Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC

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

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.

Study Overview

• Status: Terminated
• Conditions: Non-Small Cell Lung Cancer; Triple-negative Breast Cancer
• Intervention / Treatment: Biological: PF-06936308

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Encinitas, California, United States, 92024
      • UCSD Medical Center - Encinitas
    • La Jolla, California, United States, 92093
      • UC San Diego Moores Cancer Center
    • La Jolla, California, United States, 92037
      • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Hospital)
    • La Jolla, California, United States, 92037
      • UC San Diego Perlman Medical Offices
    • Los Angeles, California, United States, 90095
      • Ronald Reagan UCLA Medical Center
    • Los Angeles, California, United States, 90095
      • UCLA Hematology/Oncology
    • San Diego, California, United States, 92103
      • UC San Diego Medical Center - Hillcrest
    • Santa Monica, California, United States, 90404
      • UCLA Hematology/Oncology - Santa Monica
    • Santa Monica, California, United States, 90404
      • UCLA Hematology/Oncology - Parkside
    • Vista, California, United States, 92081
      • UCSD Medical Center - Vista
  • Florida
    • Tampa, Florida, United States, 33612
      • H Lee Moffitt Cancer Center & Research Institute Inc
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
    • Chicago, Illinois, United States, 60637
      • The University of Chicago Medical Center, CCD - Investigational Drug Service Pharmacy
    • New Lenox, Illinois, United States, 60451
      • University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
    • Orland Park, Illinois, United States, 60462
      • Orland Park - University of Chicago Center for Advanced Care
  • Indiana
    • Lafayette, Indiana, United States, 47905
      • Horizon Oncology Research, LLC
    • Lafayette, Indiana, United States, 47905
      • InnerVision Advanced Medical Imaging
  • Kansas
    • Fairway, Kansas, United States, 66205
      • The University of Kansas Clinical Research Center
    • Fairway, Kansas, United States, 66205
      • The University of Kansas Cancer Center, Investigational Drug Services
    • Westwood, Kansas, United States, 66205
      • The University of Kansas Cancer Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Hospital
    • Louisville, Kentucky, United States, 40202
      • Norton Cancer Institute Downtown
    • Louisville, Kentucky, United States, 40202
      • Norton Cancer Institute Pharmacy, Downtown Pharmacy
  • Missouri
    • Creve Coeur, Missouri, United States, 63141
      • Siteman Cancer Center - West County
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • Saint Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital
    • Saint Louis, Missouri, United States, 63129
      • Siteman Cancer Center - South County
    • Saint Louis, Missouri, United States, 63110
      • Washington University Infusion Center Pharmacy
    • Saint Peters, Missouri, United States, 63376
      • Siteman Cancer Center - St. Peters
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37203
      • The Sarah Cannon Research Institute
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah, Huntsman Cancer Institute
    • Salt Lake City, Utah, United States, 84112
      • University of Utah, Huntsman Cancer Hospital
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center - Translational Research Unit (TRU)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose escalation (Part 1); Participants with NSCLC or TNBC were enrolled at escalating dose levels s of the VBIR-2 regimen.	Biological: PF-06936308; PF-06936308 components will be administered 4 times per cycle. A cycle is 4 months.; Other Names: Vaccine-based immunotherapy regimen-2 (VBIR-2)
Experimental: Dose Expansion (Part 2); Participants with metastatic NSCLC will be enrolled at the expansion dose level identified during Part 1 of the study.	Biological: PF-06936308; PF-06936308 components will be administered 4 times per cycle. A cycle is 4 months.; Other Names: Vaccine-based immunotherapy regimen-2 (VBIR-2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Participant will have CT scans/MRI until disease progression for up to 3 years
Incidence and grade of treatment-emergent adverse events including DLTs	DLTs in order to determine the maximum tolerated dose	Baseline up to Day 29 in Cycle 1 (each cycle is 4 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tremelimumab and sasanlimab single dose PK parameter (Cmax)	Maximum observed plasma concentration of tremelimumab and sasanlimab (Cmax).	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
Tremelimumab and sasanlimab single dose PK parameter (Tmax)	Time to maximum concentration of tremelimumab and sasanlimab (Tmax)	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
Tremelimumab and sasanlimab single dose PK parameter AUC	Area under the curve from time zero extrapolated to infinity of tremelimumab and sasanlimab	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
Tremelimumab and sasanlimab after multiple doses PK parameter (Ctrough)	Trough concentration after multiple doses of tremelimumab and sasanlimab (Ctrough)	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
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	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
Objective response rate using RECIST 1.1	Proportion of participants who achieve complete response or partial response.	Participant will have CT scans/MRI at baseline and every 8 weeks until disease progression for up to 3 years
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.	Participant will have CT scans/MRI at baseline and every 8 weeks until disease progression for up to 3 years
Progression-free survival using RECIST 1.1	Kaplan-Meier curve for progression up to 3 years.	Participant will have CT scans/MRI at baseline and every 8 weeks until disease progression for up to 3 years

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2018
• Primary Completion (Actual): September 27, 2021
• Study Completion (Actual): September 27, 2021

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 18, 2018

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Breast Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Breast Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Triple Negative Breast Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: C3621001; VBIR-2 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No