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Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC

Primary Purpose

Non-Small Cell Lung Cancer, Triple-negative Breast Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-06936308
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

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

Inclusion Criteria:

Part 1:Histological or cytological diagnosis of non-small cell lung cancer or triple-negative breast cancer. Adequate bone marrow, renal and liver function.

Part 2: Histological or cytological diagnosis of metastatic non-small cell lung cancer previously treated with 1 or 2 regimens in metastatic setting including a CPI and platinum-based chemotherapy. Adequate bone marrow, renal and liver function.

Exclusion Criteria:

  • Known symptomatic brain metastases
  • ECOG performance status greater than or equal to 2
  • Concurrent immunotherapy
  • History of or active autoimmune disorders (including but not limited to: myasthenia gravis, thyroiditis, pneumonitis, rheumatoid arthritis, multiple sclerosis, systemic lupus, erythematosus, scleroderma) and other conditions that disorganize or alter the immune system.
  • History of inflammatory bowel disease.
  • Current use of any implanted electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators.
  • Presence of any surgical or traumatic metal implants at the site of administration

Sites / Locations

  • UCSD Medical Center - Encinitas
  • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Hospital)
  • UC San Diego Perlman Medical Offices
  • UC San Diego Moores Cancer Center
  • Ronald Reagan UCLA Medical Center
  • UCLA Hematology/Oncology
  • UC San Diego Medical Center - Hillcrest
  • UCLA Hematology/Oncology - Parkside
  • UCLA Hematology/Oncology - Santa Monica
  • UCSD Medical Center - Vista
  • H Lee Moffitt Cancer Center & Research Institute Inc
  • The University of Chicago Medical Center, CCD - Investigational Drug Service Pharmacy
  • University of Chicago Medical Center
  • University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
  • Orland Park - University of Chicago Center for Advanced Care
  • Horizon Oncology Research, LLC
  • InnerVision Advanced Medical Imaging
  • The University of Kansas Cancer Center, Investigational Drug Services
  • The University of Kansas Clinical Research Center
  • The University of Kansas Cancer Center
  • Norton Cancer Institute Downtown
  • Norton Cancer Institute Pharmacy, Downtown Pharmacy
  • Norton Hospital
  • Siteman Cancer Center - West County
  • Barnes-Jewish Hospital
  • Washington University Infusion Center Pharmacy
  • Washington University School of Medicine
  • Siteman Cancer Center - South County
  • Siteman Cancer Center - St. Peters
  • Tennessee Oncology, PLLC
  • The Sarah Cannon Research Institute
  • University of Utah, Huntsman Cancer Hospital
  • University of Utah, Huntsman Cancer Institute
  • University of Washington Medical Center - Translational Research Unit (TRU)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dose escalation (Part 1)

Dose Expansion (Part 2)

Arm Description

Participants with NSCLC or TNBC were enrolled at escalating dose levels s of the VBIR-2 regimen.

Participants with metastatic NSCLC will be enrolled at the expansion dose level identified during Part 1 of the study.

Outcomes

Primary Outcome Measures

To evaluate Clinical Benefit Rate (CBR)
Proportion of participants who achieve complete response, partial response or stable disease for more than 6 months at 12, 24 and 36 months using RECIST 1.1. criteria.
Incidence and grade of treatment-emergent adverse events including DLTs
DLTs in order to determine the maximum tolerated dose

Secondary Outcome Measures

Tremelimumab and sasanlimab single dose PK parameter (Cmax)
Maximum observed plasma concentration of tremelimumab and sasanlimab (Cmax).
Tremelimumab and sasanlimab single dose PK parameter (Tmax)
Time to maximum concentration of tremelimumab and sasanlimab (Tmax)
Tremelimumab and sasanlimab single dose PK parameter AUC
Area under the curve from time zero extrapolated to infinity of tremelimumab and sasanlimab
Tremelimumab and sasanlimab after multiple doses PK parameter (Ctrough)
Trough concentration after multiple doses of tremelimumab and sasanlimab (Ctrough)
Anti drug antibody (ADA) response of tremelimumab and sasanlimab after SC administration with the other components.
Incidence and titers of anti-drug antibodies against tremelimumab and sasanlimab
Objective response rate using RECIST 1.1
Proportion of participants who achieve complete response or partial response.
Duration of response using RECIST 1.1
Median time from first response (complete or partial) until disease progression for up to 3 years in responders.
Progression-free survival using RECIST 1.1
Kaplan-Meier curve for progression up to 3 years.

Full Information

First Posted
August 29, 2018
Last Updated
April 29, 2022
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03674827
Brief Title
Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC
Official Title
A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of a Vaccine-based Immunotherapy Regimen-2 (VBIR-2) (PF-06936308) for Advanced Non-small Cell Lung Cancer and Metastatic Triple-negative Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to the review of the asset (VBIR-2) within the Sponsor's oncology portfolio; the study was not terminated because of safety concerns.
Study Start Date
November 27, 2018 (Actual)
Primary Completion Date
September 27, 2021 (Actual)
Study Completion Date
September 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Part 1of the study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of increasing doses of a vaccine-based immunotherapy regimen (VBIR-2) for patients with advanced or metastatic non-small cell lung cancer and metastatic triple-negative breast cancer. Part 2 will evaluate the safety, pharmacokinetics and pharmacodynamics, immunogenicity and preliminary evidence of efficacy of the Expansion dose of VBIR-2 in participants with advanced or metastatic non-small cell lung cancer.
Detailed Description
The study is divided into two parts, Dose Escalation (Part 1) in participants with NSCLC and TNBC without acceptable alternative treatment options, followed by Dose Expansion (Part 2) in participants with NSCLC who have progressed on or after treatment with platinum-based chemotherapy and treatment with 1 immune checkpoint inhibitor, given concurrently or sequentially with chemotherapy. Part 1 has been completed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer, Triple-negative Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose escalation (Part 1)
Arm Type
Experimental
Arm Description
Participants with NSCLC or TNBC were enrolled at escalating dose levels s of the VBIR-2 regimen.
Arm Title
Dose Expansion (Part 2)
Arm Type
Experimental
Arm Description
Participants with metastatic NSCLC will be enrolled at the expansion dose level identified during Part 1 of the study.
Intervention Type
Biological
Intervention Name(s)
PF-06936308
Other Intervention Name(s)
Vaccine-based immunotherapy regimen-2 (VBIR-2)
Intervention Description
PF-06936308 components will be administered 4 times per cycle. A cycle is 4 months.
Primary Outcome Measure Information:
Title
To evaluate Clinical Benefit Rate (CBR)
Description
Proportion of participants who achieve complete response, partial response or stable disease for more than 6 months at 12, 24 and 36 months using RECIST 1.1. criteria.
Time Frame
Participant will have CT scans/MRI until disease progression for up to 3 years
Title
Incidence and grade of treatment-emergent adverse events including DLTs
Description
DLTs in order to determine the maximum tolerated dose
Time Frame
Baseline up to Day 29 in Cycle 1 (each cycle is 4 months)
Secondary Outcome Measure Information:
Title
Tremelimumab and sasanlimab single dose PK parameter (Cmax)
Description
Maximum observed plasma concentration of tremelimumab and sasanlimab (Cmax).
Time Frame
Pre-dose on Day 1, Day 3-6, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each cycle is 4 months); pre-dose on Day 1 and Day 29 on Cycle 2; every 5 months thereafter up to Month 22; every 6 months thereafter up to 3 years
Title
Tremelimumab and sasanlimab single dose PK parameter (Tmax)
Description
Time to maximum concentration of tremelimumab and sasanlimab (Tmax)
Time Frame
Pre-dose on Day 1, Day 3-6, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each cycle is 4 months); pre-dose on Day 1 and Day 29 on Cycle 2; every 5 months thereafter up to Month 22; every 6 months thereafter up to 3 years
Title
Tremelimumab and sasanlimab single dose PK parameter AUC
Description
Area under the curve from time zero extrapolated to infinity of tremelimumab and sasanlimab
Time Frame
Pre-dose on Day 1, Day 3-6, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each cycle is 4 months); pre-dose on Day 1 and Day 29 on Cycle 2; every 5 months thereafter up to Month 22; every 6 months thereafter up to 3 years
Title
Tremelimumab and sasanlimab after multiple doses PK parameter (Ctrough)
Description
Trough concentration after multiple doses of tremelimumab and sasanlimab (Ctrough)
Time Frame
Pre-dose on Day 1, Day 3-6, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each cycle is 4 months); pre-dose on Day 1 and Day 29 on Cycle 2; every 5 months thereafter up to Month 22; every 6 months thereafter up to 3 years
Title
Anti drug antibody (ADA) response of tremelimumab and sasanlimab after SC administration with the other components.
Description
Incidence and titers of anti-drug antibodies against tremelimumab and sasanlimab
Time Frame
Day 1, Day 29 and Day 85 on Cycle 1 (each cycle is 4 months); Day 29 on Cycle 2, every 4 months thereafter up to Month 22; every 6 months thereafter up to 3 years
Title
Objective response rate using RECIST 1.1
Description
Proportion of participants who achieve complete response or partial response.
Time Frame
Participant will have CT scans/MRI at baseline and every 8 weeks until disease progression for up to 3 years
Title
Duration of response using RECIST 1.1
Description
Median time from first response (complete or partial) until disease progression for up to 3 years in responders.
Time Frame
Participant will have CT scans/MRI at baseline and every 8 weeks until disease progression for up to 3 years
Title
Progression-free survival using RECIST 1.1
Description
Kaplan-Meier curve for progression up to 3 years.
Time Frame
Participant will have CT scans/MRI at baseline and every 8 weeks until disease progression for up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Part 1:Histological or cytological diagnosis of non-small cell lung cancer or triple-negative breast cancer. Adequate bone marrow, renal and liver function. Part 2: Histological or cytological diagnosis of metastatic non-small cell lung cancer previously treated with 1 or 2 regimens in metastatic setting including a CPI and platinum-based chemotherapy. Adequate bone marrow, renal and liver function. Exclusion Criteria: Known symptomatic brain metastases ECOG performance status greater than or equal to 2 Concurrent immunotherapy History of or active autoimmune disorders (including but not limited to: myasthenia gravis, thyroiditis, pneumonitis, rheumatoid arthritis, multiple sclerosis, systemic lupus, erythematosus, scleroderma) and other conditions that disorganize or alter the immune system. History of inflammatory bowel disease. Current use of any implanted electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators. Presence of any surgical or traumatic metal implants at the site of administration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
UCSD Medical Center - Encinitas
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Hospital)
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UC San Diego Perlman Medical Offices
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCLA Hematology/Oncology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UC San Diego Medical Center - Hillcrest
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
UCLA Hematology/Oncology - Parkside
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
UCLA Hematology/Oncology - Santa Monica
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
UCSD Medical Center - Vista
City
Vista
State/Province
California
ZIP/Postal Code
92081
Country
United States
Facility Name
H Lee Moffitt Cancer Center & Research Institute Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
The University of Chicago Medical Center, CCD - Investigational Drug Service Pharmacy
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
City
New Lenox
State/Province
Illinois
ZIP/Postal Code
60451
Country
United States
Facility Name
Orland Park - University of Chicago Center for Advanced Care
City
Orland Park
State/Province
Illinois
ZIP/Postal Code
60462
Country
United States
Facility Name
Horizon Oncology Research, LLC
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
InnerVision Advanced Medical Imaging
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
The University of Kansas Cancer Center, Investigational Drug Services
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
The University of Kansas Clinical Research Center
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
The University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Norton Cancer Institute Downtown
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Norton Cancer Institute Pharmacy, Downtown Pharmacy
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Norton Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Siteman Cancer Center - West County
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University Infusion Center Pharmacy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Siteman Cancer Center - South County
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63129
Country
United States
Facility Name
Siteman Cancer Center - St. Peters
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
The Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
University of Utah, Huntsman Cancer Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
University of Utah, Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
University of Washington Medical Center - Translational Research Unit (TRU)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C3621001
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC

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