (apx 8-12 weeks post vaccine)

Secondary Outcome Measure Information:

Title

Preliminary efficacy, as measured by objective response rate

Description

Number of patients that experience tumor response vs. stable disease vs. progression as determined by PI assessment of standard of care scans

Time Frame

up to 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed advanced metastatic melanoma Male or female participants who are at least 18 years of age on the day of signing informed consent Participants must be planned or scheduled by their treating physician to receive PD-1 therapy or PD-1 plus anti CTLA-4 therapy as standard of care Participant (or legally acceptable representative if applicable) provides written informed consent for the trial Participant must have at least 1 lesion that is at least 8 mm in size and is cutaneous, subcutaneous, palpable, or amenable to ultrasound guided core biopsy. The lesion chosen for biopsy can also be a target lesion but does not have to be a target lesion Adequate organ function as defined below. Standard of care labs drawn within 45 days prior to consent may be used for the purposes of determining eligibility ANC >/= 1500/uL platelets >/=100,000/uL Hemoglobin >/= 9.0 g/dL Exclusion Criteria: Uveal or mucosal melanoma Any women known to be pregnant or breastfeeding Any prior systemic therapy for metastatic melanoma (prior surgery is allowed) Known diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone or equivalent), or any other form of immunosuppressive therapy within 7 days prior to first research biopsy Patients with symptomatic CNS metastases and/or carcinomatous meningitis a) Patients with asymptomatic, stable CNS metastases are allowed provided that they are not on >10mg prednisone daily History of or active (non-infectious) pneumonitis that required steroids Active infection requiring systemic therapy Known history of Human Immunodeficiency Virus (HIV) infection Known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. NOTE: no testing for Hepatitis B or Hepatitis C is required Known history of active TB (Bacillus Tuberculosis) History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with subject's participation for the full duration of the study, or make it not in the best interest of the subject to participate, in the opinion of the treating physician Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial History of allogenic tissue or solid organ transplant History of allergic reaction to IPOL or Td vaccine Receipt of Td vaccine within 30 days prior to starting IO therapy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Carol Ann Wiggs, BSN

Phone

919-684-0281

carolann.wiggs@duke.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Georgia Beasley, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carol Ann Wiggs, BSN

Phone

919-684-0281

carolann.wiggs@duke.edu

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

IPD will only be used internally by the study team

Learn more about this trial

A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy

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